`
`Applicant(s): P. Bonutti
`
`Confirmation No: 6375
`
`Application No: 10/722,102
`
`Attorney Docket No: 780-A03-012C
`
`Filed: November 25, 2003
`
`Group Art Unit: 3733
`
`For: KNEE ARTHROPLASTY METHOD
`
`Examiner: P. Philogene
`
`RESPONSE TO OFFICE ACTION
`
`Mail Stop AMENDMENT
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 223l3—l450
`
`Dear Sir:
`
`In reply to the Office Action mailed July 9, 2007, please enter this Response into the file of"
`
`the above—entitled application.
`
`In accordance with USPTO practice, each section of this Response begins on a separate
`
`sheet. Applicant submits, these amendments and remarks serve to clarify the present invention,
`
`and are independent of patentability.
`
`WMT 1016-1
`
`WMT 1016-1
`
`
`
`Applicant(s): P. Bonutti
`Application No.: 10/722,102
`Examiner: P. Philogene
`
`Amendments to the Claims
`
`1. (Currently amended) A method of performing surgery on a patient’s knee including a
`
`femur and a tibia, the method comprising the steps of:
`
`making an incision in a knee portion ofa leg of the patient;
`
`expanding the incision from an unexpanded confi guration to an expanded confi guration bv
`
`applying force against opposite edge portions of the incision;
`
`positioning a cutting guide through the expanded incision and on a [[side]] surface ofa
`
`distal end portion of the femur: the cutting guide sized to be received in the expanded
`
`configuration;
`
`moving a cutting tool through the incision into engagement with a guide surface on the
`
`cutting guide;
`
`cutting the femur by moving the cutting tool aiong the guide surface,
`
`wherein the cutting guide is positioned free of an extramcdullary or intramedullary
`
`alignment rod using navigation references derived from the surface of the bone to be out said
`
`navigation references derived independently from an intramedullary device.
`
`2. (Currently amended) The method. of claim 1 wherein the [[side]] surface is a medial g
`
`lateral side of the distal end portion of the femur.
`
`3. (Canceled)
`
`4. (Original) The method of claim 1 wherein a computer navigation system is used in the
`
`positioning step.
`
`5. (Original) The method of claim 1 wherein the positioning step includes removably
`
`attaching the cutting guide to the side surface of the distal end portion of the femur
`
`WMT 1016-2
`
`WMT 1016-2
`
`
`
`Applicant(s): P. Bonutti
`Application No.: 10/722,l02
`Examiner: P. Phiiogcnc
`
`6. (Original) The method of claim 5 wherein the cutting guide is removably attached with
`
`first and second pins extending through holes in the cutting guide and into the femur.
`
`7. (Original) The method of claim 1 wherein the guide surface comprises a plurality of
`
`straight guide segments.
`
`8. (Original) The method of claim 7 wherein the plurality of straight guide segments
`
`comprises:
`
`a distal guide segment disposed in a plane which extends perpendicular to a longitudinal
`
`central axis of the femur and extends through lateral and. medial condyles of the femur;
`
`an anterior chamfer guide segment disposed in a plane which extends at an acute angle to a
`
`plane containing the distal guide surface;
`
`a posterior chamfer guide segment disposed in a plane which extends at an acute angle to a
`
`plane containing the distal guide surface. the plane containing the posterior chamfer guide
`
`surface extending perpendicular to the plane containing the anterior chamt‘er guide surface;
`
`an anterior guide segment disposed in a plane which extends perpendicular to a plane
`
`containing the distal guide surface and extends generally parallel to a longitudinal central axis of
`
`the femur; and
`
`a posterior guide surface disposed in a plane which extends parallel to a plane containing
`
`the anterior guide surface and perpendicular to a plane containing the distal guide surface,
`
`9. (Currently amended) The method of claim 1 further comprising the step of removing at
`
`least a portion of the [[side]] surface of the distal end portion of the femur prior to positioning the
`
`cutting guide such that a flattened section of the side surface is created and abuttingiy engaged by
`
`a major side surface of the cutting guide when the cutting guide is positioned thereon.
