PATENT COOPERATION TREATY
`
`PCT
`
`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY
`
`(Chapter II of the Patent Cooperation Treaty)
`(PCT Article 36 and Rule 70)
`
`Applicant's or agent's file reference
`206085-0059-00WO
`
`FOR FURTHER
`ACTION
`
`See Form PCT/IPEA/416
`
`International filing date (day/month/year)
`International application No.
`28 August 2020 (28.08.2020)
`PCT/US2020/048516
`International Patent Classification (LPC) or both national classification and IPC
`IPC: A61B 17/68, 17/00, 17/16, 17/58, 17/84, 17/86
`CPC: A61B 17/68, 17/00, 17/16, 17/58, 17/84, 17/86
`Applicant
`MUSC FOUNDATION FOR RESEARCH DEVELOPMENT
`
`Priority date (day/month/year)
`29 August 2019 (29.08.2019)
`
`1. This report is the international preliminary examination report, established by this International Preliminary Examining Authority
`under Article 35 and transmitted to the applicant according to Article 36.
`
`
`
`This REPORTconsists of atotal of _9_sheets, including this cover sheet.
`
`This report is also accompanied by ANNEXES, comprising:
`
`a.
`
`(sent to the applicant and to the International Bureau) a total of 16 sheets, as follows:
`
`
`
`sheets of the description, claims and/or drawings which have been amended and/or sheets containing rectifications
`authorized by this Authority, unless those sheets were superseded or cancelled, and any accompanyingletters (see
`Rules 46.5, 66.8, 70.16, 91.2, and Section 607 of the Administrative Instructions).
`[| sheets containing rectifications, where the decision was made by this Authority not to take them into account because
`they were not authorized by or notified to this Authority at the time when this Authority began to draw up this report,
`and any accompanyingletters (Rules 66.4bis, 70.2(e), 70.16 and 91.2).
`[| superseded sheets and any accompanyingletters, where this Authority either considers that the superseding sheets
`contain an amendmentthat goes beyond the disclosure in the international application as filed, or the superseding
`sheets were not accompanied bya letter indicating the basis for the amendments in the applicationasfiled, as indicated
`in item 4 of Box No. I and the Supplemental Box (see Rule 70.16(b)).
`carrier(s))
`(sent
`to the
`International Bureau only) a total of Gndicate
`type and number of electronic
`
`containing a sequencelisting, in the form of an Annex C/ST.25 text file, as
`indicated in the Supplemental Box Relating to Sequence Listing (see paragraph 3ter of Annex C of the Administrative
`Instructions).
`
`b. [|
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`This report contains indicationsrelating to the following items:
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`Box No. [
`[| Box No. IT
`C] Box No.II
`[| Box No. TV
`Box No. V
`
`. VI
`
`Basis of the report
`Priority
`Non-establishment of opinion with regard to novelty, inventive step and industrial applicability
`Lack of unity of invention
`Reasoned statement under Article 35(2) with regard to novelty, inventive step and industrial applicability;
`citations and explanations supporting such statement
`Certain documents cited
`
`Certain defects in the international application
`
`Certain observations on the international application
`
`Date of submission of the demand
`
`Date of completion of this report
`
`04 January 2021 (04.01.2021)
`
`16 June 2021 (16.06.2021)
`
`Nameand mailing address of the [PEA/US
`COMMISSIONER FOR PATENTS MAIL STOP PCT,
`ATTN: IPEA/USP.O. BOX 1450 ALEXANDRIA, VA
`22313-1450, UNITED STATES OF AMERICA
`Facsimile No. (571)273-8300
`Form PCT/IPEA/409 (cover sheet) (January 2015)
`
`Authorized officer
`
`EDUARDO ROBERT
`
`Telephone No. 571-272-4719
`
`

`

`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY||International application No.
`PCT/US2020/048516
`
`Basis of the report
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`which is the language of a
`
`received by this Authority on
`received by this Authority on
`
`
`
`
`as originally filed/furnished.
`Nos.
