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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7 January 2026 has been entered.
Claim Status
Applicant’s Remarks filed 7 January 2026 have been entered. Claims 1 and 3-25 are pending.
Response to Arguments
Applicant's arguments filed 7 January 2026 have been fully considered but they are not persuasive. Applicant’s arguments regarding the 112(a) rejection of claims 7-11 do not overcome the rejection. It is understood that the “bone anchoring component” may be represented by the “translation coupler” and its “arms”, or the “translation member”, however there is no support in the specification for the directional language in claim 7 of “pushing the bone anchoring component away from the knee arthroplasty prosthesis”. Paragraph 0201 of Applicant’s specification only refers to “…press[ing] against the translation coupler lock surface 46 and push[ing] the first and second translation coupler arms of the translation coupler 40 down against the first and second translation member arms of the translation member 30.”. “Down” and “away” are not understood directional equivalents and the specification fails to teach pushing “away”, therefore the 112(a) new matter rejection is maintained.
Applicant's arguments filed 7 January 2026 regarding claims 1 and 3-6 have been fully considered but they are not persuasive. Regarding Applicant’s argument that “Byrd still does not teach a person of skill in the art how the McCue device can be assembled in the order recited in claim 1, including ‘…after the [McCue] rotary plate is coupled to the bone-facing side of the arthroplasty prosthesis…’” (pg. 12-13 of remarks), Examiner respectfully disagrees. Byrd teaches that its Figs. 3A-D illustrate a method 200 by which the tibial prosthesis is assembled which includes passing insert 28 through a peripheral opening 202 and into recess 40 which couples insert 28 to the underside (i.e., bone-facing side) of tibial bearing component 26 first, as seen by Figs. 3A-B, and then coupling the tibial baseplate 24 with the tibial bearing component 26 after the insert 28 has been placed, as seen by Fig. 3C. Examiner views Byrd’s insert 28 to be analogous to McCue’s rotary disc 48 since both are centrally located, inserted features managing the movement between upper and lower tibial implant components, and therefore finds reason to utilize Byrd’s method 200 of assembly, as stated in the previous office action, to assemble the implant taught by McCue. Therefore, McCue in view of Byrd does teach “after the rotary plate is coupled to the bone-facing side of the arthroplasty prosthesis, coupling a bone anchoring component to the rotary plate to movably couple the bone anchoring component relative to the bone-facing side of the arthroplasty prothesis”, as stated in claim 1, and the rejection of claims 1 and 3-6 is maintained.
Applicant’s arguments with respect to claims 7-25 have been considered but are moot because the new ground of rejection does not rely on any previous combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In Applicant’s Amendments filed 10 August 2025, claim 7 has been amended to state “…engaging a distal end of a locking fastener against a surface of the bone anchoring component and pushing the bone anchoring component away from the knee arthroplasty prosthesis to frictionally lock the bone anchoring component in the relative position…” in lines 13-16. In Applicant’s remarks, it is claimed that support can be found for this amendment in [0201-0202] of the specification, however the specification only refers to the locking fastener “…press[ing] against the translation coupler lock surface 46 and push[ing] the first and second translation coupler arms of the translation coupler 40 down against the first and second translation member arms of the translation member 30.” [0201]. Examiner is unable to find particular support in the specification for “pushing the bone anchoring component away from the knee arthroplasty prosthesis to frictionally lock the bone anchoring component” since it appears as though the only pushing that occurs is related to the translation coupler arms and further, there is no particular mention of the direction of said pushing being “away” as the claim states. This amendment is inconsistent with the language of claim 7, and therefore considered new matter; claims 8-11 are rejected by dependency.
Claim Rejections - 35 USC § 103
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 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 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over McCue et al. (EP 0956836 A1), “McCue” in view of Byrd et al. (US Pat. No. 10675153 B2), “Byrd”.
