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 .
Response to Arguments
Applicant’s arguments filed 9/23/2025 have been considered. Claims 1 and 8 have been amended such that they are now directed to a bicompartmental embodiment as opposed to a unicompartmental embodiment. As such, arguments regarding the rejections of claims 1, 3-8, and 11-15 are moot in view of the new grounds of rejection necessitated by the amendments. Arguments regarding the rejection of claims 16 and 20 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Since claim 16 has been amended to incorporate the limitations of now canceled claim 18, claims 16 and 20 are now rejected under 35 U.S.C. 103 as being unpatentable over Blackwell in view of Waugh in further view of Coon. Applicant argues Waugh does not disclose or suggest that edge 16 was designed or intended to cut bone tissue. Applicant points out that Waugh describes each fin is inverted V-shaped in cross-section and inherently provides an upwardly facing edge 16 and quotes Waugh as saying “permitting the upper part of the component to be driven into the distal surface of the femur and upwardly into the femur shaft”. Applicant states the edge is “merely an incidental geometric line formed by the V-shaped fins, and it’s only disclosed function is to serve as a resisting line to permit the component to be hammered or forced into the bone”. These arguments are not persuasive because, as pointed out by applicant, Waugh specifically teaches the V-shaped edge permits driving the component into bone. Therefore, the V-shaped edge is not “merely an incidental geometric line” and is specifically designed for driving/cutting into bone. When the pointed edge of Waugh is driven into bone, the edge inherently cuts the bone as it is driven into the bone. Further, the structure taught by Waugh is identical to the structure claimed, namely the protrusion including a cutting edge and a base, the base disposed between the cutting edge and a surface of the femoral component, wherein the cutting edge gradually becomes thinner along an extending direction thereof. As such, the examiner maintains that Waugh clearly teaches the cutting edge and base as claimed for the purpose of permitting the part to be driven into bone. It is standard in the art to provide tapered leading edges for insertion in bone.
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.
Claims 8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bascoulergue et al. EP0709074A1 (hereafter referred to as Bascoulergue) in view of Fell et al. US 2010/0249941 (hereafter referred to as Fell).
Regarding claim 8, Bascoulergue discloses a tibial component (figs. 4-6), comprising a top surface 16b, a bottom surface 16a opposite to the top surface, wherein the tibial component includes at least one protrusion 21 disposed on the bottom surface (figs. 4-6), wherein the at least one protrusion gradually becomes thinner along an extending direction away from the bottom surface (figs.4-6 appear to show a tapered edge), and a longitudinal direction of the at least one protrusion is substantially perpendicular to a medial-lateral direction of the tibial component (figs.4-6 show protrusion 21 extends in an anterior-posterior direction which is perpendicular to the medial-lateral direction), wherein the at least one protrusion has a thickest part where the at least one protrusion directly connects to the bottom surface (figs.4 and 6), and wherein the tibial component further includes a slot 50 which passes through the top surface and the bottom surface and divides the tibial component into a first portion 52 and a second portion 52, the first portion and second portion are connected by a connection portion 33 (fig.6), wherein the tibial component further includes at least one through hole 40 on the first portion and the second portion, the at least one through hole passes through the top surface and the bottom surface (fig.6). Bascoulergue discloses the invention substantially as claimed but does not disclose that the at least one protrusion includes a receded incision positioned on a rear edge of the at least one protrusion and the receded incision is receded in a direction from posterior to anterior.
Fell teaches a knee joint prosthesis, in the same field of endeavor, wherein a tibial component includes at least one first protrusion 22 disposed on a bottom surface 14, wherein the at least one first protrusion gradually becomes thinner along an extending direction away from the bottom surface (fig.32 shows a tapering from the bottom surface to tip 40), and a longitudinal direction of the at least one first protrusion is substantially perpendicular to a medial-lateral direction of the tibial component (fig.31 shows the protrusion extends in an anterior-posterior direction which is perpendicular to the medial-lateral direction), wherein the at least one first protrusion has a thickest part 38 where the at least one first protrusion directly connects to the bottom surface (fig.32), wherein the at least one first protrusion includes a receded incision 30 positioned on a rear edge of the at least one first protrusion and the receded incision is receded in a direction from posterior to anterior (see annotated fig.30 of Fell below) for the purpose of providing stability to the prosthesis through improved anchoring in the tibia (par.130).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the protrusion taught by Fell, including a protrusion that gradually becomes thinner and has a receded incision, for each of the protrusions 21 of Bascoulergue in order to improve the stability of the tibial component in the tibia.
