IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant(s): P. Bonutti
`
`Confirmation No.1 6375
`
`Application No;
`
`l0/722,l02
`
`Attorney Docket No: 780-A03—0l 2C
`
`Filed: November 25, 2003
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`Group Art Unit: 3733
`
`For:
`
`KNEE ARTH ROPLASTY METHOD
`
`Examiner: P. Philogcnc
`
`RESPONSE TO FINAL OFFICE ACTION
`
`Mail Stop AF
`Commissioner for Patents
`PO. Box 1450
`Alexandria, VA 22313—1450
`
`Dear Sir:
`
`Responsive to the Advisory Action mailed January 2|, 20l0 and in Further reply to the
`
`Final Office Action mailed September 22, 2009, please enter the following amendments and
`
`remarks into the file ofthc above-entitled application.
`
`This Response is being filed after the Final Office Action in order to place the application
`
`in condition for allowance or alternatively, in a better form for appeal. The amendments to the
`
`claims require only a cursory review by the Examiner. and thus, should be entered.
`
`In accordance with USPTO practice, each section ofthis Response begins on a separate
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`sheet. Applicant submits, these remarks serve to clarify the present invention, and are
`
`independent ofpatentability.
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`App]ieant(s): P,Bonu1n
`Application N0.: 10/722,102
`Examiner: Pi Philogcnc
`
`Amendments to the Claims:
`
`1. (Currently amended) A method of replacing at least a portion Ufa patient’s knee, the
`
`method comprising the steps of:
`
`making an incision in a knee portion ofa leg ofthe patient sized—smalletLt-han—t-he-pemen-ef
`
`
`
`determining a position ofa cutting guide using references derived independently from an
`
`intramedullary device;
`
`positioning a cutting guide using the determined position, passing the cutting guide through
`
`the expanded incision and on a surface ofa distal end portion of an unresccted femur, the cutting
`
`guide secured to the bone free of an extramedullary or intramedullary alignment rodrthe-eutt-ing
`
`moving a cutting tool through the incision into engagement with a guide surface on the
`
`cutting guide; and
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`forming at least an initial cut on the femur by moving the cutting tool along the guide
`
`surface;
`
`attaching a replacement portion ofthe knee to the cut surface, the replacement portion
`havinu a transverse dimension that is lar :er than a transverse dimension of the wide surface.
`
`
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`2. (Previously presented) The method ofclaim I wherein the surface is a medial or lateral
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`side ofthc distal end portion ofthe femur
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`3. (Canceled)
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`4. (Previously presented) The method of claim 1 wherein a computer navigation system is
`
`used in the determining step.
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`5. (Original) The method of claim I wherein the positioning step includes rcmovably
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`I‘d
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`Applieant(s): P. Bonutli
`Application No.: 10/721102
`Examiner: P. Philogcne
`
`attaching the cutting guide to the side surface ofthe distal end portion ofthe femur.
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`6. (Original) The method of 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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`7. (Original) The method of claim l wherein the guide surface comprises a plurality of
`
`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
`
`central axis ofthe femur and extends through lateral and medial condyles ofthe femur;
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`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 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 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. (Canceled)
`
`10. (Original) The method of claim 1 wherein said step ofcutting the femur includes
`
`utilizing the guide surface on the cutting guide to guide the cutting tool during making of an
`
`initial portion ofa cut in the femur, and completing the cut in the femur while guiding the cutting
`
`tool with a surface formed during making ofthe initial portion ofthe cut in the femur.
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`Applicnn1(s): P. Bonuiti
`Application N0.: lO/‘722,|02
`Examiner: P, Philogcnc
`
`ll. (Canceled)
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`12. (Previously presented) The method of claim 10 wherein the cutting guide is removed
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`from a side surface ofthe distal end portion ofthe femur after making the initial portion of the
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`cut and before completion ofthe cut.
