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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`A))plicztnt(sj: P. Bonutii
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`Application No; 10/721102
`Filed: November 25, 2003
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`ConfinnatinnNo.: 6375
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`Attorney Docket No: 780—A03»0l2C
`Group Art Unit- 3733
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`Per; KNEE AR‘I‘IIROPLAS’I‘YMETHOD
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`“Examiner; P.1’hilogenc
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`RESPONSE TO OFFICE ACTION
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`Mail Stop AMENDMENT
`Commissioner for Patents
`PO. Box 1450
`Alexandria VA 32313-1450
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`Dear Sir:
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`in reply to the Office Action mailed January 30, 2007, and Interview conducted
`April 10, 2007: please enter this Response into the file of the above-entitled application
`In accordance with USl-‘TO practice, each section ofthis Response begins on a separate sheet
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`Applicant submits, these amendments and remarks SBI‘VQ to clarify the present invention, and are
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`independent of patcntabiiityu
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`WMT 1014-1
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`Applicnni(s): P. Bonulti
`Application No: ”#722,102
`Examiner: P. Pliilogene
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`In The Specification
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`Please replace paragraph [0001} with the. following:
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`This application is a continuation ol‘ US patent application Serial No.
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`l0/l 91,75l filed July 8, 2002. This application is also continuation-impart of
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`LLS. patent application Serial No. 09/976,396 filed October l l, 200l. This
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`application is also coniimiation-in-paIT of US. patent application Serial No.
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`09/941,185 filed August 28., 200). This application is also a continnationvin-pari
`of US. patent upplicalion Serial ‘No. 09/566,070. This application is also a
`continuationiii—part 01’ US. patent application Serial No. 09/737,380 filed
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`December 15, 2000. This application is also a continuation-impala of US. palem
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`application Serial No. 09/569,020 filed May 1 l, 2000. This applicaiion is also a
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`continuation—in—part of U.S. patent application Serial No. 09/4833676 filed
`January 14, 2000. This application is also a continuatiouwinvpaii of US. patent
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`application Serial No. 09/798,870 filed March 1, 2-000 21311. This application is
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`also a contimialimi in part of US, patent application Serial No. 09.:’526,949 filed
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`on March 16, 2000. This application is also a continuation-in-part of US. paient
`application Serial No. 09/789,62l filed l'icbruaiy 2], 2001.
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`WMT 1014-2
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`Applicantt's): P. Bonutti
`Application No; l0/722,l02
`Examiner: P. Philogene
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`Amendments to the. Claims
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`l. (Original) A method ofpertorming surgery on a patient’s knee including a femur and a
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`tibia, the method comprising, the steps of:
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`making an incision in a knee portion of a leg of the patient;
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`positioning a cutting guide through the incision and on a side surface of a, distal end portion
`of the femur;
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`moving a cutting tool through the incision into engagement with a guide surface on the
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`cutting guide;
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`cutting the femur by moving the cutting tool along the guide surface,
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`wherein the cutting guide is positioned free ofan extramedullary or. intramedullary
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`alignment rod,
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`‘2. (Original) The method of claim 1 wherein the side surface is a medial side of the distal
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`end portion of the femur.
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`3, (Originai) ’l‘he method of claim l wherein the side surface is a lateral side oi’thc distal
`end portion of the femur.
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`4. (Original) The method oi‘elaim 1 wherein a computer navigation system is used in. the
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`positioning step‘
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`5. (Original) The method of claim 1 wherein the positioning step includes removably
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`attaching the cutting guide to the side surface of the distal end portion of the femur.
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`6. (Original) The method oiz‘claim 5 wherein the cutting guide is removably attached with
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`first and second. pins extending through holes in the cutting guide and into the femur.
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`Applicant(s): P. Bonutti
`Application No: til/722,102
`Examiner: P. Philogcnc
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`7. (Original) The method of claim 1 wherein the guide surface comprises a plurality of
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`straight guide segments.
