ELECTRONICALLY FELED
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`IN
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` fr AND TRADEMARK O
`PA
`JINTFED
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`Tn re:
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`Patent application of
`Medical University of South Carolina
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`: Group Art Unit:
`© TBD
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`Serial No.
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`TED
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`Filed:
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`February 28, 2022
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`For:
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`Decorticating Screw
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`>: Examiner:
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`TBD
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`: Attorney Docket No.:
`206085-0059-00US
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`This Preliminary Amendmentts filed in the above referenced application. Applicant
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`respecttully requests that the arnendment be entered and considered prior to an examination on
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`the merits.
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`No fee is believed duefor the filing of this amendment. However, please charge anyfee
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`that is due, and credit any overpayment, to deposit account no. 50-5366.
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`

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`Prehirnary Amendment Dated: 2/28/2022
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`Amendments to the Specification:
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`Please amend the paragraph beginning at page 1, line 5, which starts with “This applicationis
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`entitled to”, with the following amended paragraph:
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`This application #-entHled-to-is a national stage filing of International Patent
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`Application No. PCT/U$260/485 16 file
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` d on August 28, 2020, which claim priority to US.
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`Provisional Patent Application No. 62/893,672, filed August 29, 2019, the-contente-bothof
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`which are incorporated by reference herein in-ts-entizety their entireties.
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`Page 2 of 11
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`Prehirnary Amendment Dated: 2/28/2022
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`
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`This listing of claims will replace all prior versions, andlistings, of claims in the application:
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`Listing of Clams:
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`1.
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`(Original) A decorticating screwdevice, comprising:
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`a substantially cylindrical body, the body having a distal threaded section,
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`a proximal threaded section, a central ring having one or more decorticating elements.
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`2.
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`(Original} The device of claim 1, wherein the screwdevice further
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`coniprises a lumen running between a proximal opening and a distal opening.
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`3.
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`(Original) Phe device of claim 2, wherein the screw device further
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`comprises a cap having a threaded lumen sizedto fit over the proximal threaded section of the
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`body and a proximal lip having a diameter greater than a diameter of the cap.
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`4.
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`(Original) The device of claim 3, wherein the central ring is
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`independently rotatable from the threaded distal section.
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`5.
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`(Original) The device of claim 4, wherein the screw device further
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`comprises one or more lateral openings fluidly connected to the lumen.
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`6.
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`(Original) The device of claim 1, wherein the screwdevice comprises one
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`or more cutting flutes at a distal end.
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`7.
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`(Original) The device of claim 1, wherein the screw device comprises one
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`or more pointed tips at a distal end.
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`3.
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`(Original) Phe device of claim 1, wherein the proximal threaded section
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`comprises a threading selected from the group consisting of: knuckle threads, trapezoidal
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`threads, square threads, and buttress threads.
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`Page 3 of 11
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`Prehirnary Amendment Dated: 2/28/2022
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`9.
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`(Original) Phe device of claim 1, wherein the proximal threaded section
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`comprises a rounded or tapered proximal end.
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`10.
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`(Currently Amended) The device of claim 1, wherein the central ring is
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`attached to the proximal threaded section, such that the central ring and proximal threaded
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`section are independently rotatable from the threaded distal threaded section.
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`ll.
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`(Original) The device of claim 1, wherein the central ring is movable in
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`proximal and distal directions to increase the reach of the one or more decorticating elements.
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`12.
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`(Original) The device of claim 1, wherein the screw device comprises two
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`or more external slots formed between the distal threaded section, the central ring, and the one or
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`more decorticating elements, such that cach external slot is sized to receive a pin of a screw
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`driving device.
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`13.
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`(Original} The device of claim 1, wherein the one or more decorticating
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`elements each comprise one or more surface voids configured to accept graft material ortissue
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`ingrowth.
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`14.
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`(Currently Amended) The device of claim [[11]3, wherein the cap
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`comprises one or more surface voids configured to accept graft material or tissue ingrowth.
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`13.