Regarding claim 11, see Bascoulergue fig.6 for the through holes 40 being away from the protrusion 21. Also see Fell par.149 and figs. 85-87 which disclose a screw through the body.
Regarding claim 12, see Fell fig.32 wherein the first base is considered proximal portion 38 and the first cutting edge is considered the distal portion that gradually becomes thinner to distal end 40.
Regarding claim 13, the claim does not define what the at least one engagement portion is, therefore any part of the tibial component of Bascoulergue in view of Fell can be considered at least one engagement portion since any portion can be engaged in some way.
Regarding claim 14, Bascoulergue discloses the tibial component of claim 8 as discussed above but does not disclose that the tibia component further includes an engagement groove disposed on a sidewall.
Fell teaches a tibial component, in the same field of endeavor, wherein a groove 92 is located in a sidewall for the purpose of allowing a surgeon to add agents (fig.110; par.161).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tibial component of Bascoulergue to include a groove in the sidewall as taught by Fell in order to allow for the surgeon to apply agents as needed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Bascoulergue in view of Fell as applied to claim 8 above, and further in view of Shelton et al. US 2009/0130167 (hereafter referred to as Shelton). Bascoulergue in view of Fell discloses the tibial component of claim 8 as discussed above but does not disclose that the tibial component has a second sidewall having a plurality of apertures.
Shelton teaches a tibial prosthesis, in the same field of endeavor, wherein a bearing portion comprises a side wall having a plurality of apertures (fig.7) wherein the apertures may be through holes (pars. 73 and 109) for the purpose of holding and delivering a drug (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the device comprising a plurality of apertures/through holes taught by Shelton on the sidewall of the tibial component of Bascoulergue in view of Fell in order to deliver a drug and treat the tissue of the joint.
Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Bascoulergue in view of Fell and further in view of Waugh et al. US 3,869,731 (hereafter referred to as Waugh).
Regarding claims 1 and 4, Bascoulergue in view of Fell discloses the tibial component of claim 8 as discussed above which is the same as the tibial component of claim 1. However, Bascoulergue in view of Fell does not disclose a knee joint prosthesis further comprising a femoral component, carried by the tibial component, wherein the femoral component includes at least one second protrusion disposed on a surface thereof opposite to the tibial component, wherein the femoral component further includes a second slot which divides the femoral component into a lateral condyle portion and a medial condyle portion connected by a second connection portion, wherein the second protrusion further includes a second cutting edge and a second base, the second base is disposed between the second cutting edge and a surface of the femoral component, and the second cutting edge gradually becomes thinner along an extending direction thereof.
Waugh teaches a knee joint prosthesis, in the same field of endeavor, wherein the knee joint prosthesis comprises a femoral component, carried by a tibial component (fig.1), wherein the femoral component includes at least one second protrusion 12, 14 (fig.3) disposed on a surface thereof opposite to the tibial component (figs. 1-4), wherein the femoral component further includes a second slot (see figs.3-4 for a slot between condyles) which divides the femoral component into a lateral condyle portion 6 or 8 and a medial condyle portion 8 or 6 connected by a second connection portion 10 (fig.3). The femoral component is provided for the purpose of substituting for a malfunctioning or diseased human knee, leaving the cruciate and collateral ligaments in place and functioning normally (col.2, lines 16-40). Waugh further teaches wherein the second protrusion 12, 14 further includes a second cutting edge 16 and a second base (considered the portion of the protrusion closer to the bone contacting surface of the femoral component), the second base is disposed between the second cutting edge and a surface of the femoral component, and the second cutting edge gradually becomes thinner along an extending direction thereof (figs. 1-4) for the purpose of permitting the component to be driven into the surface of the bone (col.3, ll.23-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the femoral component taught by Waugh with the tibial component of Bascoulergue in view of Fell in order to replace a malfunctioning or diseased femur of a patient thereby providing a total knee joint prosthesis.
