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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first side geometry, second side geometry, indicator, inner cavity, outwardly projecting flange, and inwardly projecting anterior overhang must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 32 is objected to because of the following informalities: “The universal tibial insert of claim 22, therein the keyed lock plate”. The Examiner suggests that this informality is corrected to “The universal tibial insert of claim 22, wherein the keyed lock plate”. 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 2-4 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.
Regarding claim 2, which depends upon the parameter of geometry congruence with the femoral component condyles as defined in claim 1, “such that the first side geometry and the second side geometry are relatively more congruent with the medial condyle and relatively less congruent with the lateral condyle”; of claim 1. Claim 2 states “that the first side geometry and the second side geometry have approximately the same congruence with the medial condyle and the lateral condyle”; which contradicts the limitation as recited in claim 1. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite. Claims 3-4 are also rendered indefinite due to their dependency from indefinite claim 2.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5, and 9-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nguyen et al. (US Patent No. 11,911,280).
Regarding claim 1, Nguyen discloses a universal tibial insert (Figs. 24A-24F, tibial insert 2410), comprising: a base (Col. 18, lines 28-32, base 2411) selectively engageable with a tibial baseplate (Fig. 24A-24F, tibial baseplate component 2440); and an upwardly presented articular surface (Fig. 24A-24F, Tibial articulation surface 2412) having a first side geometry (Fig. 24B-24C, Medial articulation surface 2420) and a second side geometry (Fig. 24B-24C, Lateral articulation surface 2421) configured to interface with one of a medial condyle (Fig. 25A, Medial condyle 2402) or a lateral condyle (Fig. 25A, lateral condyle 2403) of a femoral component (Fig. 24A, Femoral component 2401) in articulatory relation thereof, the articular surface being symmetrical about a median plane (Col. 18, lines 59-62, 2412 interfaces with symmetric 2401) such that the first side geometry (Fig. 24B-24C, Medial articulation surface 2420) and the second side geometry (Fig. 24B-24C, Lateral articulation surface 2421) are relatively more congruent with the medial condyle and relatively less congruent with the lateral condyle (Col. 18, lines 59-67, tibial insert 2410, “may be specific to one side or the other”) when in either one of a first orientation (right knee) for use in one of a right total knee arthroplasty or a left total knee arthroplasty (Col. 18, lines 59-67) or a second orientation (left knee) for use in the other of the right total knee arthroplasty or the left total knee arthroplasty (Col. 18, lines 59-67).
Regarding claim 2, Nguyen further discloses the first side geometry (Medial articulation surface 2420) and the second side geometry (Lateral articulation surface 2421) are reciprocal (Fig. 24A-F) such that the first side geometry and the second side geometry have approximately the same congruence (Col. 18, lines 59-67) with the medial condyle (Fig. 25A, Medial condyle 2402) and the lateral condyle (Fig. 25A, lateral condyle 2403).
Regarding claim 5, Nguyen further discloses the femoral component (Fig. 24A, femoral component 2401) comprises a symmetrical femoral component or an asymmetrical femoral component (Col. 18, lines 59-62).
Regarding claim 9, Nguyen further discloses each of the first side geometry (Medial articulation surface 2420) and the second side geometry (Lateral articulation surface 2421) include a respective anterior peak (Medial high point 2427) terminating to a medial side of the universal tibial insert (Fig. 24D-24F) and a posterior peak (lateral high point 2430) terminating to a lateral side of the universal tibial insert (Fig. 24D).
Regarding claim 10, Nguyen further discloses the anterior peak (Medial high point 2427) is positioned medial to the median plane (Col. 19, lines 44-47, Fig. 24F, medial perimeter 2426).
Regarding claim 11, Nguyen further discloses the first orientation (right knee) is approximately 180 degrees relative to the second orientation (left knee) (Col. 18, lines 59-67).
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) 3, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US Patent No. 11,911,280), as applied to claims 1 and 2 above, and further in view of Parisi et al. (US Patent No. 8,690,954).
Regarding claim 3, Nguyen fails to disclose wherein a radii of the medial condyle of the femoral component relative to a radii of the first side geometry or a radii of the second side geometry comprises a medial ratio of about 1:1 to 1:1.2.