`
`10. (Original) The method of claim l wherein said step of cutting the femur includes
`
`utilizing the guide surface on the cutting guide to guide the cutting tool during making of an
`
`L»)
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`WMT 1016-3
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`WMT 1016-3
`
`
`
`Applicant(s): P. Bonutti
`Application No: 10f722,102
`Examiner:
`l’. Philogene
`
`initial portion of a cut in the femur, and completing the cut in the femur while guiding the cutting
`
`tool with a surface formed during making of the initial portion of the cut in the femur.
`
`11. (Currently amended) The method of claim 10 wherein the cutting guide is positioned
`
`n {[the]] g side surface of the distal end portion of the femur during completion of the cut.
`
`12. (Currently amended) The method ofclaim 10 wherein the cutting guide is removed
`
`from [[the]] a side surface of the distal end portion of the femur after making the initial portion
`
`of the cut and before completion of the cut.
`
`13. (Currently amended) A total knee replacement cutting guide for forming a cut surface
`
`on a bone in preparation to receive a total joint replacement component comprising:
`
`a disposable cutting guide member fabricated from a polymeric material and designed for a
`
`single use, having a body configured—and dimensioned for attachment to a {[sidcll surface of an
`
`end portion of the bone free of an cxtramedullary or intramedullary alignment rod; and
`
` at least one guide surface
`
`ofthe—aardeanember—the—aHeasteneugmdeserfaeeeenfigmed—and dimensioned for engagement
`
`with a cuttingtool to thereby direct the cutting tool mnakmg—enlya-pertienefithe—eut—sefiaee
`
`wherein said cutting guide. being both polymeric and disposable: is readily modified in
`
`successive iterations for new or customized instrumentation.
`
`14. (Original) The total knee replacement cutting guide of claim 13 wherein the guide
`
`member attaches to either a medial or lateral side surface of the end portion of the bone.
`
`15. (Original) The total knee replacement cutting guide of claim 13 wherein the at least one
`
`guide surface includes a distal end surface having opposite ends spaced apart by a distance which
`
`is less than a distance that the total joint replacement component extends across the bone when
`
`implanted.
`
`WMT 1016-4
`
`WMT 1016-4
`
`
`
`Applicant(s): P. Bonutti
`Application Nos 10/722,102
`Examiner: P. Philogene
`
`16. (Original) The total knee replacement cutting guide of claim 15 wherein the guide
`
`member has an aperture for receiving a pin to thereby secure the guide member to the bone.
`
`17. (Original) The total knee replacement cutting guide ofclaim 16 wherein the at least one
`
`guide surface includes:
`
`an anterior chamfer guide segment disposed in a plane which extends at an acute angle to a
`
`plane containing the distal guide surface;
`
`a posterior chamfer guide segment disposed in a plane which extends at an acute angle to a
`
`plane containing the distal guide surface, the plane containing the posterior chamfer guide
`
`surface extending perpendicular to the plane containing the anterior ehamfer guide surface;
`
`an anterior guide segment disposed in a plane which extends perpendicular to a plane
`
`containing the distal guide surface and extends generally parallel to a longitudinal central axis of
`
`the femur; and
`
`a posterior guide surface disposed in a plane which extends parallel to a plane containing
`
`the anterior guide surface and perpendicular to a plane containing the distal guide surface.
`
`18. (Original) The total knee replacement cutting guide of claim 16 wherein the cutting
`
`guide is a non-captured cutting guide.
`
`19. (Currently amended) A method of performing surgery on a joint in a patient including a
`
`first bone and a second bone, the method comprising the steps of:
`
`fabricating a disposable cuttin‘g‘guidc= designed for a single use from a polymeric material
`
`and modified for updated or customized instrumentation“
`
`making an incision proximal to the joint in the patient;
`
`positioning [[a]] the cutting guide through the incision and on a side surface of an end
`
`portion of the first bone before the anterior surface of said first bone is resected;
`
`moving a cutting tool through the incision into engagement with a guide surface on the
`
`WMT 1016-5
`
`WMT 1016-5
`
`
`
`Applicant(s): P. Bonutti
`Application No: 10/722102
`Examiner: P. Philogene
`
`cutting guide;
`
`cutting the first bone by moving the cutting tool along the guide surface,
`
`wherein the cutting guide is positioned tree—et—an—eeetramedallaryLer—Hatranaeded-lary
`
`alignment—red using navigation references derived from the surface of the bone to he cut. said
`
`navigation references derived independently from an intramedullgy device.
