DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 06/09/2026 with respect to the drawing objections have been fully considered and they are persuasive in part.
Applicant argues that the first and second side geometries are shown in Figs. 1, 8-9, and 11-13, and has amended independent claims 1-4, 6, and 22-25 to first articular surface and second articular surface. First articular surface and second articular surface both do not have feature numbers associated with them in the specification and the drawing objection is therefore upheld. See updated claim objections suggesting to amend first articular surface to medial articular surface (Fig. 1, 38) and second articular surface to lateral articular surface (Fig. 1, 42) to clarify these features.
Applicant argues that the claimed feature “indicator” is described with respect to a “color” which cannot be shown in the figures. This argument is persuasive and the drawing objection to the claimed feature “indicator” has been withdrawn.
Applicant argues that the claimed feature “inner cavity” is shown and described with respect to Figs. 1, 4, and 5. The examiner disagrees as there is no feature number associated with an inner cavity and therefore is not clear as to where this is described in the figures. The drawing objection is upheld.
Applicant argues that the claimed feature “outwardly projecting flange” is shown and described with respect to Fig. 3. The examiner disagrees as there is no feature number associated with an outwardly projecting flange and therefore is not clear as to where this is described in the figures. The drawing objection is upheld.
Applicant argues that the claimed feature “inwardly projecting anterior overhang” is shown and described with respect to Figs. 4-7. The examiner agrees that the inwardly projecting anterior overhang is shown as anterior overhang 76. This argument is persuasive and the drawing objection to the claimed feature “inwardly projecting anterior overhang” has been withdrawn.
Applicant’s arguments, filed 06/09/2026, with respect to claim objections have been fully considered and are persuasive. The objection of claim 32 has been withdrawn.
Applicant’s arguments, see page 8, filed 06/09/2026, with respect to the rejection(s) of claim(s) 2-4 under 35 USC 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see pages 9-14, filed 06/09/2026, with respect to the rejection(s) of claim(s) 1, 2, 5, and 9-11 under 35 USC 102(a)(2) have been fully considered and are persuasive. Applicant amended independent claim 1 to recite “the first side articular surface and the second side articular surface each being symmetrical, but comprising different geometries relative to one another” and “the other one of the first side articular surface or the second side articular surface is consistently relatively less congruent with the lateral condyle when the universal tibial insert is in either one of a first orientation for use in one of a right total knee arthroplasty or a left total knee arthroplasty or a second orientation for use in the other of the right total knee arthroplasty or the left total knee arthroplasty”. Applicant argues that Nguyen fails to disclose these amended limitations, and the examiner agrees. Therefore, the rejection has been withdrawn. However, upon further consideration as necessitated by amendment, a new grounds of rejection for claims 1-11 is made in view of Ries et al. (U.S Patent No. 8,568,485).
Applicant's arguments, see pages 14-15, filed 06/09/2026, with respect to the rejections of claim 12 under 35 USC 103 have been fully considered but they are not persuasive.
In regards to independent claim 12, applicant argues that Ries fails to disclose a keyed lock plate that is generally symmetrical across a median plane and a frontal plane. However, it is the examiners position that Ries does teach a keyed lock plate (Figs. 33-38, inferior side 408 (boss 412) engages with baseplate 14 (superior surface 28 is an upwardly projecting peripheral edge of cavity 22 of 14)). Ries teaches the keyed lock plate as claimed, as the keyed lock plate just requires notches that are sized and shaped for reception of an upwardly projecting peripheral edge of the tibial baseplate (Application specification [0009]). Ries teaches the keyed lock plate is generally symmetrical across a median plane and a frontal plane as the keyed lock plate (408) is a part of the tibial inset (402) which can be used on either the left or right knee (Col. 16, lines 13-15). In order to provide the left and right knee use by 180 degree rotation, the insert would have to be symmetrical in both the frontal and median planes as required by claim 12.
Applicant’s arguments, see pages 14-15, filed 06/09/2026, with respect to the rejection of claim 22 under 35 USC 103 have been fully considered and are persuasive in part. Applicant amended independent claim 22 to recite “the first side articular surface and the second side articular surface each being symmetrical, but comprising different geometries relative to one another”. Applicant argues that Nguyen fails to disclose these amended limitations, and the examiner agrees. Therefore, the rejection under Nguyen has been withdrawn. Applicant further argues that Ries fails to disclose a keyed lock plate that is generally symmetrical across a median plane and a frontal plane. However, it is the examiners position that Ries does teach a keyed lock plate (Figs. 33-38, inferior side 408 (boss 412) engages with baseplate 14 (superior surface 28 is an upwardly projecting peripheral edge of cavity 22 of 14)). Ries teaches the keyed lock plate as claimed, as the keyed lock plate just requires notches that are sized and shaped for reception of an upwardly projecting peripheral edge of the tibial baseplate (Application specification [0009]). Ries teaches the keyed lock plate is generally symmetrical across a median plane and a frontal plane as the keyed lock plate (408) is a part of the tibial inset (402) which can be used on either the left or right knee (Col. 16, lines 13-15). In order to provide the left and right knee use by 180 degree rotation, the insert would have to be symmetrical in both the frontal and median planes as required by claim 22. However, upon further consideration as necessitated by amendment, a new ground(s) of rejection is made in view of Ries et al. (U.S Patent No. 8,568,485) in view of Wogoman et al. (U.S Patent No. 11,510,784).
