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 .
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Protogirou (US Patent No. 6224600 B1).
Regarding Claim 1, Protogirou discloses an apparatus for bone fixation (Fig. 1), comprising: a nail (2+7+6+3) comprising a proximal end (at 2 in Fig. 1) and a distal end (at 5 in Fig. 1); a suture lock (2) disposed at the proximal end of the nail (fig. 1); a tightening device (10+11, col. 5; ln. 1-7); and a suture (1) extending at least between the suture lock and the tightening device (Fig. 1).
Regarding Claim 2, the nail comprises an internal channel (see dotted lines in components shown in Fig. 5-10 showing that parts are hollow to receive element 1), and wherein the suture (1) is disposed within the internal channel (Fig. 1).
Regarding Claim 3, the tightening device (10+11) when actuated is configured to pull the suture in a distal direction within the internal channel thereby transitioning the suture lock from an unlocked position to a locked position (col. 5; ln 1-12).
Claim(s) 1-3, 5-15, 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wales et al. (US Patent No. 11471199 B2).
(First Interpretation) Regarding Claim 1, Wales discloses an apparatus for bone fixation (Fig. 8), comprising: a nail (610) comprising a proximal end (at 750 in Fig. 8) and a distal end (at 640 in Fig. 8); a suture lock (750) disposed at the proximal end of the nail (fig. 8); a tightening device (690+700); and a suture (680) extending at least between the suture lock (750) and the tightening device (690+700) (Fig. 8).
(First Interpretation) Regarding Claim 2, the nail comprises an internal channel (630), and wherein the suture (680) is disposed within the internal channel (Fig. 8).
(First Interpretation) Regarding Claim 3, the tightening device (690+700) when actuated is configured to pull the suture in a distal direction within the internal channel thereby transitioning the suture lock (750) from an unlocked position to a locked position (col. 18; ln. 5-45).
(First Interpretation) Regarding Claim 6, the suture lock (750) is disposed within the internal channel in the unlocked and locked positions (element 750 is in the channel 630 in both positions shown in Fig. 8), and wherein transitioning the suture lock from the unlocked position to the locked position forces a nail wall of the nail radially outward (col. 17;ln. 46-62).
(First Interpretation) Regarding Claim 7, the locked position of the suture lock (750) comprises a compressed state of the unlocked position (suture lock 750 is pulled inwards compressing the device’s length when in the locked position, col. 17; ln 46-62).
(Second Interpretation) Regarding Claim 1, Wales discloses an apparatus for bone fixation (Fig. 8), comprising: a nail (portion shown below) comprising a proximal end (end towards side 750 in Fig. 8) and a distal end (end towards side 640 in Fig. 8); a suture lock (shown below, elements 750+670) disposed at the proximal end of the nail (fig. 8); a tightening device (690+700); and a suture (680) extending at least between the suture lock (750+670) and the tightening device (690+700) (Fig. 8).
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(Second Interpretation) Regarding Claim 2, the nail comprises an internal channel (630), and wherein the suture (680) is disposed within the internal channel (Fig. 8).
(Second Interpretation) Regarding Claim 3, the tightening device (690+700) when actuated is configured to pull the suture in a distal direction within the internal channel thereby transitioning the suture lock (750+670) from an unlocked position to a locked position (col. 18; ln. 5-45).
(Second Interpretation) Regarding Claim 5, the suture lock is external to the nail in the unlocked and locked positions (shown in the figure above, the lock structure is separate and external to the nail structure).
(Second Interpretation) Regarding Claim 8, an outer diameter of the suture lock (portion 670) is greater in the locked position (shown as dotted line in Fig. 8) compared to the unlocked position (shown as solid line in Fig. 8) (col. 18; ln. 5-45).
(Second Interpretation) Regarding Claim 9, the suture lock (750+670) comprises a semi-rigid device configured to expand and secure itself into a bone when transitioned from the unlocked position to the locked position(col. 18; ln. 5-45).
(Second Interpretation) Regarding Claim 10, the internal channel has an internal recess configured to house an end of the suture (760) (Fig. 8), and wherein the internal recess surrounds the tightening device (shown below).