`
`20. (Currently amended) The method of claim 19 wherein the side surface is a medial g
`
`lateral side of the end portion of the first bone.
`
`21. (Canceled)
`
`22. (Original) The method of claim 19 wherein a computer navigation system is used in the
`
`positioning step.
`
`23. (Original) The method of claim 19 wherein the positioning step includes removably
`
`attaching the cutting guide to the side surface of the end portion of the first bone.
`
`24. (Original) The method of claim 23 wherein the cutting guide is removably attached
`
`with first and second pins extending through holes in the cutting guide and into the first bone.
`
`25. (Original) The method of claim 19 wherein the guide surface comprises a plurality of
`
`straight guide segments.
`
`26. (Original) The method of claim 25 wherein the plurality of straight guide segments
`
`comprises:
`
`a distal guide segment disposed in a plane which extends perpendicular to a longitudinal
`
`central axis of the first bone;
`
`an anterior chamfer guide segment disposed in a plane which extends at an acute angle to a
`
`WMT 1016-6
`
`WMT 1016-6
`
`
`
`Applicant(s): P, Bonutti
`Application No.: 10/722,102
`Examiner: P. Philogene
`
`plane containing the distal guide surface;
`
`a posterior chamfer guide segment disposed in a plane which extends at an acute angle to a
`
`plane containing the distal guide surface, the plane containing the posterior chamfer guide
`
`surface extending perpendicular to the plane containing the anterior chamfer guide surface;
`
`an anterior guide segment disposed in a plane which extends perpendicular to a plane
`
`containing the distal guide surface and extends generally parallel to a longitudinal central axis of
`
`the first bone; and
`
`a posterior guide surface disposed in a plane which extends parallel to a plane containing
`
`the anterior guide surface and perpendicular to a plane containing the distal guide surface.
`
`27. (Original) The method of claim 19 further comprising the step of removing at least a
`
`portion of the side surface prior to positioning the cutting guide such that a flattened section of
`
`the side surface is created and. abuttingly engaged by a major side surface of the cutting guide
`
`when the cutting guide is positioned thereon.
`
`28. (Original) The method of claim 19 wherein said step of cutting the first bone includes
`
`utilizing the guide surface on the cutting guide to guide the cutting tooi during making of an
`
`initial portion of a cut in the first bone, and completing the cut in the first bone while guiding the
`
`cutting tool with a surface formed during making of the initial portion of the cut in the first bone.
`
`29. (Original) The method of claim 28 wherein the cutting guide is positioned on the side
`
`surface of the end portion of the first bone during completion of the cut.
`
`30. (Original) The method of claim 29 wherein the cutting guide is removed from the side
`
`surface of the end portion of the first bone after making the initial portion of the cut and before
`
`completion of the cut.
`
`31. (Previously presented) The method. of claim 1. wherein said incision is between. about
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`WMT 1016-7
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`WMT 1016-7
`
`
`
`Applicanfls): P. Bonutti
`Application No.: 10(722,'102
`Examiner: P. Philogcne
`
`seven and about thirteen centimeters.
`
`32. (Previously presented) The method of claim 1, where said positioning step further
`
`includes the step of using light beams.
`
`33. (Previously presented) The method of claim 1, wherein in said step of making an
`
`incision, said incision is offset from the center of said knee area.
`
`34. (Previously presented) The method of claim 13, wherein said at least one guide surface
`
`includes a guide surface corresponding to each guide surface required by said joint replacement
`
`component.
`
`35. (Previously presented) The method of claim 19, wherein after said step of cutting,
`
`further including the steps of:
`
`removing said cutting guide; and,
`
`guiding said cutting tool using cuts formed in said cutting step to complete said cuts.
