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
The amendment filed October 6, 2025 has been entered. Claims 1-2 and 4-17 are currently pending.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan et al. (US 2018/0249998, hereinafter “Chavan”) in view of Stone et al. (US 2006/0190042, hereinafter “Stone”).
Regarding claim 1, Chavan discloses the invention substantially as claimed including a suture button insertion method comprising (button‐suture assembly 100, paragraph 0033 and 0055):
forming a bone hole through a first bone and a second bone (holes in multiple bones described in paragraph 0037);
inserting, via a button inserter (button inserter/flipper 700, paragraph 0055), a suture button (base plate 110; paragraph 0033 and 0042) through the bone hole such that the suture button exits on the other side of the bone hole (figure 19E paragraph 0055),
wherein the button inserter includes a shaft (interpreted as the main body 701; paragraph 0055 figure 19B) having an insertion tip (tip 703, paragraph 0055 figure 19A), a pusher rod within the shaft ( interpreted as the inner shaft/flipper 705 as this functions as a pusher rod/flipper, annotated figure 19E below and paragraph 0055), and a trigger (push button 707, paragraph 0055), wherein activating the trigger causes the pusher rod to translate within the shaft (“The button inserter/flipper 700 depicted in FIGS. 19A-19B is comprised of a main body 701, compression spring 702, tip 703 push button 707, spring plunger 704, and inner shaft/flipper 705. The button/inserter flipper 700 inserts the button-suture assembly 100 through a bone bore and flips it behind the distal cortex in a forward motion. The button suture assembly 100 is loaded into the tip 703 of the instrument and existing sutures 102 are passed along the lengthwise groove and lightly tensioned to facilitate passing through the hole 708. The button inserter/flipper 700 is then inserted into the drilled hole 708. When the button 101 is past the distal cortex, it is flipped by simultaneously applying tension on the sutures 102 and pushing the proximal push button 707 fully as shown in FIG. 19E. The button 101 may provide tactile feedback when fully pressed by means of spring plunger 704. While button/inserter flippers 700 known in the art flip the button in a retrograde motion, the tension is actually maintained in the button-suture assembly 100 and allows for forward actuation of the button 101. The button inserter/flipper 700 is then withdrawn from the hole 708, leaving a flipped button 101 on the distal bone surface.” Paragraph 0055),
wherein the suture button includes: an opening (111 or 112) for receiving a suture (120), wherein the opening is located on a support (examiner interpreted region of 110 annotated in figure 1 below), a first wing extending from the support (annotated figure 1 below), and a second wing extending from the support directly opposite the first wing (annotated figure 1 below), wherein the second wing includes a chamfered end (merriam-webster.com defines chamfer as “a beveled edge”; interpreted chamfered end shown in annotated figure 19E close-up below), wherein suture is positioned through the single opening and on a side of the button inserter (seen in figures 19C and 19D), wherein the second wing is positioned within a slot of the insertion tip during insertion, the chamfered end facing towards the side of the button inserter with the suture and the first wing remaining outside of and extending away from the insertion tip (Figure 1 for first and second wing and annotated figure 19E below for position); and
deploying the suture button from the button inserter, thereby causing the suture button to rotate towards the side of the button inserter with the suture (paragraph 0055 and figures 19A-19E), wherein deploying the suture button includes activating the trigger thereby causing the pusher rod to force the suture button out of the insertion tip (paragraph 0055), wherein the second wing comprises a fixed end connected to the support and a free end opposite the fixed end, wherein the free end of the second wing comprises the chamfered end of the suture button (annotated figure 1 below), wherein the chamfered end of the suture button includes a near edge and a far edge relative to the pusher rod, and wherein the pusher rod contacts the near edge as the pusher rod forces the suture button out of the insertion tip (annotated figure 1 and 19E below).