Regarding claim 1, McCue teaches a method for replacing a natural articular surface on a bone (abstract) comprising: movably mating a first adjustable attachment feature (Fig. 9, recessed region 36) of an arthroplasty prosthesis (Fig. 1, tibial prosthesis 10) with a second adjustable attachment feature (Fig. 11, rotating disc 48) by coupling a rotary plate of the second adjustable attachment feature (Fig. 11, rotating disc 48 is a rotary plate) to a bone-facing side of the arthroplasty prosthesis (Fig. 1, inferior surface 20); after the rotary plate is coupled to the bone-facing side of the arthroplasty prosthesis (Fig. 7, rotating disc 48 is attached to inferior surface 20 [0021]), coupling a bone anchoring component (Fig. 1, keel 14) to the rotary plate (Fig. 11, rotating disc 48 is attached to inferior surface 20, keel 14 is attached to rotating disc 48 (col. 4, par. 4)) to movably couple the bone anchoring component (Fig. 1, keel 14) relative to the bone-facing side of the arthroplasty prothesis (Fig. 1, keel 14 is fixable to inferior surface 20 [0008]); securing a bone engagement surface (Fig. 1, tibial tray mating portion 22) of the bone anchoring component (Fig. keel 14) to a resected surface of the bone (tibial prosthesis is matable with resected proximal tibia (abstract)); and replacing the natural articular surface on the bone with an articular surface on a joint-facing side of the arthroplasty prosthesis (tibial prosthesis comprises a tibial platform having an inferior surface matable to a resected proximal tibia (abstract)), but fails to teach after the rotary plate is coupled to the bone-facing side of the arthroplasty prosthesis, coupling a bone anchoring component to the rotary plate to movably couple the bone anchoring component relative to the bone-facing side of the arthroplasty prothesis.
Byrd teaches a tibial prosthesis wherein after the rotary plate (Figs. 3A-C, method 200 comprises passing insert 28 through opening 202 and into recess 40 (col. 7, par. 4-5)) is coupled to the bone-facing side of the arthroplasty prosthesis (Figs. 3A-C, underside of tibial bearing component 26 prior to attachment of tibial baseplate 24), coupling a bone anchoring component (Fig. 3C, tibial baseplate 24) to the rotary plate (Fig. 3B, insert 28) to movably couple the bone anchoring component relative to the bone-facing side of the arthroplasty prothesis (Fig. 3C, method 200 comprises tibial baseplate 24 to tibial bearing component 26 after insert 28 has been placed (col. 7, par. 4-5)). Byrd discloses that the insert, fastener, tibial baseplate, and tibial bearing component reduce micro-motion of the tibial bearing component relative to the tibial baseplate (col. 6, lines 48-51). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the arthroplasty prosthesis taught by McCue with the assembly method taught by Byrd in order to limit wear between individual parts once the implant is assembled.
Regarding claim 3, McCue teaches wherein movably mating the first adjustable attachment feature (Fig. 9, recessed region 36) with the second adjustable attachment feature (Fig. 11, rotating disc 48) comprises: inserting the rotary plate of the second adjustable attachment feature (Fig. 11, rotating disc 48) into a rotary recess of the first adjustable attachment feature (Fig. 11, rotating disc 48 engages with recessed region 36) to rotatably couple the bone anchoring component (Fig. 1, keel 14) to the bone-facing side (Fig. 1, inferior surface 20) of the arthroplasty prosthesis (Fig. 1, tibial prosthesis 10).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over McCue et al. (EP 0956836 A1), “McCue” in view of Byrd et al. (US Pat. No. 10675153 B2), “Byrd” and further in view of Reich et al. (US 2008/0306603 A1), “Reich”.
Regarding claim 4, McCue teaches wherein movably mating the first adjustable attachment feature (Fig. 9, recessed region 36) with the second adjustable attachment feature (Fig. 11, rotating disc 48) to translatably couple the bone anchoring component (Fig. 1, keel 14) to the bone-facing side (Fig. 1, inferior surface 20) of the arthroplasty prosthesis (Fig. 1, tibial prosthesis 10), but McCue in view of Byrd fails to teach a translation coupler with a translation member.
