ELECTRONICALLY FILED
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re:
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`Patent application of
`MUSC FOUNDATION FOR
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`RESEARCH DEVELOPMENT
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`: Group Art Unit:
`:
`3773
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`Serial No.:=17/639,038 : Examiner:
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`DAVID C COMSTOCK
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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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`: Attorney Docket No.:
`206085-0059-00US
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`AMENDMENT
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`This amendmentis filed in response to the non-final Office Action mailed May 9, 2024.
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`An excess claims fee for five independent claims in excess of three is submitted herewith.
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`No otherfee is believed due for the filing of this response. However, please charge any
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`fee that is due, and credit any overpayment, to deposit account no. 50-5366.
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`

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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`Amendments to the Specification:
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`Please replace the ABSTRACTon page34 with the following amended ABSTRACT:
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`ABSTRACT
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`
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`Fhe-presentinventiondecorticatine-providesD ecortiating screws and insertion tools for
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`
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`implanting the decorticating screws—Fhe including screwsthatanchorinto a first and a second
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`bone to fuse the two bones together. The screws includea rotatable bladed section to decorticate
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`a joint space betweenthe first and second bone. The screwsalso optionally include a cap to
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`secure the screws in the bone and apply compressionto the joint to be fused. In some
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`embodiments, the decorticating screws are useful for sacroiliac (SI) joint fusion.
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`No new matter has been added.
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`Page 2 of 13
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`

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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`Amendments to the Claims:
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`This listing of claims will replace all prior versions, and listings, of claims in the application:
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`Listing of Claims:
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`1.
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`(Currently Amended) A decorticating screw device, comprising:
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`a substantially cylindrical body, the body having a distal threaded section, a proximal
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`threaded section, a central ring having one or more decorticating elements;
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`wherein the central ring is independently rotatable from the distal threaded section.
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`2.
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`(Original) The device of claim 1, wherein the screw device further comprises a lumen
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`running between a proximal opening anda distal opening.
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`3.
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`(Original) The device of claim 2, wherein the screw device further comprises a cap
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`having a threaded lumensized to fit over the proximal threaded section of the body and a
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`proximallip having a diameter greater than a diameter of the cap.
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`4.
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`5.
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`(Canceled)
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`(Currently Amended) The device of claim [[4]]2, wherein the screw device further
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`comprises one or morelateral openings fluidly connected to the lumen.
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`6-30.
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`(Canceled)
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`31.
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`(Original) A method of fusing a joint betweena first bone and a second bone,
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`comprising the steps of:
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`providing a decorticating screw having a threaded distal section, a threaded
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`proximalsection, a rotatable central ring having one or more decorticating elements, a lumen
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`running between a proximal opening anda distal opening, and one or morelateral openings
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`fluidly connected to the lumen;
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`Page 3 of 13
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`

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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`inserting the screw into a joint in need of fixation, such that the distal section is
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`positioned in a first bone, the proximalsection is positioned in a second bone, andthe central
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`ring is positioned in a joint space betweenthe first bone and the second bone;
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`rotating the central 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 of the screw, such
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`that the at least one graft material enters the lumen andexits the one or more lateral openings of
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`the screw;
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`placing a cap onto the proximalsection of the screw; and
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`screwing a lock screw into the proximal opening of the screw.
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`32.
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`(Original) The method of claim 31, wherein the graft material is selected from the group
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`consisting of: autologous bonegrafts, allogeneic bone grafts, xenogeneic bonegrafts,
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`hydroxyapatite, calctum phosphate, calcium sulphate, bioactive glass, polymers, cements, and
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`combinations thereof.
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`33.
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`(Previously Presented) The device of claim 5, wherein the screw device comprises one
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`or more cutting flutes at a distal end.
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`34.
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`(Previously Presented) The device of claim 5, wherein the screw device comprises one
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`or more pointedtips at a distal end.
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`35.
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`(Cancelled)
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`36.
