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 .
Information Disclosure Statement
The information disclosure statement filed 08/10/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The information disclosure statement filed 08/10/2025 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Rejections - 35 USC § 102
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 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.
Claims 15, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tipirneni et al. (U.S. Publication No.2009/0306718 A1; hereinafter “Tipirneni”).
Regarding claim 15, Tipirneni discloses a bone fixation assembly (Figure 1R) comprising: an elongate fixation member comprising: a longitudinal passageway formed through the elongate fixation member (wherein lagwire 12 resides through anchor component 2 and cap 20); a proximal portion (anchor component 2) couplable to a first bone fragment of a bone (see Figures 4A-4G); and a distal portion (cap 20) couplable to a second bone fragment of the bone to provide fixation of the second bone fragment relative to the first bone fragment (see Figures 4A-4G); a flexible tensioning element (lagwire 12 and filament 199) configured to pass through the longitudinal passageway (via lagwire 12) and form a loop that spans the first and second bone fragments to secure the elongate fixation member to the bone (see loop formed by filament 199 in Figure 1R); and a tension locking mechanism (lever clutch 300 as shown in Figure 2H) configured to lock and maintain a selected tension force applied to the flexible tensioning element (para.0101-0102), wherein: the loop spanning the first and second bone fragments spans a bone fracture intermediate the first and second bone fragments (Figures 4A-4G); and the selected tension force applied to the flexible tensioning element is locked and maintained by the tension locking mechanism to preload the bone fracture in compression to resist tensile force imparted across the bone fracture, thereby maintaining fixation of the first bone fragment relative to the second bone fragment (para.0101-0102).
Regarding claim 19, Tipirneni further discloses wherein the elongated fixation member further comprises an anchor reception chamber (see head 302 of cap 20 in Figure 2H) configured to receive at least a portion of a threaded bone anchor therein (cover 70) to provide a secondary lock that maintains the selected tension force applied to the flexible tensioning element (para.0101-0102).
Regarding claim 20, Tipirneni further discloses wherein the anchor reception chamber (302) is formed within the distal portion of the elongate fixation member (cap 20).
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Allowable Subject Matter
Claims 1-14 are allowed.
Claims 1-14 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claims 1 and 8. In particular, none of the cited references teach or suggest a bone fixation assembly comprising a first cortical fixation element configured to engage a first cortical surface on the first bone fragment adjacent the proximal portion of the elongate fixation member; a second cortical fixation element configured to engage a second cortical surface on the second bone fragment adjacent the distal portion of the elongate fixation member; and a flexible tensioning element configured to pass through the longitudinal passageway of the elongate fixation member and couple intermediate the first and second cortical fixation elements to provide a compression force therebetween, as required by independent claims 1 and 8.
Claims 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 16-18 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found to disclose, or suggest the claimed combination of limitations recited in independent claim 15. In particular, none of the cited references teach or suggest: wherein the tension locking mechanism comprises: a tension chamber formed within the elongate fixation member; a tension chamber locking surface positioned within the tension chamber; a taper bullet receivable within the tension chamber; and a taper bullet locking surface shaped to engage the tension chamber locking surface, wherein: a first end of the flexible tensioning element is configured to couple with the taper bullet; and a second end of the flexible tensioning element is configured to: exit the longitudinal passageway at a distal end of the elongate fixation member; wrap back around the first and second bone fragments to form the loop spanning the first and second bone fragments; enter back into the longitudinal passageway at a proximal end of the elongate fixation member; pass through the tension chamber formed within the elongate fixation member such that the flexible tensioning element becomes trapped between the tension chamber locking surface and the taper bullet locking surface; and exit the longitudinal passageway at the distal end of the elongate fixation member, as required by dependent claim 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vitale et al. U.S. Publication No.2020/0000505 A1
Gorsline et al. U.S. Publication No.2014/0228845 A1
Pham et al. U.S. Publication No.2011/0282346 A1
Pieske U.S. Publication No.2009/0287213 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773