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 articular surface, second articular surface, inner cavity, and outwardly projecting flange 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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5, and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ries et al. (U.S Patent No. 8,568,485).
Regarding claim 1, Ries discloses a universal tibial insert (Figs. 33-38, tibial insert trial 402), comprising: a base (Figs. 33-38, inferior side 408) selectively engageable (Col. 13, lines 35-36) with a tibial baseplate (tibial baseplate 14); and an upwardly presented articular surface (Figs. 33-38, superior side 406) having a first side articular surface (Figs. 33-38, medial articular surface 424) and a second side articular surface (Figs. 33-38. Lateral articular surface 426) configured to interface with one of a medial condyle (Fig. 38, femoral condyle 58) or a lateral condyle (Fig. 38, femoral condyle 59) of a femoral component (Col. 13, lines 35-36, Figs. 33A-38, femoral implant 12) in articulatory relation thereof, the first side articular surface and the second side articular surface each being symmetrical (Col. 23, lines 5-10), but comprising different geometries relative to one another such that one of the first side articular surface (424) or the second side articular surface (426) is consistently relatively more congruent (Col. 13, lines 35-36 states that “the articular surfaces 424, 426 are shaped and curved to align with the femoral implant 12”) with the medial condyle (58) and the other of the first side articular surface (424) or the second side articular surface (426) is consistently relatively less congruent (Col. 13, lines 35-36 states that “the articular surfaces 424, 426 are shaped and curved to align with the femoral implant 12”) with the lateral condyle (59) when the universal tibial insert (402) is 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 or a second orientation (left knee) for use in the other of the right total knee arthroplasty or the left total knee arthroplasty (Paragraph [0121]).
Regarding claim 2, Ries further discloses the first side articular surface comprises a medial articular surface (Figs. 33-38, medial articular surface 424) and the second side articular surface comprises a lateral articular surface (Figs. 33-38. Lateral articular surface 426) such that the medial articular surface (424) of the universal tibial insert (402) interfaces with the medial condyle (Fig. 38, femoral condyle 58) of the femoral component (femoral implant 12) and the lateral articular surface (426) of the universal tibial insert (402) interfaces with the lateral condyle (Fig. 38, femoral condyle 59) of the femoral component (12).
Regarding claim 5, Ries further discloses the femoral component (femoral implant 12) comprises a symmetrical femoral component or an asymmetrical femoral component (Figs. 33-38, Implant 12 engages with 402, Col. 23, lines 5-10, the tibial insert 402 can be symmetric or asymmetric, therefore implant 12 can be as well).
Regarding claim 9, Ries further discloses each of the first side articular surface (Figs. 33-38, medial articular surface 424) and the second side articular surface (Figs. 33-38. Lateral articular surface 426) include a respective anterior peak (see annotated Fig. 38 below) terminating to a medial side (Col. 13, lines 35-36 states that “the articular surfaces 424, 426 are shaped and curved to align with the femoral implant 12”) of the universal tibial insert (Fig. 24D-24F) and a posterior peak (see annotated Fig. 38 below) terminating to a lateral side (Col. 13, lines 35-36 states that “the articular surfaces 424, 426 are shaped and curved to align with the femoral implant 12”) of the universal tibial insert (402).
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Regarding claim 10, Ries further discloses the anterior peak (see annotated Fig. 38 above) is positioned medial to the median plane (Col. 13, lines 35-36 states that “the articular surfaces 424, 426 are shaped and curved to align with the femoral implant 12”).
Regarding claim 11, Ries further discloses the first orientation (right knee) is approximately 180 degrees relative to the second orientation (left knee) (Paragraph [0121]).
