OK TO ENTER: EMHJ‘
`
`[N THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant: P. Bonutti
`
`Confirmation No: 356?
`
`Application No.:
`
`|0f684.904
`
`Attorney Docket No: 780-A03—OIZB
`
`Filed: October 14,2003
`
`For: KNEE ARTHROPLASTY METHOD
`
`Group An Unit: 3733
`
`Examiner: M. Hoffman
`
`RESPONSE TO OFFICE ACTION
`
`Mail Stop AF
`Commissioner For Patents
`PO. Box 1450
`Alexandria, VA 223 | 3-1450
`
`Dear Sir:
`
`In response to the Final Office Action mailed March IS, 2009, please enter this Response
`
`into the file ofthe above-entitled application.
`
`In accordance with LJSPTO practice, each section ofthis Response begins on a separate
`
`sheet. Applicant submits, these amendments and remarks serve to clarify the present invention,
`
`and are independent of patcntability.
`
`S&N EXHIBIT 1024
`
`S&N v. BSI
`
`|PR2013-00629
`
`S&N EXHIBIT 1024
`S&N v. BSI
`IPR2013-00629
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant: Pt Bonutti
`
`Confirmation No; 3567
`
`Application No; 10.t684,904
`
`Attorney Docket No: 780~A03-0128
`
`Filed: October I4, 2003
`
`For:
`
`KNEE ARTHROPLASTY METHOD
`
`Group Art Unit: 3733
`
`Examiner: M. Hoffman
`
`RESPONSE TO FINAL OFFICE ACTION
`
`AND RES QUEST FOR CONTINUED EXAMINATION
`
`PURSUANT TO 37 CPR. §l.l 14
`
`Mail Stop RCE
`Commissioner for Patents
`PO. Box I450
`Alexandria, VA. 22313-1450
`
`Dear Sir:
`
`Introductory Comments
`
`In response to the Office Action mailed March 18. 2009. and Advisory Opinion mailed
`
`June 30. 2009. Applicant requests continued examination pursuant to 37 C.F.R. §l.ll4, Please enter
`
`the following amendments and remarks into the file for the abOve-idcntified application. This
`
`response replaces the response filed June IS, 2009.
`
`In accordance with USPTO practice each section ofthis Response begins on a separate sheet.
`
`Applicant submits, this response serves to clarify the present invention, and is independent of
`
`patentability.
`
`

`

`Applicant: P. Bonulti
`Applieat ion No.: |0I684304
`Examiner: M. Hoffman
`
`Amendments to the Claims:
`
`I. (Currently amended) A method ofperforming a knee arthroplasty surgery on a leg oFa
`
`patient, comprising:
`
`making an incision in a knee portion ofthe leg having a length not more than 13 cm:
`
`displacing a patella in the knee portion ofthe leg from a normal position to an offset
`
`position with an inner side ofthe patella facing inward; and
`
`positioning a cutting tool proximal to at least one of an upper or a lower portion ofthe leg
`
`and cutting bone ofthc leg while the patella is maintained offset From a normal position and not
`evened.
`
`2. (Canceled)
`
`3. {Previously presented) The method ofclaim 1, further comprising:
`
`expanding the incision by applying a Force against opposite edge portions oftlie incision,
`
`wherein the displacement of the patella from the normal position to the offset position is
`
`performed contemporaneOusly with the expanding of the incision.
`
`4. (Original) The method ofelaim I. further comprising cutting an end surface of at least
`
`one of the upper or lower portions of the leg.
`
`5. (Previously presented) The method of claim 4 comprising:
`
`mmring at least one implant through the incision while the patella is offset from the normal
`
`position with the inner side ofthe patella facing inward; and
`
`connecting the at least one implant with the cut end portion ofat least one ofthe upper or
`
`lower portions ofthe leg.
`
`6. (Original) The method of claim I, further comprising connecting a guide member to at
`
`least one of the upper or lower portions of the leg.
`
`
`
`