`
`36. (Previously presented) The method of claim 19, wherein in said step of positioning,
`
`said cutting guide is sized smaller than said side surface.
`
`37. (Previously presented) The method of claim 19, wherein after said step of positioning,
`
`further including the step of:
`
`aligning said cutting guide using markings on said side surface.
`
`38. (New) The method of claim 1, where said cutting guide is disposable in that it is
`
`fabricated of a polymeric material at a lower cost than a reusable metallic cutting guide, and by
`
`being designed to be used in a single procedure and thereafter discarded.
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`WMT 1016-8
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`WMT 1016-8
`
`
`
`Applicant(s): P. Bonutti
`Application No: 10/722,102
`Examiner: P. Philogene
`
`39. (New) The cutting guide ot’claim 13, wherein alignment of said cutting guide is
`
`performed by means selected from the group consisting of: computer navigation, preoperative
`
`imaging, and extramedullary alignment.
`
`WMT 1016-9
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`WMT 1016-9
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`
`
`Applicant(s): P. Bonutti
`Application No: 10/722,102
`Examiner: P. Philogene
`
`Remarks
`
`Claims 1-39 are presented for the Examiner’s review and consideration. Herein, claims l~2,
`
`9, 11—13, and 19—20 have been amended; claims 38—39 have been added; and claims 3 and 21
`
`have been canceled. Applicant believes the claim amendments and the accompanying remarks,
`
`herein, serve to clarify the present invention and are independent ol‘parentability. No new matter
`
`has been added.
`
`35 U.S.C. §102te) Rejection — Coates
`
`Claims 1—37 were rejected under 35 U.S.C. §102(e) as being anticipated by Coates
`
`(5,035,699) (“Coates”). For reasons set forth below, Applicant respectfully submits that this
`
`rejection should be withdrawn.
`
`Coates discloses a surgical device for accurately positioning and cutting a patellar groove in
`
`a resected distal femur to receive a patellar track portion of a prosthesis, including a guide
`
`element adapted to {it over the distal end of a resected femur... (Abstract). With reference to
`
`Fig. l of Coates, end 14 is adapted to fit on the posterior side of the resected femur and consists
`
`of2 arms adapted to [it over the medial and lateral condyles of the femur. (Col. 2, lns. 31—33).
`
`The central portion of the cutting guide 10 consists of an elongated opening 23 which exposes at
`
`least the distal and anterior aspects of the resected femur so that a patellar groove may be cut
`
`therein. (Id).
`
`Thus Coates is directed to a cutting guide which is aiigned by being positioned on a resected
`
`femur. Coates does not address how the femur is resected, however at the time of C-oates, the
`
`commonly accepted method was through the use of an intramedullary rod. There is no suggestion
`
`in Coates of an alternative method.
`
`In contrast, the present invention discloses methodlis] of performing surgery, and
`
`instruments, implants, and other surgical implements that can be used in surgery. The surgery
`
`may be of any desired type. (fit[0002}). The surgery may be performed on any desired joint in a
`
`patient’s body. ld.
`
`1.0
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`WMT1016-1O
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`WMT 1016-10
`
`
`
`Applicant(s): P. Bonutti
`Application No.: 10/722,102
`Examiner: P.1’hilogenc
`
`When the femoral cuts are to be made on the distal end portion 124 of the femur 126. the
`
`femoral cutting guide 750 is connected to the distal end of the femur.
`
`(11[0490]).
`
`...extramedullary instrument could be employed. if desired, the base 1376 could be pinned
`
`directly to the femur in a manner analogous to the cutting guide 800 (Fig. 54). (1d). Alternatively,
`
`the base 1376 could be positioned on the femur using a computer navigation system. (1d).
`
`It is contemplated that emitters, receivers, and/or reflectors of computer navigation systems
`
`could be pinned or otherwise attached onto the femur 126 and tibia 214 to provide cutting
`
`positions and to facilitate ligament balancing through relatively small incisions. (‘11[0288]'). The
`
`computer navigation system may utilize three or four separate registers which have optical
`
`feedback to a central unit. (1d). The computer navigation system may utilize electromagnetic or
`
`photo-optical feedback.