`
`13-18. (Canceled)
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`19. (Currently amended) A method of replacing at least a portion ofajoint in apatient, the
`
`method comprising the steps of:
`
`obtaining a customized cutting guide fabricated for the patient based on preoperative and
`
`el-in-iea—l information, the cuttingguidc positionable in a pro-determined position on a bone of the
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`joint using references derived independently from an intramedullagy device;
`
`making an incision proaei-mal adjacent to the joint in the patientfihe—ineisien—si—zed—srml—ler
`
`
`
`positioning the cutting guide using in the fidetermined position[[,]] by passing the cutting
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`guide through the incision and on a surface of an end portion of an unresected bone ofthejoint;
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`moving a cutting tool through the incision into engagement with a guide surface on the
`
`positioned cutting guide;
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`cutting the unreseeted bone ofthe joint for the first time, by moving the cutting tool along
`
`the guide surface;
`
`attaching a replacement portion of the knee to the cut surface, the replacement portion
`
`having a transverse dimension that is lagger than a transverse dimension ofthe guide surface; and
`
`disposing ofthe cutting guide, as it is no longer safely usable eeuseful—in—a—sabsequent
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`pfeeedru-rertheeatting—gaidehMHg—been—eontafiunated—or the bone for which it was custom
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`fabricated having been cut and therefore changed.
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`Applieant(s): P. Bonutti
`Application N0.: 10/7211 02
`Examiner: P. Philogcnc
`
`20. (Previously presented) The method of claim 19 wherein the side surface is a medial or
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`lateral side ofthe end portion ofthe first bone.
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`21-22. (Canceled)
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`23. (Original) The method ofclaim l9 wherein the positioning step includes removably
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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
`
`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 wherein the guide surface comprises a plurality of
`
`straight guide segments.
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`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 ofthc first bone;
`
`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 chamfcr 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. (Canceled)
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`Applicant(s): P. Bonutli
`Appliealion No.2 lO/722.ll)2
`Examiner: P. Philogcnc
`
`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 tool during making ofan
`
`initial portion ofa 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
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`surface ofthe end portion of the first bone during completion of the cut.
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`30. (Original) The method of claim 29 wherein the cutting guide is removed from the side
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`surface ofthe end portion of the first bone after making the initial portion ofthe cut and before
`
`completion ofthe cut.
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`31-32. (Canceled)
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`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.
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`34. (Canceled)
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`35. (Previously presented) The method of claim 19, wherein after said step of cutting,
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`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,
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`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:
`
`
`
`
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`Applicanl(s): P. Bonutti
`Application No.: 10/721102
`Examiner: P. Philngenc
`
`aligning said cutting guide using markings on said side surface.
`
`38-39. (Canceled)
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`40. (Previously presented) The method of claim I, wherein the determining step includes
`
`adjusting the determined position to correct a deformity ofthe joint.
`
`41. (Previously presented) The method of claim 1, wherein the portion ofa patient’s knee
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`replaced is at least a portion of an articulating surface ofthe joint.
`
`42. (Canceled)
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`43. (Previously presented) A method of replacing at least a portion ofa patient’s knee, the
`
`method comprising the steps of:
`
`making an incision in a knee portion ofa leg ofthe patient;
`
`expanding the incision from an uncxpanded configuration to an expanded configuration by
`
`applying force against opposite edge portions ofthe incision;
`
`determining a position ofa cutting guide using references derived independently from an
`
`intramedullary device;
`
`positioning a cutting guide using the determined position, passing the cutting guide through
`
`the expanded incision and on a surface ofa distal end portion of an unresected bone, the cutting
`
`guide secured to the bone free of an exti‘amedullary or intramedullaiy alignment rod. 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; and
`
`forming at least an initial cut on the bone by moving the cutting tool along the guide
`
`surface;
`
`attaching a replacement portion ofthe knee to the cut surface, the replacement portion
`
`having a transverse dimension that is larger than a transverse dimension of the guide surface.
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`Applicanl(s): P. Bonutti
`Application No.1 10/722,102
`Examiner: P. Philogcnc
`
`44. (Previously presented) The method of claim 43, wherein the cutting guide is
`
`customized to a patient’s bone, and further including the step of disposing ofthc cutting guide,
`
`as the cutting guide is no longer useful as the bone for which it has been customized has been cut
`
`and thereby changed.
`
`45. (Previously presented) The method of claim 43, wherein the cutting guide is Fabricated
`
`from a plurality of cutting guide parts, and further including the step of disposing of at least one
`
`of said plurality of cutting guide parts.
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`46. (Previously presented) The method of claim 43, wherein the replacement portion ofthe
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`knee is attached without dislocating the kncejoint.
`
`47. (Previously presented) The method of claim 43, wherein the bone is cut with a mill.
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`48. (Previously presented) The method of claim 43, wherein the bone is cut using a robotic
`
`arm .