`as amended (together with any statement) under Article 19
`Nos.*
`Nos.* 1-57. received by this Authority on _04 January 2021 (04.01.2021)
`the drawings:
`pages _1/41-41/41 as originally filed/furnished.
`
`received by this Authority on
`pages*
`
`pages*
`received by this Authority on
`
`a sequencelisting - see Supplemental Box Relating to Sequence Listing.
`3, [| The amendments haveresulted in the cancellation of:
`
`the description, pages
`
`the claims, Nos.
`
`
`
`the drawings, sheets/figs
`
`
`
`the sequencelisting (specify):
`4. [| This report has been established as if (some of) the amendments annexed to this report and listed below had not been made,
`since either they are considered to go beyondthe disclosure as filed, or they were not accompaniedbya letter indicating the
`basis for the amendments in the applicationas filed, as indicated in the Supplemental Box (Rules 70.2(c) and (c-bis)):
`
`
`the description, pages
`
`the claims, Nos.
`
`1. With regard to the language, this report is based on:
`the international application in the language in which it wasfiled.
`[| a translation of the international application into
`translation furnished for the purposesof:
`[|
`international search (Rules 12.3(a) and 23.1(b))
`[|
`publication of the international application (Rule 12.4(a))
`[|
`international preliminary examination (Rules 55.2(a) and/or 55.3(a) and (b))
`With regard to the elements of the international application, this report is based on (replacement sheets which have been furnished
`to the receiving Office in response to an invitation under Article 14 are referred to in this report as “originally filed” and are
`not annexedto this report):
`C]
`the international application as originally filed/furnished, or
`the description:
`pages 1-28 as originally filed/furnished.
`pages*
`pages*
`the claims:
`
`* If item 4 applies, some orall of those sheets may be marked “superseded.”
`
`
`
`the drawings, sheets/figs
`
`5. [|
`
`
`
`the sequencelisting (specify):
`is report has been established:
`taking into account the rectification of an obvious mistake authorized by or notified to this Authority under Rule 91
`(Rules 66.1(d-bis) and 70.2(e)).
`without taking into account the rectification of an obvious mistake authorized by or notified to this Authority under
`Rule 91(Rules 66.4bis and 70.2(e)).
`
`6. With regard to top-up searches (Rules 66.1lter and 70.2(f)):
`
`A top-up search wascarried out by this Authority on
`16 June 2021 (16.06.2021)
`[| Additional relevant documents have been discovered during the top-up search.
`[| No top-up search wascarried out by this Authority because it would serve no useful purpose.
` 7. [| Supplementary international search report(s) from Authority(ies)
`
`have been received and taken into account in establishing this report (Rule 45bis.8(b) and (c)).
`
`Form PCT/IPEA/409 (Box No. I) (January 2015)
`
`

`

`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY||International application No.
`PCT/US2020/048516
`
`Reasoned statement under Article 35(2) with regard to novelty, inventive step and industrial applicability;
`citations and explanations supporting such statement
`
`1. Statement
`
`Novelty (N)
`
`Claims
`Claims
`
`1-32
`None
`
`Inventive step (LS)
`
`Claims
`Claims
`
`9-17, 20-23, 25, 28, 36-44, 47-50, 52, 55
`1-8, 18, 19, 24, 26, 27, 29-35, 45, 46, 51, 53, 54, 56, 57
`
`Industrial applicability (IA)
`
`Claims
`Claims
`
`1-57
`None
`
`32; para. [0010]; para. [0028]) away from the central ring (Fig. 1E, intermediate member 30) such that the
`
`Regarding claim 19, modified Lorio discloses the device of claim 18. Modified Lorio does not explicitly
`disclose wherein the closed position positions the decorticating elements adjacent to the central ring such
`that they have a diameter substantially equal to a diameter of the threaded distal section, and wherein the
`open position positions the decorticating elements away from the central ring such that the decorticating
`elements extend beyond the diameter of the threadeddistal section. Dawsonteaches the decorticating
`device (Fig. 1E, implant 20; para. [0010]; para. [0028]), wherein the closed position positions the
`decorticating elements (Fig. IE, the decorticating elements defined by strips 32; para. [0010]; para. [0028])
`adjacent to the central ring (Fig. IE, intermediate member 30) such that they have a diameter substantially
`equal to a diameter of the threaded distal section (Fig. 1 A, when the strips are in the first shape, the strips
`32 have a diameter substantially equal to a diameter of distal member 28; para. [0026]), and wherein the
`open position positions the decorticating elements (Fig. 1E, the decorticating elements defined by strips
`
`2. Citations and explanations (Rule 70.7)
`
`eneneenen ee EXPLANATION-----------
`
`Claims 1, 7, 18, 19, 24, 26, 29 and 30 lack an inventive step under PCT Article 33(3) as being obvious
`over Lorio in view of Dawsonetal. (hereinafter Dawson).