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`8. (Original) The method of claim 7 wherein the plurality of straight guide segments
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`comprises:
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`a distal guide segment disposed in a. plane which extends perpendicular to a longitudinal
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`central axis of the femur and extends through lateral and medial eondyles ot‘ the femur;
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`an anterior chaml‘er guide segment disposed in a plane which extends at an acute angle to a
`plane containing the distal guide surface;
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`I
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`a posterior ehamfer guide segment disposed in a plane which extends at an acute angle to a
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`plane containing the distal guide surface, the plane containing the posterior chamfer guide
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`surface extending perpendicular to the plane containing the anterior chamfer guide surface;
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`an anterior guide segment disposed in a plane which extends perpendicular to a plane
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`containing the distal guide surface and extends generally parallel to a longitudinal central axis of
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`the femur; and
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`a posterior guide surface disposed in a plane which extends parallel to a plane containing
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`the anterior guide surface and perpendicular: to a plane containing the distal guide. surface;
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`9. (Original) The method ol’claim 1 further comprising the step of removing at least a
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`portion ofthe side surface prior to positioning the cutting guide such that a flattened section of
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`the side surface is created and ahuuingly engaged by a major side surface of the cutting guide
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`when the cutting guide is positioned thereon.
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`10. (Original) The method of claim l wherein said step of cutting the femur includes
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`utilizing the guide surface on the cutting guide to guide the cutting tool during making ol" an
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`initial portion olfa cut in the femur, and completing the cut in the femur while guiding the cutting
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`t00l with a surface formed during making of the initial portion ofthe cut in the femur.
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`Applieantfs): P. Bonulti
`Application No: lOl722, l 02
`Examiner:
`I! Philogcne
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`l l. (Original) The method ol‘elaim 10 wherein the cutting guide is positioned on the side
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`surface of the distal end portion of the femur during completion of thercut.
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`12‘ (Original) The method oi” claim 10 wherein the cutting guide is removed from the side
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`surface of the distal end portion of the femur alter making the initial portion of the cut and before
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`completion of the cut.
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`13, (Original) A total knee replacement cutting guide for forming a cut surface on a bone in
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`preparation to receive a totaljoint replacement component comprising:
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`a guide member having a body configured and dimensioned for attachment to a side surface.
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`of an end portion of the bone free oi‘an cxttamedullary or intramcdullaty alignment rod; and
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`at least one guide surface extending from one side of the guide member to an opposite side
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`oi‘the guide member, the at. least. one guide surface configured and dimensioned for engagement
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`with a cutting tool to thereby direct the cutting tool in making only a portion of the cut. surface.
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`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.
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`15: (Original) Thetotal knee replacement cutting guide of claim 13 wherein the at least one
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`guide surface includes a distal end surface- having opposite ends spaced apart by a distance which
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`is less than a distance that the total joint replacement component extends across the bone when
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`implanted
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`16. (Original) The total knee replacement cutting guide oi‘claim 15 wherein the guide
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`member has an aperture for receiving a pin to thereby secure the guide member to the bone.
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`Applicantds): P. Bonutti
`Application No: lO/722,l02
`Examiner: Pi Philogenc
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`17. (Original). The total knee replacement cutting guide ol’elaim 16 wherein the at least one
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`guide surface includes:
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`an anterior chaml'er guide segment disposed in a plane which extends at an acute angle to a
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`plane containing the distal guide surfacef
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`a posterior chamfer guide segment disposed in a plane which extends in an acute angle to a
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`plane containing the distal guide surface; the plane containing the posterior chamfer guide
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`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
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`containing the distal guide surface and extends generally parallel to a longitudinal central axis of
`the femur; and
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`a posterior guide surface disposed in a plane which extends parallel to a plane containing
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`the anterior guide surface and perpendicular to a plane containing the distal guide surface.
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`18. (Original) The total knee replacement cutting guide of claim 16 wherein the cutting
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`guide is a non—captured cutting guide.
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`1/.
`19. (Original) A method ot’perlionning surgery on a joint in a patient including a first bone
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`and a second bone, the method comprising the steps of:
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`making an incision proximal to thejoint in the patient;
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`positioning a cutting guide through the incision and on a side surface of an end portion of
`the first bone;
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`moving a cutting tool through the incision into engagement with a guide surface on the
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`cutting guide;
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`cutting the first bone by moving the cutting tool along the guide surface,
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`wherein the cutting guide is positioned free of an extramedullaiy or intrarnedullary
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`alignment rod.