Reich teaches a knee joint prosthesis having a translation coupler (Fig. 10, adapter 434) configured to movably couple with the translation member (Fig. 10, first coupling member 426) coupled to the bone-facing side (Fig. 10, lower surface 424) of the arthroplasty prosthesis (Fig. 10, implant part 410). Reich discloses that it is advantageous for parts of the implant to be adaptably mounted on the implant component in different positions to ideally match the anatomy of a patient [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the combine the teachings of McCue and Reich to create an implant with a translation member and coupler that allow for adjustable positioning and better customization to patient anatomy.
Regarding claim 5, McCue teaches wherein movably mating the first adjustable attachment feature (Fig. 9, recessed region 36) with the second adjustable attachment feature (Fig. 11, rotating disc 48) comprises: inserting the rotary plate (Fig. 11, rotating disc 48 is a rotary plate) of the second adjustable attachment feature into a rotary recess of the first adjustable attachment feature (Fig. 11, rotating disc 48 engages with recessed region 36) to rotatably couple the bone anchoring component (Fig. 1, keel 14) to the bone-facing side (Fig. 1, inferior surface 20) of the arthroplasty prosthesis (Fig. 1, tibial prosthesis 10), but McCue in view of Byrd fails to teach mating a translation coupler with a translation member of the rotary plate to translatably couple the bone anchoring component to the bone-facing side of the arthroplasty prosthesis.
Reich teaches a knee joint prosthesis mating a translation coupler (Fig. 10, adapter 434) with a translation member (Fig. 10, first coupling member 426) of the rotary plate to translatably couple the bone anchoring component to the bone-facing side (Fig. 10, lower surface 424) of the arthroplasty prosthesis (Fig. 10, implant part 410). Reich discloses that it is advantageous for parts of the implant to be adaptably mounted on the implant component in different positions to ideally match the anatomy of a patient [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the combine the teachings of McCue and Reich to create an implant with a translation member and coupler that allow for adjustable positioning and better customization to patient anatomy.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over McCue et al. (EP 0956836 A1), “McCue” in view of Byrd et al. (Us Pat. No. 10675153 B2), “Byrd” and further in view of Lee et al. (US Pat. No. 8142510 B2), “Lee”.
Regarding claim 6, McCue teaches engaging the bone engagement surface (Fig. 1, tibial tray mating portion 22) of the bone anchoring component (Fig. 1, keel 14) with the resected surface of the bone (abstract); with respect to the bone-facing side (Fig. 1, inferior surface 20) of the arthroplasty prosthesis (Fig. 1, tibial prosthesis 10), but McCue in view of Byrd fails to teach transmitting at least one force between the resected surface and the bone engagement surface to movably self-locate the bone anchoring component.
Lee teaches a mobile tibial assembly transmitting at least one force (Fig. 2, force vectors, 50, 52, 58) between the resected surface (Fig. 2, top side of tibia 16) and the bone engagement surface (Fig. 2, bottom surface 26) to movably self-locate the bone anchoring component (Fig. 2, forces generated during use is directed toward the center of the tibial tray 12 and surgically-prepared surface of the proximal end of tibia 16 (col. 7, par. 6 – col. 8, par. 2). Lee discloses that the size of the angle established between the surfaces of the tibial tray are selected so that the forces exerted during use of the implant are transferred toward the center of the tibia (col. 7, par. 6). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the device taught by McCue with the shape and forces taught by Lee in order to ensure placement of the implant during use.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over McCue et al. (EP 0 956 836 A1), “McCue” in view of German et al. (US 2004/0049286 A1), “German” and further in view of Aram et al. (US 2008/0091272 A1), “Aram”.
