Detailed Action
This is the final office action for US application number 18/125.626. Claims are evaluated as filed on April 6, 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 .
Response to Arguments
Applicant’s arguments with respect to claims 15-21 have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
Applicant's arguments filed April 6, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Boileau, Bernardoni, and Petry teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant' s argument that Bernardoni does not disclose the tensioner tip capable of use with the claimed button (Remarks p. 11-12), Examiner notes that, as detailed in the rejection below, Boileau discloses the claimed button and engagement tip while Bernardoni teaches features of the tension delivery and measurement portion of the tensioner.
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(s) 8, 10-14, 20, and 21 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 8 is/are is unclear with regards to “a second portion of the syndesmosis construct” in line 22 relative to an unrecited ‘first portion’ or the intent of reciting the suture as a second portion. Examiner is interpreting this as referring to, and suggests amending as, “a
Claim(s) 20 and 21 is/are is unclear with regards to the recitation of cleats that are in addition to the slits of claim 15. That is, paragraph 119 discloses that “In some embodiments, the cleats may comprise narrowing slits formed in the wings” and paragraph 11 discloses that “In some embodiments, the first coupler31 may comprise one or more features that are coupled to or formed in the first wing131 including, but not limited to: a first proximal shoulder or first shoulder331, a first distal shoulder333, a first proximal cleat 431, and/or a first distal cleat 531.” However, Figs. 7A-7C provide labels for cleats 431, 531, 432, and 532 with arrows directed to slits. Thus, it appears that, for the shown embodiment, the term cleats is used to refer to the slits, which does not support the recitation of slits and cleats as provided by claims 20 and 21 due to the current claim 15 amendment. Further, the ordinary meaning of the term cleat is “a strip fastened across something to give strength or hold in position;” or “a projecting piece (as on the bottom of a shoe) that furnishes a grip” (https://www.merriam-webster.com/dictionary/cleat). Thus, Examiner is interpreting the claimed cleats broadly as referring to the portion of the coupler that defines the slit and suggests amending to clarify. Further, Examiner notes that the significance of reciting multiple regions of one shown section of the structure is unclear with regards to reciting ‘wing’, ‘coupler’, and ‘cleat’, which all appear to refer to an extension/projection from the central portion of the slider with no distinction between the claim terms.
Claim(s) 10-14 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 15-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petry et al. (US 2018/0085109, hereinafter “Petry”).
As to claim 15, Petry discloses a tensioner (100) capable of use for applying tension force to a syndesmosis construct implanted relative to a syndesmosis joint of a patient (¶37 discloses use for any type of tissue including bone requiring suture attachment and appropriate tension), the tensioner comprising: a body (40) comprising: a proximal end (left end as shown in Fig. 5, Fig. 5); a distal end (right end as shown in Fig. 5, Fig. 5); and an intermediate portion (shown between proximal and distal ends in Fig. 5, Fig. 5) extending between the proximal and distal ends of the body (as defined, Fig. 5); a shaft (30, 50) comprising: a proximal end (left end as shown in Fig. 5, Fig. 5); a distal end (right end as shown in Fig. 5, Fig. 5); and a longitudinal axis (along the longest dimension of the shaft as shown in Fig. 5 as generally horizontal with a slight upward angle, Fig. 5), wherein the distal end of the shaft is capable of translatingly moving relative to the body (when handle 20 is rotated relative to 40, Figs. 1, 5, and 7) from a first proximal position closer to the body (when handle 20 is appropriately rotated relative to 40 while 22 is engaged with the threads of 40 that are shown in Fig. 5) to a second distal position further away from the body (when handle 20 is appropriately rotated relative to 40 while 22 is engaged with the threads of 40 that are shown in Fig. 5); and a slide (10) comprising: a first coupler (portion of upper wing used for coupling the suture portion 81 in Fig. 13 as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) comprising a first slit (upper slit of proximal cleat as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) facing toward a proximal end of the tensioner (Fig. 1), the first coupler capable of coupling a first flexible element of the syndesmosis (81) construct to the slide (Fig. 13); and a second coupler (portion of lower wing used for coupling the suture portion 83 in Fig. 13 as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) comprising a second slit (lower slit of proximal cleat as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) facing toward the proximal end of the tensioner (Fig. 1), the second coupler capable of coupling a second flexible element of the syndesmosis (83) construct to the slide (Fig. 13); wherein the first and second flexible elements are capable of being coupled to the slide (Fig. 13) while the distal end of the shaft is moved from the first proximal position to the second distal position (Figs. 1, 5, 7, and 13, ¶37) capable of causing a first tension force to be applied to the first flexible element (Fig. 13, ¶37) and a second tension force (Fig. 13, ¶37) to be applied to the second flexible element (Fig. 13, ¶37) and capable of causing the slide to translate distally along the body from a third proximal position relative to the body (when handle 20 is rotated relative to 40, Figs. 1, 5, 7, and 13, ¶37) to a fourth distal position relative to the body (when handle 20 is rotated relative to 40, Figs. 1, 5, 7, and 13, ¶37) in response to the first and second tension forces that are applied to the first and second flexible elements (Figs. 1, 5, 7, and 13, ¶37).