`
`it is contemplated that the imaging of the knee portion 7'6 of the patient’s leg 70 may be
`
`done preoperatively, on an out—patient basis. (1110556]). The implant 950, which has been shaped
`
`to conform to the space between the surfaces 958 and 960. may then be moved to an operating
`
`room for insertion into a patient during the surgical procedure. (1d).
`
`...Discusscd throughout this specification, the present invention includes disposable surgical
`
`implants and instruments. (11[0706]). One advantage of the disposable system is that the
`
`disposable cutting blocks could easily be modified for new or updated instrumentation or for
`
`customized instrumentation. GMT/12]).
`
`Thus, the present invention provides for attachment of a cutting guide to a femur without
`
`first resecting the femur, and without connection to an EM or IM rod. Moreover, the present
`
`invention provides for disposable cutting blocks, which, because they are made from a low cost,
`
`easy to manufacture polymer, may be modified for each use to accommodate custom
`
`requirements.
`
`11
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`WMT 1016-11
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`WMT 1016-11
`
`
`
`Applicant(s): P. Bonutti
`Application No: 10/722,102
`Examiner: P. Philogcne
`
`As discussed above, Coates does not provide a means for connecting or aligning a cutting
`
`guide without first resecting the knee for a total knee replacement. Of course, alignment must be
`
`performed for the resection, and no means are disclosed for such. Notwithstanding this, it is clear
`
`that the cutting guide of Coates is not aligned with respect to knee, generally, but to the resection,
`
`only. Thus, Coates does not provide a means of positioning a cutting guide without a prior
`
`resection of the femur, and the anterior section, in particular. In addition, the use of
`
`intramedullary alignment is implicit in Coates. Further, there is no discussion of disposable
`
`instrumentation in Coates, nor of the attendant benefits of same.
`
`Claim 1 recites, inter alia, positioning a cutting guide on a surface ofa distal end portion of
`
`the femur, positioned free of an extramedullary or intramedullary rod, and positioned using
`
`navigation references derived from the surface oi‘the bone to be cut, and not derived from an
`
`intramedullary device.
`
`Claim 13 recites, inter alter, a disposable cutting guide member fabricated from a polymeric
`
`material and designed for a singie use, having a body dimensioned for attachment to a surface of
`
`an end portion of the bone free of an extramedullary or intramedullary alignment rod, and
`
`wherein said cutting guide, being both polymeric and disposable, is readiiy modified in
`
`successive iterations for new or customized instrumentation.
`
`Claim 19 recites, inter alia, fabricating a disposable cutting guide, designed for a singie use
`
`from a polymeric material, and modified for updated or customized instrumentation, and
`
`positioning the cutting guide through the incision and on a side surface of an end portion of the
`
`first bone before the anterior surface of said first bone is resccted, using navigation references
`
`derived from the surface of the bone to be cut, and not derived from an intramcdullary device.
`
`Accordingly, Applicant respectfully submits that independent claims 1, 13, and 19 are
`
`patentable over Coates. Claims 3 and 21 are canceled. As claims 2 and 4—12 depend from claim
`
`1
`
`; claims 14-18 depend from claim 13; and claims 20 and 22—29 depend from claim 19, these
`
`dependent claims necessarily include all the elements of their base claim. Accordingly, Applicant
`
`respectfully submits that the remaining dependent claims are allowable over Coates at icast for
`
`the same reasons.
`
`12
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`WMT 1016-12
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`WMT 1016-12
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`
`
`Applicant(s): P. Bonutti
`Application No: 10f722,102
`Examiner: P. Philogene
`
`in light of the foregoing, Applicant requests reconsideration and withdrawal of this section
`
`102 rejection.
`
`35 U.S.C. §102(e) Rejection — Haines
`
`Claims 1-37 were rejected under 35 U.S.C. §102(e) as being anticipated by Haines et a1.
`
`(6,056,754) (“Haines”). For reasons set forth below, Applicant respectfully submits that this
`
`rejection should be withdrawn.
