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
As of the reply filed 2/28/2026, claims 1-4 and 6-20 are pending. Claims 7-20 have been withdrawn from consideration for being directed to unelected inventions. Claim 5 remains canceled and claims 1 and 3 have been amended.
Response to Arguments
The drawings filed 2/28/2026 overcome the previously filed drawing objection, therefore this objection is withdrawn.
Applicant’s amendments to claim 1 has overcome the previously filed claim objections and rejection under 35 U.S.C. 112(b), therefore these objections and rejection are withdrawn.
Applicant's arguments filed 2/28/2026 have been considered but are not persuasive.
With respect to Applicant’s argument that “Unlike the devices contemplated by the combination of Zajac and Picha Muthu, Applicant teaches one or more tensioning handles… [and] Applicant’s tensioning handles are not pivotally connected to one another and thus can be used individually” (see Remarks pages 8-9, underlines maintained), the Examiner respectfully disagrees that this language overcomes the Zajac and Picha Muthu combination. Claim 1 merely requires “one or more tensioning handles for cinching the syndesmosis suture construct”, presenting an open alternative limitation that encompasses multiple scenarios including one tensioning handle (as argued by Applicant), two tensioning handles, three tensioning handles, and so on. The claim does not require a singular tensioning handle, nor does it require that the tensioning handles do not share a pivotable connection to one another as argued by the Applicant. The MPEP states that “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims” (see MPEP 2145 VI., see In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993)), and since Picha Muthu et al. teaches a suture manipulation device which comprises two tensioning handles (which falls under the limitation of “one or more” as claimed), the combination as proposed reads on the language of independent claim 1.
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Zajac et al. (PGPub US 2012/0123474 A1) in view of Picha Muthu et al. (PGPub US 2011/0009899 A1), Struhl (PGPub US 2009/0182335 A1), and Norton (US PGPub 2015/0342595 A1).
With respect to claim 1, Zajac et al. discloses a syndesmosis treatment assembly (abstract, see Figs. 16-20) comprising:
a syndesmosis suture construct (see Fig. 16) for securing a first bone (90 in Figs. 17-20) against a second bone (80);
wherein during cinching (this is a functional limitation within a product claim, see MPEP 2112.01), a proximal fixator (20) seats within a proximal opening of a bone hole (opening in 90, see Figs. 19-20, 20 travels through 88 and then can be fully cinched within the opening of 90 depending on the size of the bone hole, this is a functional limitation, see MPEP 2112.01);
a pull wire (86) and a deployment suture (87) coupled with a distal fixator (10, see Figs. 16-20 and PP [0076]);
wherein a suture (30 in Fig. 16, see loop 33 in Figs. 17-20) is looped through the proximal fixator (20) and the distal fixator (10);
wherein the suture (30 in Fig. 16) comprises a splice (44a) which slidably rides on one or more portions of the suture (PP [0068]: “two adjustable eyesplices 44a, 44b that are interconnected to form one adjustable loop 33. By pulling on the free braid strands 30, the individual eyesplices constrict and, in turn, reduce the loop length of loop 33”) extending between the proximal fixator (20) and the distal fixator (10, when the suture is manipulated, the splice slides on the suture between 20 and 10 to change the suture size) wherein the splice (44a) is to be positioned inside a bone hole of a patient (see MPEP 2112.01, this is functional language, 44a is configured to be positioned inside a bone hole of a patient, see Figs. 15-17); and
wherein the suture (30 in Fig. 16) is extended from a distal opening of the bone hole (opening in 90, see Figs. 19-20) and looped through the distal fixator (10, see suture 30 extending through 10 in Fig. 16) and pulled to align a longitudinal aspect of the distal fixator (10) with the bone hole (opening in 90, see alignment in Figs. 17-20);
wherein a deployment guidewire (85 in Figs. 17-18), the pull wire (86) are to maintain the syndesmosis suture construct in an elongate configuration (see elongate configuration in Fig. 20) for being inserted into the bone hole (88) drilled into a first bone (90) and a second bone (80) of the patient.
