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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/22/26 has been entered.
Response to Arguments
Applicant's arguments filed 01/22/26 have been fully considered but they are not persuasive.
On page 12 regarding prior art rejections, Applicant argues amendments overcome the rejection of record since claim 1 now incorporates claims 2-3, 7, 9, and 11.
On page 13 regarding claims 9-10, Applicant argues a person of ordinary skill would not consider Boschert’s “provision securement means” to improve the Ashby Hayes Combination since Boschert does not address movement of an implant when its implanted.
The Examiner respectfully notes that this argument is unclear, since the claims do not appear to have any requirements or limitations regarding if/how an implant engages during implantation as opposed to not during implantation.
On page 14 Applicant describes their doubtfulness that a person of ordinary skill would find Boschert within the same field of endeavor as a prosthetic knee implant.
The Examiner respectfully notes this argument is unclear, since it does not appear that Applicant is questioning the field of endeavor. However, the Examiner also makes note that the field of endeavor, of coupling orthopedic implants, is understood to be the same.
On page 14 Applicant argues further it would not be obvious to provide projections of Boschert on a coupling projection of a tibial tray of a knee joint, since the coupling of Boschert relies on provisional retaining tabs 400 to snap fit in place. Applicant concludes Boschert teaches away from removing the coupling tabs on the opening and arranging them on a coupling projection as claim 1 now requires.
The Examiner respectfully notes there does not appear to be any support for this statement or proof within Boschert to describe where they teach away from the modification suggested by the Examiner.
On page 14 Applicant argues that Ashby teaches a snap-fit connection similar to figure 20 of Boschert and argues Ashby teaches providing coupling elements only on the meniscal component, as opposed to on the coupling projection of the tibial component, which would be required to achieve Ashby’s assembly operation.
The Examiner respectfully notes no support for such a statement with proof in the record. The arguments of counsel cannot take the place of evidence in the record. See MPEP 716.01(c).
Election/Restrictions
Newly submitted claims 38-40 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 38 is drawn towards a distinct product than originally filed claim 1, which has a materially different design, mode of operation, and effect. The inventions further do not overlap in scope and are mutually exclusive, and are not obvious variants based on the current record.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 38-40 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-6, 8, 10, 17-33, 35 is/are rejected under 35 U.S.C. 103a as being unpatentable over Ashby et al. (US 5879394 A) hereinafter known as Ashby in view of Hayes (US 5458637 A), further in view of Boschert (US 20050277928 A1).
Regarding claim 1 Ashby discloses a knee joint prosthesis apparatus comprising a tibial component (Figure 1 item 1) and comprising a meniscal component (Figure 1 item 2)
wherein the tibial and meniscal components are coupled to one another in a coupling position (Figure 10) and are completely separated from one another in a separating position (Figure 5),
wherein the tibial component has a top side defining an abutment plane (Figure 6 item 35) against which a bottom side of the meniscal component (Figure 6 item 21) abuts in the coupling position (Figure 10),
wherein the apparatus further comprises a coupling device for coupling the tibial and meniscal components in the coupling position (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Ashby was considered capable of performing the cited intended use. See for example Figures 6-10)),
wherein the apparatus is transferrable from the separating position to the coupling position by a relative movement of the two components (Figures 5-10; Column 4 lines 31-37),
and the coupling device is configured in such a way that the tibial and meniscal component are displaceable relative to one another in a direction parallel to the abutment plane upon transferring the apparatus from the separating position to an intermediate position (Figures 5-6 show how movement 36 slides the boss 8 into groove 26), and are displaceable relative to and toward one another in a direction perpendicular to the abutment plane upon transferring the apparatus from the intermediate position into the coupling position (Figures 8-9 shows the movement towards one another in the direction perpendicular to the abutment plane),
wherein the coupling device comprises a first coupling element arranged on the tibial component (Figure 5 item 8) and a second coupling element arranged on the meniscal component (Figure 3 item 32),
wherein the first and second coupling elements are out of engagement in the separating position (Figures 5) and in engagement to control displacement of the apparatus from the separating position into the intermediate position, and in the coupling position (Figures 6-10),
wherein the first and second coupling elements are configured to be in engagement to allow the relative movement of the tibial and meniscal components in the direction parallel to the abutment plane (Figures 5-6 show the parallel movement 36 into recess 23) and prevent the relative movement of the tibial and meniscal components in the direction perpendicular to the abutment plane throughout movement from the separating position to the intermediate position (Figure 6 shows vertical movement being prohibited by wall 33), and prevent the relative movement of the tibial and meniscal components in the direction parallel to the abutment plane (Column 4 lines 61-63 the bearing can only move posteriorly until the boss engages the end of the recess 23) and allow the relative movement of the tibial and meniscal components in the direction perpendicular to the abutment plane upon reaching the intermediate position (shown in Figures 8-9),
wherein the first coupling element is a projection (Figures 5-10 item 8), the second coupling element is a coupling receptable with a coupling recess (Figures 5-10 show the receptable 23/32/26/27) with a coupling recess (32), wherein the receptable is configured to accommodate the projection in the intermediate position (Figures 6-7) and the receptacle accommodates at least one part of the projection in the coupling position (Figure 10),
wherein the meniscal component has an insertion opening for inserting the projection into the receptacle (Figures 5-10),
and wherein the insertion opening defines an insertion width and the projection defines a projection width,
but is silent with regards to the first and second coupling element being configured to allow the bottom side of the meniscal component to remain parallel to the abutment plane throughout movement from the separating position to the coupling position,
whether or not the recess accommodates at least one part of the projection in the coupling position,
and wherein the projection with is greater than or equal to the insertion width,
and wherein at least two coupling elements are arranged or formed on the coupling projection which are moveable to temporarily reduce the coupling projection width upon a transition from the separating position into the intermediate position.