`

`Appiicant: P. Bonutti
`Applienlion No.: I 036341.904
`Examiner: M. Hol'l‘man
`
`7. (Original) The method ofelaim 6, wherein the guide member is connected to the upper
`
`portion ofthe leg. the upper portion being a femur, the guide member including a first end
`
`portion in engagement with a lateral condyle ofthe femur, the first end portion offset medially
`
`From a lateral edge portion ofthe lateral condyle, and a second end portion in engagement with a
`
`medial condyle ofthe femur, the second end portion offset laterally From a medial edge portion
`
`ofthc medial condylc.
`
`8. (Original) The method ofclairn 7. further comprising cutting the lateral and medial
`
`condyle ofthe femur.
`
`9. (Previously presented) The method ofclairn 8, further comprising:
`
`moving at least one femoral implant through the incision while the patella is offset from the
`
`normal position with inner side ofthe patella Facing inward; and
`
`connecting the at least one femoral implant with the cut lateral and medial eomlyle ofthe
`femur.
`
`10. (Currently amended) A method of performing a knee arthroplasg surgery on a leg ofa
`
`patient, comprising:
`
`making an incision in a knee portion ofthc leg hawng—a—l-ength—oet—more—than—l—Er—em;
`
`displacing a patella in tire knee portion of the leg from a normal position to an offset
`
`position with an inner side of'the patella Facing inward;
`
`ponitioning a cutting tool proximal to at least one ofan upper or a lower portion ofthe leg;
`
`and
`
`connecting a guide member to at least one of the upper or lower portions of the leg; wherein
`
`the guide member is connected to the lower portion ofthe leg, the lower portion being a tibia;
`
`cutting a bone ofthc knee portion ofthc legI while the mtclla i; maintained in the offget
`
`position, and while no bone of the knee extends to pass outside the patient‘s bod): through said
`
`incision, until cut and removed from the ioint.
`
`
`
`

`

`Applicant: P. Bonulli
`Application No; l0:'684.904
`Examiner: M. Hoffman
`
`ll.(0riginal) The method ofclaim 10‘ further comprising cutting an end surface ofthc
`
`tibia.
`
`l2. (Original) The method of claim I 1. further comprising:
`
`moving at least one tibial implant through the incision while the patella is offset from the
`
`normal position with the inner side ofthe patella facing inward; and
`
`connecting the at least one tibial implant with the cut end portion ofthe tibia.
`
`[3. (Original) The method oF claim I. further comprising:
`
`moving a guide member into the incision, the guide member including Opposite ends spaced
`
`apart by a distance which is less than a distance between a lateral epicondyle and a medial
`
`cpicondyle on a femur;
`
`positioning the guide member on the femur in the leg ofthe patient with the opposite ends
`
`ofthe guide member aligned with an axis through the lateral and medial epieondyles;
`
`positioning the cutting tool 0n the guide member; and
`
`moving the cutting tool along a guide surface on the guide member to cut the lateral and
`
`medial epicoudyles on the Femur.
`
`[4. (Previously presented) The method ofelaim 13, further comprising:
`
`moving at least one femoral implant through the incision while the patella is offset From the
`
`normal position will: the inner side ofthe patella facing inward; and
`
`connecting the at least one Femoral implant with the cut lateral and medial cpieondyles of
`the femur.
`
`l5. (Previously presented) The method ofclaim l3, Further comprising:
`
`cutting the inner side oFthe patella in the knee ponion of the leg? wherein the inner side of
`
`the patella faces towards a posterior portion of‘ the knee portion of the leg and includes removing
`
`at least a portion ofthe inner side ofthe patella.
`
`

