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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on 2/6/2026 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/6/2026.
Claim Objections
Claims 1, 8, 12, and 14 are objected to because of the following informalities:
In claim 1, “an end of a bone” is believed to be in error for --the end of the bone-- since “an end of a bone” is already recited in line 1.
In claim 8, lines 2 and 6, “the shield” is believed to be in error for --the cement shield--.
In claim 12, line 2, “tibial void filling prosthesis” is believed to be in error for --the tibial void filling prosthesis--.
In claim 14, lines 2 and 6, “the shield” is believed to be in error for --the cement shield--.
In claim 14, line 4, “implanting the joint prosthesis onto the end of the bone” is believed to be in error for --implanting the tibial baseplate onto the proximal end of the tibia-- (see claim 10, line 12).
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.
Claim 2 is 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 2 recites the limitation "the implanting step" in line 2, but claim 1 has two implanting steps and it is unclear which “the implanting step” refers to. For examination, “the implanting step” is interpreted to refer to the step of implanting a void filling prosthesis into the intramedullary canal of claim 1.
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 1, 2, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Mikhail US 5,755,720 (hereafter referred to as Mikhail) in view of Cook US 5,004,476 (hereafter referred to as Cook).
Regarding claim 1, Mikhail discloses a method for replacing a joint at an end of a bone F (fig.9), comprising resecting an end of a bone F so as to form a resected surface 10 (fig.7 shows a resected end of the femur therefore resection must have occurred), inserting a cement plug 16 into an intramedullary canal of the bone (fig.7), implanting a void filling prosthesis 30 into the intramedullary canal, the void filling prosthesis having a channel extending entirely therethrough (fig.7), injecting bone cement 42 into the intramedullary canal between the cement plug and the resected surface while keeping the resected surface substantially free of the bone cement and so that the channel of the void filling prosthesis is substantially filled with bone cement (fig.8 shows sealing device prevents cement from contacting the resected surface and substantially filling the void filling prosthesis 30), pressurizing the bone cement while keeping the resected surface substantially free of bone cement (fig.8; col.5, lines 13-21 discloses the sealing device 44 permits bone cement to be applied under pressure into the cavity 29), and implanting a joint prosthesis P onto the end of the bone and a stem 24 extending from the joint prosthesis is positioned within the pressurized bone cement and the channel of the void filling prosthesis (figs.9-10). Mikhail further discloses the hip joint prosthesis of the invention can have a collar and be precoated (col.6, lines 57-61), but Mikhail does not disclose that a porous bone facing surface of the joint prosthesis directly contacts the resected surface.
Cook teaches a method of replacing a joint at an end of a bone, in the same field of endeavor, wherein a collar 14, which is porous coated on a bone facing surface, directly contacts a resected surface of the bone (fig.1; col.4, lines 4-8) for the purpose of achieving sound fixation, providing a physiological stress transfer and to avoid prosthesis subsidence (col.6, lines 4-8).
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 method of Mikhail to include a collar having a porous bone facing surface on the joint prosthesis as taught by Cook and to place the porous bone facing surface directly in contact with the resected surface as taught by Cook in order achieve sound fixation, provide a physiological stress transfer, and to avoid prosthesis subsidence.
Regarding claim 2, see Mikhail fig.3 which shows the void filling prosthesis 30 being conically tapered and having a porous outer surface. The void filling prosthesis 30 is press-fit into the intramedullary canal by the tamp T as shown in fig.3.
Regarding claims 5 and 6, see fig.9 of Mikhail which shows the void filling prosthesis 30 at least in the metaphysis of the bone and the joint prosthesis passing through the channel into the diaphysis of the bone.
Claims 1-3, 5-7, 10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Servidio et al. US 2015/0366567 (hereafter referred to as Servidio) in view of Mikhail and in further view of Unger US 2010/0298947 (hereafter referred to as Unger).
Regarding claim 1, Servidio discloses a method for replacing a joint at an end of a bone, comprising: resecting an end of a bone so as to form a resected surface 1410 (while Servidio does not specifically state that the proximal tibia is resected to form the surface 1410, figs.14 and 22E-F clearly show a resected planar surface 1410 which must have been resected as is commonplace in the art of knee replacements), implanting a void filling prosthesis 2300 into the intramedullary canal, the void filling prosthesis having a channel 2350 extending entirely therethrough (figs. 22A-F), injecting bone cement into the channel of the void filling prosthesis (par.109 and claim 10), and implanting a joint prosthesis 2500 onto the end of the bone such that a bone facing surface of the joint prosthesis directly contacts the resected surface and a stem 2510 extending from the joint prosthesis is positioned within the bone cement and the channel of the void filling prosthesis (figs. 22C and 22E-F). Servidio discloses the invention substantially as claimed but does not disclose inserting a cement plug into an intramedullary canal of the bone, injecting bone cement into the intramedullary canal between the cement plug and the resected surface while keeping the resected surface substantially free of the bone cement and so that the channel of the void filling prosthesis is substantially filled with bone cement, or pressurizing the bone cement while keeping the resected surface substantially free of bone cement.