`
`In Haines, a femur is resected by means of pattern plates having a cutting path with at least
`
`two continuous, non-coplanar guide surfaces. (Abstract). The cutting path has a similar profile to
`
`the interior profile of a femoral prosthesis. (Id). The cutting path guides a reciprocating,
`
`oscillating, or rotating cutting tool along a path for removing material from some or all ofthe
`
`distal femur to accept a distal femoral prosthesis. (1d).
`
`The apparatus of [Haines] comprises a number of components including a positioning
`
`apparatus, a pattern apparatus and a cutting apparatus, (Col. 6, lns. 35—37). Pattern plates 32
`
`include fixation apertures 34 extending therethrough for accepting fixation means, as will
`
`hereinafter be described, for affixing the pattern plates 32 to a bone. (Col. 8, lns. 59-61).
`
`The positioning body 120 comprises a frame 122 having sides 124, bottom 126 and. top 128
`
`arranged to form a frame having a rectangular aperture defined therewithini (Col. 10, lns. 19-22).
`
`The alignment apparatus 180 interconnects with the positioning body 120 by means of
`
`alignment guide body 182 which is a U-shaped member having sides 184 and a bottom 186.
`
`(Col. 1 1, lns. 2—5). The alignment guide body 182 is sized to fit within the rectangular aperture
`
`formed within the positioning body 120. (1d). The alignment plate 192 further includes rod guide
`
`aperture 197 which receives rod guide bolt 196 therethrough to interconnect the alignment plate
`
`192 with the IM rod guide 210... (Col. 11,1ns. 26-29).
`
`The 1M rod guide 210 includes 1M rod aperture 212 for receiving an {M rod therethrougb.
`
`(Col. 1 1, lns. 33-34). The EM rod guide 210 is interconnected at a forward end with the alignment
`
`plate 192 by means of plate attachment aperture 214 on the rod guide 21 O which receives rod
`
`guide bolt 196 therein after such bolt 196 passes through the alignment plate 192 to secure the
`
`13
`
`WMT 1016-13
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`WMT 1016-13
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`
`
`Applicant(s): P. Bonutti
`Appiication No: 10/722,102
`Examiner: P. Philogcnc
`
`rod guide 210 in a pivoting relationship with respect the alignment plate 192 at forward ends of
`
`the rod guide 210 and the alignment plate 192. (Id).
`
`The alignment plate 192 further includes a printed angular rotation scale which indicates the
`
`degree of angular rotation between the rod guide 220 and the alignment apparatus, and hence the
`
`angular rotation between the 1M rod and the positioning body 120. (Col.
`
`1 1, lns. 5165). After
`
`such alignment is determined, it can be locked into place by tightening down rod guide lock bolt
`
`200. (1d). Thereafter, with such angular rotation fixed, the pattern apparatus 30 can be positioned
`
`with respect to the bone to cut, and the positioning apparatus 110 can be removed from
`
`interconnection with the IM rod and the pattern apparatus 30, the 1M rod removed from the bone,
`
`and bone cutting can be initiated. (Id).
`
`Various fixation means, including those known in the art, can be used to fix the pattern
`
`plate or plates to the femur or other bone to be cut. FIG. 11 shows a preferred fixation means,
`
`generally indicated at 260. (Col. 12, lns. 23-25). The fixation means 260 includes a spike plate
`
`264 carrying on one side thereofa spike or spikes 262 for contacting, and even extending into,
`
`bone 261. (ld).
`
`Thus liaines discloses an intramedullary rod (1M rod) which serves to reference the
`
`positioning body, whereupon the latter orients the alignment guide. The alignment guide is used
`
`to position the pattern plates, which are in turn affixed to bone using conventional means. Once
`
`the pattern plates are affixed, the IM rod is removed and the bone cuts are carried out.
`
`Accordingly, while Haines does not appear to require a resection of the anterior surface of
`
`the bone prior to positioning a cutting guide, as in Coates, Haines none the less requires an
`
`intrameduliary rod, with its attendant drawbacks, including trauma to bone tissue, increased
`
`bleeding, and an increased potential for fat emboli. Further, as in Coates, Haines does not
`
`disclose a customized disposable cutting guide.
