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`Attorney Docket
`
`Number
`GAY—102
`First Named Inventor
`
`
`DESIGN
`K. MONTGOMERY ET AL.
`
`PATENTAPPL'CAWN
`
`
`
`Application Number
`11l281,566
`(37 CFR 1'63)
`
`
`
`
`Filing Date
`11/18/2005
`Declaration
`Declaration
`
`
`Submitted
`OR
`Submitted afler Initial
`_
`
`
`With Initial
`Filing (surcharge
`Art Unit
`3733
`Filing
`(37 CFR 1.16 (e))
`Examiner Name
`
`
`
`NOT ASSIGNED
`required)
`
`I hereby declare that:
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`
`Each inventors residence. mailing address. and citizenship are as stated below next to their name.
`
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`
`
`I believe the inventor(s) named below to be the original and first inventor(s) of the subject matter which is claimed and for
`which a patent is sougmon the invention entitled:
`DEVICES, SYSTEMS AND METHODS FOR MATERIAL FIXATION
`
`D is attached hereto
`
`Application Number.
`
`and was amended on (MM/DDIYYYY) I:] (if applicable).
`
`I hereby state that I have reviewed and understand the contents of the above identified specification. including the claims, as
`amended by any amendment specifically referred to above.
`
`
`(Title of the Invention)
`the specification of which
`
`
`
` OR
`
`
`was filed on (MM/DD/YYYY)
`as United States Application Number or PCT International
`
`
`
`
`
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`
`I acknowledge the duty to disclose information which is material to patentability as defined in 37 CFR 1.56, including for
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`DEVICES, SYSTEMS AND METHODS FOR MATERIAL FIXATION
`
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`Application Data Sheet
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`A2187app.pdf
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`2263336
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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number A-2187con
`
`.
`.
`Application Number
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`
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`
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`Title of Invention
`
`DEVICES, SYSTEMS AND METHODS FOR MATERIAL FIXATION
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
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`Secrecy Order 37 CFR 5.2
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`Applicant Information:
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`62 East Broadway
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`APPLICATION FOR UNITED STATES LETTERS PATENT
`
`KENNETH D. MONTGOMERY
`
`SIDNEY D. FLEISCHMAN
`
`JAMES G. WHAYNE
`
`KEVIN L. OHASHI
`
`NICANOR DOMINGO
`
`JOHN WRIGHT
`
`DEREK J. HARPER
`
`HEBER CROCKETT
`
`for
`
`DEVICES, SYSTEMS AND METHODS FOR MATERIAL FIXATION
`
`MOAZZAM & LATIMER LLP
`
`1474 North Point Village Center #320
`Reston, Virginia 20194-1190
`(703) 542-7813
`
`Attorney Docket No.: GAY-102
`
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`DEVICES, SYSTEMS AND METHODS FOR MATERIAL FIXATION
`
`_
`
`[0001]
`
`This US. Utility Patent Application claims priority to U.S. Provisional
`
`Patent Application Serial No. 60/628,774, filed November 18, 2004, and U.S.
`
`Provisional Patent Application Serial No. 60/671 ,510, filed April 15, 2005, the
`
`contents of each of which are hereby incorporated by reference in their entirety
`
`into this disclosure.
`
`BACKGROUND OF THE INVENTION
`
`‘ Field of the Invention
`
`[0002]
`
`The present invention relates generally to devices, systems and
`
`methods for material fixation. More specifically, the present invention relates to a
`
`technique that can be used to firmly hold a soft tissue or graft against bone tissue
`
`within a bone tunnel.
`
`Background of the Invention
`
`[0003]
`
`One of the most common needs in orthopedic surgery is the fixation of
`
`tendon to bone. The fixation of diseased tendons into a modified position is
`
`called tenodesis and is commonly required in patients with injury to the long head
`
`of the biceps tendon in the shoulder.
`
`In addition, tendons which are torn from
`
`their insertion site into bone also frequently require repair. This includes distal
`
`biceps tendon tears, rotator cuff tears, and torn flexor tendons in the hand.
`
`Tendons are also frequently used in the reconstruction of unstable joints.
`
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`Common examples include anterior cruciate ligament and collateral ligament
`
`reconstructions of the knee, medial and lateral elbow collateral ligament
`
`reconstructions, ankle collateral ligament reconstruction, finger and hand
`
`collateral ligament reconstructions and the like.
`
`[0004]
`
`Traditional techniques that are used to fix tendon to bone suffer from a
`
`number of limitations as a result of the methodology used, including the use of a
`
`“keyhole” tenodesis, pull-out sutures, bone tunnels, and interference screw
`
`fixation. The “keyhole” tenodesis requires the creation of a bone tunnel in the
`
`shape of a keyhole, which allows a knotted tendon to be inserted into the upper
`
`portion, and subsequently wedged into the lower narrower portion of the tunnel
`
`where inherent traction on the tendon holds it in place. This technique is
`
`challenging as it is often difficult to sculpt the keyhole site and insert the tendon
`
`into the tunnel.
`
`In addition, if the tendon knot unravels in the postoperative
`
`period, the tendon will slide out of the keyhole, losing fixation.
`
`[0005]
`
`Another traditional form of tendon fixation is the use of the “pull—out
`
`stitch.” With this technique, sutures attached to the tendon end are passed
`
`through bone tunnels