`

`Applicant: P. Bonutti
`Application No; l0i6843fl4
`Examiner: M. Hotl'man
`
`16: (Currently amended) A method of'pcrforming a joint arthroplastg surgery on a leg of'a
`
`patient, comprising:
`
`making an incision in a knee portion ofthe leg;
`
`displacing a patella in the knee portion of the leg from a normal position to an offset
`
`position with an inner side of the patella facing inward:
`
`
`.ositionin 1' a
`uicle assembl
`I‘oximall
`to the
`atella the uideas‘embl
`includin a air
`
`ofsubstantiall
`arallel arms and a slot havin ! a
`uide surface conl'i Itired f'or receivin a atella
`
`
`
`
`
`cutting tool;
`
`cutting the inner side oftlte patella, us inp the guide assembly, in the knee portion ofthe leg,
`
`prior to resecting the femur or the tibig, wherein while the inner side of the patella faces towards
`
`a posterior portion ofthe knee portion ofthe leg, and includes removing at least a portion ofthe
`
`inner side ofthe patellzteand
`
`
`
`17. (Original) The method of claim to. wherein positioning the guide assembly comprises
`
`extending a first parallel arm under a superior aspect ofthe patella and a second parallel arm
`
`under an inferior aspect ofthe patella. such that the guide surface is aligned with the patella.
`
`l8. (Original) The method of claim 15, Further comprising:
`
`moving at least one patella implant through the incision; and
`
`connecting the at least one patella implant to the cut inner side of the patella.
`
`[9. (Currently amended) A method ofperfon'ning a knee anhrgplasgy surgery on a leg of'a
`
`patient. comprising:
`
`making an incision in a knee portion of the legWWW;
`
`displacing a patella in the knee portion ofthe leg from a normal position to an offset
`
`position with an inner side of‘the patella Facing inward;
`
`

`

`Applicant: P. Bonutli
`Application No: 10i684‘904
`Examiner: M, Hoffman
`
`positioning a cutting tool proximal to at least one ofan upper or a lower portion ofthe leg;
`
`cutting the inner side ofthe patella in the knee portion ofthe leg, wherein the inner side of
`
`the patella faces towards a posterior portion ofthe knee portion of the leg and includes removing
`
`at least a portion ofthe inner side ofthe patella, while no bone ofthe joint extends to pass
`
`outside the body through said incision, until cut and removed from the joint; and
`
`wherein the inner side ofthe patella is cut prior to displacing the patella fi‘om the normal
`
`position to the offset position.
`
`20. (Original) The method ofelaim 19, further comprising:
`
`moving at least one patella implant through the incision prior to displacing the patella From
`
`the normal position to the offset position; and
`
`connecting the at least one patella implant to the cut inner side ofthe patella prior to
`
`displacing the patella from the normal pesition to the offset position.
`
`2] . (Currently amended) A method of performing a knee arthroplasy surgery on a leg ofa
`
`patient, comprising:
`
`_
`making an incision in a knee portion ofthe leg;
`displacing a patella in the knee portion ofthe leg from a normal position to an offset
`
`position with an iltncr side ofthe patella facing inward; and
`
`positioning a cutting tool proximal to at least one of an upper or a lower portion ofthe leg;
`
`and
`
`supporting the patient with the lower portion ofthe leg suspended from the upper portion of
`
`the leg. wherein the lower portion remains suspended from the upper portion while the incision
`
`is made in the knee portion ofthe leg and the patella is moved to the offset position with the
`
`inner side of the patella facing inward.
`
`
`
`

`

`Applicant: P. Bonulti
`Application No; l'lla’634304
`Examiner: M. Hol‘l‘man
`
`22. (Original) The method ofclaim I, further comprising;
`
`moving a leading end ofan endoscope through the incision to a posterior portion ofthe
`
`knee portion ofthe leg ofthc patient; and
`
`inspecting the posterior portion ofthe knee portion of the leg, including viewing the
`
`posterior portion ofthe knee portion through the endoscope.
`
`23. (Currently amended) A method of performing a knee arthroplastx surgery on a leg ofa
`
`patient, comprising:
`
`making an incision in a knee portion ofthe lcg having a length not more than 13 cm;
`
`displacing a patella in the knee portion ofthe leg from a normal position to an offset
`
`position with an inner side ofthe patella facing inward;
`
`positioning a cutting tool proximal to at least one of an upper or a lower portion of the keg.
`and euttinI
`n ofthele while th
` atella is in the offset 0 'ition;
`
`
`
`
`moving a leading end of an endoscope through the incision to a posterior portion ofthe
`
`knee portion ofthe leg ofthc patient;
`
`inspecting the posterior portion ofthe knee portion ofthe leg, including viewing the
`
`posterior portion of the knee portion through the endoscope; and
`
`moving the leg of the patient between a flexed condition and an extended condition,
`
`wherein the posterior portion ofthe leg is viewed, at least partially, during movement ofthe leg
`
`of the patient between the flexed and extended conditions.
`
`24. (Previously presented) The method ofclaim 1, further comprising:
`
`initiating a cut with the cutting tool along an end portion of at least one ofthe upper or
`
`lower portions ofthe leg to define a cutting surface; and
`
`completing the cut while guiding the cutting tool along the cutting surface Formed during
`
`making ofthe initial cut in an end portion ofat least one ofthc upper or lower portions ofthc
`
`leg.
`
`
`
`