However, regarding claim 1 Hayes teaches that knee joint prostheses can have two coupling elements (Figure 1 items 44/40 and items 20/23) which allow a bottom side of a top component (Figure 1 item 10) to remain parallel to an abutment plane between the top component and a bottom component (Figure 1 item 30) throughout movement (Figures 1-6) from a separate position (Figure 1) to one in which they are coupled (Figure 6). Ashby and Hayes are involved in the same field of endeavor, namely knee joint prostheses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the apparatus of Ashby so that the projection (8) and opening (32) of Ashby are corresponding sizes which allows the two to move from a separating position, to an intermediate position, and finally to the coupling position without the projection (8) impinging on the opening (32) as is taught by Hayes (Figures 1-6) since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the engagement of the two pieces without impinging as is taught by Hayes would have been obvious to try as a known engagement method in the art. This Combination is understood to result in the ability of the first and second coupling element to allow the bottom side of the meniscal component to remain parallel to the abutment plane throughout movement from the separating position to the coupling position as the claim requires.
Further, regarding claim 1 it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the apparatus of Ashby so that the recess occupied at least one exceptionally small bit of the projection in the coupling projection (e.g. a micron or so) since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art. In this case, having the projection project slightly into the recess is not understood to change the function of the invention as a whole.
Further, regarding claim 1, Boschert teaches that coupling elements which include two similarly sized components can be arranged so a projection (Figure 20 item 60) width has a greater width than an opening (Figure 20 item 42) width (Figure 20; [0061]), and further teaches at least two coupling elements (Figure 20 item 400), upon transition from a separating position to an intermediate position, are moveable to temporarily enlarge the insertion width or temporarily reducing the projection width ([0061]).
Ashby and Boschert are involved in the same field of endeavor, namely the coupling of orthopedic implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the apparatus of the Ashby Hayes Combination so that the projection width was slightly larger than the opening width as is taught by Boschert with coupling elements with temporarily deflect to allow engagement of the projection/opening, since this is a known method of ensuring two mechanical parts stay connected. since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, using a snap-fit connection between the two coupling elements as opposed to relying on abutment 16 for snap-fitting would have been obvious to try. Further, while Boschert teaches the projections are present on an opening (as opposed to a projection), the person of ordinary skill in the art at the time the invention was filed would have understood the equivalence of having the projections on the projection of the Combination as opposed to the opening, since the two are understood as interchangeable in the art. Rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C).
Regarding claims 4-5 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the recess is open in a direction exclusively perpendicular to the abutment plane (see Figure 7 which shows the boss 8 extending through part of the recess (32) in the vertical direction).
Regarding claim 6 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the meniscal component comprises the recess (Figures 5-10), which is open facing in a direction toward the tibial component for inserting at least one part of the projection (Figures 5-10) as a result of a relative movement from the intermediate position into the coupling position in the direction perpendicular to the abutment plane (see the vertical movement from Figures 8-9).
Regarding claim 8 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the projection has a coupling projection top side facing away from the abutment plane (Figures 5-6 shows the top side of projection 8 facing away from 35), wherein the insertion opening defines an upper delimiting face and a lower delimiting face which extend in parallel to the bottom side of the meniscal component (Figure 6 shows the upper and lower delimiting faces of the opening),
wherein a first distance between the lower delimiting face and the bottom side of the meniscal component is smaller than a second distance between the upper delimiting face and the bottom side of the meniscal component, and the first distance is smaller than a third distance between the projection top side and the abutment plane (Annotated Figures 8-9).
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Regarding claim 10 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein the Combination further teaches the projection width is greater than the insertion width (see the explanation/rejection to claim 1 above in light of Boschert who taches projection widths being greater than insertion widths).
Regarding claim 12 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
but is silent with regards to the coupling elements being moveable in parallel to the abutment plane.
However, regarding claim 12 it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the Ashby Hayes Boschert Combination so that the coupling elements of the Combination move parallel to the abutment plane since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of coupling elements moveable in any plane would have been obvious to try.