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`(Currently Amended) The device of claim [[1]]3, wherein the cap
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`comprises a thread-locking insert positioned at a proximal end of the threaded himen.
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`16.
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`(Currently Amended} The device of claim [[1]]3, wherein the cap lip
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`comprises a distal-facing surface having a rounded convex shape.
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`17,
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`(Currently Amended) The device of claim [711]3, wherein the cap
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`comprises a locking nut in alignment with the threaded lumen ofthe cap, the locking nut being
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`connected to the cap by one or more connecting bridges configured to break with an application
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`of a torque on the locking nut.
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`Page 4 of 11
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`

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`Prehirnary Amendment Dated: 2/28/2022
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`18.
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`(Original) The device of claim 1, wherein the one or more decorticating
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`elements are moveable between a closed position and an open position.
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`19.
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`(Currently Amended) The device of claim 18, wherein the closed position
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`positions the decorticating elements adjacent to the central ring such that they have a diameter
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`substantially equal to a diameter of the distalthreaded distal-section, and wherein the open
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`position positions the decorticating elements away from the central ring such that the
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`decorticating elements extend beyond the diameter of the distal threaded distal-section.
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`20.
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`(Original) The device of claim 18, wherein the one or more decorticating
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`elements are hingedly connected to the central ring along an axis that is in parallel with a long
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`axis of the body and are laterally swung from the closed position to the open position.
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`24.
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`(Original} The device of claim 18, wherein the one or more decorticating
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`elements are hingedly connected to the central nog along an axis that is perpendicular to a long
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`axis of the body and splay outwards from the closed pasition to the open position.
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`22.
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`(Original) The device of claim 18, wherein the one or more decorticating
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`elements are flexible wire blades retracted into the central ring in a closed position and are
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`pushable outwards from the central ring to the open position.
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`23.
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`(Original} The device of claim 18, wherein the one or more decorticating
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`elements are sheathed within the central ring in a closed position and are slideable outwards from
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`the closed position to the open position.
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`24.
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`(Original) The device of claim 18, wherein the one or more decorticating
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`elements are at least partially phable and are bendable from a closed position to an open pasition.
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`25,
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` (Qnginal) The device of claim 18, wherein the one or more decorticating
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`elements comprises at least one serration.
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`(Currently Amended) The device of claim 1, wherein the proximal
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`threaded prommateal-section has adiameter that is less than a diameter of the distal threaded distal
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`26.
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`section.
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`Page 5 of 11
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`Prehirnary Amendment Dated: 2/28/2022
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`27,
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`(Currently Amended) The device of claim [[1]]3. wherein the diameter of
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`the cap is substantially equal to a diameter of the threaded distal section.
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`28.
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`(Currently Amended) The device of claim [[1]]Z, further comprising a
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`lock screwhaving a diarneter larger than a diameter of the screwdevice lumen, the lock screw
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`being drivable into the proximal opening ofthe screw device to expand a proximal end ofthe
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`screwdevice.
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`29.
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`(Original) The device of claim 1, wherein the screw device has a length
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`between about 10 mm and about 150 mm.
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`30.
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`(Original) The device of claim 1, wherein the screw device has an outer
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`diameter between about 5 mm and about 50 mm.
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`34.
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`(Orginal) A method of fusing a jount between a first bone and a second
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`bone, comprising the steps of:
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`providing a decorticating screw having a threaded distal section, a
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`threaded proximal section, a rotatable central ring having one or more decorticating elements, a
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`lumen running between a proximal opening and a distal opening, and one or more lateral
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`openings fluidly connected to the lumen;
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`inserting the screwinto a joint in need of fixation, such that the distal
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`section is positioned in a first bone, the proximal section is positioned in a second bone, and the
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`central ring is positioned in a joint space between the first bone and the second bone;
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`rotating the certtral ring, such that the one or more decorticating elements
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`decorticate the joint space between the first bone and the second bone;
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`packing at least one graft material into the proximal opening ofthe screw,
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`such that the at least one graft material enters the hamen and exits the one or morelateral
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`openings of the screw;
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`placing a cap onto the proximal section of the screw; and
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`screwing a lock screwinto the proximal opening of the screw.