Regarding claim 3, see fig.32 of Fell wherein the first base is considered proximal portion 38 and the first cutting edge is considered the distal portion that gradually becomes thinner to distal end 40.
Regarding claim 5, Bascoulergue discloses a pad 10 located on top of the tibial component for articulation with the femur (fig.1). As such, it would follow that Bascoulergue in view of Fell in view of Waugh comprises a pad between the tibial component and the femoral component when the tibial and femoral components are secured to the patient’s tibia and femur.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bascoulergue in view of Fell in view of Waugh as applied to claim 5 above, and further in view of Shelton. Bascoulergue in view of Fell in view of Waugh discloses the knee joint prosthesis of claim 5 as discussed above but does not disclose that the pad has a sidewall having a plurality of apertures.
Shelton teaches a tibial prosthesis, in the same field of endeavor, wherein a bearing portion comprises a side wall having a plurality of apertures (fig.7) wherein the apertures may be through holes (pars. 73 and 109) for the purpose of holding and delivering a drug (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the device comprising a plurality of apertures/through holes taught by Shelton on the sidewall of the pad of Bascoulergue in view of Fell in view of Waugh in order to deliver a drug and treat the tissue of the joint.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bascoulergue in view of Fell in view of Waugh in view of Shelton as applied to claim 6 above, and further in view of Cima et al. US 2007/0088442 (hereafter referred to as Cima). Bascoulergue in view of Fell in view of Waugh in view of Shelton discloses the knee joint prosthesis of claim 6 as discussed above but Bascoulergue in view of Fell in view of Waugh in view of Shelton does not disclose that the pad further includes an abrasion meter.
Cima teaches a tibial prosthesis, in the same field of endeavor, wherein the bearing comprises wear indicators (figs. 14-19) for the purpose of non-invasively detecting wear of the prosthesis (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include wear indicators as taught by Cima in the pad of Bascoulergue in view of Fell in view of Waugh in view of Shelton in order to non-invasively detect wear of the prosthesis.
Claims 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Blackwell et al. US 2008/0133020 (hereafter referred to as Blackwell) in view of Waugh in further view of Coon et al. US 2005/0124998 (hereafter referred to as Coon).
Regarding claim 16, Blackwell discloses a femoral component 102 comprising a unicondyle portion 124, 126 and a protrusion 108 disposed on the unicondyle portion (figs. 4-6), the protrusion including a plurality of through holes 118 (fig.5), wherein a longitudinal direction of the protrusion is substantially perpendicular to a medial-lateral direction of the femoral component (figs. 4-6 show the longitudinal direction of the protrusion extends generally anterior-posterior direction which is substantially perpendicular to a medial-lateral direction of the femoral component). Blackwell discloses the invention substantially as claimed but does not disclose that the protrusion further includes a cutting edge and a base, the base is disposed between the cutting edge and a surface of the femoral component, and the cutting edge gradually becomes thinner along an extending direction thereof.
Waugh teaches a knee joint prosthesis, in the same field of endeavor, wherein a femoral component comprises a protrusion 10, 12, 14 that includes a cutting edge 16 and a base, the base is disposed between the cutting edge and a surface of the femoral component, and the cutting edge gradually becomes thinner along an extending direction thereof (figs. 1-4) for the purpose of permitting the component to be driven into the surface of the bone (col.3, ll.23-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the protrusion of the femoral component of Blackwell to include a cutting edge and a base, the base is disposed between the cutting edge and a surface of the femoral component, and the cutting edge gradually becomes thinner along an extending direction thereof as taught by Waugh in order to allow for the femoral component to be more easily inserted into the bone. Blackwell in view of Waugh discloses the femoral component substantially as claimed, but Blackwell in view of Waugh does not disclose that the femoral component further comprises two holding notches respectively located at two sides thereof.
Coon teaches a femoral component, in the same field of endeavor, wherein the femoral component further comprises two holding notches 56 and 58 respectively located at two sides of a condyle (fig.9) for the purpose of receiving a tool to assist in impacting/extracting of the prosthesis (pars.24 and 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the femoral component of Blackwell in view of Waugh to include two holding notches as taught by Coon in order to allow for assistance in insertion/removal of the prosthesis.
Regarding claim 20, see Blackwell figs.4-6 for pillar 106 on a middle segment of the protrusion.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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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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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774