Parisi also discloses a universal tibial insert (Fig. 4A-4B, tibial bearing component 212). Parisi teaches wherein a radii of the medial condyle (medial condyle 222) of the femoral component (femoral component 220) relative to a radii of the first side geometry (Col. 8, lines 41-43, “left or right knee”, medial articular compartment 216) or a radii of the second side geometry (Col. 8, lines 41-43, “left or right knee”, medial articular compartment 216) comprises a medial ratio of about 1:1 to 1:1.2 (Col. 19, lines 32-33, Figs. 4A-4C).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Nguyen’s universal tibial insert wherein a radii of the medial condyle of the femoral component relative to a radii of the first side geometry or a radii of the second side geometry comprises a medial ratio of about 1:1 to 1:1.2, as taught by Parisi, in order to have medial conformity between the tibial insert and femoral component (Col. 19, lines 10-24).
Regarding claim 4, Nguyen fails to disclose wherein a radii of the lateral condyle of the femoral component relative to a radii of the first side geometry or a radii of the second side geometry comprises a lateral ratio of about 1:1.1 to 1:2.
Parisi also discloses a universal tibial insert (Fig. 4A-4B, tibial bearing component 212). Parisi teaches wherein a radii of the lateral condyle (lateral condyle 224) of the femoral component (femoral component 220) relative to a radii of the first side geometry (Col. 8, lines 41-43, “left or right knee”, lateral articular compartment 218) or a radii of the second side geometry (Col. 8, lines 41-43, “left or right knee”, lateral articular compartment 218) comprises a lateral ratio of about 1:1.1 to 1:2 (Col. 19, lines 30-32).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Nguyen’s universal tibial insert wherein a radii of the lateral condyle of the femoral component relative to a radii of the first side geometry or a radii of the second side geometry comprises a lateral ratio of about 1:1.1 to 1:2, as taught by Parisi, in order to have lateral conformity between the tibial insert and femoral component (Col. 19, lines 10-24).
Regarding claim 6, Nguyen fails to disclose wherein at least a portion of the first side geometry and at least a portion of the second side geometry comprises a reciprocal concave geometry and a reciprocal flat geometry.
Parisi also discloses a universal tibial insert (Fig. 4A-4B, tibial bearing component 212) comprising a first side geometry (medial articular compartment 16) and a second side geometry (lateral articular compartment 18). Parisi teaches wherein at least a portion of the first side geometry and at least a portion of the second side geometry comprises a reciprocal concave geometry (Fig. 4A-4C, distal surface 260) and a reciprocal flat geometry (Col. 18, lines 40-61, Figs. 4A-4C).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s universal tibial insert wherein at least a portion of the first side geometry and at least a portion of the second side geometry comprises a reciprocal concave geometry and a reciprocal flat geometry, as taught by Parisi, in order for the surfaces to fit tightly together (Col. 18, lines 53-57).
Claim(s) 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US Patent No. 11,911,280), as applied to claim 1 above, and further in view of Wentorf et al. (US Patent No. 9,381,090).
Regarding claim 7, Nguyen fails to disclose wherein the universal tibial insert includes at least one indicator visually identifying whether the universal tibial insert is in the first orientation or the second orientation.
Wentorf also discloses a universal tibial insert (tibial prosthesis 10).
Wentorf teaches wherein the universal tibial insert includes at least one indicator (void indicator 106). It would be obvious to place the void indicator for the purpose of visually identifying whether the universal tibial insert is in the first orientation or the second orientation (Col. 24, lines 57-67, Col. 25, lines 1-4, “facilitates spatial orientation”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s universal tibial insert wherein the universal tibial insert includes at least one indicator visually identifying whether the universal tibial insert is in the first orientation or the second orientation, as taught by Wentorf, in order to provide differentiation for the surgeon (Col. 24, lines 64-66).
Regarding claim 8, Nguyen in view of Wentorf discloses the indicator comprises an alphanumeric symbol or a color-code (Col. 24, lines 57-67, Col. 25, lines 1-4).
Claim(s) 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S Patent No. 11,911,280), in view of Ries et al. (U.S Patent No. 8,568,485).
