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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2025 has been entered.
Response to Arguments
Applicant argues in the response filed 11/14/2025 that the claim amendments would overcome the 112 rejections with respect to claims 24, 25, 27, 29, 30, 34. However, it is noted the 112 issues with respect to claims 25 and 34 still remain. The 112 rejections are made below.
The applicant states the previous 103 rejections and the new claim limitations. The applicant further states broadly that 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. The applicant broadly submits the rejections have been overcome.
The examiner has made 103 rejections with respect to Shurnas, (Zajac with respect to claims 27+), Gustafson, and Denham ‘928/Denham ‘693 below with respect to the amended claims.
Further objections have been made below.
Specification
The disclosure is objected to because of the following informalities: paragraph 39 should read “…without requiring the practitioner to form any surgical knots…”
Appropriate correction is required.
Claim Objections
Claim 22 is objected to because of the following informalities: lines 3-5 state “a distal fixator configured to be passed through…and contacting the second bone, wherein the distal fixator is configured to contact the second bone”. The amended new limitation, which is italicized above, seems to be redundant since the distal fixator is already configured to be passed through and bones and contacting the second bone. For clarity purposes, the limitation should be amended for example: “: a distal fixator configured to be passed through a bone hole across the first bone and the second bone , wherein the distal fixator is configured to contact the second bone”. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: line 3 should read “proximally through . Appropriate correction is required.
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.
Claims 25, 34 are 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 25 recites the limitation "a bar" in line 2. However, claim 25 is dependent off of claim 22 which also claims “a bar” of the distal fixator in line 8. It is unclear if the “a bar” of claim 25 is the same or different bar of claim 22. For examination purposes, the limitation will be interpreted to be “[[a]] the bar” referring back to the bar of claim 22. If it is a different bar, different designation should be used, for instance “a second bar”.
Claim 34 recites the limitation "a bar" in line 2. However, claim 34 is dependent off of claim 27 which also claims “a bar” of the distal fixator in line 8. It is unclear if the “a bar” of claim 34 is the same or different bar of claim 27. For examination purposes, the limitation will be interpreted to be “[[a]] the bar” referring back to the bar of claim 27. If it is a different bar, different designation should be used, for instance “a second bar”.
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 22-26 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, 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 22, Shurnas discloses a device capable for syndesmosis treatment construct for cinching a first bone and a second bone together (paragraph 12), the syndesmosis treatment construct comprising: a distal fixator (12, figure 2) configured to be passed through a bone hole (paragraph 40, 43, 44) across the first bone (4b) and the second bone (6a) and contacting the second bone wherein the distal fixator is configured to contact the second bone (figure 6c, (paragraph 40, 43, 44); a proximal fixator (11) configured to contact the first bone; a single strand suture (13, figure 2, paragraph 36, 46) that is parallelly looped 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, the suture can have two segments, which will enter the holes in the distal fixator in opposite directions and will loop around a bar which is the structure between the holes), and extend proximally through the proximal fixator (figure 2); and opposite suture ends configured to extend from the proximal fixation (figure 2, 6d), wherein pulling on the first and second segments place the syndesmosis treatment construct into a cinched configuration (paragraph 45-46), and secure the cinched configuration of the syndesmosis treatment construct by manipulating the suture ends into a surgical knot (paragraph 46) 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 the first segment and second segment and slidable rides on the first and second segments as the proximal and distal fixators are drawn closer together.
Gustafson teaches a similar device (soft tissue reconstruction, abstract) having a distal fixator (10”, figure 7a,b, paragraph 54) capable of being passed through a bone hole, having a suture looped therethrough around a bar (between 24b,c, figure 4, 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 (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), the splice configured to slidably ride on portions of the first and second segments extending between the proximal and distal fixators and 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 (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 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 can slidable ride 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 23, with the device of Shurnas, 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 24, with the device of Shurnas, 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 a bar and extends proximally through a second aperture of the distal fixator (figure 2).
As to claim 25, with the device of Shurnas, 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 the a first aperture (figure 2).
As to claim 26, with the device of Shurnas, 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).
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 includes forming a 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
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