`
`Regarding claim 1, Lorio discloses a screw device (Tig. 6, fastener apparatus 200), comprising: a
`substantially cylindrical body (Tig. 6, shaft 204), the body (Tig. 6, shaft 204) having a distal threaded
`section (Fig. 6, distal segment 210 with threaded region 212; para. [0057]), a proximal threaded section
`(Fig. 6, proximal segment 220 with threaded region 222; para. [0059]), a central ring (Fig. 6, sleeve 240).
`
`Lorio doesnot explicitly disclose decorticating; having one or more decorticating elements. Dawson
`teaches a decorticating device (Fig. IE, implant 20; para. [0010]; para. [0028]); a central ring (Fig.
`IE, intermediate member 30) having one or more decorticating elements (Fig. IE, strips 32 define
`decorticating elements; para. [0010]; para. [0028]; claim 21). Tt would have been obvious to one of
`ordinary skill in the art at the time of the invention to modify Lorio as taught by Dawson. The motivation
`for doing so would have been to minimize tools used in a procedure, thereby minimizing surgery time.
`
`Regarding claim 7, modified Lorio discloses the device of claim 1, wherein the screw device (Fig. 6,
`apparatus 200) comprises one or more pointedtips at a distal end (Fig. 6, taper 214 forms a pointed edge;
`para. [0058]).
`
`Regarding claim 18, modified Lorio discloses the device of claim 1. Modified Lorio does not explicitly
`disclose wherein the one or more decorticating elements are moveable between a closed position and an
`open position. Dawsonteachesthe decorticating device (Fig. 1E, implant 20; para. [|O010]; para. [0028 ]),
`wherein the one or more decorticating elements (Fig. IE, the decorticating elements defined bystrips 32;
`para. [0010]; para. [0028]) are moveable between a closed position (Fig. 1A, first shape; para. [0026]) and
`an open position (Fig. 1E, second shape; para. [0026]). It would have been obviousto one of ordinary skill
`in the art at the time of the invention to modify Lorio as taught by Dawson. The motivation for doing so
`would have been to minimize a device size, thereby facilitating insertion of the device within a bone and
`joint space.
`
`Form PCT/IPEA/409 (Box No. V) (January 2015)
`
`

`

`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY||International application No.
`PCT/US2020/048516
`
`Reasoned statement under Article 35(2) with regard to novelty, inventive step and industrial applicability;
`citations and explanations supporting such statement
`decorticating elements extend beyond the diameterof the threaded distal section (Fig. 1E, in the second
`shape,the strips 32 bulge out beyond the diameter of the distal member28). It would have been obvious
`to one of ordinary skill in the art at the time of the invention to modify Lorio as taught by Dawson. The
`motivation for doing so would have been to minimize a device size, thereby facilitating insertion of the
`device within a bone andjoint space.
`
`Regarding claim 24, modified Lorio discloses the device of claim 18, wherein the one or more
`decorticating elements (Fig. IE, the decorticating elements defined by strips 32; para. [0010]; para. [0028])
`are at least partially pliable and are bendable from a closed position to an open position (Fig. 1A, Fig.