As to claim 16, Petry discloses that the slide comprises: a first wing (upper wing as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) projecting away from the slide along a first direction (up and to the right away from the portion of the slide that holds the shaft as shown in Fig. 1, Fig. 1); and a second wing (lower wing as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) projecting away from the slide along a second direction (down and to the left away from the portion of the slide that holds the shaft as shown in Fig. 1, Fig. 1).
As to claim 17, Petry discloses that the first and second directions are opposite each other (as defined, Fig. 1).
As to claim 18, Petry discloses that the first wing comprises a first shoulder (upper shoulder as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) capable of receiving at least a portion of the first flexible element thereon (if one so chooses, Fig. 13); and the second wing comprises a second shoulder (lower shoulder as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) configured to receive at least a portion of the second flexible element thereon (if one so chooses, Fig. 13).
As to claim 19, Petry discloses that the first coupler is formed on the first wing (as defined, Fig. 1); and the second coupler is formed on the second wing (as defined, Fig. 1).
As to claim 20, Petry discloses that the first coupler comprises: a first proximal cleat (upper proximal cleat as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) capable of receiving at least a first portion of the first flexible element therein (Fig. 13); and a first distal cleat (upper distal cleat as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) capable of receiving at least a second portion of the first flexible element therein (Fig. 13); and the second coupler comprises: a second proximal cleat (lower proximal cleat as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) capable of receiving at least a first portion of the second flexible element therein (Fig. 13); and a second distal cleat (lower distal cleat as interpretated in accordance with the labeling on the illustration of Fig. 1, Fig. 1) capable of receiving at least a second portion of the second flexible element therein (Fig. 13).
As to claim 21, Petry discloses that the first distal cleat is positioned distal to the first proximal cleat along the first wing of the slide (as defined, Fig. 1); and the second distal cleat is positioned distal to the second proximal cleat along the second wing of the slide (as defined, Fig. 1).
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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 of this title, 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.