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`Applicantis): P. Bonutti
`Application No.: [01722,102
`Examiner: P. Philogenc
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`20. (Original) The method of claim l9 Wherein the side surface is a medial side of the end
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`pon'ion of the first bone.
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`2]. (Original) The method of claim 19 wherein the side surface is a lateral side of the end
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`portion of the first bone
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`22. (Original) The method of claim 19 wherein a computer navigation system is used in the
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`positioning step.
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`23. (Original) The method ofclaiin l9 wherein the positioning step includes reinovahly
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`attaching the cutting guide to the side surface of the end portion of the first bone.
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`24. (Original) The method of claim 23 wherein the cutting guide is removably attached
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`with first and second pins extending through holes in the cutting guide and into the first bone.
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`25. (Original) The method of claim 19 whereinthe guide surface comprises a plurality of
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`straight guide segments.
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`26. (Original) The method of claim 25 wherein the plurality of straight guide segments
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`comprises:
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`a distal guide segment disposed in a pitine which extends perpendicular to a. longitudinal
`central axis of the first bone;
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`an anterior chemt‘er guide segment disposed in a plane which extends at an acute angle to a
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`plane containing the distal guide surface;
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`a posterior chaml'er guide segment disposed in a plane which extends at an acute angle to a
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`plane containing the distal guide surface, the plane containing the posterior chaxnfer guide
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`surface extending perpendicular to the plane containing the anterior chamt‘er guide surface;
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`WMT 1 014-7 _.............
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`WMT 1014-7
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`Applicanfis): P. Bonutti
`Application No.: 10/722,102
`Examiner: P. Philogcnc
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`an anterior guide segment disposed in a plane which extends perpendicular to a plane
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`containing the distal guide surface and extends generally parallel to a longitudinal central axis of
`the first bone; and
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`a posterior guide surface disposed in a plane which extends parallel to a plane containing
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`the anterior guide surface and perpendicular to a plane containing the distal guide surface,
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`27. (Original) The method of claim l9 further comprising the step of removing at least a
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`portion ofthe side surface prior to positioning the cutting guide such that a flattened section of
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`the side surl’ace is created and nbuttingly engaged by a major side surface 01’ the cutting guide
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`when the cutting guide is positioned thereon.
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`28. (Original) The. method of claim i9 wherein said step of cutting the first bone includes
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`utilizing> the guide surface on the cutting guide to guide the cutting tool during making of an
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`initial portion ot’a cut in the first bone; and completing the cut in the first bone while guiding the
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`cutting tool with a surface formed during making of the initial portion of the cut in the first bone,
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`29. (Original) The method of claim 28 wherein the cutting guide is positioned on the side
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`surface of the end portion of the first hone during completion of the out.
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`30. (Original) The method ol’claim 29 wherein the cutting guideis removed from thc side
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`surface of the end portion of the first bone after making the initial portion of the cut and before
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`completion of the cut
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`3 l . (New) The method of claim 1, wherein said incision is between about seven and about
`thirteen centimeters.
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`Applicnnds): P. Bonuui
`Application No: l()/722, I 02
`Examiner: P. Philugenu
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`32. (New) The method elf claim 1, where said positioning 5th further includes the step of
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`using, light beams.
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`33. (New) The method ofelaim 1., \evherein in said step ofmaking an incisiom said incision
`is offset from the center of said knee area.
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`34. (New) The method of claim 13, wherein said at least one guide. surface includes a guide
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`surface corresponding to each guide surface required by saidjoint replacement component.
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`35‘ (New) The method oi‘claim 19, wherein after said step of cutting, further including the
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`steps of:
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`removing said cutting guide; and,
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`guiding said cutting tool using cuts formed in said cutting step to complete said cuts.
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`36. (New) The method of claim 19, wherein in said step of positioning, said cutting guide
`is sized. smaller than said side surface.
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`37‘ (New) The method ofclaim l9, wherein after said siep Uifpositioning, further including
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`the step of:
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`aligning said cutting guide using markings on said side surface.
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`Applicantt’s): P. Bonutti
`Application No; tO/722.I02
`Examiner: Pr Philogene
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`Remarks
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`Claims l—37 are presented for the Examiner‘s review and consideration. In this response,
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`claims 3l—37 have been added. Applicant believes the claim amendments and the accompanying
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`remarks, herein, serve to clarify the present invention and are independent of patentability. No
`new matter has been added.