Regarding claim 12, Nguyen discloses a universal tibial insert (Figs. 24A-24F, tibial insert 2410), comprising: a keyed lock plate (Insert interface 2411), an asymmetrical tibial baseplate (baseplate component 2440), and an upwardly presented articular surface (Fig. 24A-24F, Tibial articulation surface 2412) configured to reciprocally interface with a medial condyle (Fig. 25A, Medial condyle 2402) and a lateral condyle (Fig. 25A, lateral condyle 2403) of a femoral component (Femoral component 2401) in articulatory relation therewith when the universal tibial insert is in the first orientation (Col. 18, lines 59-67, right knee) or in the second orientation (Col. 18, lines 59-67, left knee) approximately 180 degrees relative to a first orientation (Col. 18, lines 59-67). Nguyen fails to disclose the keyed lock plate is generally symmetrical across a median plane and a frontal plane and selectively engageable with an asymmetrical tibial base plate in a first orientation and a second orientation approximately 180 degrees relative to the first orientation.
Ries also discloses a universal tibial insert (Figs. 33-38, tibial insert trial 402), a keyed lock plate (Fig. 34B, tibial insert trial 402, inferior side 408), and an asymmetrical tibial baseplate (tibial baseplate 14). Ries teaches the keyed lock plate (Fig. 34B, tibial insert trial 402, inferior side 408) is generally symmetrical across a median plane and a frontal plane (Col. 16, lines 5-15) and selectively engageable with an asymmetrical tibial base plate (tibial baseplate 14) in a first orientation and a second orientation approximately 180 degrees relative to the first orientation (Col. 12, lines 59-67).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s universal tibial insert to have a keyed lock plate generally symmetrical across a median plane and a frontal plane and selectively engageable with an asymmetrical tibial base plate in a first orientation and a second orientation approximately 180 degrees relative to the first orientation, as taught by Ries, in order to interface with the tibial baseplate (Col. 13, lines 12-19) and to be used in a left and right knee (Col. 12, lines 59-67).
Regarding claim 20, Nguyen as modified by Ries, fails to disclose wherein the universal tibial insert includes a symmetric pair of apertures formed therein and in general alignment with a pair of bores in the tibial baseplate when in the first orientation and in the second orientation, the apertures and the bores having a size and shape for select slide through reception and tightening of at least one bolt therein to retain the universal tibial insert to the tibial baseplate.
Ries further teaches wherein the universal tibial insert (Figs. 33-38, tibial insert trial 402) includes a symmetric pair of apertures (insert trial channel 416) formed therein and in general alignment with a pair of bores (Fig. 38, hole 30) in the tibial baseplate (14) when in the first orientation and in the second orientation (Col. 12, lines 59-67), the apertures and the bores having a size and shape for select slide through reception and tightening of at least one bolt (cam bolt trial 404, fastener 440) therein to retain the universal tibial insert to the tibial baseplate.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s modified universal tibial insert wherein the universal tibial insert includes a symmetric pair of apertures formed therein and in general alignment with a pair of bores in the tibial baseplate when in the first orientation and in the second orientation, the apertures and the bores having a size and shape for select slide through reception and tightening of at least one bolt therein to retain the universal tibial insert to the tibial baseplate, as further taught by Ries, in order to secure the tibial insert and baseplate together while still allowing movement (Col. 14, lines 11-36, Fig. 35)
Claim(s) 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S Patent No. 11,911,280) in view of Ries et al. (U.S Patent No. 8,568,485), as applied to claim 12 above, and further in view of Wogoman et al. (U.S Patent No. 11,510,784).
Regarding claim 13, Nguyen in view of Ries further discloses the keyed lock plate (Insert interface 2411) includes a downwardly projecting base (Fig. 24A, 24E, Insert Interface 2411, downwardly projecting to interface with insert interface 2441). Nguyen in view of Ries fails to disclose a pair of lock bars in spaced apart relation relative thereto, the base and the lock bars cooperate to form a respective pair of notches therebetween having a size and shape for select reception of at least a portion of an upwardly projecting peripheral edge of the tibial baseplate.