`

`Applicant: P. Bonulli
`Application No.: loi'684.904
`Examiner: M. Hoffman
`
`25. (Currently amended) A method ofpcrforming a knee arthroplastx surgery on first and
`
`second portions ofa leg ofa patient. comprising:
`
`making an incision in a knee portion ofthe leg having a length not more than 13 cm, the
`
`length shorter than the combined width ofsaid first and second portions of' the leg;
`
`displacing a patella in the knee portion of the leg from a normal position to an offset
`
`position with an inner side of'the patelia facing inward;
`
`positioning a cutting tool proximal to at least one ofan upper or a lower portion ofthe leg;
`
`exposing the first portion ofthe leg through the incision and performing surgery on the first
`
`portion;
`
`effecting relative movement between the upper and lower portions ofthe leg, thus exposing
`
`the second portion ofthe leg through the incision, thereby enabling surgeryeutting bone ofthe
`
`l_eg on the second portion through the incision while maintaining the patella in the offset
`
`position.
`
`26. (Currently amended] A method of performing a knee arthroplasu surgery on a leg ofa
`
`patient, comprising:
`
`making an incision in a knee portion ofthe leg having a length not more than l—3—em M
`
`twice the length ofthe patella;
`
`displacing a patella in the knee portion ofthe leg from a normal position to an offset
`
`position with an inner side ofthe patella facing inward;
`
`positioning a cutting tool proximal to at least one oFan upper or a lower portion oFthe leg;
`
`and
`
`providing an output signal which is a function of tension in a ligament extending between
`
`bones in the leg ofthe patientflti
`ctltlin ’ bone ofthe le I while mainlainin I the atella in the offset .05ition.
`
`2?. (Original) A method as set Forth in claim 26, wherein providing the output signal
`
`comprises:
`
`positioning a transducer between the ligament and a bone in the knee portion ofthe leg; and
`
`
`
`

`

`Applicant: P. llonutli
`Application No: 103684.904
`'
`Examiner: M. HoiTinan
`
`providing an output signal which varies as a function ofvariations in force applied against
`
`the transducer during relative movement between the upper and lower portions ofthe leg.
`
`28. (Original) The method ofelaim I. wherein making the incision in the knee portion of
`
`the leg comprises making the incision adjacent to a medial edge portion ofthe patella.
`
`29. (Original) The method of claim 1, wherein making the incision in the knee portion of
`
`the leg comprises making an incision having a length between about seven and thirteen
`centimeters.
`
`30. (Currently amended) A method of performing a knee arthroplastx surgery on a leg of a
`
`patient, comprising:
`
`making an incision in a knee portion ofthe leg having a length not more than 13 em;
`
`displacing a patella in the knee portion ofthe leg from a normal position to an offset
`
`position with an inner side ofthe patella facing inward;
`
`positioning a cutting tool proximal to at least one of an upper or a lower portion ofthe leg;
`
`and
`
`wherein displacing the patella from the normal position to the ol‘fSet position comprises
`
`moving the patella laterally relative to the knee portion ofthe leg; and
`
`cutting bone of the knee portion ofthe leg while maintaining the patella in the pffspt
`
`position.
`
`3]. {Currently amended) A method of performing a knee arthroplasty surgery on a leg ofa
`
`patient, comprising:
`
`making an incision in a knee portion of the leg ofthe patient having a length not more than
`
`H—em a distance between about the proximal end of the tibia to about the epieondglar notch on
`
`the distal end portion of the femur;
`
`displacing the patella from the normal position to an offset position with an inner side of
`
`the patella facing inward; and
`
`