Mikhail teaches a method for replacing a joint at the end of a bone, in the same field of endeavor, wherein the method includes the steps of inserting a cement plug 16 into an intramedullary canal of the bone, injecting bone cement 42 into the intramedullary canal between the cement plug and a resected surface 10 while keeping the resected surface substantially free of the bone cement (via sealing device 44) and so that the channel of the void filling prosthesis is substantially filled with bone cement, and pressurizing the bone cement while keeping the resected surface substantially free of bone cement (fig.8; col.5, lines 13-21 discloses the sealing device 44 permits bone cement to be applied under pressure into the cavity 29) for the purpose of filling a cavity with cement for anchoring a joint prosthesis (col.6, lines 51-56).
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 method of Servidio to include the steps of inserting a cement plug into an intramedullary canal of the bone, injecting bone cement into the intramedullary canal between the cement plug and the resected surface while keeping the resected surface substantially free of the bone cement and so that the channel of the void filling prosthesis is substantially filled with bone cement, and pressurizing the bone cement while keeping the resected surface substantially free of bone cement as taught by Mikhail in order to fill the bone and void filling prothesis with cement for securing the joint prosthesis. While Servidio in view of Mikhail discloses the invention substantially as claimed, Servidio does not specifically disclose that the bone facing surface of the joint prosthesis comprises a porous surface.
Unger discloses a method for replacing a joint at an end of a bone, in the same field of endeavor, including the step of implanting a joint prosthesis 16 onto the end of the bone such that a porous bone facing surface 28 of the joint prosthesis directly contacts a resected surface (figs. 1 and 3), wherein the porous layer on the under surface of the joint prosthesis is provided for the purpose of promoting bone growth into the pores thus providing the primary means of securing the tibial tray component to the upper prepared surface of the tibia (par.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 bone facing surface of the joint prosthesis of Servidio to include a porous surface as taught by Unger in order to promote bone ingrowth for securing the prosthesis to the bone.
Regarding claim 2, see Servidio fig.22B for the void filling prosthesis 2300 being conically tapered. Servidio par.109 discusses a porous outer surface of 2300 and the prosthesis 2300 is placed in the intramedullary canal against bone and is therefore considered press-fit within the intramedullary canal.
Regarding claim 3, see Servidio figs. 22C-22D and 23G for the flutes and grooves on the stem 2510.
Regarding claims 5 and 6, see fig.23G of Servidio for stem 2600 passing through the channel of the void filling prosthesis (into the metaphysis of the bone) and into the diaphysis of the bone.
Regarding claims 5 and 7, see Servidio figs.22D-F for the stem 2510 passing through the channel of the void filling prosthesis and into the metaphysis of the bone, a length of the stem being capable of terminating within the metaphysis.
Regarding claim 10, Servidio discloses a method for revision total knee arthroplasty (par.2), comprising removing a previously implanted tibial prosthesis from a proximal end of a tibia (par.81), resecting the proximal tibia so as to form a resected surface 1410 (while Servidio does not specifically state that the proximal tibia is resected to form a resected surface, figs.14 and 22E-F clearly show a resected planar surface 1410 which must have been resected as is commonplace in the art of knee replacements), implanting a tibial void filling prosthesis 2300 into the intramedullary canal in a press-fit manner, the tibial void filling prosthesis having a channel 2350 extending entirely therethrough (figs. 2A-F), injecting bone cement into the channel of the tibial void filling prosthesis (par.109 and claim 10), and implanting a tibial baseplate 2500 onto the proximal end of the tibia such that a bone facing surface thereof directly contacts the resected surface and a stem 2510 extending from the tibial baseplate is positioned within the bone cement and the channel of the tibial void filling prosthesis (figs. 22C and 22E-F). Servidio discloses the invention substantially as claimed but does not disclose inserting a cement plug into an intramedullary canal of the tibia, injecting bone cement into the intramedullary canal between the cement plug and the resected surface while keeping the resected surface substantially free of the bone cement and so that the channel of the tibial void filling prosthesis is substantially filled with bone cement, or pressurizing the bone cement while keeping the resected surface substantially free of bone cement.
Mikhail teaches a method for revision joint arthroplasty, in the same field of endeavor, wherein the method includes the steps of inserting a cement plug 16 into an intramedullary canal of the bone, injecting bone cement 42 into the intramedullary canal between the cement plug and a resected surface 10 while keeping the resected surface substantially free of the bone cement (via sealing device 44) and so that the channel of the void filling prosthesis is substantially filled with bone cement, and pressurizing the bone cement while keeping the resected surface substantially free of bone cement (fig.8; col.5, lines 13-21 discloses the sealing device 44 permits bone cement to be applied under pressure into the cavity 29) for the purpose of filling a cavity with cement for anchoring a joint prosthesis (col.6, lines 51-56).