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(Second Interpretation) Regarding Claim 11, the end of the suture (760) wraps around the tightening device (690+700) in the internal recess when the suture lock is in the locked position (the knot 700 would require the end 760 of the suture to be wrapped around it in order to form the knot structure) (col. 18; ln. 5-45)..
(Second Interpretation) Regarding Claim 12, the tightening device comprises a locking device (knot 700 is a locking device), and wherein the suture is disposed within the internal channel and further extends at least between and beyond the locking device and the distal end of the nail (shown below).
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(Second Interpretation) Regarding Claim 13, the locking device is configured to prevent the suture from moving proximally within the internal channel (knot is tightened to prevent suture from moving) thereby preventing the suture lock from transitioning from a locked position to an unlocked position (col. 18; ln. 5-45).
Regarding Claim 14, Wales discloses a method for bone fixation, the method comprising: delivering an apparatus (600) into a first bone (col. 17; ln. 26-67), wherein the apparatus comprises: a nail (see figure below) comprising a proximal end (end towards 750 in Fig. 8) and a distal end (at 640 in Fig. 8), and an internal channel (630) (Fig. 8); a suture lock (750+670) disposed at the proximal end of the nail; a tightening device (690+700); and a suture (680) disposed within the internal channel and extending at least between the suture lock and the tightening device (Fig. 8); and securing the apparatus proximally within the first bone by actuating the tightening device thereby pulling the suture in a distal direction within the internal channel thereby transitioning the suture lock from an unlocked position to a locked position (col. 18; ln. 5-45).
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Regarding Claim 15, the apparatus further comprises a connection at the distal end 640 where the delivery tool would engage as shown and described in Fig. 14; col. 31; ln. 20-36), and wherein delivering the apparatus into the first bone is conducted by engaging a delivery device with the connection (Fig. 14; col. 31; ln. 20-36).
Regarding Claim 17, wherein transitioning the suture lock (750+670) from the unlocked position to the locked position comprises compressing and radially expanding the suture lock (col. 18; ln. 5-45) (shown as dotted line expansion in Fig. 8).
Regarding Claim 18, Wales discloses a method for bone fixation, the method comprising: delivering an apparatus (600) into a first bone (col. 17; ln. 26-67), wherein the apparatus comprises a nail (see figure below) comprising a proximal end (end towards 750 in Fig. 8) and a distal end (at 640 in Fig. 8), and an internal channel (630) (Fig. 8); a suture lock (750+670) disposed at the proximal end of the nail; a locking device (700); and a suture (680) disposed within the internal channel and extending at least between the suture lock and the distal end of the nail (shown below); and securing the apparatus proximally within the first bone by pulling the suture in a distal direction within the internal channel (suture is pulled distally from the location attached to suture lock towards the location of the locking device) thereby transitioning the suture lock from an unlocked position to a locked position(col. 18; ln. 5-45).
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Regarding Claim 19, wherein, in the locked position, the locking device (knot 700) prevents the suture from moving proximally within the internal channel thereby preventing the suture lock from transitioning from the locked position to the unlocked position(col. 18; ln. 5-45).
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marino et al. (US Publication No. 2016/0345954 A1).
Regarding Claim 18, Marino discloses a method for bone fixation, the method comprising: delivering an apparatus (10+tool) into a first bone [0020], wherein the apparatus comprises a nail (10) comprising a proximal end (end towards 30 in Fig. 2) and a distal end (at 50 in Fig. 2), and an internal channel (central opening sutures 45 passes through in Fig. 2); a suture lock (40) disposed at the proximal end of the nail; a locking device (ratchet in the tool described in [0015 and 0085]); and a suture (45) disposed within the internal channel and extending at least between the suture lock and the distal end of the nail [0085]; and securing the apparatus proximally within the first bone by pulling the suture in a distal direction within the internal channel thereby transitioning the suture lock from an unlocked position to a locked position [0085].
Regarding Claim 20, wherein pulling the suture (45) in the distal direction comprises pulling one or more suture distal ends beyond the distal end of the nail (suture is tensioned with the tool component extending past the distal end of the nail, [0085]).
Allowable Subject Matter
Claims 4, 16 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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