`

`Applicant: P. Bonulti
`Application No; i0f684304
`Examiner: M. Holfimm
`
`cutting an inner side portion ofa patella in the knee portion ofthe leg. the patella being
`=-=_—
`
`
`
`32. (Original) The method of'elaim 3]. Further comprising:
`
`moving at least one patella implant through the incision; and
`
`connecting the at least one patella implant to the cut inner side ofthe patella.
`
`33. (Original) The method of‘elaim 32, wherein the at least one patella implant is
`
`connected to the patella prior to displacing the patella from the normal position to the offset
`
`position.
`
`34. (Original) The method ofelaim 31, Further comprising positioning a cutting tool
`
`proximal to at least one ofthe upper and lower portions oflhe leg.
`
`35. (Original) The method of claim 34. further comprising cutting an end surface of at least
`
`one of an upper and lower portions ot‘the leg.
`
`36. (Original) The method of claim 35, Further comprising:
`
`moving at least one implant through the incision while the patella is offset from the normal
`
`position with the inner side of'the patella facing inward; and
`
`connecting the at least one implant with the cut end portion of at least one ofthe upper and
`
`tower portions oft'ne knee portion ofthc leg.
`
`37. (Original) The method of'elaim 35. wherein the upper portion ofthe leg is a femur and
`
`lateral and medial eondyles ofthe femur are cut.
`
`38. (Original) The method of claim 37. fithher comprising:
`
`10
`
`

`

`Applicant: P. Bonutli
`Application No.1 10I634.904
`Examiner: M. Hoffman
`
`moving at least one femoral implant through the incision while the patella is offset from the
`
`normal position with the inner side of'the patella facing inward; and
`
`connecting the at least one femoral implant with the cut laterai and medial condyles ofthe
`Femur.
`
`39. (Original) The method ofelaim 35. wherein the lower portion ofthe leg is a tibia and
`
`an end portion oftite tibia is cut.
`
`40. (Original) The method of claim 39. Further comprising:
`
`moving at least one tibial implant through the incision while the patella is oFf'sct from the
`
`normal position with the inner side ofrhe patella facing inward; and
`
`connecting the at least one tibial implant with the cut end portion ofthc tibia.
`
`41. (Original) The method of'claim 3i. wherein the inner side ofthe patella is out prior to
`
`displacing the patella From the normal position to the offset position.
`
`42. (Original) The method of claim 3 1, wherein displacing the patella From the normal
`
`position to the offset position comprises mOving the patella laterally relative to the knee portion
`
`ofthe leg.
`
`43. (Currently amended) A method of‘peri‘ot‘ming a knee anhroplasty surgery on a leg ofa
`
`patient, comprising the steps of:
`
`making an incision in a knee portion ofthe leg having a length not more than MM
`
`twice the length oftlte patella;
`
`cutting an inner side portion ofa patella in the knee portion ofthe leg, the patella remaining
`
`in a normal position relative to the knee portion;
`
`moving a patella implant through the incision;
`
`connecting the patella implant to the cat inner side portion ofthe patella;
`
`displacing the patella from the normal position to an offset position with the cut inner side
`
`portion of the patella facing inward;
`
`ll
`
`

`

`Applicant: Pi Bonutli
`Application No.: [IMF-84.904
`Examiner: M. Hoffman
`
`Cutting an end portion of at least one of an upper or a lower portion ofthc lcg;
`
`moving at least one implant through the incision while the patella is offset from the normal
`
`position with the em inner side portion of the patella facing inward; and
`
`connecting the at least one implant with the cut end portion ofat least one ofthe upper or
`
`lower portions of the leg.
`
`44. (Originai) The method of claim 43, fiirther comprising moving the patella into the
`
`normal pOsition, wherein the inner side portion ofthe patella facing towards a posterior portion
`
`ofthe knee portion;
`
`45. (Original) The method ofclaim 44, wherein the patella implant is connected to the cut
`
`inner side portion ofthe patella after moving the patella into the normal position from the offset
`
`position.
`
`46. (Original) The method of claim 43, wherein the patella implant is connected to the cut
`
`inner side portion ofthe patella prior to displacing the patella from the normal position to the
`
`offset position.
`
`47-50. (Canceled)
`
`5 l. (Previously presented) The method of claim 30, further comprising the steps of:
`
`forming an opening in a bone ofthc leg; and
`
`positioning a portion ofan intrameduilary alignment device within said opening.
`
`52. (Previously presented) The method of claim 30, further comprising the step of:
`
`positioning an extrameduliary alignment device proximate a bone ot‘the leg.
`
`53. (Previously presented) The method ofclairn 30, further comprising the step of:
`
`supporting at least the lower portion ol'the leg on a supporting member including actuating
`
`and controlling means. operative to move the lower portion ofthe leg.
`
`12
`
`
`
`

