DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 11,13, 20, and 21 are objected to because of the following informalities: Claim 11 recites “the bearing surface”, which appears to be referring to the – bearing plate – as recited in claim 5. Claim 13 recites “a baseplate component” in lines 2-3, which appears to be referring to the – tibial baseplate –, as recited in claim 12. Claims 20 and 21 recite the preamble “The knee arthroplasty system”, which appears to be referring to – The tibial trial system –, as recited in claim 19. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the tibial component" in line 2 and claim 7 recites “a tibia component” in line 3 and “the tibial component” in line 5. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether applicant is referring to the tibial trial assembly recited earlier in claim 2 or an additional tibial component. For the purpose of further examination, the examiner interprets the “tibial component” and the “tibia component” to each be referring to an additional tibial component.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,540,696 to Booth, Jr. et al. (Booth).
Regarding claim 2
Booth teaches an instrumentation set to assist the surgeon in selecting the proper implant components, in determining the amount of distal bone to resect, and in aligning instrumentation designed to resect the bone (abstract).
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Booth meets the limitations of a method of preparing a knee joint to receive a hinge knee prosthesis (abstract), comprising: mounting a tibial trial assembly (assembly of components for the tibia as shown in figs. 3 and 17) to the tibia (T) and a femoral trial assembly (assembly of components for the femur as shown in figs. 3 and 17) to the femur (F); connecting an axle (top/head portion of ratchet shaft; 56 or 84) of an axle component (ratchet shaft; 56 or 84) of the tibial trial assembly to the femoral trial assembly (figs. 3 and 17 each show an axle of axle component/ratchet shaft is connected to the femoral trial assembly); assessing patellofemoral and tibiofemoral kinematics by rotating the knee joint about the axle through flexion and extension (col. 3, lines 66-67 through col. 4, lines 1-61 discloses the process of assessing the kinematics of the joint by flexing and extending the knee); and translating the tibial trial assembly relative to the femoral trial assembly from a first predetermined distance between the respective tibial and femoral trial assemblies to a second predetermined distance between the respective tibial and femoral trial assemblies while the axle remains connected to the femoral trial assembly (col. 3, lines 45-64 discloses translation of the tibial trial assembly relative to the femoral trial assembly from a first predetermined distance to a second predetermined distance while the axle remains connected to the femoral trial assembly, as claimed).
Regarding claim 3
Booth teaches the method of claim 2, wherein the translating step includes moving the axle component that comprises the axle relative to a baseplate component (paddle; 44) of the tibial trial assembly while the axle is connected to the femoral trial assembly so as to adjust the distance between the baseplate component and the femoral trial assembly (col. 3, lines 45-64 discloses moving the axle to extend the distance between the baseplate component/paddle and the femoral trial assembly while the axle is connected to the femoral trial assembly).
Regarding claim 4
Booth teaches the method of claim 2, further comprising reading indicia through a viewing notch of a bearing plate to indicate to an operator a proper insert size for use in the hinge knee prosthesis (col. 4, lines 18-22 discloses viewing indicia; 131 through a viewing notch as shown in fig. 7).
Regarding claim 5
Booth teaches the method of claim 2, wherein the connecting step includes engaging a bearing plate (paddle; 58 or 92) to the axle component (ratchet shaft; 56 or 84) and inserting the axle into a recess disposed between first and second condylar portions of the femoral trial assembly (fig. 4 shows that the axle/ratchet shaft is disposed between at least an edge of each of the first and second condylar portions).
Regarding claim 6
Booth teaches the method of claim 2, wherein the translating step includes distracting the axle component relative to the tibial component with a threaded tool (screw; 74 is construed to be a threaded tool with which the axle component/ratchet shaft is distracted relative to the tibial component – see 112 rejection above for interpretation; col. 6, lines 6-35).
Regarding claim 7
Booth teaches the method of claim 6, wherein the translating step includes: inserting the threaded tool (screw; 74) into an opening within a boss (drive gear; 72 or 88) of the axle component; engaging internal threads defined by the boss and defined by a tibia component (ratchet housing; 46 or 47) within which the boss is received; and rotating the threaded tool to distract the axle component relative to the tibial component (col. 6, lines 58-65 disclose rotation of the threaded tool to distract the axle component relative to the tibial component – see 112 rejection above for claim interpretation).