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`An Applicant Initiated Telephonie interview with the Examiner was conducted on
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`April 10, 2007, In accordance with MPEP §7l 3.04, the substance of the interview was as
`lollows:
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`A) No exhibits were shown or demonstrations conducted.
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`B) Claims 3, 13 and )9 were discussed.
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`C) Prior art reference Masini (6,500,179) was discussed.
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`D) It was agreed that Masini was not directed to a cutting block positioned on a side surface
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`of the femur, and that Masini required Intra and Extramedullary alignment means, particularly
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`with respect to the initial resection of the distal end of the femur, requiring 1M means, and EM
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`means l20, 124, 160. Accordingly, it was agreed that the reference was overcome. 11 was further
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`agreed that the next Office Action would not be Final since no claim amendments were necessary
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`in order to overcome the rejection.
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`B) Arguments were substantially as described for item “D", above.
`F) No other pertinent matters were discussed with respect to this application, Other
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`applications were discussed during the interview, the substance of which will be detailed in
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`responses in the respective applications.
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`G) Results were as described in “D", above.
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`ll) The interview was not conducted by email,
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`Applicant(s): P.13onuui
`Application No.: 10/722,103
`Examiner: P.1’hilogcnc
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`35 U.S.C.
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`102 e Reactions
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`Claims 1—30 were rejected under 35 USO. §102(c) as being anticipated by Masini
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`(6,500,179) (“Masini”). For reasons set forth below, Applicant respectfully submits that this
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`rejection should be withdrawn.
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`The reiceiion states that Masini shows a guide having a body configured and dimensioned
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`for attachment to a side surface oi‘an end portion of a bone 130. Applicant respectfully submits
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`that cited reference 130, shown in Fig, 1, refers to the whole bone, generally. in the Specification,
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`and in all oi‘rhe figures of Masini, the guide is shown and described as being attached to the end
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`of the bone only. Accordingly, this element ol'thc claimed invention is not met by the disclosure
`of Masini.
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`Funhcr, the rejection states that Mzisini shows at least one guide surface (106,108.1 10.1.1.2)
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`extending from one Side of the guide member to an opposite side of the guide member. However,
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`in the specification and in all ofthe figures of Masini, the guide slots do not extend from one side
`of the guide to the other; rather none ofthe guide slots extend through the center portion 01' the
`device. Accordingly. this element ofthc claimed invention is also not met by the disclosure of
`Masini.
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`Masini discloses a device incmporating a plurality of cutting guides, wherein at least one of
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`the guides is used to resect or otherwise modify a bone to receive a prosthetic element... (Col. - l ,
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`1115. 50-52). ...ihe guides lake the form of parallel, spaced-apart slots extending through at least a
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`portion ofthe body... (Col. 2, ins. 3-4). ...With reference to fig.
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`1 of Masini, the device 102
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`optionally further includes a posterior gauge 120 coupled to a member 122, and an anterior gauge
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`124 coupled to a member 126. (Col. 3, ins. 17-19). With reference to fig. 2 of Masini, the
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`members 122 and 126 preferably interlock within the body of the block 104, with a manually
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`operated fastener 128 being used to compress the gauges while compressivcly urged against
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`respective protrusions ol‘a bone 130. (1d).
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`Applicantts): P, Bonutti
`Application No; l0/722.l02
`Examiner: P. Philogenc
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`With reference to fig. 3 ofMasini, ...the guide block preferably features a smooth, planar
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`backside 330, enabling the device to be positioned against a previously prepared surface such as
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`a resected distal surface. (Col. 3, lns. 49-5l). To assist in positioning subtle adjustments may be
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`achieved by moving the guide body with a fine control knob 140 which, as shown in fig. 2 ol‘
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`Masini, couples to a rod 242 and toothed element 244. (Col. 3, ins. 57-60). The element 244, in
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`turn, interacts with teeth 246 to move the entire block [up--'?] and down relative to the bone when
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`held in place by gauges 120 and l24 upon being tightened using fastener 128. (Id). Readouts 150
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`and 152 may be provided fora visual indication oi’clcment size selection, and/or one or more
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`additional “feeler gauges” such as element 160 may be used to make contact with an appropriate
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`portion ofthe bone indicative of a particular implant size. (Col. 3, 111.67 — Col. 4, in. 4).