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`49. (Previously presented) The method of claim 43, wherein in said forming step, a recess
`
`is formed in the bone, and in said attaching step, at least a part ofthc replacement portion is
`inlaid into the recess.
`
`50. (Previously presented) The method of claim 43, wherein the replacement portion of the
`
`knee includes a plurality of segments having an articulating surface.
`
`51. (Previously presented) The method of claim 43. further including the step ofinscrting
`
`a guide wire in bone ofthe knee. and wherein the replacement portion ofthe knee is provided
`
`with an opening through which the guide wire is passed.
`
`52. (Previously presented) The method of claim 43, wherein the guide surface operates to
`
`capture the cutting tool within a slot.
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`Applicanl(s): P. Bonutii
`Application No.: l0/722,102
`Examiner: P. Philogene
`
`53. (Previously presented) The method of claim 43, wherein at least a portion ofthe
`
`cutting guide is polymeric.
`
`54‘ (Previously presented) The method of claim 43, wherein in carrying out the method,
`
`the quadriceps mechanism is not cut,
`
`55. (Previously presented) The method of claim 43, wherein in carrying out the method,
`
`the articulating surface ofthe patella is maintained facing the femur.
`
`56. (Previously presented) The method of claim 43, further including the step of
`
`unpacking a sterile package containing only one cutting guide.
`
`57. (Previously presented) The method of claim 43, further including the step of
`
`unpacking a sterile package containing only one each ofa cutting guide and a replacement
`
`portion ofthe kneel
`
`58. (Currently amended) A method ofreplaeing at least a portion ofajoint in a patient, the
`
`method comprising the steps of:
`
`determifimg—a—positien—fer obtaining an alignment guide positionable on a bone using
`
`references derived independently of an intramedullary device, wherein the alignment guide is
`
`custom fabricated for the patient based on patient imaging information;
`
`positioning the alignment guide using—theeletemfined—pes-itiefi in relation to the surface of
`
`an unresected bone of thejoint;
`
`referencing a cutting guide with respect to the alignment guide; gig
`
`cutting the unresected bone ofthejoint for the first time, by moving a cutting tool along a
`
`guide surface ofthe cutting guide
`
`59. (Previously presented) The method ofclaim 58, wherein the joint is a kneejoint and a
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`Applieant(s)z P. Bonutti
`Application No.: 10/722,102
`Examiner: P. Philogcnc
`
`total knee replacement is performed.
`
`60. (Previously presented) The method of claim 58, wherein referencing the cutting guide
`
`includes positioning a pin into the bone to secure the cutting guide to the bone and wherein the
`
`pin position is determined by the alignment guide.
`
`61. (Previously presented) The method of claim 58, wherein the guide surface has a width
`
`less than the width ofthe cut portion ofthe bone.
`
`62. (Previously presented) The method of claim 58, wherein thejoint is selected from the
`
`group consisting of: finger, wrist, elbow, shoulder, spine, hip, knee, ankle, toe.
`
`63. (Previously presented) The method of claim 58, wherein at least a portion ofthe
`
`articulating surface of the joint is replaced within the cut bone.
`
`64. (Previously presented) The method of claim 63, wherein the at least a portion of the
`
`articulating surface is replaced with a material selected from the group consisting of: biological,
`
`metal. composite, polymeric, ceramic, metal/ceramic, metal/polymer, polymer/ceramic,
`
`polymer/polymer. ceramic/ceramic, and ceramic/composite.
`
`65. (Previously presented) The method of claim 58, wherein thejoint has a plurality of
`
`articulating surface compartments, and at least a portion ofthe articulating surface is not
`
`replaced in all articulating surface compartments.
`
`66. (Previously presented) The method of claim 58, wherein the cutting guide or the
`
`alignment guide is passed into the body through a cannula.
`
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`Applicanl(s)z P. Bonulti
`Application No.1 l0/722,102
`Examiner: P. Philogene
`
`Remarks
`
`Claims 1-2, 4-8, .10, 12. 19-20, 23-26, 28-30, 33, 35-37, 40-41, and 43—66 are presented for
`
`the Examiner’s review and consideration. In this response, claims l, 19, and 58 are amended,
`
`and claims 13—18, 22, 34, and 39 are cancelled. Applicant believes the claim amendments and
`
`accompanying remarks serve to clarify the present invention, and are independent of
`
`patentability. No new matter has been added.