Regarding claim 7, McCue teaches a method for replacing a natural articular surface on a bone of a knee joint (abstract) comprising: mating a prosthesis attachment feature (Fig. 9, recessed region 36) of a knee arthroplasty prosthesis (Fig. 1, tibial prosthesis 10) with a component attachment feature (Fig. 11, rotating disc 48) positioned intermediate the knee arthroplasty prosthesis and a bone anchoring component to removably couple the bone anchoring component (Fig. 1, keel 14) to a bone-facing side (Fig. 1, inferior surface 20) of the knee arthroplasty prosthesis (Fig. 1, tibial prosthesis 10); securing a bone engagement surface (Fig. 1, tibial tray mating portion 22) of the bone anchoring component (Fig. 1, keel 14) to a resected surface of the bone (abstract); and replacing the natural articular surface on the bone (abstract) with an articular surface on a joint-facing side (Fig. 1, superior surface 16) of the of the knee arthroplasty prosthesis (Fig. 1, tibial prosthesis 10), but fails to teach locking a relative position of the bone anchoring component with respect to the bone-facing side of the knee arthroplasty prosthesis by engaging a distal end of a locking fastener against a surface of the bone anchoring component and pushing the bone anchoring component away from the knee arthroplasty prosthesis to frictionally lock the bone anchoring component in the relative position.
German teaches a prosthetic knee system comprising locking a relative position of the bone anchoring component (surgeon interlocks tibial component 102 and sleeve 104 in an optimal rotational position [0049]) with respect to the bone-facing side of the knee arthroplasty prosthesis (Figs. 18-20, distal side 110 of tibial tray 106). German discloses that the tibial component and sleeve may be locked in a variety of relative positions and can be offered in different sizes in a surgical kit [0049-0051]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the bone anchoring component taught by McCue with the locking positioning taught by German in order to provide an adaptable implant based on patient needs. However, McCue in view of German fails to teach engaging a distal end of a locking fastener against a surface of the bone anchoring component and pushing the bone anchoring component away from the knee arthroplasty prosthesis to frictionally lock the bone anchoring component in the relative position.
Aram teaches a prosthesis knee system engaging a distal end of a locking fastener (Fig. 27, set screw 1016) against a surface of the bone anchoring component (Fig. 27, inner surface 1062) and pushing the bone anchoring component away from the knee arthroplasty prosthesis to frictionally lock the bone anchoring component in the relative position (Figs. 27-28, set screw 1016 is received within distal end of tapered bore 1044 and causes distal end of stem 1042 to expand outwardly (i.e., push away) against the inner surface 1062 of stem 1022 of tibial tray 1012 causing a press-fit into the stem 1022 [0187]). Aram discloses the press-fit of the implant components prevents rotational movement between the tibial insert and the tibial tray [0187]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the press-fit features taught by Aram with locking positioning taught by German and the arthroplasty prosthesis and bone anchoring component taught by McCue in order to secure the implant components in an optimal position relative to patient needs.
Regarding claim 8, McCue teaches wherein mating the prosthesis attachment feature (Fig. 9, recessed region 36) with the component attachment feature comprises: mating a rotary recess (Fig. 9, recessed region 36 is a recess for attaching components) of the prosthesis attachment feature (Fig. 9, recessed region 36) a rotary plate of the component attachment feature to removably couple the bone anchoring component with the bone-facing side (Fig. 1, inferior surface 20) of the knee arthroplasty prosthesis (Fig. 1, tibial prosthesis 10).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over McCue et al. (EP 0 956 836 A1), “McCue” in view of German et al. (US 2004/0049286 A1), “German” and Aram et al. (US 2008/0091272 A1), “Aram” and further in view of Reich et al. (US 2008/0306603 A1), “Reich”.
Regarding claim 9, McCue teaches wherein removably coupling the bone anchoring component (Fig. 7, keel 14) to the bone-facing side of the knee arthroplasty prothesis (Fig. 1, inferior side 20 of tibial tray 12 of tibial prosthesis 10) comprises: to removably couple the bone anchoring component (Fig. 7, keel 14) with the bone-facing side (Fig. 1, inferior surface 20) of the knee arthroplasty prosthesis (Fig. 1, tibial prosthesis 10), but McCue in view of German and Aram fails to teach mating a translation member of the component attachment feature with a translation coupler of the bone anchoring component.