`
`Accordingly, Applicant respectfully submits that independent claims 1, 13, and 19 are
`
`patentable over Haines. Claims 3 and 21 are canceled. As claims 2 and 4—12 depend from claim
`
`1; claims 14—1 8 depend from claim 13; and claims 20 and 22-29 depend from claim 19, these
`
`dependent claims necessarily inciude all the elements of their base claim. Accordingly, Applicant
`
`i4
`
`WMT 1016-14
`
`WMT 1016-14
`
`
`
`Appiicant(s): P. Bonutti
`Application No: 10/722,102
`Examiner: P. l’hilogene
`
`respectfully submits that the remaining dependent claims are allowable over Haines at least for
`
`the same reasons.
`
`in light of the foregoing, Applicant requests reconsideration and withdrawal of this section
`
`102 rejection.
`
`New Claims
`
`Claim 38 has been added to specify, inter alia, that the cutting guide of claim 1 is
`
`disposable. Claim 39 has been added to specify, inter alia, means of aligning the cutting guide of
`
`claim 13. Support for these claims may be found in the discussion of the present invention, in
`
`support of arguments pertaining to Coates, above.
`
`Conclusion
`
`111 the light of the foregoing remarks, this application is now in condition for allowance and
`
`early passage of this case to issue is respectfully requested. If any questions remain regarding this
`
`amendment or the application in general, a telephone call to the undersigned would be
`
`appreciated since this should expedite the prosecution of the application for all concerned.
`
`No fees are believed to be due. However, please charge any required fee (or credit any
`
`overpayments of fees) to the Deposit Account of the undersigned, Account No. 500601
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`(Docket No. 780—A03—012C).
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`Respectfully submitted,
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`”Que c
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`Paul Bianeo, Reg. #43500
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`Customer Number: 33771
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`FLEIT KAlN GIBBONS GUTMAN BONGINI & BIANCO, PL.
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`21355 East Dixie Highway, Suite 115
`Miami, Florida 33180
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`Tel: 305—830-2600; Fax: 305—830—2605
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`15
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Application of: P. Bonutti
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`Confirmation No: 6375
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`Application No: 10/722,102
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`Group Art Unit: 3733
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`Filed: November 25, 2003
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`Attorney Docket No: 780~A03—012C
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`For: KNEE ARTHROPLASTY METHOD
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`Examiner: P. Philogene
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`INFORMATION DISCLOSURE STATEMENT
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`PURSUANT TO 37 CPR. § 1.56
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`Commissioner for Patents
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`Alexandria, VA 22313
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`Sir:
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`In accordance with the duty of disclosure provisions of C.F.R. § 1.56, there is hereby
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`provided certain information, which the Examiner may consider material to the examination of" the
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`subject U .S. patent application. It is requested that the Examiner make this information ofrecord if
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`it is deemed material to the examination of the application.
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`A revised Form PTO/SB/O8 listing all patents, publications, applications, or other
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`information submitted for consideration is enclosed. Copies of the listed US. Patents and Published
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`U .8. Patent Applications, are not being submitted pursuant
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`to the USPTO’s waiver of the
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`requirement of 37 CPR. § 1 .98(a)(2)(i).
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`Enclosures accompanying this Information Disclosure Statement are: (a) copy of the cited
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`foreign patent applications.
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`No admission is made that the information cited in this Statement is, or is considered to be
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`prior art. material to patentability nor a representation that a search has been made.
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`The $180.00 fee set forth in 37 CTR. §1.17 (p) in accordance with 37 CTR. §1.97 (e). The
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`required fee was paid Via Credit Card along with the Electronic Submission. The commissioner is
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`authorized to charge any additional fee required or credit any overpayment For this Information
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`Disclosure Statement to Deposit Account No. 503410 (Attorney Docket No. 780—A03—012C).
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`Dated:
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`‘ m WW.
`(’1 £2L-x
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`4”“
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`dates-r
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`Respectfully submitted,
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`w
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`
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`Paul D. Bianco (Reg. No. 43,500)
`Attorney for Applicant
`Fleit, Kain, Gibbons, Gutman, Bongini & Bianco PL.
