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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/20/2026 has been entered.
Response to Arguments
Regarding the previous claim objection of claim 12, the amendment is acknowledged and the objection is withdrawn.
Regarding the previous 112(d) rejection of claims 10 and 11, the previous amendments to claims 8 and 12 are acknowledged. The inclusion of “suitable for implantation into the bone hole” in claim 10 is sufficient to overcome the 112(d) rejection by further defining functional aspects of the limitation. The 112(d) rejection of claim 11 is also withdrawn. However, upon further consideration, claim 11 is rejected under 112(a) since the limitation is not a duplication of a limitation previously recited in claim 8 and the written description does not have support for the push rod comprising an additional “a generally elongate member including a shaft extending from a distal end to a proximal gripping end”.
Applicant’s arguments, see pages 4-5, filed 07/20/2026, with respect to the rejection(s) of claim(s) 8 under Zajac in view of Bonutti and Lin have been fully considered and are persuasive. The examiner agrees that modified Zajac fails to disclose “one or more tensioning handles for 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 more tensioning handles wherein the elongate member includes a shaft extending from a distal end to a proximal gripping end”. Therefore, the rejection has been withdrawn. However, upon further consideration, a 112(a) rejection is made for lack of support in the written description.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 20: “the gripping end” should recite “the proximal gripping end”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8 and 10-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 recites the limitation “one or more tensioning handles for 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 more tensioning handles wherein the elongate member includes a shaft extending from a distal end to a proximal gripping end”. The language in the limitation is not found anywhere in the written description. The written description does discuss cinching the syndesmosis suture construct by way of tensioning suture ends 124, 128 of the syndesmosis suture construct by a practitioner. Para. 0034 of the instant application states “The opposite suture ends 124, 128 extending from the proximal fixator 112 facilitate a practitioner, such as a surgeon, pulling on the suture 120 to place the syndesmosis suture construct 104 into a cinched configuration suitable for pressing bones together.”. The suture ends 124, 128 are not described in the written description as “one or more tensioning handles” and does not describe nor show in the drawings having “one or more suture grooves” disposed along its length. Structurally, para. 0034 of the specification recites “a suture 120 is looped through the proximal fixator 112 and the distal fixator 116 such that opposite suture ends 124, 128 extend from the proximal fixator 112” and does not further define any other structural language in regards to the suture ends. Therefore, the written description does have support for one or more suture ends for cinching the syndesmosis suture construct (see last two lines of claim 8: “wherein opposite suture ends of the suture extend from the proximal fixator and facilitate placing the syndesmosis suture construct into a cinched configuration”). The written description does not have support for “one or more tensioning handles for 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 more tensioning handles wherein the elongate member includes a shaft extending from a distal end to a proximal gripping end” as claimed.
Claim 11 recites the limitation “wherein the push rod comprises a generally elongate member including a shaft extending from a distal end to a proximal gripping end”. Claim 8 recites “wherein the push rod comprises an elongate member including a shaft extending from a distal end to a proximal gripping end”. As stated in the remarks filed 07/20/2026, the limitation of claim 11 according to applicant is not a matter of duplication of parts. Therefore, the limitation of claim 11 recites that the push rod comprises an additional “generally elongate member”. The written description describes the push rod as “The push rod 140 is a generally elongate member including a shaft 152 extending from a distal end 156 to a proximal gripping end 160” in para. 0037. Fig. 4 further illustrates the push rod as described in the written description. However, the push rod is not further described to have an additional elongate member as claimed in claim 11. Therefore, the written description does have support for the push rod comprising one elongate member as recited in claim 8. The written description does not have support for an additional “generally elongate member including a shaft extending from a distal end to a proximal gripping end” as claimed.
Claims 10 and 12 are rejected based on their dependency to rejected claims 8 and 11, as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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