However, Zajac et al. fails to disclose:
one or more tensioning handles cinching the syndesmosis suture construct, wherein the one or more tensioning handles comprise a generally elongate member having one or more suture grooves disposed along a length of the one or more tensioning handles wherein the elongate member [includes] a shaft extending from the distal end to a proximal gripping end;
wherein the one or more suture grooves are each configured to fixedly receive a portion of suture such that a surgeon may grasp the tension handle during pulling the suture;
a proximal deploying suture comprising an insertion assembly for implanting the syndesmosis suture construct in a patient;
wherein the proximal deploying suture is coupled with the proximal fixator;
wherein the proximal deployment suture is additionally to maintain the syndesmosis suture construct in an elongate configuration for being inserted into the bone hole drilled into a first bone and a second bone of the patient.
In the same field of suture devices (abstract), Picha Muthu et al. teaches a suture manipulation device (10 in Fig. 1A) comprising:
one or more tensioning handles (20 and 21) configured to cinch a syndesmosis suture construct (PP [0026]: “jaw members 40 and 41 comprise inward-facing gripping surfaces 42 and 43, which may comprise grooves, teeth, roughened surfaces, cutting (ablative) surfaces etc. for gripping or otherwise manipulating, e.g., tissue, or bars, loops or hooks for manipulating sutures”, the device is configured to manipulate sutures therefore it is configured to cinch a syndesmosis suture construct), wherein the one or more tensioning handles (20 and 21) comprise a generally elongate member (20 and 21 are elongate shafts) having one or more suture grooves (grooves between 42 and 43 in Fig. 1B) disposed along a length of the one or more tensioning handles (the grooves are disposed along 44 and 45 of 20 and 21) wherein the elongate member (20 and 21) [includes] a shaft (21 and 20 can each be considered shafts, therefore the elongate member includes a shaft) extending from [a] distal end (end ‘B’) to a proximal gripping end (end ‘A’);
wherein the one or more suture grooves (grooves between 42 and 43) are each configured to fixedly receive a portion of suture (PP [0026]: “jaw members 40 and 41 comprise inward-facing gripping surfaces 42 and 43, which may comprise grooves, teeth, roughened surfaces, cutting (ablative) surfaces etc. for gripping or otherwise manipulating, e.g., tissue, or bars, loops or hooks for manipulating sutures”) such that a surgeon may grasp the tension handle during pulling the suture (the user may grasp 25 and 26 of 20 and 21 while pulling a suture).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the assembly disclosed by Zajac et al. to further include the tensioning handle as taught by the Picha Muthu et al. reference. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have been a combination of prior art elements (the suture manipulator of Picha Muthu et al. with the syndesmosis assembly of Zajac et al.) that would have yielded predictable results, since each element merely performs the same function as it does separately (the suture manipulator of Picha Muthu et al. would be used to manipulate and cinch the sutures of Zajac et al.) and the only difference between the invention as presently claimed and the prior art is the lack of actual combination of these elements in a single prior art reference (see MPEP 2143 A.).
However, Zajac et al. as modified by Picha Muthu et al. further fails to disclose a proximal deploying suture comprising an insertion assembly for implanting the syndesmosis suture construct in a patient;
wherein the proximal deploying suture is coupled with the proximal fixator;
wherein the proximal deployment suture is additionally to maintain the syndesmosis suture construct in an elongate configuration for being inserted into the bone hole drilled into a first bone and a second bone of the patient.