`
`35 U.S.C. q102
`
`Claims 13-18, and 39, were rejected under 35 U.SiC. §102(b) as being anticipated by
`
`Jenkins. Jr. (US. 5,722,978), and under 35 U.S.C. §102(e) as being anticipated by Mansmann
`
`(US. 6,132,468). Without prejudice and without conceding the validity ofthc rejections, in
`
`order to expedite prosecution, Applicant has herein cancelled claims 13-18, 22, 34, and 39.
`
`In light ofthe foregoing, Applicant respectfully requests reconsideration and withdrawal of
`
`the §102 rejections.
`
`With respect to comments made in the Advisory Action mailed January 4,2010, it is
`
`asserted that any device or component could be adjusted to a single patient’s bone. Applicant
`
`respectfully submits, however, that “custom fabricated” is clearly distinct from “adjusted”. As to
`
`the assertion that the claims do not define structure as to how the cutting guide is “custom
`
`fabricated for a single patient’s bone”, Applicant notes, at least, that the claims recite a custom
`
`guide fabricated based on “preoperative” or “patient imaging information", neither of which are
`
`suggested or taught by the cited references. The foregoing arguments additionally apply to the
`
`travelling guide of Mansmann.
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`| l
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`Applicant{s): P. Bonutti
`Application No.: 10/722,102
`Examiner: P. Philogcnc
`
`Amendment After Final Rejection
`
`Although the Examiner has discretion over entry of amendments submitted after final
`
`rejection, any amendment that will place the application either in condition for allowance or in
`
`better form for appeal may be entered. See MPEP 714.12. Any amendment after final rejection
`
`should require only a cursory review by the Examiner, such as an amendment cancelling claims.
`
`adopting Examiner suggestions, and/or removing issues for appeal. See MPEP 7.14.13 11.
`
`Applicant respectfully requests entry of the amendments and remarks presented herein into
`
`the file for the above-identified application.
`
`In this response. claims 13-18, 22. 34 and 39 have been cancelled. and claims 1 and 19 have
`
`been amended to incorporate subject matter from allowed claim 43.
`
`Accordingly. the claim amendments made herein are acceptable for entry as. in accordance
`
`with the guidelines. the amendments only cancel claims and incorporate allowed subject matter.
`
`Furthermore, all subject matter presented in the claims (as amended herein) has been
`
`previously presented. No new matter, which would require a further search by the Examiner, has
`been added.
`
`Based upon all the above, it is clear that the amendments made herein require only a
`
`cursory review by the Examiner. Therefore, the instant Response places the application in
`
`condition for allowance or alternatively, in a better form for appeal. and should be entered.
`
`Allowable Subject Matter
`
`Applicant acknowledges with appreciation that claims 1-2, 4-8. lO-l2, 19-20, 22-26, 28-30,
`
`33—37, 40-41, and 43-66 were allowed.
`
`12
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`Applicant(s): 1". Bonutli
`Appliealion No.1 10/722.l()2
`Examiner: P. Philogcnc
`
`Conclusion
`
`In the light ofthe foregoing remarks, this application is now in condition for allowance and
`
`early passage ofthis 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 ofthe application for all concerned.
`
`A Fee of$l,l 10 is believed to be due for a three month extension. However, please charge
`
`any required fee (or credit any overpayments offecs) to the Deposit Account ofthe undersigned.
`
`Account No. 50060] (Docket No. 780-A03-012C).
`
`Respectfully submitted,
`
`./ Paul D. Bianco/
`
`Paul D. Bianca, Reg. #43,500
`
`Customer Number: 33771
`FLEJT GIBBONS GUTMAN BONGlNl & BIANCO, FL.
`21355 East Dixie Highway. Suite 115
`Miami. Florida 33180
`Tel: 305-830-2600; Fax: 305-830—2605, pbianeo@fggbb.eom
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`sufficient postage as first class trail in an enve ope addressed to
`Filed
`'Commissionerfor Patents. PO Box 1450, Alexandria, VA 22313-
`Application Number
`November 25, 2003
`1450" {37 CFR1.B(a)]
`10/722,102
`Of‘l ——
`For KNEE ARTHROPLASTY METHOD
`Art Unit
`Examiner
`
`Signature
`
`name
`TVPEd or Printed Dir
`
`
`n Fuentes
`
`W33
`
`PHILOGENE, PEDRO
`
`Applicant hereby appeals to the Board of Patent Appeals and interferences from the last decision of the examiner.