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`(Cancelled)
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`37.
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`(Previously Presented) 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 threadedsection are
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`independently rotatable from the distal threaded section.
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`Page 4 of 13
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`

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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`38.
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`(Previously Presented) The device of claim 5, wherein the central ring is movable in
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`proximalanddistal directions to increase the reach of the one or more decorticating elements.
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`39.
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`(Canceled)
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`40.
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`(Cancelled)
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`41.
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`(Previously Presented) 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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`(Previously Presented) The device of claim 5, wherein the cap comprises a thread-
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`locking insert positioned at a proximal end of the threaded lumen.
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`43.
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`(Cancelled)
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`44.
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`(Cancelled)
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`45.
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`(Previously Presented) 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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`(Previously Presented) The device of claim 45, wherein the closed position positions the
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`decorticating elements adjacent to the central ring such that they have a diameter substantially
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`equal to a diameter of the 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 elements extend
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`beyond the diameter of the distal threaded section.
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`47-50. (Canceled)
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`51.
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`(Previously Presented) The device of claim 45, wherein the one or more decorticating
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`elementsare at least partially pliable and are bendable from a closed position to an open position.
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`Page 5 of 13
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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`52.
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`(Previously Presented) The device of claim 45, wherein the one or more decorticating
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`elements comprisesat least one serration.
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`53.
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`(Previously Presented) The device of claim 5, wherein the proximal threaded section has
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`a diameter that is less than a diameter of the distal threaded section.
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`54.
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`(Canceled)
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`55.
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`(Canceled)
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`56.
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`(Previously Presented) The device of claim 5, wherein the screw device has a length
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`between about 10 mm and about 150 mm.
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`57.
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`(Previously Presented) The device of claim 5, wherein the screw device has an outer
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`diameter between about 5 mm and about 50 mm.
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`58.
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`(New) A decorticating screw device, comprising:
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`a substantially cylindrical body, the body having a distal threaded section, a proximal
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`threaded section, a central ring having one or more decorticating elements;
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`a lumen running between a proximal opening and a distal opening of the body; and
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`two or more external slots formed between thedistal threaded section, the central ring,
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`and the one or more decorticating elements, such that each externalslot is sized to receive a pin
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`of a screw driving device.
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`59,
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`(New) A decorticating screw device, comprising:
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`a substantially cylindrical body, the body having a distal threaded section, a proximal
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`threaded section, a central ring having one or more decorticating elements; and
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`a lumen running between a proximal opening and a distal opening ofthe body;
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`wherein the one or more decorticating elements are moveable between a closed position
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`and an open position; and
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`Page 6 of 13
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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`wherein the one or more decorticating elements are hingedly connectedto the central ring
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`along an axis that is in parallel with a long axis of the body andare laterally swung from the
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`closed position to the open position.
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`60.
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`(New) A decorticating screw device, comprising:
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`a substantially cylindrical body, the body having a distal threaded section, a proximal
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`threaded section, a central ring having one or more decorticating elements; and
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`a lumen running between a proximal opening and a distal opening ofthe body;
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`wherein the one or more decorticating elements are moveable between a closed position
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`and an open position; and
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`wherein the one or more decorticating elements are hingedly connectedto the central ring
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`along an axis that is perpendicular to a long axis of the body and splay outwards from the closed
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`position to the open position.
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`61.
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`(New) A decorticating screw device, comprising:
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`a substantially cylindrical body, the body having a distal threaded section, a proximal
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`threaded section, a central ring having one or more decorticating elements; and
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`a lumen running between a proximal opening and a distal opening ofthe body;
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`wherein the one or more decorticating elements are moveable between a closed position
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`and an open position; and
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`wherein the one or more decorticating elements are flexible wire blades retracted into the
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`central ring in a closed position and are pushable outwards from the central ring to the open
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`position.
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`62.