Reich teaches a knee joint prosthesis comprising mating a translation member (Fig. 10, first coupling member 426) of the component attachment feature (Fig, 10, square surface region 433 of implant component 414) with a translation coupler (Fig. 10, adapter 434) of the bone anchoring component (Fig. 10, shaft 416). Reich discloses that it is advantageous for parts of the implant to be adaptably mounted on the implant component in different positions to ideally match the anatomy of a patient [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the bone anchoring component and the component attachment feature taught by McCue with the translation member and coupler taught by Reich in order to create an implant that allows for adjustable positioning and better customization to patient anatomy.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over McCue et al. (EP 0 956 836 A1), “McCue” in view of German et al. (US 2004/0049286 A1), “German” and Aram et al. (US 2008/0091272 A1), “Aram” and further in view of Lee et al. (US Pat. No. 8142510 B2), “Lee”.
Regarding claim 10, McCue teaches engaging the bone engagement surface (Fig. 1, inferior surface 20) of the bone anchoring component (Fig. 7, keel 14) with the resected surface of the bone (abstract), and the bone-facing side (Fig. 1, inferior surface 20) of the knee arthroplasty prosthesis (Fig. 1, tibial prosthesis 10), but McCue in view of German and Aram fails to teach transmitting at least one force between the resected surface and the bone engagement surface to movably self-locate the bone anchoring component.
Lee teaches a mobile tibial assembly transmitting at least one force (Fig. 2, force vectors, 50, 52, 58) between the resected surface (Fig. 2, top side of tibia 16) and the bone engagement surface (Fig. 2, bottom surface 26) to movably self-locate the bone anchoring component (Fig. 2, forces generated during use is directed toward the center of the tibial tray 12 and surgically-prepared surface of the proximal end of tibia 16 (col. 7, par. 6 – col. 8, par. 2). Lee discloses that the size of the angle established between the surfaces of the tibial tray are selected so that the forces exerted during use of the implant are transferred toward the center of the tibia (col. 7, par. 6). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the device taught by McCue with the shape and forces taught by Lee in order to ensure placement of the implant during use.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over McCue et al. (EP 0 956 836 A1), “McCue” in view of German et al. (US 2004/0049286 A1), “German” and Aram et al. (US 2008/0091272 A1), “Aram” and Lee et al. (US Pat. No. 8142510 B2), “Lee”, and further in view of O’Neil et al. (US Pat. No. 6709461 B2), “O’Neil”.
Regarding claim 11, McCue teaches the bone anchoring component (Fig. 7, keel 14) with respect to the bone-facing side (Fig. 1, inferior surface 20) of the knee arthroplasty prosthesis (Fig. 1, tibial prosthesis 10), but McCue in view of German and Aram and Lee fails to teach activating a locking mechanism to prevent further movement of the bone anchoring component.
O’Neil teaches a modular joint prosthesis comprising activating a locking mechanism (Fig. 3, securing member 16) to prevent further movement of the bone anchoring component (Fig. 3, securing member 16 locks tibial bearing insert 12 and tibial plateau 14 together preventing translational movement of the two elements (col. 5, lines 46-49)). O’Neil discloses that the securing member can be a variety of shapes and forms with dimensions to fit its complementary bore (col. 5, lines 50-53). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the device taught by McCue with the locking mechanism taught by O’Neil in order to secure parts of the device with each other and prevent wear of the device.
Claims 12-25 are rejected under 35 U.S.C. 103 as being unpatentable over Aram et al. (US 2008/0091272 A1), “Aram”.