`IE, strips 32 bulge out from a first shape to a second shape; para. [0026]). It would have been obvious
`to one of ordinary skill in the art at the time of the invention to modify Lorio as taught by Dawson. The
`motivation for doing so would have been to minimize a device size, thereby facilitating insertion of the
`device within a bone and joint space.
`
`Regarding claim 26, modified Lorio discloses the device of claim 1, wherein the threaded proximal section
`(Fig. 6, proximal segment 220) has a diameterthat is less than a diameter of the threaded distal section
`(Fig. 6, a diameter of the proximal segment220is less than a diameter of the distal segment 210; para.
`[0068]).
`
`Regarding claim 29, modified Lorio discloses the device of claim 1, wherein the screw device(Fig. 6,
`apparatus 200) has a length between about 10 mm and about 150 mm (the proximal segmenthas a length
`between approximately | millimeter to approximately 30 millimeters, the distal segment has a length
`between approximately | millimeter to approximately 30 millimeters, and the intermediate segment has a
`length between approximately | millimeter to approximately 30 millimeters; para. [0051]).
`
`Regarding claim 30, modified Lorio discloses the device of claim 1, wherein the screw device (Mig. 6,
`apparatus 200) as an outer diameter between about 5 mm and about 50 mm (the intermediate segment
`has a diameter between approximately 1 millimeter to approximately 20 millimeters; para. [0052]; para.
`[0061]).
`
`prints
`Claims 2-5, 27, 31, 32, 34, 45, 46, 51, 53, 54, 56 and 57 lack an inventive step under PCT Article 33(3) as
`being obvious over Lorio in view of Dawson etal. (hereinafter Dawson) and Amendia,Inc. (hereinafter
`Amendia).
`
`
`
`Regarding claim 2, modified Lorio discloses the device of claim 1, wherein the screw device (Fig.
`6, apparatus 200) further comprises a lumen(Fig. 8, lumen 208). Modified Lorio does not explicitly
`disclose running between a proximal opening and a distal opening. Amendia teaches a device (Fig. 7B,
`screw 10A), a lumen (Fig. 7B, chamber 12) running between a proximal opening (Fig. 7B, opening 33;
`para. [(0037]) and a distal opening (Fig. 7B, opening 15; para. [0038]). It would have been obvious to
`one of ordinary skill in the art at the time of the invention to modify Lorio as taught by Amendia. The
`motivation for doing so would have beento facilitate the addition of autograft or allograft bone or other
`biocompatible and bioactive materials to the screw implantation, thereby enhancing new bone growth and
`rapid fusion of the fusion screw, as taught by Amendia (para. [0006]; para. [0044]; para. [0047]).
`
`Regarding claim 3, modified Lorio discloses the device of claim 2, wherein the screw device (Fig. 6,
`apparatus 200) further comprises a cap (Fig. 6, retention member 260) having a threaded lumen(Fig. 6,
`shaft portion 262 has a lumen withinternal threading; para. [0064]) sized to fit over the proximal threaded
`section (Fig. 6, segment 220/structure 222; para. [0059]) of the body (Fig. 6, the lumen of the shaft portion
`262 can pass over the proximal segment 220 of the shaft 204; para. [0064]) and a proximallip (Fig. 6,
`flange 264) having a diameter greater than a diameterof the cap (Fig. 6, a diameterof the flange 264 is
`greater than a diameter of a shaft portion 262 of the retention member 260).
`
`Regarding claim 4, modified Lorio discloses the device of claim 3, wherein the central ring (Fig. 6, sleeve
`240) is independently rotatable from the threaded distal section (Fig. 6, the sleeve 240 is independently
`rotatable from the distal segment 210; para. [0060]-[0061]).
`
`Regarding claim 5, modified Lorio discloses the device of claim 4, wherein the screw device (Fig. 6,
`apparatus 200) further comprises one or more lateral openings (Fig. 3, Fig. 8, openings; para. [0048]; para.
`[0067]) fluidly connected to the lumen(Tig. 6, Fig. 8, the lumen 208 is in fluid communication with one
`or more opening on the shaft 204; para. [0067]).