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`Page 6 of 11
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`Prehirnary Amendment Dated: 2/28/2022
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`32.
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`(Original) The method of claim 31, wherein the graft material is selected
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`from the group consisting of: autclogous bone grafts, allogeneic bore grafts, xenogeneic bone
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`grafts, hydroxyapatite, calcium phosphate, calcium sulphate, bioactive glass, polymers, cements,
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`and combinations thereof,
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`33
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`(New) The device of claim 5, wherein the screw device comprises one or
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`more cutting flutes at a distal end.
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`34,
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`(New) The device of claim 5, wherein the screwdevice comprises one or
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`more pointed tips at a distal end.
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`35.
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`(New} The device of claim 5, wherein the proximal threaded section
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`comprises a threading selected from the group consisting of knuckle threads, trapezoidal
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`threads, square threads, and buttress threads.
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`36.
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`(New) The device of claim 5, wherein the proximal threaded section
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`comprises a rounded or tapered proximal end.
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`37.
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`(New) The device of claim 5, wherein the central ring is attached to the
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`proximal threaded section, such that the central ring and proximal threaded section are
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`independently rotatable from the distal threaded section.
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`38.
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`(New} The device of claim 5, wherein the central mng is movable in
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`proximal and distal directions to increase the reach of the one or more decorticating elements.
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`39.
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`(New) The device of claim 5, wherein the screw device comprises two or
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`more external slots formed between the distal threadedsection, the certtral ring, and the one or
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`more decorticating elements, such that each external slot is sized to receive a pin of a screw
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`driving device.
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`40.
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`(New) The device of claim 5, wherein the one or more decorticating
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`elements each comprise one or more surface voids configured to accept graft material or tissue
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`ingrowth.
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`Page 7 of 11
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`Prehirnary Amendment Dated: 2/28/2022
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`At.
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`(New} The device of claim 5, wherein the cap comprises one or more
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`surface voids configured to accept graft material or tissue ingrowth.
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`42.
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`(New) The device of claim 5, wherein the cap comprises a thread-locking
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`insert positioned at a proximal end of the threaded lumen.
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`43.
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`(New) The device of claim 5, wherein the cap lip comprises a distal-
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`facing surface having a rounded convex shape.
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`44.
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`(New} The device of claim 5, wherein the cap comprises a locking nut in
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`alignment with the threaded lumen of the cap, the locking nut being connected to the cap by one
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`or more connecting bridges configured to break with an application of a torque on the locking
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`nut.
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`45.
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`(New) The device of claim 5, wherein the one or more decorticating
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`elements are moveable between a closed position and an open position.
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`46.
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`(New) The device of claim 45, wherein the closed position positions the
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`decorticating elements adjacent to the certtral ring such that they have a diameter substantially
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`equal to a diameter ofthe distal threaded section, and wherein the open position positions the
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`decorticating elements away from the central ring such that the decorticating clements extend
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`beyond the diameter of the distal threaded section.
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`A?
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`(New} The device of claim 45, wherein the one or more decorticating
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`elements are hingedly connected to the central ring along an axis that is in parallel with a long
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`axis of the body and are laterally swung from the closed position to the open position.
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`AB.
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`(New} The device of claim 45, wherein the one or more decorticating
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`elements are hingedly connected to the central ring along an axis that is perpendicular to a long
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`axis of the body and splay outwards from the closed position to the open position.
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`Page 8 of 11
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`Prehirnary Amendment Dated: 2/28/2022
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`49,
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`(New) The device of claim 45, wherein the one or more decorticating
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`elements are flexible wire blades retracted into the central ring in a closed position andare
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`pushable outwards from the central ring to the open position.
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`30.
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` (New} The device of claim 45, wherein the one or more decorticating
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`elements are sheathed within the central ring in a closed position andare slideable outwards from
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`the closed position to the open position.