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`Thus, Masini does not disclose or suggest a guide member free ofextramedullary or
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`intramedullary alignment means. Rather, Masini discloses anterior and posterior gauges
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`extending from the block and interlocking within the block, operative with a fine control knob
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`and gear. There is not suggested other means by which the block is positioned. Moreover, the
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`block of Masini is positioned against a flat distal end of the bone, which in the prior art, requires
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`an intramedullary device for its creation.
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`Additionally, as discussed above, Masini doesnot disclose or suggest a guide member
`positioned on a side surface ol’an end portion ol’ a bone, nor does’Masini disclose or suggcst a
`guide surface extending from one side of the guide member to an opposite side of the guide
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`member.
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`I
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`In contrast, the present invention relates to a new and improved method of performing
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`surgety, and instruments, implants, and other surgical implements that can be used in surgery.
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`(Background). Regardless of the type oi‘surgety to be performed, a limited incision may
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`advantageously be utilized. (id). The incision 114 is movable relative to the distal end portion
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`124 of the femur 126 to maximize exposure of the femur through the limited length of the
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`incision. (M01741). ...tbe minimally invasive surgical instruments, implants, systems, and
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`methods disclosed herein represent a significant deviation from those used in open surgical
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`procedures... (M07140.
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`/\ppttcant(s): P. Bonntti
`Application No.2 10/722,102
`Examiner: 'Pi Phiiogcnc
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`Although any one ofmany known surgical procedures may be undertaken through the
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`limited incision, down sized instrumentation for use in the making ofcuts in a femur and/or tibia
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`may be moved through or part way through the incision. (1i[0013]) The down sized
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`instrumentation may be smaller than implants to be positioned in the knee portion of the
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`patient. (Id).
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`With reference to Fig. S4 of the present invention ..a femoral cutting guide 800 is
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`illustrated as being mounted on a lateral surface 802 ol’the femur 126, (1][0494D- However, the
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`femoral cutting guide 800 could be mounted on the medial surface of the femur 126 if
`desired. (1d).
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`‘
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`it is contemplated that the down sized instrtunent‘ation may have cutting tool guide surfaces
`of reduced length. (1[[0014]). The length of the cutting tool guide surfaces may be less than the
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`icng’th of a cut to be made on a bone, (Id). A cut on a bone in the patient may be completed using
`previously cut surfaces as a guide for the cutting tool. (id).
`As such, the present invention provides a means For cutting bone, where the guide member
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`is tree of extramedullary or intramedullary members. As noted above, Masini l‘ails’to disclose a
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`guide member Free of extra or intramodullary members, a guide used on a side surface ot‘a bone,
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`or a guide with a surface extending from one side of the guide to an opposite side.
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`Claim 1 recites, inter cilia, A method of performing surgery on a patient’s knee including a
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`femur and a tibia, the method comprising the steps of: making an incision in a knee portion of a
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`leg of the patient; positioning a cutting guide through the incision and on a side surface ol’a distal
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`end portion of the femur; moving a cutting. tool through the incision into engagement with a
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`guide surface on the. cutting guide; cutting the femur by moving the cutting tool along the guide
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`surface, wherein the cutting guide is positioned free ofan extramedullary or intramcdnllary
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`alignment rod.
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`Claim 13 recites, inter alia, a total knee replacement cutting guide for forming acut. surface
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`on a bone in preparation to receive a total joint replacement component comprising: a guide
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`member having a body configured and dimensioned for attachment to a side surface of an end
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`portion of the bone free of an extramedullary or intramedullary alignment rod; and at least one
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`AppiiCfllli(S)i P. Bonurti
`Application No: iii/722.102
`Examiner: 1?.Philogene
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`guide surface attending from one side of the guide member to an opposite side of the guide
`member, the at least one guide surface configured and dimensioned for engagement with a
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`cutting tool to thereby direct the cutting tool in making only a portion of the cut surface.