Wogoman also discloses a universal tibial insert (tibial tray insert 18, 20, 22), a downwardly projecting base (80), a keyed lock plate (Fig. 2) and a tibial baseplate (16). Wogoman teaches a pair of lock bars (70, 72, see annotated Fig. 2 below) in spaced apart relation relative thereto, the base (80) and the lock bars (70, 72) cooperate to form a respective pair of notches therebetween (70, 72, 80) having a size and shape for select reception of at least a portion of an upwardly projecting peripheral edge of the tibial baseplate (62, see annotated Fig. 2 below).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s modified universal tibial insert to include a pair of lock bars in spaced apart relation relative thereto, the base and the lock bars cooperate to form a respective pair of notches therebetween having a size and shape for select reception of at least a portion of an upwardly projecting peripheral edge of the tibial baseplate, as taught by Wogoman, in order to secure the tibial insert and tibial baseplate together (Col. 17, lines 54-64).
Regarding claim 14, Nguyen in view of Ries, and further in view of Wogoman, further discloses wherein one of the pair of lock bars (70, see annotated Fig. 2 above) selectively engages an anterior tibial channel (66, see annotated Fig. 1 above formed by an anterior overhang extending inwardly (62, see annotated Fig. 1 above) from the upwardly projecting peripheral edge (62, see annotated Fig. 1 above) thereof and the other of the pair of lock bars (72, see annotated Fig. 2 above) selectively resides within a keyed channel (68, see annotated Fig. 1 above) of the tibial baseplate.
Regarding claim 15, Nguyen in view of Ries, and further in view of Wogoman further discloses the pair of lock bars (72, see annotated Fig. 2 above) comprise a width approximately equal to that of the keyed channel (68, see annotated Fig. 1 above), thereby stabilizing side-to-side movement (Col. 17, line 53) of the universal tibial insert (tibial tray insert 18, 20, 22) relative to the tibial baseplate (16).
Regarding claim 16, Nguyen in view of Ries, and further in view of Wogoman further discloses wherein each of the pair of lock bars (70, see annotated Fig. 2 above) include a chamfered projection (70, see annotated Fig. 2 above) forming a lock bar channel (86, see annotated Fig. 2 above) that selectively engages the anterior overhang (62, see annotated Fig. 1 above).
Regarding claim 17, Nguyen in view of Ries, and further in view of Wogoman fails to disclose wherein the base includes a reciprocal pair of outwardly projecting ledges forming a pair of grooves therein that selectively engage a pair of inwardly projecting posterior overhangs on opposite sides of the keyed channel of the tibial baseplate for slotted reception therewith.
Wogoman further teaches wherein the base includes a reciprocal pair of outwardly projecting ledges (82, 84, see annotated Fig. 2 above) forming a pair of grooves (82, 84, see annotated Fig. 2 below) therein that selectively engage a pair of inwardly projecting posterior overhangs (64, see annotated Fig. 1 below) on opposite sides of the keyed channel (68, see annotated Fig. 1 below) of the tibial baseplate for slotted reception therewith.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s modified universal tibial insert wherein the base includes a reciprocal pair of outwardly projecting ledges forming a pair of grooves therein that selectively engage a pair of inwardly projecting posterior overhangs on opposite sides of the keyed channel of the tibial baseplate for slotted reception therewith, as further taught by Wogoman, in order to secure the tibial insert and tibial baseplate together (Col. 18, lines 1-13)
Regarding claim 18, Nguyen in view of Ries, and further in view of Wogoman fails to disclose wherein the downwardly projecting base is of a size and shape for select reception within an inner cavity of the tibial baseplate formed by the upwardly projecting peripheral edge.
Wogoman further teaches wherein the downwardly projecting base (80) is of a size and shape for select reception within an inner cavity (60, see annotated Fig. 2 above of the tibial baseplate formed by the upwardly projecting peripheral edge (62, see annotated Fig. 2 above).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed inventio, to have modified Nguyen’s modified universal tibial insert wherein the downwardly projecting base is of a size and shape for select reception within an inner cavity of the tibial baseplate formed by the upwardly projecting peripheral edge, as further taught by Wogoman, in order to secure the tibial insert and tibial baseplate together (Col. 18, lines 5-13).