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`21355 East Dixie Highway
`Suite 1 15
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`Miami, Florida 33180
`305-830—2600 (telephone)
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`Please lyue a plltR signm inside this box ?
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`P'I‘O/SB/OEA (10-96)
`Approved for use through 10161190. OMB 06514)th
`Patent and 'I‘I'adentar-k Ottiee: US Department oi'Cnnnnercc
`Under the Paperwork Reduction Act of I‘J95, no persons are required to respond to a collection of information unEess it contains a valid OMB control mnnher
`Substitute for form l449Ar’PTO
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` Complete If Known
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`INFORMATION DISCLOSURE STATEMENT
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`IN AN APPLICATION
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`(use as many sheets as necessary)
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`P. Philmene
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`—-—-—-_ van-Aos—mc
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`US. PATENT DOCUMENTS
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`Application Number
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`l
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`First Named Inventor
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`10/722‘ 102
`November 25, 2003
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`US, Patent Document
`Kind Code3
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`Name of Patentce or Applicant of
`Cited Document
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`Date of Publication
`ot‘Citcd Document
`MM-DD-YY
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`Page-3= Columns, Lines Where
`Relevant Passages or Relevant
`Fioure-s A
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`FOREIGN PATENT DOCUMENTS
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`Foreign Patent Document
`Date of
`Pages, Columns= Lines.
`Kind Code5
`Publication
`Where Relevant Passage-i
`Name of Patentee or Applicant of Cited
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`(ifknown)
`Dnsument
`of‘Cited
`orReievant Figures
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`Document
`Appear
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`MM-DDA’Y
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`.
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`Office3 Nnmber4
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`Examiner
`Initials
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`Dale consmered
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`initial ifreference considered. whether or not Citation is in conformance with MI’EP (309 Draw line through citation if not in confumlr'mce and not constdcrcd.
`Examiner:
`Include copy ol‘this form with next communication to applicant.
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`‘ Enter Office that issued the document, by the two—letter code t'Wll’ Standard S'l'fil‘
`' Unique citation designation numbeL 2 See attached Kinds of US, Patent Documents,
`For Japanese patent ducumentst the indication nfthe year ofthe reign nt'tltc Emperor must precede the setial ttunibcroi‘tlte patent document,
`l Kind ofdoctmtent hy the
`uppi'opl'iate symbols as indicated an the document under WIPO Standard ST‘IE ifpossihie n Applicnnt is to place a check mark her: it‘ English language 'I‘I'flnslmion is
`attached.
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`"
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`r\l1_VCE!tl'ttTlCl115 on the :mount
`Burden Hour Statement: This form is estimated to take 2.0 hours to complete. Time will vary depending upon the need: ot'the individual case,
`oftime you are required to complete this form should he sent to the Chief Information Officer. Patent and Trademark Gilles. Washingtort‘ DC 1023 ll
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`RADERMACHER
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`IIIWO9325157
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`Electronic Patent Application Fee Transmittal
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`Title of Invention:
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`Knee arthroplasty method
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`Attorney Docket Number:
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`780-A03-012C
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`Paul David Bianco/Dinah Fuentes
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`—--m-
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`Miscellaneous:
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`Total in USD ($)
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`Title of Invention:
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`Knee arthroplasty method
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`First Named Inventor/Applicant Name:
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`International Application Number: —
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`Payment information:
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`File Listing:
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`_1009094650_001.pdf
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`2243452060673660477423558b91a72
`602339985
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`483915
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`Multipart Description/PDF files in .zip description
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`Information Disclosure Statement (IDS) Filed
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`Foreign Reference
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`W093025157.pdf
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`2424384
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`3364ad588413612185695801020813502
`905b7649
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`Fee Worksheet (PTO-06)
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`fee-info.pdf
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`6224382068314de7417b41221b62464b
`09324937
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`Warnings:
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`Information
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`Information:
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`Warnings
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable.
`It serves as evidence of receipt
`similar to a Post Card, as described in MPEP 503.
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`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see
`37 CFR 1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date
`shown on this Acknowl