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
Claim 22, and dependent claims 23-26 thereof, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
Claim 22 has been amended to positively recite the suture comprising a free (splice) and a stich splice. Support for the free and stitch splice can be found in paragraphs 35-39, figure 3a which is directed to Species A. The applicant elected Species B in the response filed 10/05/2022. Since claims 22-26 are directed to a species non-elect, the claims have been withdrawn.
Response to Arguments
Applicant argues in the response filed 08/12/2026/14/2025 that the claim amendments would overcome the 112 rejections with respect to claims 22, 25, 34. It is to be noted there was not a 112 rejection with respect to claim 22 in the previous office action filed 02/13/2026. However there was a claim objection. The previous claim objection has been withdrawn since the claims are withdrawn. It is be noted the claim amendment to claim 25 would not overcome the previous 112 rejection with respect to claim 25. However the claim 25 is withdrawn as stated above. The claim amendments would overcome the 112 rejection with respect to claim 34. The 112 rejection with respect to claim 34 has been withdrawn.
The applicant seems to have recited the limitations of claim 22 and argued “those skilled in the art would appreciate that looping a single strand suture through the proximal and distal fixators with the first and second segments extending in opposite directions around a bar provides both practical and technical advantages”. However there does not seem to be any arguments with respect to the prior art specifically why the amendments would overcome the prior art rejections and/or why the prior art would not be able to read on the claims of record.
It is noted the applicant does not address the new amendments with respect to “free and stich” splices with respect to claim 22 nor any statements/argument with respect to independent claim 27. The amendments to claim 22 are directed to a non-elected species and therefore claims 22-26 are withdrawn.
The examiner maintains the rejection with respect to claims 27-35 below.
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.
Claim 27-35 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2008/0177302 to Shurnas in view of U.S. Patent Publication 2015/0157449 to Gustafson, and U.S. Patent Publication 2012/01234747 to Zajac, U.S. Patent Publication 2009/0054928 to Denham (herein Denham ‘928) and/or in view of and/or as evidenced by U.S. Patent Publication 2012/0046693 to Denham (herein Denham ‘693).
As to claim 27, Shurnas discloses a method for a syndesmosis treatment construct for cinching a first bone and a second bone together (paragraph 12, the construct will be capable of reading on a syndesmosis treatment construct which will be used in a method for cinching two bones of the foot together), the syndesmosis treatment construct comprising configuring a distal fixator (12) to be passed through a bone hole across the first bone (7b) and the second bone (6a) and contacting the second bone (figure 6c-d, paragraph 44-46); configuring a proximal fixator (11) to contact the first bone; looping a single strand suture (13) through the proximal and distal fixators (figure 2), the suture having first and second segments extending through the distal fixator in opposing directions around a bar (figure 2, two different strands are looped through the distal fixator through two holes where a bar is between the holes), and extending proximally through the proximal fixator (figure 2), configuring the opposite suture ends to extend from the proximal fixator (figure 2), pulling on the first and second segments to place the syndesmosis treatment construct into a cinched configuration and wherein securing the cinched configuration of the syndesmosis treatment construct by manipulating the suture ends into a surgical knot (paragraph 44-47) but is silent about a deployment suture hole and a suture cradle disposed at opposite ends of the distal fixator, and the suture comprising a splice disposed between a first segment and a second segment of a suture configuring the splice to slidably ride on portions of the first and second segments extend between the proximal and distal fixators, and the splice rids on the first and second segments as the proximal and distal fixators are drawn closer together.
If, however, it would not be known that the method of Shurnas would be able to read on a method for a syndesmosis treatment construct, Shurnas does disclose the teachings can be used for additional applications (paragraph 54). Zajac teaches a similar suture looped through anchors device used as syndesmosis treatment construct (paragraph 7). It would have been obvious to one of ordinary skill in the art before the effective filing date to use the device of Shurnas as a syndesmosis treatment construct in a method in order for using similar devices and method to fix fracture fixations.