`

`Appliwnt: P, Bonuui
`Application No.: 10f684.904
`Examiner: M. Hoffman
`
`54. {Previously presented) The method of claim 30, further comprising the step of:
`
`viewing at least a portion of the interior of the leg during surgery using viewing
`
`instrumentation selected from the group consisting of: endoscope, fluoroscope, magnetic
`
`resonance imaging unit (MR1).
`
`55. (Previously presented) The method ofclaim 30, further comprising the step of:
`
`performing at least part ofthe surgery using a robotic device.
`
`56. (Previously presented) The method ofclaim 30, further comprising the step of:
`
`generating and projecting an image on a bone of the leg using a computer, said image
`
`operative to guide cutting of'the bone.
`
`57. (Previously presented) The method of'claim 30, further comprising the step of:
`
`implanting an implant including a plurality of layers, at least one ofsaid layers including at
`
`least one material selected from the group consisting of: fetal cells, bone cells, embryonal cells,
`stem cells.
`
`58. (Previously presented) The method of'claim 30, further comprising the steps of:
`
`sequentially passing portions of an implant through said incision; and,
`
`affixing at least two ofsaid implant portions, one to the other, within the leg, in association
`
`with one side of the knee joint.
`
`59. (Previously presented) The method oFclaim 30, further comprising the steps of:
`
`replacing at least a portion oi‘a single condyle with an implant; and,
`
`replacing at least a portion ofa trochlear grOOve with an implant.
`
`60. (Previously presented) The method of claim 30. wherein the cutting tool is Fabricated at
`
`a lower cost than a reusable cutting tool by being designed to be used in a single procedure and
`thereafter discarded.
`
`l3
`
`
`
`

`

`Applicant: P. Bonutti
`Application No: 10:17:84,904
`Examiner: M. Hoffman
`
`61 . {Previously presented] The method ofclaim 30, further comprising the step of:
`
`positioning said cutting tool proximal to a side surface ofthe distal end ofthe femur to
`
`guide cutting the bone of'the leg.
`
`62. {Previously presented) The method oi'elaim 30, further cornprising the steps of:
`
`making a second incision in a knee portion ofthe leg;
`
`inserting at least one item through said second incision selected from the group consisting
`
`of': visualization instrument, inflatable balloon, part of'a multi part implant, and surgical
`i natrum entation.
`
`63. (Withdrawn — Currently amended) A method of repairing a patella on a leg ofa patient,
`
`comprising:
`
`making an incision in a knee portion ofthe leg having a length not more than +3-em a
`
`distange between, about the proximal end ofthe tibia to about the epicendylar notch on the di§tal
`
`end portion ofthe femur:
`
`cutting the patella while the patella is not everted, forming an elongated channel or
`
`projection on the patella, the patella cut without first resecting the femur or tibia; and
`
`sliding a patcllar implant, having a channel or projection mateably engageable with the
`
`channel or projection formed in the patella. onto the patella, from a medial or lateral approach to
`
`the patella, thereby affixing said implant onto the patella;
`
`whereby the patella may be cut, and the implant engaged, without a requirement of
`
`substantial subluxation of the patella.
`
`64. (Withdrawn) A method of repairing a patella on a leg ofa patient, comprising:
`
`making an incision in a knee portion ofthe leg having a length not more than l3 cm;
`
`passing a guide wire through the incision;
`
`attaching the guide wire to the patella;
`
`panting a cutting tool along the guide wire. to contact and cut the patella while the patella is
`
`not evened, preparing the patella For a patellar implant; and
`
`I4
`
`
`
`