`
`Regarding claims 27 and 54, modified Lorio discloses the device of the respective preceding claim,
`wherein the diameter of the cap (Fig. 6, sleeve 260) is substantially equal to a diameter of the distal
`Form PCT/IPEA/409 (Box No. V) (January 2015)
`
`

`

`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY||International application No.
`PCT/US2020/048516
`
`Reasoned statement under Article 35(2) with regard to novelty, inventive step and industrial applicability;
`citations and explanations supporting such statement
`threaded section (Fig. 7, a diameter of the sleeve 260 is substantially equal to a diameterof the distal
`segment 220; para. [0068]).
`
`Regarding claim 31, Lorio discloses a method (Figs. 10-14, method 400) of fusing a joint betweenafirst
`bone and a second bone(of fusing two boneportions; para. [0074]), comprising the steps of: providing
`(Fig. 6, an apparatus 200 is provided) a screw (Fig. 6, apparatus 200) having a threaded distal section
`(Fig. 6, distal segment 210 with threaded region 212; para. [0057]), a threaded proximal section (Fig.
`6, proximal segment 220 with threaded region 222; para. [0059]), a rotatable central ring (Fig. 6, sleeve
`240; para. [0060]-[0061]), a lumen (Fig. 8, lumen 208), and one or more lateral openings (Fig. 3, Fig. 8,
`openings; para. [0048]; para. [0067]) fluidly connected to the lumen (Fig. 6, Fig. 8, the lumen 208is in
`fluid communication with one or more opening on the shaft 204; para. [0067]); inserting the screw (Fig.
`
`fusion of the fusion screw as taught by Amendia (para. [0006]; para. [(0044]).
`
`6, apparatus 200) into a joint in need offixation (Fig. 11, Fig. 12, one or more fastener apparatus 200is
`inserted through openings 350a, 350b; para. [0079]), such that the distal section (Fig. 6, distal segment
`210) is positioned in a first bone (Fig. 12, sacrum 320; para. [0079]; para. [0082]), the proximalsection
`(Fig. 6, proximal segment 220) is positioned in a second bone (Fig. 12, ilium 340; para. [0079]; para.
`[0082]), and the central ring (Fig. 6, sleeve 240) is positioned in a joint space betweenthe first bone and
`the second bone (Fig. 11, Fig. 12, the intermediate segmentis positioned proximate the two surfaces 322,
`342 to be attached; para. [0079]); packing at least one graft material into the proximal opening of the
`screw (Fig. 12, a clinician introduces a graft material, such as a bone graft material, to a target location;
`para. [0067]; para. [0087]), such that the at least one graft material enters the lumen (Fig. 6, lumen 208)
`and exits the one or more lateral openings of the screw (Fig. 6, fluids are introduced through the lumen
`and out of openings such that the introduced fluid contacts osseous tissue; para. [0087]); placing a cap
`(Fig. 6, retention member 260) onto the proximal section (Fig. 6, proximal segment 220) of the screw (Fig.
`6, Fig. 7, the retention member260 is coupled to the proximal segment 220; para. [0056]). Lorio does not
`explicitly disclose decorticating; central ring having one or more decorticating elements, lumen running
`betweena proximal opening and a distal opening; rotating the central ring, such that the one or more
`decorticating elements decorticate the joint space betweenthe first bone and the second bone; screwing
`a lock screw into the proximal opening of the screw. Dawson teaches a method (method; para. [(0034]), a
`decorticating device (Fig. IE, implant 20; para. [0010]; para. [0028]); a central ring (Fig. IE, intermediate
`member 30) having one or more decorticating elements (Fig. IE, strips 32 define decorticating elements;
`para. [0010]; para. [0028]; claim 21); rotating the central ring (Fig. IE, intermediate member 30), such
`that the one or more decorticating elements (Fig. IE, the decorticating elements defined bystrips 32)
`decorticate the joint space betweenthe first bone and the second bone(a facet tool is moved suchthat
`the cutting strips abrade a desired amountof cartilage from the facet joint; para. [0010]; para. [0028]). It
`would have been obvious to one of ordinary skill in the art at the time of the invention to modify Lorio as
`taught by Dawson. The motivation for doing so would have been to minimize tools used in a procedure,
`thereby minimizing surgery time. Amendia teaches a method (method; para. [0011]), a lumen (Fig.