Gustafson teaches a similar device and method (soft tissue reconstruction, abstract) having a distal fixator (10”, figure 7a,b, paragraph 54) and a deployment suture hole (24d’’) and suture cradle (28a”) at opposite ends of the distal fixator for the purpose of providing a smooth thinner surface through which the filaments can be disposed (paragraph 54) and assisting in placement of the suture. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the distal fixator of Gustafson with the suture cradle and deployment suture holes as the distal fixator of Shurnas in order for providing an anchor with smooth thinner surfaces through which the filaments can be disposed.
Denham ‘928 teaches a similar device and method (coupling tissue using sutures, abstract) comprising a suture comprising a splice (30, any of the previously disclosed passage portions 30 as seen in figure 2a, b, 3, 4a, 5,6,7, that are usable in the embodiment of figure 26 having a single suture loop, paragraph 60) disposed between a first segment and a second segment (figure 26) of the suture, configuring the splice to slidably ride on portions of the first and second segments extending between the proximal and distal fixators, where the splice slidably rides on the first and second segments as proximal and distal fixators are drawn closer together, (paragraph 31-33, the ends are passed into and out of the splice, therefore the splice will slidably ride on the first and second segments) for the purpose of resisting reverse relative movements of the suture once it is tightened (paragraph 31). Denham ‘693 also teaches a similar device and method (coupling tissue with a suture, abstract), having a splice (figure 1-4, 10) which can slidable ride on first and segments of a suture where ends of the suture can be tied into a knot (paragraph 39, 47). Denham ‘693 can either further teach or provide evidence that a splice as taught by Denham ‘928 can be used in a system and method where the ends of the suture are tied into a knot. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use the splice of Denham ‘928 in the suture of Shurnas which slidable rides on the first and second segments of the suture as the proximal and distal fixators are drawn closer together in order for resisting reverse relative movements of the suture once it is tightened.
As to claim 28, with the device of Shurnas, Zajac, Gustafson, and Denham ‘928/Denham ‘693 above, Shurnas discloses the first and second segments are parallelly looped through the distal fixator and the first and second segments are looped in opposite directions (figure 2). The segments are parallel and are looped in opposite directions in order to have the end segments extend from the proximal fixator.
As to claim 29, with the device of Shurnas, Zajac, Gustafson, and Denham ‘928/Denham ‘693 above, Shurnas (with the distal fixator as modified by Gustafson) reads on the second segment extends distally through a first aperture of the distal fixator, loops around the bar and extends proximally through a second aperture of the distal fixator (figure 2).
As to claim 30, with the device of Shurnas, Zajac, Gustafson, and Denham ‘928/Denham ‘693 above, Shurnas (with the distal fixator as modified by Gustafson) reads on the first segment extends distally through a second aperture of the distal fixator, loops around the bar and extends proximally through a first aperture (figure 2).
As to claim 31, with the device of Shurnas, Zajac, Gustafson, and Denham ‘928/Denham ‘693 above, Shurnas discloses the looping the first and second segments in opposite direction inhibits an undesirable rotation of the distal fixator upon cinching the syndesmosis treatment construct (figure 2). The functional aspect to the undesirable rotation of the distal fixator upon cinching is functional inherent based on the structure.
As to claim 32, with the method of Shurnas, Zajac, Gustafson, and Denham ‘928/Denham ‘693 above, Shurnas discloses configuring the proximal fixator includes forming a bar (the center bar that separates the apertures as seen in figure 2) that separates a first aperture and a second aperture (figure 2).
As to claim 33, with the method of Shurnas, Zajac, Gustafson, and Denham ‘928/Denham ‘693 above, Shurnas discloses the looping the second segment around the bar before passing the second segment through the splice (figure 2).
As to claim 34, with the method of Shurnas, Zajac, Gustafson, and Denham ‘928/Denham ‘693 above, Shurnas discloses configuring the distal fixator forms the bar that separates a first aperture and a second aperture (figure 2).
As to claim 35, with the method of Shurnas, Zajac, Gustafson, and Denham ‘928/Denham ‘693 above, Shurnas discloses looping the first segment through the distal fixator includes routing the first segment around the bar in opposites to the second segment (figure 2).
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