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 method of Servidio to include the steps of inserting a cement plug into an intramedullary canal of the tibia, injecting bone cement into the intramedullary canal between the cement plug and the resected surface while keeping the resected surface substantially free of the bone cement and so that the channel of the tibial void filling prosthesis is substantially filled with bone cement, and pressurizing the bone cement while keeping the resected surface substantially free of bone cement as taught by Mikhail in order to fill the bone and tibial void filling prothesis with cement for securing the tibial prosthesis. While Servidio in view of Mikhail discloses the invention substantially as claimed, Servidio does not specifically disclose that the bone facing surface of the tibial prosthesis comprises a porous surface.
Unger discloses a method for replacing a joint at an end of a tibia, in the same field of endeavor, including the step of implanting a tibial joint prosthesis 16 onto the end of the bone such that a porous bone facing surface 28 of the prosthesis directly contacts a resected surface (figs. 1 and 3), wherein the porous layer on the under surface of the prosthesis is provided for the purpose of promoting bone growth into the pores thus providing the primary means of securing the tibial tray component to the upper prepared surface of the tibia (par.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 bone facing surface of the tibial prosthesis of Servidio to include a porous surface as taught by Unger in order to promote bone ingrowth for securing the prosthesis to the bone.
Regarding claim 15, Servidio fig.2B shows resected surfaces of the distal femur and cutting block 202, therefore a resection step inherently occurred. Servidio discloses the invention is directed to total knee replacement revision procedures (par.2) and removing a previously implanted femoral prosthesis would be required to implant a new femoral component. See Servidio figs.9A and 9F for femoral component 902 and femoral void filling prosthesis 910. Par.90 discloses implanting femoral void filling prosthesis 910 in the bone cavity prior to implantation of the femoral component 902 and par.92 discloses securing them using bone cement. Servidio discloses the invention substantially as claimed but does not disclose the steps of inserting a cement plug into an intramedullary canal of the femur, injecting bone cement into the intramedullary canal between the cement plug and the resected surface while keeping the resected surface substantially free of the bone cement and so that the channel of the void filling prosthesis is substantially filled with bone cement, or pressurizing the bone cement while keeping the resected surface substantially free of bone cement.
Mikhail teaches a method for replacing a joint at the end of a bone, in the same field of endeavor, wherein the method includes the steps of inserting a cement plug 16 into an intramedullary canal of the bone, injecting bone cement 42 into the intramedullary canal between the cement plug and a resected surface 10 while keeping the resected surface substantially free of the bone cement (via sealing device 44) and so that the channel of the void filling prosthesis is substantially filled with bone cement, and pressurizing the bone cement while keeping the resected surface substantially free of bone cement (fig.8; col.5, lines 13-21 discloses the sealing device 44 permits bone cement to be applied under pressure into the cavity 29) for the purpose of filling a cavity with cement for anchoring a joint prosthesis (col.6, lines 51-56).
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 method of Servidio to include the steps of inserting a cement plug into an intramedullary canal of the femur, injecting bone cement into the intramedullary canal between the cement plug and the resected surface while keeping the resected surface substantially free of the bone cement and so that the channel of the void filling prosthesis is substantially filled with bone cement, and pressurizing the bone cement while keeping the resected surface substantially free of bone cement as taught by Mikhail in order to fill the bone and femoral void filling prothesis with cement for securing the femoral component. While Servidio in view of Mikhail discloses the invention substantially as claimed, Servidio does not specifically disclose that the bone facing surface of the femoral component comprises a porous surface.
Unger discloses a method for replacing a joint at an end of a bone, in the same field of endeavor, including the step of implanting a joint prosthesis 16 onto the end of the bone such that a porous bone facing surface 28 of the joint prosthesis directly contacts a resected surface (figs. 1 and 3), wherein the porous layer on the under surface of the joint prosthesis is provided for the purpose of promoting bone growth into the pores thus providing the primary means of securing the component to the prepared surface of the bone (par.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 bone facing surface of the femoral component of Servidio to include a porous surface as taught by Unger in order to promote bone ingrowth for securing the component to the femur.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Servidio in view of Mikhail and Unger as applied to claim 3 above, and further in view of Harris et al. US 2016/0278929 (hereafter referred to as Harris 2016). Servidio in view of Mikhail and Unger discloses the method of claim 3 as discussed above, but Servidio does not disclose that the flutes each extend from a root to a tip thereof and each having a dual taper such that a distance between the root and the tip of the flute decreases along a first length portion of the stem at a first taper angle and a second length portion of the stem at a second taper angle, the second taper angle differing from the first taper angle.