Regarding claim 19, Nguyen in view of Ries, and further in view of Wogoman fails to disclose wherein the keyed lock plate includes an outwardly projecting flange having a size and shape for seated reception on an upper surface of the peripheral edge of the tibial baseplate while the downwardly projecting base simultaneously seats flush within the inner cavity of the tibial baseplate.
Wogoman further teaches wherein the keyed lock plate (Fig. 2) includes an outwardly projecting flange (86, 100, see annotated Fig. 2 below) having a size and shape for seated reception on an upper surface of the peripheral edge (62, see annotated Fig. 2 below) of the tibial baseplate while the downwardly projecting base (80, see annotated Fig. 2 below) simultaneously seats flush within the inner cavity (60, see annotated Fig. 2 below) of the tibial baseplate.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s modified universal tibial insert wherein the keyed lock plate includes an outwardly projecting flange having a size and shape for seated reception on an upper surface of the peripheral edge of the tibial baseplate while the downwardly projecting base simultaneously seats flush within the inner cavity of the tibial baseplate, as further taught by Wogoman, in order to secure the tibial insert and tibial baseplate together (Col. 17, lines 54-64).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S Patent No. 11,911,280) in view of Ries et al. (U.S Patent No. 8,568,485), as applied to claim 12 above, and further in view of Hofmann et al. (U.S Publication No. 2025/0009517 A1).
Regarding claim 21, Nguyen in view of Ries fails to disclose the universal tibial insert including an adhesive selected from the group consisting of a fibrin adhesive, collagen adhesive, polyurethane, epoxy resin, cyanoacrylates, polyesters, and zinc polycarboxylate coupling the universal tibial insert to the tibial baseplate.
Hofmann also discloses a universal tibial insert (tibial component 24). Hofmann teaches the universal tibial insert including an adhesive selected from the group consisting of a fibrin adhesive, collagen adhesive, polyurethane, epoxy resin, cyanoacrylates, polyesters, and zinc polycarboxylate coupling the universal tibial insert to the tibial baseplate (Paragraph [0051]). Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Nguyen’s and Ries’ universal tibial insert including an adhesive selected from the group consisting of a fibrin adhesive, collagen adhesive, polyurethane, epoxy resin, cyanoacrylates, polyesters, and zinc polycarboxylate coupling the universal tibial insert to the tibial baseplate, as taught by Hofmann, in order to couple the system together (Paragraph [0051]).
Claim(s) 22-23, 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S Patent No. 11,911,280) in view of Ries et al. (U.S Patent No. 8,568,485) and Wogoman et al. (U.S Patent No. 11,510,784).
Regarding claim 22, Nguyen discloses a universal tibial insert (Figs. 24A-24F, tibial insert 2410), comprising: an upwardly presented articular surface (Fig. 24A-24F, Tibial articulation surface 2412) having a first side geometry (Fig. 24B-24C, Medial articulation surface 2420) and a second side geometry (Fig. 24B-24C, Lateral articulation surface 2421) each configured to interface with one of a medial condyle (Fig. 25A, Medial condyle 2402) or a lateral condyle (Fig. 25A, lateral condyle 2403) of a femoral component (Fig. 24A, Femoral component 2401) in articulatory relation, the first side geometry and the second side geometry being symmetrical about a median plan (Col. 18, lines 59-62, 2412 interfaces with symmetric 2401) and relatively more congruent with the medial condyle than the lateral condyle (Col. 18, lines 59-67).
Nguyen fails to disclose a keyed lock plate generally symmetrical across a median plane and a frontal plane and selectively engageable with an asymmetrical tibial base plate, the keyed lock plate including a downwardly projecting base and a pair of lock bars in spaced apart relation relative thereto cooperating to form a groove in between for select reception and retainment of at least a portion of an upwardly projecting peripheral edge of the tibial baseplate.
Ries also discloses a universal tibial insert (Figs. 33-38, tibial insert trial 402) and an asymmetrical tibial baseplate (tibial baseplate 14). Ries teaches a keyed lock plate (Fig. 34B, tibial insert trial 402, inferior side 408) generally symmetrical across a median plane and a frontal plane (Col. 16, lines 5-15) and selectively engageable with an asymmetrical tibial base plate (tibial baseplate 14).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Nguyen’s universal tibial insert to include a keyed lock plate generally symmetrical across a median plane and a frontal plane and selectively engageable with an asymmetrical tibial base plate, as taught by Ries, in order to use the insert in either the right or left knee making it universal (Col. 16, lines 5-15).