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 Ries et al. (U.S Patent No. 8,568,485), 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, Ries fails to disclose wherein a radii of the medial condyle of the femoral component relative to a radii of the medial articular surface 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 articular surface (Col. 8, lines 41-43, “left or right knee”, medial articular compartment 216) or a radii of the second side articular surface (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 Ries’ universal tibial insert wherein a radii of the medial condyle of the femoral component relative to a radii of the first side articular surface or a radii of the second side articular surface 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, Ries fails to disclose wherein a radii of the lateral condyle of the femoral component relative to a radii of the lateral articular surface 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 articular surface (Col. 8, lines 41-43, “left or right knee”, lateral articular compartment 218) or a radii of the second side articular surface (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 Ries’ universal tibial insert wherein a radii of the lateral condyle of the femoral component relative to a radii of the first side articular surface or a radii of the second side articular surface 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, Ries fails to disclose wherein at least a portion of the first side articular surface and at least a portion of the second side articular surface comprises a reciprocal concave articular surface and a reciprocal flat articular surface.
Parisi also discloses a universal tibial insert (Fig. 4A-4B, tibial bearing component 212) comprising a first side articular surface (medial articular compartment 16) and a second side articular surface (lateral articular compartment 18). Parisi teaches wherein at least a portion of the first side articular surface and at least a portion of the second side articular surface comprises a reciprocal concave articular surface (Fig. 4A-4C, distal surface 260) and a reciprocal flat articular surface (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 Ries’ universal tibial insert wherein at least a portion of the first side articular surface and at least a portion of the second side articular surface comprises a reciprocal concave articular surface and a reciprocal flat articular surface, 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 Ries et al. (U.S Patent No. 8,568,485), as applied to claim 1 above, and further in view of Wentorf et al. (US Patent No. 9,381,090).
Regarding claim 7, Ries 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 Ries’ 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, Ries 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 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]).
Claims 22-23, 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Ries et al. (U.S Patent No. 8,568,485) in view of Wogoman et al. (U.S Patent No. 11,510,784).
Regarding claim 22, Ries discloses a universal tibial insert (Figs. 33-38, tibial insert trial 402), comprising: 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); and an upwardly presented articular surface (Figs. 33-38, articular surface 422) having a first side articular surface (Figs. 33-38, medial articular surface 424) and a second side articular surface (Figs. 33-38. Lateral articular surface 426) each configured to interface with one of a medial condyle (Fig. 38, femoral condyle 58) or a lateral condyle (Fig. 38, femoral condyle 59) of a femoral component (Col. 13, lines 35-36, Figs. 33A-38, femoral implant 12) in articulatory relation, the first side articular surface and the second side articular surface each being symmetrical (Col. 23, lines 5-10), but comprising different geometries relative to one another, so as to be relatively more congruent with the medial condyle than the lateral condyle (Col. 13, lines 35-36 states that “the articular surfaces 424, 426 are shaped and curved to align with the femoral implant 12”).
Ries fails to disclose 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.
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 Ries’ 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, Ries in view of Wogoman discloses the universal tibial insert (Figs. 33-38, tibial insert trial 402) of claim 22, wherein the first side articular surface (424)and the second side articular surface (426) are reciprocal of one another (Col. 23, lines 5-10).
Regarding claim 29, Ries as modified by 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, Ries as modified by 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, Ries as modified by 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 above) 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 above) while the downwardly projecting base simultaneously seats flush within the inner cavity.
Regarding claim 32, Ries in view of Wogoman further discloses wherein the keyed lock plate (Fig. 34B, tibial insert trial 402, inferior side 408) and the upwardly presented articular surface (Figs. 33-38, articular surface 422) couple to the tibial baseplate (baseplate 14) 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 Ries et al. (U.S Patent No. 8,568,485) in view of 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, Ries in view of Wogoman fails to disclose wherein a radii of the medial condyle relative to at least one radii of the first side articular surface and at least one radii of the second side articular surface 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 articular surface (Col. 8, lines 41-43, “left or right knee”, medial articular compartment 216) and at least one radii of the second side articular surface (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 Ries’ modified universal tibial insert wherein a radii of the medial condyle relative to at least one radii of the first side articular surface and at least one radii of the second side articular surface 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, Ries in view of Wogoman and Parisi fails to disclose wherein a radii of the lateral condyle relative to at least another radii of the first side articular surface and at least another radii of the second side articular surface 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 articular surface (Col. 8, lines 41-43, “left or right knee”, lateral articular compartment 218) and at least another radii of the second side articular surface (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 Ries’ modified universal tibial insert wherein a radii of the lateral condyle relative to at least another radii of the first side articular surface and at least another radii of the second side articular surface 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 Ries et al. (U.S Patent No. 8,568,485) in view of 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, Ries in view of 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 Ries in view of 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 Ries et al. (U.S Patent No. 8,568,485) in view of 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, Ries in view of 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 Ries’ in view of Wogoman 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, Ries as modified by 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.L.C./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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