Harris 2016 teaches a method of replacing a joint at an end of a bone, in the same field of endeavor, wherein a stem 14 of a tibial prosthesis 10 comprises a plurality of flutes 36, 38, 40, 42 and a plurality of grooves extending between the flutes (figs.2 and 5), wherein the flutes each extend from a root to a tip thereof and each having a dual taper such that a distance between the root and the tip of the flute decreases along a first length portion of the stem at a first taper angle and a second length portion of the stem at a second taper angle, the second taper angle differing from the first taper angle (at least figs.2, 4, and 6 show at least two different taper angles for the upper and lower sections of the stem) for the purpose of reducing the volume of the distal end of the stem to better fit the tibial canal (par.42). Harris 2016 further teaches the four flutes/fins provide rotational stability and strength (par.39).
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 stem of the tibial prosthesis of Servidio to include the four tapered flutes taught by Harris 2016 in order to prevent rotation while better fitting the tibial intramedullary canal.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Servidio in view of Mikhail and Unger as applied to claim 10 above, and further in view of Harris JR US 2023/0157831 (hereafter referred to as Harris 2023). Servidio in view of Mikhail and Unger discloses the method of claim 10 as discussed above, and further discloses forming a bone void in a metaphysis of the tibia (figs. 14-21), and inserting the tibial void filling prosthesis in the bone void such that a central axis of the tibial void filling prosthesis extends substantially perpendicular to a plane defined by the resected surface (figs.22E-F and 23E-F), wherein the step of implanting the tibial baseplate includes inserting the stem into the channel of tibial void filling prosthesis and docking the stem with the tibial void filling prosthesis so as to orient the bone facing surface parallel to the resected surface (figs.22E-F and 23E-F). However, Servidio in view of Mikhail and Unger does not disclose resecting the proximal tibia along a plane obliquely oriented relative to a mechanical axis of the tibia.
Harris 2023 teaches a method for revision knee arthroplasty (par.21 discloses revision procedures), in the same field of endeavor, wherein preparation of the tibia includes resecting the proximal tibia along a plane obliquely oriented (illustrated by angles delta and/or theta) relative to a mechanical axis of the tibia for the purpose of providing kinematic alignment of the knee joint prosthesis (pars. 10 and 78; figs. 7A-7F). Harris 2023 further teaches that the lower surface of the baseplate rests upon the resected tibial surface which means the bone facing surface is parallel to the resected surface (par.79).
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 method of Servidio in view of Mikhail and Unger to include the step of resecting the proximal tibia along a plane obliquely oriented relative to a mechanical axis of the tibia as taught by Harris 2023 in order to provide kinematic alignment of the knee prosthesis.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Servidio in view of Mikhail, Unger, and Harris 2023 as applied to claim 12 above, and further in view of Harris 2016. Servidio in view of Mikhail, Unger, and Harris 2023 discloses the method of claim 12 as discussed above, but Servidio does not disclose that the flutes each extend from a root to a tip thereof and each having a dual taper such that a distance between the root and the tip of the flute decreases along a first length portion of the stem at a first taper angle and a second length portion of the stem at a second taper angle, the second taper angle differing from the first taper angle.
Harris 2016 teaches a method of replacing a joint at an end of a bone, in the same field of endeavor, wherein a stem 14 of a tibial prosthesis 10 comprises a plurality of flutes 36, 38, 40, 42 and a plurality of grooves extending between the flutes (figs.2 and 5), wherein the flutes each extend from a root to a tip thereof and each having a dual taper such that a distance between the root and the tip of the flute decreases along a first length portion of the stem at a first taper angle and a second length portion of the stem at a second taper angle, the second taper angle differing from the first taper angle (at least figs.2, 4, and 6 show at least two different taper angles for the upper and lower sections of the stem) for the purpose of reducing the volume of the distal end of the stem to better fit the tibial canal (par.42). Harris 2016 further teaches the four flutes/fins provide rotational stability and strength (par.39).
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 stem of the tibial prosthesis of Servidio to include the four tapered flutes taught by Harris 2016 in order to prevent rotation while better fitting the tibial intramedullary canal.
Allowable Subject Matter
Claims 8, 9, and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose, teach, or suggest the step of placing a cement shield onto the resected surface, the shield having a channel extending therethrough, and wherein the step of implanting the joint prosthesis onto the end of the bone includes inserting the stem through the channel of the cement shield so that cement expelled from the bone flows through the channel of the shield away from the resected surface. Cement shields are generally known for use while applying cement but the prior art does not disclose, teach, or suggest using a cement shield while implanting a joint prosthesis onto the end of the bone as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ferro et al. US 2017/0312084 discloses a stem comprising flutes having two different taper angles.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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