Claim(s) 8 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boileau et al. (US 2014/0277185, hereinafter “Boileau”, and line drawing version of Figures in US 9,402,650) in view of Bernardoni et al. (US 2023/0218330, hereinafter “Bernardoni”)
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 8 and 10-14, Boileau discloses a tensioner system (2100, 1300, Figs. 13A-13C and 21A-21C, ¶s 183 and ; where ¶183 discloses use of tensioner 2100 with the screw button of Figs. 12-16 and ¶184 discloses that a tension measuring mechanism can be included to indicate the tensile force applied to the suture) capable of use for applying tension force to a syndesmosis construct implanted relative to a syndesmosis joint of a patient (¶s 179, 182, and 183), the tensioner system comprising: a button (1300, Figs. 13A-13C) comprising: a first recess (upper left 1332 as shown in Fig. 13B, Fig. 13B) formed through the button (Fig. 13B); a second recess (lower left 1332 as shown in Fig. 13B, Fig. 13B) formed through the button (Fig. 13B); and a ridge (left 1330 as shown in Fig. 13B, Fig. 13B) positioned intermediate the first recess and the second recess (as defined); and a tensioner (2100, Figs. 21A-21C) comprising: a body (2104) comprising: a proximal end (right end as shown in Fig. 21A, Fig. 21A); a distal end (left end as shown in Fig. 21A, Fig. 21A); and an intermediate portion (shown between proximal and distal ends in Fig. 21A, Fig. 21A) extending between the proximal and distal ends of the body (as defined, Fig. 21A); a shaft (2102) comprising: a proximal end (right end as shown in Fig. 21A, Fig. 21A); a distal end (left end as shown in Fig. 21A, Fig. 21A); and an engagement tip (2102a, Figs. 21A and 21C) located on the distal end of the shaft (as defined, Figs. 21A and 21C) shaped to engage the button (Figs. 21A and 21C, ¶183), the engagement tip comprising an engagement tip slot (space between posts 2126a, 2126b, Fig. 21C) capable of engaging the ridge of the button (Figs. 13B and 21C, ¶183); and a slide body (2106) capable of coupling with a portion of the syndesmosis construct (via 2124, Figs. 21A and 21B, ¶181); wherein the engagement tip is capable of translatingly moving relative to the body from a first proximal position closer to the body to a second distal position further away from the body (Figs. 21A-21C, ¶179), wherein the engagement tip is capable of being engaged with button (¶183) while the portion of the syndesmosis construct is coupled to the slide (¶181) and the engagement tip is moved from the first proximal position to the second distal position (¶179) to cause a tension force to be applied to the syndesmosis construct (¶182); wherein a tension measuring mechanism can be coupled to the slide body in some implementations to indicate the tensile force applied to the suture (¶184). As to claim 10, Boileau discloses that the engagement tip comprises at least one prong (2126a, 2126b) shaped to be received within at least one of the first recess and the second recess formed in the button (Figs. 13B and 21C, ¶183). As to claim 11, Boileau discloses that the at least one prong of the engagement tip comprises: a first prong (2126a) shaped to be received within the first recess formed in the button (Figs. 13B and 21C, ¶183); and a second prong (2126b)opposite the first prong (as defined, Figs. 21C), the second prong shaped to be received within the second recess formed in the first portion of the syndesmosis construct button (Figs. 13B and 21C, ¶183), the second recess opposite the first recess (as defined, Fig. 13B). As to claim 12, Boileau discloses that the engagement tip slot is positioned intermediate the first prong and the second prong (as defined, Fig. 21C). As to claim 13, Boileau discloses that the engagement tip comprises at least one angled ramp (see illustration of Fig. 21C, i.e. proximal facing surface positioned between the prongs that is shown to be sloped/beveled in Fig. 21C, Fig. 21C) shaped to guide the second portion of the syndesmosis construct during tension (due to the shown shape, Fig. 21C). As to claim 14, Boileau discloses that the engagement tip comprises: a first angled ramp (left angled ramped shown on the illustration of Fig. 21C, i.e. the left proximal facing surface positioned between the prongs that is shown to be sloped/beveled in Fig. 21C, Fig. 21C) shaped to guide a first flexible element of the syndesmosis construct during tension (due to the shown shape, Fig. 21C); and a second angled ramp (left angled ramped shown on the illustration of Fig. 21C, i.e. the right proximal facing surface positioned between the prongs that is shown to be sloped/beveled in Fig. 21C, Fig. 21C) shaped to guide a second flexible element of the syndesmosis construct during tension (due to the shown shape, Fig. 21C).
Boileau is silent to the engagement tip is translatably movable relative to the body from a first proximal position closer to the body to a second distal position further away from the body; and a slide configured to couple with a portion of the syndesmosis construct and translate distally along the body in response to tension applied to the portion of the syndesmosis construct, wherein the engagement tip is configured to be engaged with button while the second portion of the syndesmosis construct is coupled to the slide and the engagement tip is moved from the first proximal position to the second distal position to cause the slide to translate distally along the body from a third proximal position relative to the bod to a fourth distal position relative to the body in response to the tension force applied to the syndesmosis construct, i.e. Boileau is silent to the structural differences for include the tension measuring mechanism that can be included to indicate the tensile force applied to the suture of ¶184.