`7B, chamber 12) running between a proximal opening (Fig. 7B, opening 33; para. [0037]) and a distal
`opening (Fig. 7B, opening 15; para. [0038]); screwing a lock screw (Fig. 7B, cap 40; para. [0047]) into the
`proximal opening (Fig. 7A, opening 33) of the screw (Fig. 7B, a threaded male end 43 of cap 40 engages
`female threaded portion 33; para. [0047]). It would have been obvious to one of ordinary skill in the art at
`the time of the invention to modify Lorio as taught by Amendia. The motivation for doing so would have
`been to facilitate the addition of autograft or allograft bone or other biocompatible and bioactive materials
`to the screw after implantation, as taught by Amendia (para. [0047]).
`
`Regarding claim 32, modified Lorio discloses the method of claim 31. Modified Lorio does not explicitly
`disclose wherein the graft material is selected from the group consisting of: autologous bonegrafts,
`allogeneic bone grafts, xenogeneic bone grafts, hydroxyapatite, calctum phosphate, calcium sulphate,
`bioactive glass, polymers, cements, and combinations thereof. Amendia teaches the method (method;
`para. [0011]), wherein the graft material is selected from the group consisting of: autologous bone grafts,
`allogeneic bone grafts, xenogeneic bone grafts, hydroxyapatite, calctum phosphate, calcium sulphate,
`bioactive glass, polymers, cements, and combinations thereof (the addition of autograft; para. [0047]). It
`would have been obvious to one of ordinary skill in the art at the time of the invention to modify Lorio as
`taught by Amendia. The motivation for doing so would have been to enhance new bone growth and rapid
`
`Form PCT/IPEA/409 (Box No. V) (January 2015)
`
`

`

`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY||International application No.
`PCT/US2020/048516
`
`Reasoned statement under Article 35(2) with regard to novelty, inventive step and industrial applicability;
`citations and explanations supporting such statement
`
`Regarding claim 34, modified Lorio discloses the claimed device, wherein the screw device (Fig. 6,
`apparatus 200) comprises one or more pointedtips at a distal end (Fig. 6, taper 214 forms a pointed edge;
`para. [0058 ]).
`
`Regarding claim 45, modified Lorio discloses the claimed device with the following exception. Modified
`Lorio does not explicitly disclose wherein the one or more decorticating elements are moveable between
`a closed position and an open position. Dawson teaches the decorticating device (Fig. 1E, implant 20;
`para. [0010]; para. [0028]), wherein the one or more decorticating elements (Tig. IE, the decorticating
`elements defined by strips 32; para. [0010]; para. [0028]) are moveable between a closed position (lig.
`1A, first shape; para. [0026]) and an open position (Fig. 1E, second shape; para. [0026]). It would have
`been obviousto one of ordinary skill in the art at the time of the invention to modify Lorio as taught by
`Dawson. The motivation for doing so would have been to minimize a device size, thereby facilitating
`insertion of the device within a bone and joint space.
`
`Regarding claim 46, modified Lorio discloses the claimed device with the following exception. Modified
`Lorio does not explicitly disclose wherein the closed position positions the decorticating elements adjacent
`to the central ring such that they have a diametersubstantially equal to a diameter of the threaded distal
`section, and wherein the openposition positions the decorticating elements away fromthe central ring
`such that the decorticating elements extend beyond the diameter of the threaded distal section. Dawson
`teaches the decorticating device (Tig. 1E, implant 20; para. [0010]; para. [0028]), wherein the closed
`position positions the decorticating elements (Fig. IE, the decorticating elements defined by strips 32;
`para. [0010]; para. [0028]) adjacentto the central ring (Fig. IE, intermediate member 30) suchthat
`they have a diameter substantially equal to a diameter of the threadeddistal section (Fig. 1 A, when
`the strips are in the first shape, the strips 32 have a diameter substantially equal to a diameterof distal
`member28; para. [0026]), and wherein the open position positions the decorticating elements (Fig. 1E,
`the decorticating elements defined by strips 32; para. [0010]; para. [0028]) away from the central ring
`(Fig. 1E, intermediate member 30) such that the decorticating elements extend beyond the diameter of
`the threadeddistal section (Fig. 1E, in the second shape, the strips 32 bulge out beyond the diameter
`of the distal member 28). It would have been obvious to oneof ordinary skill in the art at the time of
`the invention to modify Lorio as taught by Dawson. The motivation for doing so would have beento
`minimize a device size, thereby facilitating insertion of the device within a bone and joint space.