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`(New) A decorticating screw device, comprising:
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`a substantially cylindrical body, the body having a distal threaded section, a proximal
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`threaded section, a central ring having one or more decorticating elements; and
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`a lumen running between a proximal opening and a distal opening ofthe body;
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`wherein the one or more decorticating elements are moveable between a closed position
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`and an open position; and
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`Page 7 of 13
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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`wherein the one or more decorticating elements are sheathed within the central ring in a
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`closed position and are slidable outwards from the closed position to the open position.
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`63.
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`(New) A decorticating screw device, comprising:
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`a substantially cylindrical body, the body having a distal threaded section, a proximal
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`threaded section, a central ring having one or more decorticating elements;
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`a lumen running between a proximal opening and a distal opening of the body; and
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`a lock screw having a diameter larger than a diameter of the screw device lumen,the lock
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`screw being drivable into the proximal opening of the screw device to expand a proximal end of
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`the screw device.
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`Page 8 of 13
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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`REMARKS/ARGUMENTS
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`Review andreconsideration of the subject application in view of the present amendment
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`is respectfully requested. Claims 1-3, 5, 31-34, 37, 38, 41, 42, 45, 46, 51-53 and 56-63 are
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`currently pending, claims 1 and 5 have been amended, claims 58-63 are new, and claims 6-30,
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`35, 36, 39, 40, 43, 44, 47-50, 54 and 55 have been canceled. Applicant respectfully requests
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`reconsideration and allowance.
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`Allowable Subject Matter
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`Original claims 31 and 32 have been deemed allowable. Further, previously presented
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`claims 39, 47-50 and 55 have been deemed allowable subject matter if amended to independent
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`form.
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`Claims 58-63 are written in independent form to include the allowable subject matter of
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`previous claims 39, 47-50 and 55 respectively. Accordingly, Applicant requests notification that
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`these claims are in condition for allowance.
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`Amendments to the Claims
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`Claim 1 has been amendedto include subject matter previously recited in claim 4.
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`Claims 58-63 are written in independent form to include the allowable subject matter of
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`previous claims 39, 47-50 and 55 respectively.
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`Specification
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`The abstract of the disclosure stands objected to becauseit uses terminology thatis
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`implied: “The present invention provides”.
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`Applicant has amendedthe abstract to remove terminology that is implied, rendering the
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`objection moot.
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`Page 9 of 13
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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`Claim Objections
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`Applicant has canceled claim 4, rendering the objection moot.
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`Claim Rejections — 35 USC § 103
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`Claims 1-5, 34, 37, 38, 41, 45, 46, 51-53, 56 and 57 stand rejected under 35 U.S.C. 103
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`as being unpatentable over Lorio (2015/0313720) in view of Dawsonetal. (2006/0276790).
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`Claim 1 has been amendedto include subject matter previously recited in claim 4. Amended
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`claim 1 nowrecites:
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`Claim 1: A decorticating screw device, comprising:
`a substantially cylindrical body, the body having a
`distal threaded section, a proximal threadedsection, a
`central ring having one or more decorticating elements;
`wherein the central ring is independently rotatable
`from the distal threaded section.
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`In the rejection of claim 1, the Examiner acknowledgesthat Lorio fails to disclose decorticating
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`elements and instead relies on Dawson’s decorticating elements 32 shownin device 20 ofFig.
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`1E. According to the Examiner, it would have been obvious to configure the screw device of
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`Lorio with the decorticating elements of Dawsonto facilitate joint preparation in a simple
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`minimally invasive manner. Further, with regard to the claim limitation of a central ring
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`independently rotatable from the distal threaded section, the Examiner(in the rejection of claim
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`4) argues Lorio paragraphs 0061 and 0062 rendersthis limitation obvious.
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`Applicant respectfully disagrees and requests the rejection of currently amendedclaim 1
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`be withdrawnforat least the following reasons.