[AltContent: textbox (Free end of second wing)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Chamfer (shown bevel or curvature))][AltContent: connector][AltContent: rect][AltContent: rect][AltContent: arrow][AltContent: textbox (Support)][AltContent: connector][AltContent: textbox (First wing)][AltContent: connector][AltContent: rect]
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However, Chavan fails to disclose the suture button includes a single opening for receiving a suture. Stone discloses a similar suture button insertion method (Figs 24-28 using a button inserter (150; Figs 21-22) and suture button (102). The button inserter includes a shaft (156) having an insertion tip (160), a pusher rod (162) within the shaft, and a trigger (164), wherein activating the trigger causes the pusher rod to translate within the shaft (para [0054, 0057]). The suture button (102) includes: a single opening (130) for receiving suture (106), wherein the single opening is located on a support (128), a first wing (distal extension including 124) extending from the support, and a second wing (proximal extension including 122) extending from the support directly opposite the first wing, wherein the second wing includes a chamfered end (beveled ends) (see annotated Fig 2 below; para [0050]), wherein the suture (106) is positioned through the single opening and on a side of the button inserter (Figs 5, 19), wherein the second wing is positioned within the insertion tip during insertion such that the chamfered end is facing towards the side of the button inserter with the suture (Figs 19, 23); and deploying the suture button from the button inserter, thereby causing the suture button to rotate towards the side of the button inserter with the suture (Fig 24), wherein deploying the suture button includes activating the trigger (164) thereby causing the pusher rod to force the suture button out of the insertion tip (para [0054]), wherein the second wing comprises a fixed end connected to the support and a free end opposite the fixed end, wherein the free end of the second wing comprises the chamfered end of the suture button (see annotated Fig 2 below).
[AltContent: textbox (Single opening)][AltContent: textbox (Support)][AltContent: arrow][AltContent: rect]
[AltContent: connector][AltContent: arrow][AltContent: textbox (Far edge)][AltContent: textbox (Near edge)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Fixed end)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (2nd wing)][AltContent: textbox (1st wing)][AltContent: arrow][AltContent: rect][AltContent: rect]
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chavan such that the suture button comprised a single opening for receiving the suture, as taught by Stone, or to replace the suture button of Chavan with the suture button comprising a single opening of Stone, since substitution of one known element (button having multiple openings for a suture as taught by Chavan) for another element (button having a single opening for receiving a suture as taught by Stone) providing the same function to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Claim 2. Chavan teaches the suture button insertion method of the claim 1 rejection above. Chavan continues to teach wherein activating the trigger causes an end of the pusher rod to translate exterior to the insertion tip (which would occur when the button is pushed out by the pusher rod as there are side openings at the tip 703, best seen in figure 19C and 19D, wherein the pusher rod 705 would be exposed to space/body fluid/air outside of the tip when the pusher rod is pushed all the way up, such as in figure 19E and would be exterior to the insertion tip; paragraph 0055, 19C-19D).
Claim 17. Chavan teaches the suture button insertion method of the claim 1 rejection above. Chavan continues to teach wherein positioning the second wing of the suture button within the insertion tip such that the chamfered end is facing towards the side of the button inserter facilitates the suture button to rotate towards the side of the button inserter (the slope of the chamfered end on the near side allows for the button’s end to lean towards the side of the button inserter best seen in the middle portion of figure 19E; paragraph 0055 figure 19E).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan (US 20180249998) and Stone (US 2006/0190042), as applied to claim 1 above, and further in view of Armacost et al. (US 20180318097, herein after “Armacost”).
Claim 4. Chavan and Stone teach the suture button insertion method of the claim 1 rejection above. Chavan does not teach the methods further comprise determining a desired positioning of the suture button via radiographic imaging prior to deploying the suture button. In a similar field of endeavor of implantation of button-suture systems (paragraph 0052), Armacost teaches a surgeon can check the trajectory of a syndesmosis hole by checking with x-ray imaging prior to inserting the implant and re-drill if the trajectory needs to be changed if needed based on the imaging (paragraph 0050). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify the combination of Chavan and Stone with the teachings of x-ray imaging prior to implantation of Armacost in order to check if the trajectory of the hole is proper for implantation of the button-suture system.