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`St.
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`{New} The device of claim 45, wherein the one or more decorticating
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`elements are at least partially pliable and are bendable from a closed position to an open pasition.
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`52.
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`(New) The device of claim 45, wherein the one or more decorticating
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`elements comprises at least one serration.
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`53.
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`(New} The device of claim 5, wherein the proximal threaded section has a
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`diameter that is less than a diameter of the distal threaded section.
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`$4,
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`(New) The device of claim 5, wherein the diameter of the cap is
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`substantially equal to a diameterof the distal threaded section.
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`55,
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`(New} The device of claim 5, further comprising a lock screw having a
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`diameter larger than a diameter of the screwdevice lumen, the lock screwbemg drivable inte the
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`proximal opening of the screw device to expand a proximal end ofthe screw device.
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`56.
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` (New} The device of claim 5, wherein the screw device has a length
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`between about 10 mm and about 150 mim.
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`87,
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`(New} The device of claim 5, wherein the screw device has an outer
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`diameter bebween about 5 mm and about 50 mm.
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`Page 9 of 11
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`Prehirnary Amendment Dated: 2/28/2022
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`R
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`Reviewand consideration of the subject application in view of the present amendmentis
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`respecttully requested. Claims 1-57 are currently pending, claims 10, 14-17, 19, 26-28 have
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`been amended, and claims 33-57 are new. The claims have been amendedto track the
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`Amendment Under Article 34 filed in the PCT on January 4, 2021. Applicant respectfully
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`requests that this amendment be entered and considered prior to an exarnination on the merits.
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`Basis for the amendments:
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`Claim 10 has been amended to provide antecedent basis to recite “proximal threaded
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`section” and “distal threaded section.” The basis for this amendment can be found at least in
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`original claim 1.
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`Claim 14 has been amended to depend from claim 3 to provide antecedent basis for “the
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`cap.” The basis for this amendment can be found at least in original claim 3.
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`Claim 1S has been amended to depend from claim 3 to provide antecedent basis for “the
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`cap.” The basis for this arnendment can be foundat least in original claim 3.
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`Claim 16 has been amendedto depend from claim 3 to provide antecedent basis for “the
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`cap.” The basis for this amendment can be found at least in original claim 3.
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`Claim 17 has been amended to depend from claim 3 to provide antecedent basis for “the
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`cap.” The basis for this amendment can be found at least in original claim 3.
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`Claim 19 has been amendedto provide antecedent basis to recite “distal threaded section.”
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`Thebasis for this amendment can be found at least in original claim1.
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`Claim 26 has been amended to fix a typographical error to now recite “the proximal
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`threaded section has a diameter that is less than a diameter of the distal threaded section.” The
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`basis for this amendment can be found at least on page 22, lines 20-21 and original claim 1.
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`Page 10 of 11
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`Prehirnary Amendment Dated: 2/28/2022
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`Claim 27 has been amended to depend from claim 3 to provide antecedent basis to recite
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`“distal threaded section.” The basis for this amendment can be found on page 3, lines 18-19 and
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`in original claim1.
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`Claim 28 has been amended to depend from claim 2 to provide antecedent basis. The basis
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`for this amendment can be found on page 3, lines 19-21.
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`Claims 33-57 are new. The basis for these claims can be found on pages 2-3 of the
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`description.
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`No new matter has been added.
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`If itis determined that the application is not in a condition for allowance, the Examineris
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`invited to initiate a telephone interview with the undersigned attorney to expedite prosecution of
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`the present application.
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`Date: February 28, 2022
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`Respectfully submitted,
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`MEDICAL UNIVERSITY OF SOUTH CAROLINA
`
`/Ryan D. Artis/
`Ryan D. Artis
`Reg. No. 67,798
`Attorney for Applicant
`
`Riverside Law LLP
`175 Strafford Ave, Suite 100
`Wayne, PA 19087
`215-268-3888 (main)
`215-268-3871 (fax)
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`Page li of 11
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