`

`Applicant: P. llonulti
`Application No.: I0f634304
`Examiner: M. Hoffman
`
`affixing a patellar implant to the patella. upon the cut portion of the patella, from a medial,
`
`lateral, or retrograde approach to the patella;
`
`whereby the patella may be cut, and the implant engaged, without a requirement of
`
`substantial subluxation of the patella.
`
`65. (Withdrawn — Currently amended} A method of performing surgery on a leg of a
`
`patient, comprising:
`
`making an incision in a knee portion of‘ the leg having a length not more than +3-em a
`
`distance between, about the proximal end of the tibia to about the epicondylar notch on the distal
`
`end portion ofthe femur:
`
`disconnecting one ofa medial or lateral collateral ligament;
`
`hinging open the joint space, thereby moving the patella medially or laterally without
`
`substantially stretching the patcllar ligaments;
`
`performing a surgical procedure within thcjoint space; and
`
`reconnecting the disconnected collateral ligament;
`
`whereby when the patella is moved. an aceessible area within thejoint space is increased,
`
`thereby facilitating the surgery. without a requirement of substantial subluxation ofthe patella.
`
`66. {Withdrawn — Currently amended) A method ofpcrforming a knee arthroplasty surgery
`
`on a leg ofa patient. comprising:
`
`making an incision in a knee portion ofthe leg having a length not more than 13 cm;
`
`cutting the patella while the patella is not cvertcd;
`
`attaching at least one transducer operative to indicate a force transmitted between the
`
`patella and the femur; and
`
`attaching at least one inflatable bladder to the patella, operative to change a force
`
`transmitted between the patella and the femur;
`
`whereby one or both of said transducer or bladder may be left inside the body after surgery,
`
`and
`
`whereby patellar tracking may be corrected by inflating the at least one inflatable bladder,
`
`based on a force indicated by said at least one transducer.
`
`15
`
`
`
`
`
`

`

`Applicant: P. Bonulti
`Application No; mate‘s-11.904
`Examiner: M. Hoffman
`
`67'. (Withdrawn — Currently amended) A method ofperf'orming surgery on knee of'a
`
`patient, comprising:
`
`making an incision adjacent to a side surface ofthe patella of the knee, having—Mew
`
`mere-thaa—B-em extending betweenI and having} length no longer than a distance between,
`
`about the proximal end ofthe tibia to about the epieondvlar notch on the distal end portion ofthe
`
`m;
`
`positioning a guide, comprising two parallel arms and asaw guiding surface, in contact
`
`with the patella, by inserting the arms through the incision, one arm positioned under a superior
`
`aspect ofthe patella. and another arm under an inferior aspect ofthe patella, thus aligning the
`
`saw guiding surface with a portion ofthe patella to be cut',
`
`.
`cutting a surface ofthe patella using the saw guiding surface,
`affixing a patellar implant to the patella, upon the cut portion ofthe patella, from a medial,
`
`lateral, or retrograde approach to the patella;
`
`whereby the patella may be cut, and the implant engaged, without a requirement of'
`
`Substantial subluxation ofthe patella.
`
`16
`
`

`

`Applicant: P. Bonulti
`Application No.: |0f584t904
`Examiner: M. Hoffman
`
`REMARKS
`
`Claims 1, 3-46 and 51-6? are presented for the Examiner‘s review and consideration. In this
`
`response, claims 1, [0. 16, 19. 21, 23, 25-26. 30-31, 43, and withdrawn claims 63 and 65-67
`
`have been amended. Claims 63-67 were deemed to be constructively non-elected in the Office
`
`Action mailed March IX, 2009, and were therein withdrawn. Applicant believes the
`
`accompanying remarks herein serve to clarify the present invention and are independent of'
`
`patentability. No new matter has been added.
`
`Election r' Restrictions
`
`A restriction was required between inventions (1): claims 1. 3-46, and 51-62; (H): claims
`
`63—65, and 6?; and (iii): claim 66. A constructive election oflnvention (l) was declared, and
`
`claims 63-67 were withdrawn, For reasons set fOI‘tll helm-v, Applicant respectfully submits that
`the restriction and constructive election should be withdrawn.
`
`Claims 63-67 include, or have been amended to include, subject matter relating to joint
`
`arthroplasty, incision size, a non-cverted or non-subiuxed patella, and cutting the patella, all
`
`subject matter oflhe original claims. Claims 63-67 add additional elements, further defining the
`invention.
`
`As such, Applicant respectfully submits that the Restriction Requirement is no longer
`
`applicable, and in light ofthc foregoing, Applicant respectfully requests that the Requirement for
`Restriction and Constructive Election be withdrawn.
`
`35 U.S.C. §l03 Rejection
`
`Claims 1, 4-12, [6-21, 24-25, 28-46, 51-52 and 57-61 were rejected under
`
`35 U.S.C. §103{a) as being unpatentable over Johnson et al. (US. Patent No. 5,683,469)
`
`(“Johnson") in view of Weddell (US. Patent No. 6.174.314) (“Weddell");
`
`Claim 3 was rejected under 35 U.S.C. §103la) as being unpatentablc over Johnson in view
`
`of Weddell Further in view of Howell (U.S. Patent No. 6,0]9,767) (“Howell”);
`
`Claims 22-23. 54-56 and 62 were rejected under 35 U.S.C. §103(a) as being unpatcntable
`
`over Johnson in view of Waddcll further in view ofWang et al. (U.S. Patent No. 6,102,850)
`
`(“Wang");
`
`I7
`
`