Claim(s) 5-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan (US 2018/0249998) and Stone (US 2006/0190042), as applied to claim 1 above, and further in view of Earhart et al. (US 2018/0085110, hereinafter “Earhart”). Chavan and Stone teach the suture button insertion method of the claim 1 rejection above. Chavan teaches wherein the suture button is a first suture button (110) and further teaches a second suture button (101) connected to the first suture button via the suture (120) (Fig 1). Chavan does not teach the methods wherein the method further comprises loading a second suture button on the button inserter by holding the second suture button against a button post of the button inserter as claimed.
In a similar field of endeavor of button/anchor-suture assemblies for bone implantation (paragraphs 0001), Earhart discloses the combination of first (12) and second (24) suture buttons, wherein the second suture button is coupled to the first suture button via the suture (22) (paragraph 0032-33, see figure 3). The method further comprises loading the second suture button (24) on the button inserter by holding the second suture button (24) against a button post (arms 44) of the button inserter and wrapping the suture (22) around a suture bollard (20) of the suture inserter (paragraphs 0029, 0032; Figs 3-4), wherein the button post of the button inserter comprises a first post and a second post spaced apart from the first post (pair of arms 44) (paragraph 0029), wherein holding the second suture button against the button post of the button inserter comprises placing a pulley peg of the second suture button in a space (groove 38) between the first post and the second post (paragraph 0029, Fig 4) and securing the suture by the pulley peg of the second suture button; and pulling a free end of the suture through an opening of a head of the second suture button (paragraphs 0028, 00032). The method further comprises deploying the second suture button (24) by translating the button inserter away from the first bone and/or the second bone after the first suture button is deployed, removing the button inserter from the bone hole, and tensioning the suture so that the suture is tensioned between the first suture button and the second suture button thereby causing the first suture button to contact the second bone and the second suture button to contact the first bone (paragraphs 0035-0036). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Chavan to include loading a second suture button connected to the first suture button by the suture onto the button inserter, as taught by Earhart, for the purpose of using a single insertion tool to deliver a first button to a first target location and a second button to a second target location along a side of the bone to secure adjacent tissue together.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan (US 2018/0249998) and Stone (US 2006/0190042), as applied to claim 1 above, and further in view of Thornes (US 2003/0236555, herein after “Thornes”).
Chavan and Stone teach the suture button insertion method of the claim 1 rejection above. Chavan continues to teach wherein a gap is formed between the second wing of the suture button and the insertion tip when the second wing is fully inserted within the insertion tip (best seen in the first of three diagrams of figure 19E as the gap is interpreted to be the distance between the distal end of the second wing and the very distal end of the insertion tip). Chavan is silent to wherein the method comprises using the gap to determine how far the button inserter needs to be inserted through the bone hole via radiographic imaging prior to deploying the suture button. In a similar field of endeavor of bone fixation buttons, Thornes teaches the progress of the button may be followed intra-operatively using an x-ray image intensifier (paragraph 0047). Therefore, it would have been obvious one of ordinary skill in the art before the effective filing date of the invention to modify the combined methods with Thornes’ teachings of using an x-ray image intensifier during the procedure in order to monitor the progress of the button, gap, and bone hole before deployment to confirm proper positioning.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2 and 4-17 filed October 6, 2025 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.
It is noted Applicant’s arguments filed December 20, 2024, with respect to the rejection(s) of claim(s) 1-3 and 17 under 35 USC 102(a)(2) as being anticipated by Chavan (US 2018/0249998) were persuasive, as noted in the April 10, 2025 Office Action. Chavan fails to disclose the suture button includes a single opening as recited. However, upon further consideration, a new ground(s) of rejection is made in view of Chavan in combination with Stone (US 2006/0190042) to modify the suture button to have a single opening.
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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771