`
`does not explicitly disclose wherein the screw device comprises one or more cutting flutes at a distal end.
`
`Regarding claim 51, modified Lorio discloses the claimed device, wherein the one or more decorticating
`elements (Fig. IE, the decorticating elements defined bystrips 32; para. [0010]; para. [0028]) are at least
`partially pliable and are bendable from a closed position to an open position (Fig. 1A, Fig. IE, strips
`32 bulge out from a first shape to a second shape; para. [0026]). It would have been obvious to one of
`ordinary skill in the art at the time of the invention to modify Lorio as taught by Dawson. The motivation
`for doing so would have been to minimize a device size, thereby facilitating insertion of the device within
`a bone and joint space.
`
`Regarding claim 53, modified Lorio discloses the claimed device, wherein the threaded proximal section
`(Fig. 6, proximal segment 220) has a diameterthat is less than a diameter of the threadeddistal section
`(Fig. 6, a diameter of the proximal segment 220 is less than a diameterof the distal segment 210; para.
`[0068)).
`
`Regarding claim 56, modified Lorio discloses the claimed device, wherein the screw device (Fig. 6,
`apparatus 200) has a length between about 10 mm and about 150 mm (the proximal segment has a length
`between approximately 1 millimeter to approximately 30 millimeters, the distal segment has a length
`between approximately 1 millimeter to approximately 30 millimeters, and the intermediate segment has a
`length between approximately 1 millimeter to approximately 30 millimeters; para. [0051]).
`
`Regarding claim 57, modified Lorio discloses the claimed device wherein the screw device (Fig. 6,
`apparatus 200) as an outer diameter between about 5 mm and about 50 mm (the intermediate segment
`has a diameter between approximately | millimeter to approximately 20 millimeters; para. [0052]; para.
`[0061]).
`
`Claims 6 and 33 lack an inventive step under PCT Article 33(3) as being obvious over Lorio in view of
`Dawsonetal. (hereinafter Dawson) and Mis Ip Holdings Llc (hereinafter Mis).
`
`Regarding claims 6 and 33, modified Lorio discloses the device of the respective preceding claim. Lorio
`
`Form PCT/IPEA/409 (Box No. V) (January 2015)
`
`

`

`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY||International application No.
`PCT/US2020/048516
`
`Reasoned statement under Article 35(2) with regard to novelty, inventive step and industrial applicability;
`citations and explanations supporting such statement
`Mis teaches a device (Fig. 24A,stabilizer device 2400), wherein the screw device (Fig. 24A, stabilizer
`device 2400) comprises one or more cutting flutes (Fig. 24A, self-tapping feature 2404; para. [0256]-
`[0257]) at a distal end (Tig. 24A, on a distal threaded section 2402; para. [0256]). It would have been
`obvious to one of ordinary skill in the art at the time of the invention to modify Lorio as taught by Mis.
`The motivation for doing so would havebeento cut threads into bone, thereby facilitating insertion of the
`device as taught by Mis (para. [0256]).
`
`Claims 8 and 35 lack an inventive step under PCT Article 33(3) as being obvious over Lorio in view of
`Dawsonetal. (hereinafter Dawson) and Trinity Orthopedics, Lie (hereinafter Trinity).
`
`Regarding claims 8 and 35, modified Lorio discloses the device of the respective preceding claim.