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`According to MPEP 2143.03, “All words in a claim must be considered in judging the
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`patentability of that claim against the prior art.” Jn re Wilson,424 F.2d 1382, 1385, 165 USPQ
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`494, 496 (CCPA 1970). When determining whether a claim is obvious, an examiner must make
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`Page 10 of 13
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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`“a searching comparison of the claimed invention — including all its limitations — with the
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`teaching ofthe priorart.” Jn re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995) (emphasis added).
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`Thus, “obviousness requires a suggestion ofall limitations in a claim.” CFMT;) Inc. v. Yieldup
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`Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985
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`(CCPA 1974)).
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`Applicant submits that there is no motivation to modify Lorio to include decorticating
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`elements that are rotatable independent from the distal threaded section. Lorio teaches
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`intermediate expandable members for applying compression to surrounding osseoustissue, not
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`for decorticating or removing it. See e.g. Lorio paragraph 0061 cited above, see paragraph 0040;
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`“ upon alteration of the distance D between the distal segment 120 and proximal segment 140,
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`a clinician can advantageously compress or decompress osseous tissue between the two segments
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`120, 140... Such compression can beneficially enhance fusion of osseoustissue between the
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`proximal segment 120 and distal segment 140...”; and see paragraph 0036, “...can
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`advantageously provide an increase in compression of osseoustissue about the expanded
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`intermediate segment 160 to facilitate fusion about the segment 160...”. Accordingly, Lorio’s
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`objective is to create compression proximate to intermediate portions, not decorticate or remove
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`tissue proximate to intermediate portions. Decorticating or removing tissue would actually
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`enlarge and decompress the space, not compress it. Accordingly, there is no suggestion to
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`modify Lorio to include decorticating elements since such a modification would promote
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`decompression, not compression, and render Lorio unsatisfactory for its intended purpose (see
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`e.g. MPEP 2143.01, if a proposed modification would render the prior art invention being
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`modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to
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`make the proposed modification, In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984).
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`Page 11 of 13
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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`Forat least the reasons stated above, Applicant submits that Lorio in view of Dawson
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`fails to render amended claim 1 obvious. Further, Applicant submits that claims 2, 3, 5, 34, 37,
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`38, 41, 45, 46, 51-53, 56 and 57, which ultimately depend on currently amendedclaim 1, are in
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`condition for allowancefor at least the reasons stated above for claim 1.
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`Claims 33 and 42 stand rejected under 35 U.S.C. 103 as being unpatentable over Lorio
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`(2015/0313720) in view of Dawsonetal. (2006/0276790), as applied above, and further in view
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`of Whipple etal. (2016/0242820).
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`Applicant submits that for at least the reasons provided above for claim 1, from which
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`claims 33 and 42 ultimately depend, claims 33 and 42 are in condition for allowance. Applicant
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`further submits that Whipple fails to cure the deficiencies of Lorio and Dawson since Whipple
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`fails to suggest a central ring independently rotatable from a distal threaded section andfails to
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`otherwise properly suggest modifying Lorio to include decorticating elements.
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`Page 12 of 13
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`Application No.: 17/639,038
`Response Dated: 8/8/2024
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`In light of the foregoing, it is respectfully submitted that the present application is in
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`condition for allowance and notice to that effect is hereby requested. If it is determined that the
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`application is not in a condition for allowance, the Examineris invited to initiate a telephone
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`interview with the undersigned attorney to expedite prosecution of the present application.
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`Date: August 8, 2024
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`Respectfully submitted,
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`MUSC FOUNDATION FOR RESEARCH DEVELOPMENT
`
`/Ryan D. Artis/
`Ryan D. Artis
`Reg. No. 67,798
`Attorney for Applicant
`
`Riverside Law LLP
`175 Strafford Avenue, Suite 100
`Wayne, PA 19087
`215-268-3888 (main)
`215-268-3871 (fax)
`518-708-6044 (direct)
`E-Mail: docketsi@riversidelaw.cam
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`Page 13 of 13
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