Regarding claim 8
Booth teaches the method of claim 2, wherein the translating step is performed with the tibia and femur being in about 90 degrees of flexion (col. 3, lines 45-55 discloses translation performed when the knee joint is flexed as claimed; fig. 3 shows the flexion at about 90 degrees).
Regarding claim 9
Booth teaches the method of claim 2, wherein the translating step includes disengaging a first groove (fig. 19 shows a first groove of the gear; 72 for example) disposed along a length of the boss (drive gear; 72 or 88) from a bearing plate (drive teeth; 70 or 85) of the tibial trial assembly, and engaging a second groove (fig. 19 shows a second groove of the gear; 72 for example) disposed along the length of the boss (drive gear; 72 or 88) and offset from the first groove with the bearing plate (fig. 19 shows a second groove of the boss/gear being engaged with the bearing plate/drive teeth that is offset from the first groove).
Regarding claim 10
Booth teaches the method of claim 9, wherein the first groove is associated with the first predetermined distance, and the second groove is associated with the second predetermined distance (the first groove of the gear is associated with the first predetermined distance and the second groove of the gear is associated with the second predetermined distance as claimed).
Regarding claim 11
Booth teaches the method of claim 5, wherein the axle is rigidly fixed and immovable relative to a shaft portion of the axle component (top/head portion of ratchet shaft; 56 or 84 is rigidly fixed and immovable relative to the shaft portion of ratchet shaft; 56 or 84), and the bearing surface is disposed entirely between the condylar portions (fig. 4 shows that the bearing plate/paddle; 58 or 92 is disposed entirely between at least an edge of each of the first and second condylar portions).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Booth, as applied to claim 2 above, in view of US Patent No. 7,806,896 B1 to Bonutti (Bonutti).
Regarding claim 12
Booth teaches the method of claim 2. Booth also teaches that selecting a proper size of prosthetic components is an important factor which affects the success of the procedure (col. 1, lines 24-36) and includes a guide (100) with indicia to determine how much bone should be removed (col. 4, lines 8-27) and correlating to various sizes of femoral prosthetic components available to be implanted by the surgeon (col. 7, lines 2-8). However, Booth does not teach further comprising coupling a keel trial to a tibial baseplate of the tibial trial assembly such that keel portions of the keel trial extend through keel slots of the tibial baseplate.
Bonutti teaches an improved method of performing surgery on a joint in a patient’s body, such as a knee (abstract). More specifically, Bonutti teaches the use of provisional implants that are releasably positioned relative to the femur and tibia, for the purpose of aiding the surgeon in assessment of the function and balance of the various ligaments, and also teaches that the provisional implants can be combined with cutting guides or other instrumentation (col. 30, lines 19-30). Further, Bonutti teaches a tibial punch (274) that is coupled to a tibial baseplate (270) such that keel portions extend through keel slots of the baseplate (fig. 26), for the purpose of creating an opening formed in the tibia to accommodate a keel of a final implant that provides stability when inserted in the tibia (col. 32, lines 12-18; fig. 27).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Booth to include the use of provisional implants, combined with the guides of Booth, and to specify that a keel trial is coupled to a tibial baseplate of the tibial trial assembly such that keel portions of the keel trial extend through keel slots of the tibial baseplate, in order to create an opening formed in the tibia to accommodate a keel of a final implant that provides stability when inserted in the tibia, as taught by Bonutti.
Regarding claim 13
Booth in view of Bonutti teaches the method of claim 12. Bonutti also teaches wherein the coupling step includes positioning the keel trial such that a bridge connecting the keel portions is posterior to a boss opening of a baseplate component of the tibial trial assembly and spans between the keel slots (when inserted into the tibia bone through the baseplate, the keel trial shown in fig. 26 which includes a bridge connecting the keel portions, is positioned posterior to a boss opening of the baseplate and spans between the keel slots – see annotated fig. 26 below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Booth in view of Bonutti to specify that the coupling step includes positioning the keel trial such that a bridge connecting the keel portions is posterior to a boss opening of a baseplate component of the tibial trial assembly and spans between the keel slots, in order to create an opening formed in the tibia to accommodate a keel of a final implant that provides stability when inserted in the tibia, as taught by Bonutti.