Regarding claim 12, Aram teaches a method for replacing a natural articular surface on a bone of a knee joint comprising: rotatably mating a prosthesis attachment feature (Fig. 94, aperture 4154) of a knee arthroplasty prosthesis (Fig. 94, rotating tibial insert 4106) with a component attachment feature (Fig. 94, post 4120) by coupling a rotary plate of the component attachment feature to a bone-facing side of the knee arthroplasty prosthesis (Fig. 94, top surface of post 4120 facing the same direction as upper surface 4112 which couples with bottom surface 4152 (Fig. 95) [0252]); securing a bone engagement surface of the bone anchoring component to a resected surface of the bone (Fig. 94, bottom surface 4114 of tibial tray 4102 engages with tibial canal [0247-248]); and replacing the natural articular surface on the bone with an articular surface on a joint-facing side of the knee arthroplasty prosthesis (Fig. 95, upper bearing surface 4150 of rotating tibial insert 4106), but fails to teach translatably mating a bone anchoring component with the component attachment feature by coupling the bone anchoring component to a translation member to translatably mate the bone anchoring component relative to the bone-facing side of the knee arthroplasty prosthesis.
However, a first embodiment of Aram teaches translatably mating a bone anchoring component with the component attachment feature by coupling the bone anchoring component to a translation member to translatably mate the bone anchoring component relative to the bone-facing side of the knee arthroplasty prosthesis (Fig. 108, stem 4808 comprises flange 4828 which engages with guide track 4812 on the bottom surface 4810 of tibial tray 4802). Aram discloses that the guide track extends across the bottom of the tibial tray in a medial-lateral direction and may be designed to extend in other directions [0298]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prothesis and component attachment features taught by Aram with the translation member taught by the first embodiment of Aram in order to provide increased adjustability of the implant to best suit patient needs.
Regarding claim 13, Aram teaches wherein rotatably mating the prosthesis attachment feature with the component attachment feature comprises: mating a rotary recess of the prosthesis attachment feature with the rotary plate of the component attachment feature (Fig. 95, post 4120 is received in aperture 4154 so that bottom surface 4152 of tibial insert 4106 is in contact with upper surface 4112 of tibial tray 4102 [0252]).
Regarding claim 14, Aram teaches the component attachment feature (Fig. 94, post 4120) and bone anchoring component (Fig. 94, tibial tray 4102), but fails to teach a translation member and coupler.
However, a first embodiment of Aram teaches wherein translatably mating the bone anchoring component (Fig. 108, stem 4804) with the component attachment feature comprises: mating the translation member (Fig. 108, guide track 4812) of the component attachment feature with a translation coupler (Fig. 108, flange 4828) of the bone anchoring component (Fig. 108, stem 4804) to removably couple the bone anchoring component with the bone-facing side of the knee arthroplasty prosthesis (Fig. 108, flange 4828 is sized to be received in opening 4820 of guide track 4812 on bottom surface 4810 of tibial tray 4802 [0299]). Aram discloses that the guide track extends across the bottom of the tibial tray in a medial-lateral direction and may be designed to extend in other directions [0298]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prothesis and component attachment features taught by Aram with the translation member taught by the first embodiment of Aram in order to provide increased adjustability of the implant to best suit patient needs.
Regarding claim 15, Aram teaches engaging the bone engagement surface of the bone anchoring component with the resected surface of the bone (Fig. 94, bottom surface 4114 of tibial tray 4102 engages with tibial canal [0247-248]), but fails to teach transmitting at least one force between the resected surface and the bone engagement surface to movably self-locate the bone anchoring component with respect to the bone-facing side of the knee arthroplasty prosthesis.
However, a first embodiment of Aram teaches transmitting at least one force between the resected surface and the bone engagement surface to movably self-locate the bone anchoring component with respect to the bone-facing side of the knee arthroplasty prosthesis (Fig. 108, stem 4804 may be slid or positioned in a desired location along guide track 4812 and then secured to tibial tray 4802 [0299]). Aram discloses that the guide track extends across the bottom of the tibial tray in a medial-lateral direction and may be designed to extend in other directions [0298]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prothesis and component attachment features taught by Aram with the translation member taught by the first embodiment of Aram in order to provide increased adjustability of the implant to best suit patient needs.