Wogoman also discloses a universal tibial insert (tibial tray insert 18, 20, 22), a keyed lock plate (Fig. 2), and a tibial baseplate (16). Wogoman teaches the keyed lock plate including a downwardly projecting base (80) and a pair of lock bars (70, 72, see annotated Fig. 2 below) in spaced apart relation relative thereto cooperating to form a groove (82, 84, see annotated Fig. 2 below) in between for select reception and retainment of at least a portion of an upwardly projecting peripheral edge (62, see annotated Fig. 2 below) of the tibial baseplate.
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to have modified Nguyen’s modified universal tibial insert to have the keyed lock plate including a downwardly projecting base and a pair of lock bars in spaced apart relation relative thereto cooperating to form a groove in between for select reception and retainment of at least a portion of an upwardly projecting peripheral edge of the tibial baseplate, as taught by Wogoman, in order to secure the tibial insert and tibial baseplate together (Col. 18, lines 5-13).
Regarding claim 23, Nguyen in view of Ries, and further in view of Wogoman discloses the universal tibial insert (Figs. 24A-24F, tibial insert 2410) of claim 22, wherein the first side geometry and the second side geometry are reciprocal of one another (Col. 18, lines 59-67, Figs. 24A-24F).
Regarding claim 29, Nguyen in view of Ries, and further in view of Wogoman discloses wherein the pair of lock bars (70, 72, see annotated Fig. 2 above) comprise a width approximately equal to that of a keyed channel (68, see annotated Fig. 1 above) of the tibial baseplate and include a chamfered projection (70, see annotated Fig. 2 above) selectively engageable underneath an inwardly projecting anterior overhang (62, see annotated Fig. 1 above) of the tibial baseplate.
Regarding claim 30, Nguyen in view of Ries, and further in view of Wogoman further discloses the downwardly projecting base includes a reciprocal pair of ledges (82, 84, see annotated Fig. 2 above) forming a pair of slots (68, see annotated Fig. 1 above) therein that selectively engage a pair of inwardly projecting posterior overhangs (64, see annotated Fig. 1 above) on opposite sides of the keyed channel (68, see annotated Fig. 1 above).
Regarding claim 31, Nguyen in view of Ries, and further in view of Wogoman further discloses the downwardly projecting base (80) is of a size and shape for select reception within an inner cavity (60, see annotated Fig. 2 below) of the tibial baseplate and an outwardly projecting flange (86, 100, see annotated Fig. 2 below) of the keyed lock plate is of a size and shape for seated reception on an upper surface of the peripheral edge (62, see annotated Fig. 2 below) while the downwardly projecting base simultaneously seats flush within the inner cavity.
Regarding claim 32, Nguyen in view of Ries, and further in view of Wogoman further discloses wherein the keyed lock plate (Insert interface 2411) and the upwardly presented articular surface (Fig. 24A-24F, Tibial articulation surface 2412) couple to the tibial baseplate (baseplate component 2440) in a first position for use in a right total knee arthroplasty or a second position 180 degrees (Col. 18, lines 59-67) relative to the first position for use in a left total knee arthroplasty (Col. 18, lines 59-67).
Claim(s) 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S Patent No. 11,911,280) in view of Ries et al. (U.S Patent No. 8,568,485) and Wogoman et al. (U.S Patent No. 11,510,784), as applied to claim 22 above, and further in view of Parisi et al. (US Patent No. 8,690,954).
Regarding claim 24, Nguyen in view of Ries and Wogoman fails to disclose wherein a radii of the medial condyle relative to at least one radii of the first side geometry and at least one radii of the second side geometry comprises a medial ratio of about 1:1 to 1:1.2.