Regarding claim 14
Booth in view of Bonutti teaches the method of claim 13. Bonutti also teaches wherein the coupling step includes positioning the keel trial such that the bridge of the keel trial is received within an indented surface of an insert of the tibial trial assembly (col. 31, lines 50-54 discloses a trial tibial bearing insert mounted on the tibial trial base plate and col. 97, lines 1-2 discloses openings having a countersink/indented surface for accommodating keel head).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Booth in view of Bonutti to specify that the coupling step includes positioning the keel trial such that the bridge of the keel trial is received within an indented surface of an insert of the tibial trial assembly, in order to create an opening formed in the tibia to accommodate a keel of a final implant that provides stability when inserted in the tibia, as taught by Bonutti.
Regarding claim 15
Booth meets the limitations of a method of preparing a knee joint to receive a hinge knee prosthesis (abstract), comprising: mounting a tibial trial assembly to the tibia and a femoral trial assembly to the femur (fig. 3 shows a tibial trial assembly mounted to the tibia and a femoral trial assembly mounted to the femur); connecting an axle of an axle component of the tibial trial assembly to the femoral trial assembly (head of ratchet shaft; 56 or 84 is connected to the femoral trial assembly as shown in fig. 4); and moving the tibial trial assembly in a linear direction relative to the femoral trial assembly while the axle remains connected to the femoral trial assembly (col. 3, lines 45-64 discloses movement of the tibial trial assembly in a linear direction relative to the femoral trial assembly from a first predetermined distance to a second predetermined distance while the axle remains connected to the femoral trial assembly, as claimed).
Booth also teaches a baseplate component (paddle; 44) and includes a guide (100) with indicia to determine how much bone should be removed (col. 4, lines 8-27), and correlating to various sizes of femoral prosthetic components available to be implanted by the surgeon (col. 7, lines 2-8). However, Booth does not teach further comprising coupling a keel trial to the baseplate of the tibial trial assembly.
Bonutti teaches an improved method of performing surgery on a joint in a patient’s body, such as a knee (abstract). More specifically, Bonutti teaches the use of provisional implants that are releasably positioned relative to the femur and tibia, for the purpose of aiding the surgeon in assessment of the function and balance of the various ligaments, and also teaches that the provisional implants can be combined with cutting guides or other instrumentation (col. 30, lines 19-30). Further, Bonutti teaches a tibial punch (274) that is coupled to a tibial baseplate (270) such that keel portions extend through keel slots of the baseplate (fig. 26), for the purpose of creating an opening formed in the tibia to accommodate a keel of a final implant that provides stability when inserted in the tibia (col. 32, lines 12-18; fig. 27).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Booth to include the use of provisional implants, combined with the guides of Booth, and to specify that a keel trial is coupled to the baseplate of the tibial trial assembly, in order to create an opening formed in the tibia to accommodate a keel of a final implant that provides stability when inserted in the tibia, as taught by Bonutti.
Regarding claim 16
Booth in view of Bonutti teaches the method of claim 15. Booth also teaches wherein the moving step includes sliding a boss of the axle component through an opening in the baseplate component (paddle; 44) such that the axle component (ratchet shaft; 56 or 84) moves from a first position relative to the baseplate component to a second position relative to the baseplate (col. 3, lines 45-64 discloses movement of the ratchet from a first position relative to the baseplate to a second position relative to the baseplate).