In the same field of suture fastener devices (abstract), Struhl teaches a suture construct (see Figs. 7-8) comprising a proximal fixator (252b) and a distal fixator (252a), and further including:
a proximal deploying suture (210) comprising an insertion assembly for implanting the syndesmosis suture construct in a patient (PP [0037]: “by pulling the sutures 210, 212 on the fastener body 252b upward, the fastener body 252a assumes a horizontal position in FIG. 10 to lock onto the underside of the coracoid 12”, these extra sutures 210 and 212 enable implantation by allowing repositioning of the proximal fixator 252b);
wherein the proximal deploying suture (210) is coupled with the proximal fixator (252b);
wherein the proximal deployment suture (210) is additionally to maintain the syndesmosis suture construct in an elongate configuration for being inserted into the bone hole drilled into a first bone and a second bone of the patient (see Figs. 11-12 and PP [0037-0038], this suture provides a way of tensioning the construct to situate it as desired within a bone hole).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the Zajac et al. and Picha Muthu et al. combination to incorporate the teachings of Struhl and include the proximal deployment suture as claimed. One of ordinary skill in the art would have been motivated to perform this modification in order to easily alter the orientation of the proximal fixator and the distal fixator such that they can be seated in their proper places (see Struhl PP [0037-0038]).
Zajac et al. as modified by Picha Muthu et al. and Struhl further fails to disclose a sleeve and a pushrod configured to facilitate inserting the syndesmosis suture construct into the patient wherein the syndesmosis suture construct and the pushrod are retained within the sleeve during inserting the syndesmosis suture construct to the patient.
In the same field of deploying suture anchors into a bone tunnel (abstract), Norton teaches a delivery tool (150 in Figs. 2B-C) comprising a sleeve (162) and a pushrod (166) configured to facilitate inserting the suture anchor into the patient (see Fig. 9C with unmarked suture assembly, see also 10 in Fig. 1) wherein the suture anchor (unmarked suture assembly in Fig. 7C, see anchor 14) and the pushrod (166) are retained within the sleeve (162) during inserting the suture anchor to the patient (see Figs. 7C and 8C).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Zajac et al., Picha Muthu et al., and Struhl to further incorporate the teachings of Norton and include the sleeve and pushrod for facilitating insertion of the syndesmosis construct. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have involved applying a known technique (the use of a sheath/pushrod delivery tool as taught by Norton to deploy a suture anchor construct within a bone hole) to improve similar devices (the combination of Zajac et al., Picha Muthu et al., and Struhl as proposed) in the same way. Furthermore, incorporating the delivery tool of Norton would promote alignment of the suture anchor within the bone hole, thus preventing damage should the anchor become misaligned upon insertion (see PP [0004] of Norton).
Regarding claim 2, Zajac et al. as modified by Picha Muthu et al., Struhl, and Norton further discloses wherein the insertion assembly includes the deployment guidewire (85 in Figs. 17-18 of Zajac et al.) and a proximal deployment suture (210 in Figs. 11-12 of Struhl, these two components, when combined, can be considered part of an insertion assembly because they facilitate the insertion and placement of the suture construct and fixators).
Regarding claim 3, Zajac et al. as modified by Picha Muthu et al., Struhl, and Norton further discloses wherein the deployment guidewire (85 in Figs. 17-18 of Zajac et al.) is a generally elongate member that includes a sharpened distal end (PP [0076]: “A long straight needle 85”) suitable for being passed through the bone hole (88) drilled into the first bone (90) and the second bone (80) of a patient (see Figs. 17-18, 85 is passed through 88).
Regarding claim 4, Zajac et al. as modified by Picha Muthu et al., Struhl, and Norton further discloses wherein the pull wire (86 in Figs. 17-20 of Zajac et al.) is attached to a proximal end of the deployment guidewire (85) and coupled with the distal fixator (10) comprising the syndesmosis suture construct (see Fig. 18, 86 couples to 10 via 20 and 33).
Regarding claim 6, Zajac et al. as modified by Picha Muthu et al., Struhl, and Norton further discloses wherein the deployment suture (87 in Figs. 17-20 of Zajac et al.) is configured to enable a surgeon to cause the distal fixator (10) of the syndesmosis suture construct to contact a far cortex of the second bone (80, this is functional language, see MPEP 2112.01, 87 is capable of being adjusted or pulled on such that 10 contacts a far cortex of bone 80).
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 Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached on (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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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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