Regarding claim 16, Aram teaches a second embodiment comprising activating a locking mechanism to prevent further movement of the bone anchoring component with respect to the bone-facing side of the knee arthroplasty prosthesis (Figs. 98-99, fastener 4340 is inserted into passageway 4342 of tibial insert 4304 and threaded into threaded aperture 4346 of tibial tray 4302 to secure the components together [0265] and further works to restrict or prevent rotation of tibial insert 4304 relative to tibial tray 4302 [0266]). Aram discloses that the fastener works to reduce micro-motion and lift-off between the tibial implant components [0266]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the fastener taught by the second embodiment of Aram with the bone anchoring component and knee arthroplasty prosthesis taught by Aram in order to prevent implant malfunction while inside the patient.
Regarding claim 17, Aram teaches a second embodiment wherein activating the locking mechanism comprises rotating a locking fastener in a first direction to prevent further movement of the bone anchoring component with respect to the bone-facing side of the knee arthroplasty prosthesis (Figs. 98-99, fastener 4340 is a screw that is inserted into passageway 4342 of tibial insert 4304 and threaded into threaded aperture 4346 of tibial tray 4302 to secure the components together [0265] and further works to restrict or prevent rotation of tibial insert 4304 relative to tibial tray 4302 [0266]). Aram discloses that the fastener works to reduce micro-motion and lift-off between the tibial implant components [0266]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the fastener taught by the second embodiment of Aram with the bone anchoring component and knee arthroplasty prosthesis taught by Aram in order to prevent implant malfunction while inside the patient.
Regarding claim 18, Aram teaches wherein: at least a majority of the bone anchoring component is located outside an intramedullary canal of the bone when the bone anchoring component is secured to the bone (Fig. 95, only stem 4110 of tibial tray 4102 is embedded in patient's tibia [0248]).
Regarding claim 19, Aram teaches a method for replacing a natural articular surface on a bone comprising: removably mating a prosthesis attachment feature (Fig. 94, aperture 4154) of an arthroplasty prosthesis (Fig. 94, rotating tibial insert 4106) with a component attachment feature (Fig. 94, post 4120) of a bone anchoring component (Fig. 94, tibial tray 4102) to removably couple the bone anchoring component to a bone-facing side of the arthroplasty prosthesis (Fig. 95, post 4120 is received within aperture 4154 to couple bottom surface 4152 of rotating tibial insert 4106 and tibial tray 4102 together [0252]); securing a bone engagement surface of the bone anchoring component to a resected surface of the bone (Fig. 94, bottom surface 4114 of tibial tray 4102 engages with tibial canal [0247-248]); and replacing the natural articular surface on the bone with an articular surface on a joint-facing side of the of the arthroplasty prosthesis (Fig. 95, upper bearing surface 4150 of rotating tibial insert 4106), wherein: the component attachment feature comprises a rotary plate configured to couple with the prosthesis attachment feature (Fig. 95, post 4120 is received within aperture 4154), but fails to teach the rotary plate comprises only a single centrally located fastener hole formed therethrough configured to receive a locking fastener therein that is configured to selectively lock the bone anchoring component in a selected one of a plurality of different relative translational positions with respect to the bone-facing side of the arthroplasty prosthesis.
Aram teaches a first embodiment wherein the rotary plate comprises only a single centrally located fastener hole formed therethrough configured to receive a locking fastener therein (Fig. 108, flange 4828 is secured to tibial tray 4802 via a fastener such as a screw into a threaded aperture (not shown) [0299]) that is configured to selectively lock the bone anchoring component in a selected one of a plurality of different relative translational positions with respect to the bone-facing side of the arthroplasty prosthesis (Fig. 108, stem 4804 may be slid or positioned in a desired location along guide track 4812 and then secured to tibial tray 4802 [0299]). Aram discloses that the guide track extends across the bottom of the tibial tray in a medial-lateral direction and may be designed to extend in other directions [0298]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prothesis and component attachment features taught by Aram with the translation member taught by the first embodiment of Aram in order to provide increased adjustability of the implant to best suit patient needs.
Regarding claim 20, Aram teaches wherein: the prosthesis attachment feature and the component attachment feature comprise complementary circular shapes with each other (Fig. 95, post 4120 is received within aperture 4154 and both are circular in shape).