Regarding claim 17
Booth in view of Bonutti teaches the method of claim 16. Booth also teaches wherein the moving step includes disengaging a first groove (fig. 19 shows a first groove of the gear; 72 for example) disposed along a length of the boss (drive gear; 72 or 88) with a bearing plate (drive teeth; 70 or 85), and engaging a second groove along the length of the boss and offset from the first groove with the bearing plate (fig. 19 shows a second groove of the gear; 72 for example) along the length of the boss (drive gear; 72 or 88) and offset from the first groove with the bearing plate (fig. 19 shows a second groove of the boss/gear being engaged with the bearing plate/drive teeth that is offset from the first groove), wherein the first groove is associated with the first position and the second groove is associated with the second position (the first groove of the gear/boss is associated with the first position and the second groove is associated with the second position as claimed).
Regarding claim 18
Booth in view of Bonutti teaches the method of claim 17. Booth also teaches wherein the bearing plate (drive teeth) has a distally facing bearing surface that interfaces with a proximally facing bearing surface of an insert (pawl; 50 or 76) of the tibial trial assembly when the axle component is in both the first and second positions (col. 6, lines 6-65 discloses interfacing between the bearing plate and an insert when the axle/ratchet shaft is in both the first and second positions).
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2010/0174378 A1 to Metzger et al. (Metzger) in view of Bonutti.
Regarding claim 19
Metzger teaches a prosthesis system for replacing a knee joint between a femur and a tibia (abstract). Metzger meets the limitations of a tibial trial system comprising: a tibial component (18) including a baseplate (52); an axle component (yoke; 110) slidably coupled to the tibial component (paragraph 0079 discloses that the yoke is slidably coupled along axis; 150 to move between distance D2 and distance D1; figs. 17 and 18), the axle component including a boss (inferior portion; 122), an axle support extending from the boss (superior portion; 120 shown to be extending from inferior portion/boss in fig. 2), and an axle on the axle support (axle post; 112); wherein the axle is configured to be received in a femoral component such that the tibial component is rotatable relative to the femoral component about a rotation axis of the axle (paragraph 0082 discloses that the axle is received in the femoral component; 16 and that the femoral component rotates about the rotation axes 45 and 135 defined by the axle).
Metzger also teaches that the knee joint is secured to a tibia and femur that have been surgically resected in a manner known in the art (paragraph 0070). However, Metzger does not teach that the baseplate defines keel slots a keel trial coupled to the tibial component, the keel trial including keel portions configured to extend through the keel slots.
Bonutti teaches an improved method of performing surgery on a joint in a patient’s body, such as a knee (abstract). More specifically, Bonutti teaches the use of provisional implants that are releasably positioned relative to the femur and tibia, for the purpose of aiding the surgeon in assessment of the function and balance of the various ligaments, and also teaches that the provisional implants can be combined with cutting guides or other instrumentation (col. 30, lines 19-30). Further, Bonutti teaches a tibial punch (274) that is coupled to a tibial baseplate (270) such that keel portions extend through keel slots of the baseplate (fig. 26), for the purpose of creating an opening formed in the tibia to accommodate a keel of a final implant that provides stability when inserted in the tibia (col. 32, lines 12-18; fig. 27).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tibial trial system of Metzger to include the use of provisional implants, to ensure that the implants are properly positioned after resection of the bones, and to specify that a keel trial is coupled to the baseplate of the tibial component, in order to create an opening formed in the tibia to accommodate a keel of a final implant that provides stability when inserted in the tibia, as taught by Bonutti.
Regarding claim 20
Metzger in view of Bonutti teaches the knee arthroplasty system of claim 19. Metzger further comprising a bearing plate (tibial bearing; 20) adjustably coupled to the boss (120), wherein the boss includes a plurality of grooves spaced along a longitudinal direction of the boss, and the bearing plate is configured to be removably coupled to each of the plurality of grooves (paragraphs 0078-0079 discloses a plurality of grooves used to adjustably couple the boss to the bearing plate as claimed).
Regarding claim 21
Metzger in view of Bonutti teaches the knee arthroplasty system of claim 19. Metzger teaches wherein when the axle (112) is received in the femoral component (16), the tibial component (18) is configured to be moved in a linear direction relative to the femoral component while the axle remains connected to the femoral component (figs. 17 and 18 show that the tibial component is fully capable of moving in a linear direction relative to the femoral component while the axle is connected to the femoral component).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
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