`Modified Lorio does not explicitly disclose wherein the proximal threaded section comprises a threading
`selected from the group consisting of: knuckle threads, trapezoidal threads, square threads, and buttress
`threads. Trinity teaches a device (Fig. 1A, screw 100), wherein the proximal threaded section (Fig. 1A,
`proximal segment 110) comprises a threading selected from the group consisting of: knuckle threads,
`trapezoidal threads, square threads, and buttress threads (Fig. 1A, the threads of proximal segment 110 are
`buttress threads). It would have been obviousto one of ordinary skill in the art at the time of the invention
`to modify Lorio as taught by Trinity. The motivation for doing so would have been to form a thread with
`low friction properties and high shear strength.
`
`a pin of a screw driving device.
`
`Claims 9-17, 20-23, 25, 28, 36-44, 47-50, 52 and 55 meetthe criteria set out in PC'T Article 33(2)-(3),
`becausethe prior art does not teach or fairly suggest:
`
`Regarding claims 9 and 36, the priorart of record, individually or in combination, does not teach or
`fairly suggest the claimed device, wherein the proximal threaded section comprises a rounded or tapered
`proximal end. The following prior art is made of record to support and further define the reasonsthat
`claims 9 and 36 meetthecriteria set out in PCT Article 33 (2)-(3):
`
`Modified Lorio discloses the claimed device, except modified Lorio fails to disclose the elements of
`wherein the proximal threaded section comprises a roundedor tapered proximal end.
`
`Regarding claims 10 and 37, the prior art of record, individually or in combination, does not teach or
`fairly suggest the claimed device, wherein the central ring is attached to the proximal section, such that
`the central ring and proximal section are independently rotatable from the threadeddistal section. The
`following prior art is made of record to support and further define the reasons that claims 10 and 37 meet
`the criteria set out in PCT Article 33 (2)-(3):
`
`Modified Lorio discloses the claimed device, except modified Lorio fails to disclose the elements of
`wherein the central ring is attached to the proximalsection, such that the central ring and proximal section
`are independently rotatable from the threaded distal section.
`
`Regarding claims 11 and 38, the prior art of record, individually or in combination, does not teach or
`fairly suggest the claimed device, wherein the central ring is movable in proximal and distal directions to
`increase the reach of the one or more decorticating elements. The following priorart is made of record to
`support and further define the reasons that claims 11 and 38 meet the criteria set out in PCT Article 33 (2)-
`(3):
`
`Modified Lorio discloses the claimed device, except modified Lorio fails to disclose the elements of
`wherein the central ring is movable in proximal and distal directions to increase the reach of the one or
`more decorticating elements.
`
`Regarding claims 12 and 39, the prior art of record, individually or in combination, does not teach or
`fairly suggest the claimed device, wherein the screw device comprises two or more external slots formed
`between the distal threaded section, the central ring, and the one or more decorticating elements, such
`that each external slot is sized to receive a pin of a screw driving device. The following prior art is made
`of record to support and further define the reasons that claims 12 and 39 meetthe criteria set out in PCT
`Article 33 (2)-(3):
`
`Modified Lorio discloses the claimed device, except modified Lorio fails to disclose the elements of
`wherein the screw device comprises two or more external slots formed between the distal threaded section,
`the central ring, and the one or more decorticating elements, such that each externalslot is sized to receive
`
`Form PCT/IPEA/409 (Box No. V) (January 2015)
`
`

`

`INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY||International application No.
`PCT/US2020/048516
`
`Reasoned statement under Article 35(2) with regard to novelty, inventive step and industrial applicability;
`citations and explanations supporting such statement
`
`Regarding claims 13 and 40, the prior art of record, individually or in combination, does not teach or fairly
`suggest the claimed device, wherein the one or more decorticating elements each comprise one or more
`surface voids configured to accept graft material or tissue ingrowth. ‘The following prior art is made of
`record to support and further define the reasonsthat claims 13 and 40 meetthe criteria set out in PCT
`Article 33 (2)-(3):
`
`Modified Lorio discloses the claim