`

`Applicant: I‘. Bonutli
`Application No; lflr6843ti4
`Examiner: M. Hoffman
`
`Claims 26-27 were rejected under 35 U.S.C. §103(a) as being unpatcntable ovcr Johnson in
`
`view oFWaddell, further in view oFGustiio (US. Patent No. 5,733,292) (“Gustilo”);
`
`Claim 53 was rejected under 35 U.S.C. §103(a) as being unpatentable over Johnson in view
`
`of Weddell, Further in WC“? of Whitt (US. Patent No. 4,373,709} {”Whitt");
`
`Claims I, 4-21, 24—25, 2846. 5 l —52 and 57—61 were rejected under 35 U.S.C. §103(a) as
`
`being unpatcntable over Haincs (US. Patent No. 5,643,272) ("Haines”) in view ofWaddell;
`
`Claim 3 was rejected under 35 U.S.C. §103(a) as being unpatentablc over Haincs in view of
`
`Waddell, Further in view ofWang;
`
`Claims 22-23. 54-56 and 62 were rejected under 35 U.S.C. §103(a) as being unpatentable
`
`over Haines in view of Weddell, further in view of Wang;
`
`Claims 26-27 were rejected under 35 U.S.C. §103(a) as being unpatcntable over Haines in
`
`view of Weddell, further in view oqustiio. Claim 53 was rejected under 35 U.S.C. §i03[a) as
`
`being unpatentable over Haincs in view of Weddell, further in view of Gustilo; and.
`
`Ciaim 53 was rejected under 35 U.S.C. §103(a) as being unpatentable over Hairtes in view
`of Waddcll further in view of Whitt.
`
`For reasons set forth below, Applicant respectfully submits that the rejections should be
`withdrawn.
`
`Initially. Applicant respectfully notes that previous Office Actions failed to provide
`
`adequate reasoning or citations within the prior art for assertions ofdisclosures therein. This
`
`delays prosecution, and prejudices the Applicant. In addition, the Office Actions do not meet the
`
`requirements ofMPEP §§707.0?, 2 M2, and 2l43.01(|V}, and 37 C.F.R. §§I .104 (particularly
`
`l. 104(c)(2)) and 1.! I3. Applicant respectfully requests, in order to expedite and advance
`
`prosecution of'this application, that the requisite supporting citations and rationale are provided
`in Future Office Communications at the time the Communication. is issued.
`
`Discussions ofJohnson and Haines were provided in a previous response, and in the
`
`interests ofbrevity. those discussions are incorporated by reference herein.
`Weddell
`
`In Weddell. “a method and apparatus For resectionirtg a human patella in a normal anatomic
`
`position during a total knee arthroplasty is disclosed". (Col. 5, in. 60—62). Using an adapter base
`
`such as base 12 or 212, the guide ID is mounted directly on a component ofthe total knee
`
`IS
`
`
`
`

`

`Applicant: P. Bonulli
`Application No; 103634.904
`Examiner: M. Holean
`
`system. such as the femoral or tibial trial. (Col. 6, In. 28-30). Typically, the knee should be held
`
`in a flexed position From 0 to 90 degrees. with 60 degrees being the preferred position. (Col. 7,
`
`in. 49-51). Weddell additionally stat