`Claim 19 recites, inter (film, a method ot‘pert‘orminr,f surgery on ajoint in a patient including
`a first bone and a second hone, the method minimising the steps of: making an incision proximal
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`to thcjoint in the patient; positioning, a cutting guide through the incision and on a side surface of
`an end nation of the first hone; moving a cutting tool through the incision into engagement With
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`a guide surface on the. cutting guide; cutting the first bone by moving the cutting tool along the
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`, guide surface, wherein the cutting guide is positioned free of an extramedullury or intrmnedullar)’
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`alignment rod.
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`Accordingly, applicant respectfully submits that independent claims 1, 13, and 19 are
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`patentable over Masini. As claims 2-12 depend from claim I; claims 14- 18 depend from claim
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`13; and claims 20—29 depend I‘rom claim 19, these dependent claims necessarily include all the
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`elements oftheir base claim, Accordingly, Applicant respectfully submits that the dependent
`cl aims are Allowable over Masini for the same reasons.
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`In light ot‘the foregoing, Applicant requests reconsideration and withdrawal o't‘the section
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`102 rejection.
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`Applicant.(s): P, Bonuui
`Application No: 10/722.102
`Examiner:
`i’. l’hilogcnc
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`Qpnclusion
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`in the light of the [foregoing remarks, this application is now in condition for allowance and
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`early passage of this case to issue is respectfully requested if any questions remain regarding this
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`amendment or the application in general, a telephone call to the undersigned would be
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`appreciated since this should expedite the prosecution of the application for all concerned.
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`A fee of 335015 believed to he clue for 7 additional dependent claims. A credit card
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`payment form is being submitted herewith. However, please charge any required fee (or credit
`any overpaymenls of fees) to the Deposit Acohunt of the undersigned, Account No. 50060]
`(Docket No. 780-A03~0l2C).
`
`Respectfully submitted,
`
`Paul Bianco, Reg. #113,500
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`Customer Number: 33771
`PLEIT RAIN GIBBONS GUTMAN BONGINI & BLANCO, P.L.
`2l355 East Dixie Highway, Suite 115
`Miami, Florida 33180
`Tel: 305-830—2600: Fax: 305-830-2605
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`Electronic Patent Application Fee Transmittal
`10722102
`Application Number:
`
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`25vNOV-2003
`Filing Dale:
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`Title of Invention:
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`Knee arthroplasly melhod
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`
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`First Named inventor/Applicant Name:
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`
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`Paul David Bianca/Dinah Fuentes
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`Attorney Docket Number:
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`780-A03-012C
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`__l
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`Filed as Large Entity
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`Utility
`Filing Fees
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`Filer: Peter M. Bonutti
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`
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`Description
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`V]
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`Fee Code
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`Qua ntity
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`Sub-Total in
`USD($)
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`V"—
`Basic Filing:
`
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`Pages:
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`Claims:
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`Claims in excess of 20
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`Miscellaneous-Filing:
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`Petition:
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`Pate nt-Appeals-and-Interierence:
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`Post~Allowanoe~and~Post-lssuanoez
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`Extension-of—Time:
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`Description
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`Fee Code
`Quantity
`Amount
`SUB—813:; m
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`Miscellaneous:
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`L
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`Total in USD ($)
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`350
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`Electronic Acknowledgement Receipt
`EFS ID:
`I 17269397
`Application Number:
`1 10722102
`
`International Application Number:
`x
`
`6375
`(I
`_
`Confirmation Number:
`
`Title of invention:
`
`Knee arthroplasty method
`
`
`
`
`
`
`Peter M. Bonutli
`First Named inventor/Applicant Name:
`
`Customer Number:
`33771
`
`
`Filer:
`Paul David Bianco/Dinah Fuentes
`
`Filer Authorized By:
`Paul David Bianco
`
`‘1-——l
`Attorney Docket Number:
`780~A03v012C
`
`
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`Receipt Date:
`30-APR-2007
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`
`
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`Filing Déte:
`25-Nov-2003
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`
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`Time Stamp:
`11:08:57
`
`
`Application Type:
`Utility
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`
`
`Payment information:
`
`Submitted with Payment
`yes
`
`
`Payment was successfully received in RAM
`$350
`RAM confirmation Number
`1895
`
`Deposit Account
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`7
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`File Listing:
`Pages
`Multi
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`Document
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`WMT1014-18
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`WMT 1014-18
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