Bernardoni teaches a tensioner (1, Figs. 1-4, ¶58) capable of applying tension force to a syndesmosis construct implanted relative to a syndesmosis joint of a patient (¶58 discloses tensioning a surgical thread), the tensioner comprising: a body (16, 31) comprising: a proximal end (16a); a distal end (16b); and an intermediate portion (central portion as shown in Fig. 2, Fig. 2) extending between the proximal and distal ends of the body (Fig. 2); a shaft (15) comprising: a proximal end (15c, 15a); a distal end (left end of 15 as shown in Figs. 1-4, Figs. 1-4); and an engagement tip (11) located on the distal end of the shaft (Figs. 1-4) shaped to engage a first portion of the syndesmosis construct (Figs. 1-4), the engagement tip comprising an engagement tip slot (17), wherein the engagement tip is capable of translatingly moving relative to the body (Figs. 2-3, ¶81) from a first proximal position closer to the body (Fig. 3) to a second distal position further away from the body (Fig. 2); and a slide (20) capable of coupling with a second portion of the syndesmosis construct and translating distally along the body in response to tension applied to the second portion of the syndesmosis construct (Figs. 2 and 3, ¶s 62, 64, 71, and 81), wherein the engagement tip is capable of being engaged with the first portion of the syndesmosis construct while the second portion of the syndesmosis construct is coupled to the slide and the engagement tip is moved from the first proximal position to the second distal position capable of causing a tension force to be applied to the syndesmosis construct (Figs. 1-4, ¶s 62-68); the slide translates distally along the body (Figs. 2 and 3, ¶81) from a third proximal position relative to the body (Fig. 3) to a fourth distal position relative to the body (Fig. 2), in relation to an amount of tension force applied to the syndesmosis construct (Figs. 2 and 3, ¶s 81 and 87); wherein the engagement tip comprises at least one prong (14s, Figs. 1-4); wherein a tension measuring mechanism (2, 3, 15a, Figs. 1-3, ¶s 84-87) is capable of indicate the tensile force applied to the portion of the construct (Figs. 1-3, ¶s 84-87). As to claim 13, Bernardoni teaches that the engagement tip comprises at least one angled ramp (19s) shaped to guide the second portion of the syndesmosis construct during tension (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4, ¶96). As to claim 14, Bernardoni d teaches that the engagement tip comprises: a first angled ramp (upper 19 as shown in Fig. 1, Fig. 1) shaped to guide a first flexible element of the syndesmosis construct during tension (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4); and a second angled ramp (lower 19 as shown in Fig. 1, Fig. 1) shaped to guide a second flexible element of the syndesmosis construct during tension (Figs. 1-4 show the tip features shaped to be capable of achieving such a function, Figs. 1-4).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the tensioner with the broadly disclosed tension measuring mechanism as disclosed by Boileau by replacing the body and slide body and corresponding connections to the shaft and modifying the proximal end of the shaft as disclosed by Boileau with the body, slider, and corresponding structures for tensioning the suture as taught by Bernardoni in order to detect and indicate the tension value to which the thread/portion of the construct is subjected in the use of the tensioner (Bernardoni ¶86) so that the surgeon can monitor whether the tension applied to the thread is adequate in real time (Bernardoni ¶86), i.e. to provide a known tension measuring mechanism to indicate the tensile force applied to the suture of (Boileau ¶184). That is, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to replace the features of the tensioner that connect to the tip and the suture and those therebetween as disclosed by Boileau with the features of the tensioner that connect to the tip and the suture and those therebetween as taught by Bernardoni in order to detect and indicate the tension value to which the thread/portion of the construct is subjected in the use of the tensioner (Bernardoni ¶86) so that the surgeon can monitor whether the tension applied to the thread is adequate in real time (Bernardoni ¶86), i.e. to provide a known tension measuring mechanism to indicate the tensile force applied to the suture of (Boileau ¶184).
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Allowable Subject Matter
Claims 1-7 are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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