Regarding claim 21, Aram teaches wherein removably mating the prosthesis attachment feature with the component attachment feature comprises: inserting the rotary plate of the component attachment feature into a rotary recess of the prosthesis attachment feature to removably couple the bone anchoring component to the bone-facing side of the arthroplasty prosthesis (Figs. 94-95, post 4120 is received within aperture 4154 to couple rotating tibial insert 4106 and tibial tray 4102 together [0252]).
Regarding claim 22, Aram teaches engaging the bone engagement surface with the resected surface of the bone (Fig. 94, bottom surface 4114 of tibial tray 4102 engages with tibial canal [0247-248]), but fails to teach transmitting at least one force between the resected surface and the bone engagement surface to movably self-locate the bone anchoring component with respect to the bone-facing side of the arthroplasty prosthesis.
Aram teaches a first embodiment comprising transmitting at least one force between the resected surface and the bone engagement surface to movably self-locate the bone anchoring component with respect to the bone-facing side of the arthroplasty prosthesis (Fig. 108, stem 4804 may be slid or positioned in a desired location along guide track 4812 and then secured to tibial tray 4802 [0299]). Aram discloses that the guide track extends across the bottom of the tibial tray in a medial-lateral direction and may be designed to extend in other directions [0298]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the prothesis and component attachment features taught by Aram with the translation member taught by the first embodiment of Aram in order to provide increased adjustability of the implant to best suit patient needs.
Regarding claim 23, Aram teaches a second embodiment comprising activating a locking mechanism to prevent further movement of the bone anchoring component with respect to the bone-facing side of the arthroplasty prosthesis (Figs. 98-99, fastener 4340 is inserted into passageway 4342 of tibial insert 4304 and threaded into threaded aperture 4346 of tibial tray 4302 to secure the components together [0265] and further works to restrict or prevent rotation of tibial insert 4304 relative to tibial tray 4302 [0266]). Aram discloses that the fastener works to reduce micro-motion and lift-off between the tibial implant components [0266]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the fastener taught by the second embodiment of Aram with the bone anchoring component and knee arthroplasty prosthesis taught by Aram in order to prevent implant malfunction while inside the patient.
Regarding claim 24, Aram teaches a second embodiment wherein activating the locking mechanism comprises rotating the locking fastener in a first direction to prevent further movement of the bone anchoring component with respect to the bone-facing side of the arthroplasty prosthesis (Figs. 98-99, fastener 4340 is a screw that is inserted into passageway 4342 of tibial insert 4304 and threaded into threaded aperture 4346 of tibial tray 4302 to secure the components together [0265] and further works to restrict or prevent rotation of tibial insert 4304 relative to tibial tray 4302 [0266]). Aram discloses that the fastener works to reduce micro-motion and lift-off between the tibial implant components [0266]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the fastener taught by the second embodiment of Aram with the bone anchoring component and knee arthroplasty prosthesis taught by Aram in order to prevent implant malfunction while inside the patient.
Regarding claim 25, Aram teaches a third embodiment engaging at least one first anti-rotation feature (Fig. 68, protrusions 2282) of the arthroplasty prosthesis (Fig. 68, tibial insert 2214) with at least one second anti-rotation feature (Fig. 67, recesses 2280 mate with protrusions 2282 [0234]) of the bone anchoring component (Fig. 67, tibial tray 2212) to resist rotation of the bone anchoring component with respect to the bone-facing side of the arthroplasty prosthesis (Figs. 67-68, protrusions 2282 and recesses 2280 engage in order to precent rotation of tibial insert 2214 relative to tray 2212 [0234]). Aram discloses that the protrusions and recesses prevent rotation and micromotions between the tibial insert and tray components [0234]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the tibial base plate and bone anchoring component taught by Aram with the first and second anti-rotation features taught by Aram’s second embodiment in order to avoid unnecessary wear between the implant components and prolong implant life.
Conclusion
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/G.G.R./ Examiner, Art Unit 3774
/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774