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`Electronic Patent Application Fee Transmittal
`10722102
`Application Number:
`
`
`Filing Date:
`
` Title oflnvention:
`
`25-Nov-2003
`
`Knee arthropiasty method
`
`
`
`Peter M. Bonutti
`First Named Inventor/Applicant Name:
`
`
`Filer:
`
`Paul David Bianca
`
`780-A03»012C
`Attorney Docket Number:
`
`
`Filed as Large Entity
`
`Utility under 35 USC 1 1 1 (a) Filing Fees
`
`FeeCode
`‘
`
`Description
`
`-m
`
`Sub-Total in
`USDlS)
`
`
`
`
`
`
`
`
`Basic Filing:
`r—
`
`Pages:
`
`
`Claims:
`
`
`
`Miscellaneous—Filing:
`
`
`Petition:
`
`Patent-Appeals—and-lnterference:
`
`Notice of appeal
`
`540
`
`Extension-of—Time:
`
`
`Post-AIIowance-and-Post-lssuance:
`
`
`
`
`WMT1017-15
`
`WMT 1017-15
`
`

`

`“
`
`
`
`
`
`'
`
`Quantnym USDIS)
`
`Sub—Total in
`
`
`
`Description
`
`
`
`Extenslon 7 3 months with 30 paid
`
`
` Miscellaneous:
`
`F
`
`C d
`
`ee 0 e
`
`
`
`Total in USD (5)
`
`
`
`WMT 1017-16
`
`WMT 1017-16
`
`

`

`Electronic Acknowledgement Receipt
`
`
`7258668
`
` Application Number: 10722102
`
`
`International Application Number:
`
`
`Confirmation Number:
`
`
`
`
`Title of Invention:
`
`Knee anhroplasty method
`
`____—__——__—_.________—___l
`
`
`
`First Named lnventorlApplicant Name: Peter M. Bonutti
`
`33771
`Customer Number:
`.____—_——_————y
`Filer:
`Paul David Blanco
`
`
`Filer Authorized By:
`
`Attorney Docket Number:
`
`—__—_—____—l
`
`; 780-A03—012C
`
`
`
`
`
`
`
`
`
`Receipt Date:
`22-MAR-2010
`
`
`Filing Date:
`25-NOV»2003
`
`
`Time Stamp:
`
`Application Type:
`
`17:09:03
`
`Utility under 35 USC 111(a)
`
`
`
`
`Payment information:
`Submitted with Payment yes
`
`Credit Card
`Payment Type
`
`
`Payment was successfully received in RAM
`RAM confirmation Number
`
`
`Deposit Account
`
`Authorized User
`
`
`File Listing:
`
`Document
`File Size(Bytes)l
`
`
`Number
`Document Description
`File Name
`Message Digest
`
`Part I.zip (ifappl.)
`
`
`
`WMT1017-17
`
`WMT 1017-17
`
`

`

`
`45980
`I
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`mulxfltxbi‘di58474ulyddm44LanI%
`
`Extension ofTime
`
`extendpdf
`
`no
`
`1
`
`Warnings:
`
`195657
`
`2
`
`AppealAmendpdf
`
`yes
`
`13
`
`Wu!!!“ W440 1 Ida | Hal)!92.:9354 REM]
`3199
`
`Multipart Description/POP files in .zip description
`
`
`
`Amendmem After Final
`1
`1
`
`
`Claims
`
`Applicant Arguments/Remarks Made in an Amendment
`
`
`Warnings:
`Information:
`r
`
`2
`
`11
`
`10
`
`13
`
`
`
`
`
`
`
`
`3
`
`Notice oprpeal Filed
`
`41675
`AppealNoteipdf —____—_.
`Rhnmrmmhmaswamduumnmfll
`ahebfl
`
`no
`
`1
`
`Warnings:
`Information:
`
`3’621
`
`4
`
`Fee Worksheet (PTO-875)
`
`fee-info.pdf
`
`Ohm‘lramiiflflffiHSdfliiilfill‘MllO‘liWI
`192']
`
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`2
`
`Warnings:
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`
`3T4933
`
`Total Files Size (in bytes)+
`
`
`
`
`
`WMT1017-18
`
`WMT 1017-18
`
`