Parisi also discloses a universal tibial insert (Fig. 4A-4B, tibial bearing component 212). Parisi teaches wherein a radii of the medial condyle (medial condyle 222) relative to at least one radii of the first side geometry (Col. 8, lines 41-43, “left or right knee”, medial articular compartment 216) and at least one radii of the second side geometry (Col. 8, lines 41-43, “left or right knee”, medial articular compartment 216) comprises a medial ratio of about 1:1 to 1:1.2 (Col. 19, lines 32-33, Figs. 4A-4C). Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Nguyen’s modified universal tibial insert wherein a radii of the medial condyle relative to at least one radii of the first side geometry and at least one radii of the second side geometry comprises a medial ratio of about 1:1 to 1:1.2, as taught by Parisi, in order to have medial conformity between the tibial insert and femoral component (Col. 19, lines 10-24).
Regarding claim 25, Nguyen in view of Ries, Wogoman, and Parisi fails to disclose wherein a radii of the lateral condyle relative to at least another radii of the first side geometry and at least another radii of the second side geometry comprises a lateral ratio of about 1:1.1 to 1:2.
Parisi further teaches wherein a radii of the lateral condyle (lateral condyle 224) relative to at least another radii of the first side geometry (Col. 8, lines 41-43, “left or right knee”, lateral articular compartment 218) and at least another radii of the second side geometry (Col. 8, lines 41-43, “left or right knee”, lateral articular compartment 218) comprises a lateral ratio of about 1:1.1 to 1:2 (Col. 19, lines 30-32). Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Nguyen’s modified universal tibial insert wherein a radii of the lateral condyle relative to at least another radii of the first side geometry and at least another radii of the second side geometry comprises a lateral ratio of about 1:1.1 to 1:2, as further taught by Parisi, in order to have lateral conformity between the tibial insert and femoral component (Col. 19, lines 10-24).
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S Patent No. 11,911,280) in view of Ries et al. (U.S Patent No. 8,568,485) and Wogoman et al. (U.S Patent No. 11,510,784), as applied to claim 22 above, and further in view of Hofmann et al. (U.S Publication No. 2025/0009517 A1).
Regarding claim 26, Nguyen in view of Ries and Wogoman fails to disclose an adhesive selected from the group consisting of a fibrin adhesive, collagen adhesive, polyurethane, epoxy resin, cyanoacrylates, polyesters, and zinc polycarboxylate secures the universal tibial insert to the tibial baseplate.
Hofmann also discloses a universal tibial insert (tibial component 24) and a femoral component (femoral component 22). Hofmann teaches an adhesive selected from the group consisting of a fibrin adhesive, collagen adhesive, polyurethane, epoxy resin, cyanoacrylates, polyesters, and zinc polycarboxylate secures the universal tibial insert to the tibial baseplate (Paragraph [0051]). Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Nguyen’s in view Ries’ and Wogomans’ universal tibial insert including an adhesive selected from the group consisting of a fibrin adhesive, collagen adhesive, polyurethane, epoxy resin, cyanoacrylates, polyesters, and zinc polycarboxylate secures the universal tibial insert to the tibial baseplate, as taught by Hofmann, in order to couple the system together (Paragraph [0051]).
Claim(s) 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (U.S Patent No. 11,911,280), in view of Ries et al. (U.S Patent No. 8,568,485) and Wogoman et al. (U.S Patent No. 11,510,784), as applied to claim 22 above, and further in view of Wentorf et al. (US Patent No. 9,381,090).
Regarding claim 27, Nguyen in view of Ries and Wogoman fails to disclose wherein the universal tibial insert includes at least one indicator visually identifying whether the universal tibial insert is in one of a pair of orientations relative to the tibial baseplate.
Wentorf also discloses a universal tibial insert (tibial prosthesis 10). Wentorf teaches wherein the universal tibial insert includes at least one indicator (void indicator 106) visually identifying whether the universal tibial insert is in one of a pair of orientations relative to the tibial baseplate (Col. 24, lines 57-67, Col. 25, lines 1-4). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to have modified Nguyen’s modified universal tibial insert wherein the universal tibial insert includes at least one indicator visually identifying whether the universal tibial insert is in one of a pair of orientations relative to the tibial baseplate, as taught by Wentorf, in order to provide differentiation for the surgeon (Col. 24, lines 64-66).
Regarding claim 28, Nguyen in view of Ries, Wogoman and Wentorf further discloses the indicator comprises an alphanumeric symbol or a color-code (Col. 24, lines 57-67, Col. 25, lines 1-4).
Conclusion
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/KARI L COCHRAN/Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774