Regarding claim 13 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Boschert further teaches the coupling elements are deflectable [against a restoring device] from a coupling element base position in which the restoring device/coupling elements do not exert a restoring force on the coupling elements, to a coupling element deflected position ([0061]).
Regarding claims 13-17 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein the Combination further teaches the two coupling elements are deflectable against a restoring device from a coupling element base position in which the restoring device does not exert a restoring force on the coupling elements, to a coupling element deflected position (this is stated as a functional limitation, which the coupling elements of Boschert are understood capable of achieving: see [0061]), wherein the restoring device comprises a restoring element which is associated with one of the two coupling elements, and the coupling elements comprise the restoring element, wherein the restoring element comprises two restoring elements and the coupling elements comprise the first and second restoring element, the restoring element being a spring element (the “restoring device” is not positively claimed, indicating its restoring element is likewise not positively claimed. Alternatively, see Boschert [0061] which indicates two deflectable elements which spring apart/return to their original position in response to a force).
Regarding claim 18 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the projection comprises at least one coupling member (Figure 6-10 item 17), and the receptacle comprises at least one coupling member receptacle (Figures 6-10 item 26/27), and in the coupling position, the coupling member engages into the coupling member receptacle (Figure 10).
Regarding claim 19 the Ashby Hayes Boschert Combination teaches the apparatus of claim 18 substantially as is claimed,
wherein Ashby further discloses the coupling member is projecting from the first coupling element (Figures 6-10 item 8).
Regarding claim 20 the Ashby Hayes Boschert Combination teaches the apparatus of claim 18 substantially as is claimed,
wherein Ashby further discloses the coupling member projects facing away from the coupling element in the direction perpendicular to the abutment plane (Figures 6-10 item 8).
Regarding claim 21 the Ashby Hayes Boschert Combination teaches the apparatus of claim 18 substantially as is claimed,
wherein Ashby further discloses the coupling member receptacle is a groove that is open facing a direction toward the abutment plane (Figures 6-10 show the coupling member receptacle groove formed within 8, under flange 17).
Regarding claim 22 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1substantially as is claimed,
wherein Ashby further discloses the projection comprises a first portion extending directly from the top side of the tibial component (Figures 5-6 item 8), and a second portion adjoining the first portion (Figures 5-6 item 17), and wherein a maximum extent of the first portion in a plane parallel to the abutment plane is smaller than a maximum extent of the second portion in the plane parallel to the abutment plane (Figures 5-6).
Regarding claim 23 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the meniscal and tibial components are moveable relative to one another in the coupling position (Column 5 lines 17-20).
Regarding claim 24 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the coupling device forms a rotary bearing device for rotatably bearing the two components together in the coupling position (Column 5 lines 17-20; Figure 11; Column 2 lines 1-4).
Regarding claim 25 the Ashby Hayes Boschert Combination teaches the apparatus of claim 24 substantially as is claimed,
wherein Ashby further discloses the rotary bearing devices comprises the first and second coupling elements (Column 5 lines 17-20; Figures 10-11; Column 2 lines 1-4).
Regarding claims 26-27 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the first and second coupling elements are formed rotationally symmetrical (Figure 5 shows the circular configuration of 8; Figure 4 shows the rotational symmetry of the second (item 32)), and define an axis of rotation in relation perpendicular to the abutment plane to which the two components are rotatably mounted relative to one another in the coupling position (Column 2 lines 1-4; Column 5 lines 5-10).
Regarding claim 28 the Ashby Hayes Boschert Combination teaches the apparatus of claim 26 substantially as is claimed,
wherein Ashby further discloses the first or second coupling elements are displaceable relative to the axis of rotation and pivotable relative to the axis of rotation (see Figures 8-9 showing the vertical displacement and refer to the connection seen in Figure 10 along with Column 2 lines 1-4).
Regarding claim 29 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the coupling recess is open facing in a direction toward the abutment plane (Figure 7 shows part of the recess 32 which is vertically open to receive the coupling element 8),
the coupling recess and coupling projection are formed rotationally symmetrical (Figure 5 shows the projection 8 being rotationally symmetrically; Figure 4 shows the recess 32 being symmetrical) and define and axis of rotation , in relation to which the meniscal and tibial components are rotatably mounted relative to one another in the coupling position (Column 2 lines 1-4), and
the recess is concentric around the axis of rotation (see Figures 4-5).
Regarding claim 30 the Ashby Hayes Boschert Combination teaches the apparatus of claim 22 substantially as is claimed,
wherein Ashby further discloses the first portion of the coupling projection defines an axis of rotation in relation to which the meniscal and tibial components are rotatably mounted relative to one another in the coupling position (Figures 5-6 show the projection’s axis 8 around which the tibial and meniscal components pivot when coupled in the configuration of Figure 10), and
an undercut that is open in parallel to the abutment plane is formed between the top side of the tibial component and the second portion in a region of the first portion and surrounds the axis of rotation (Figure 5-6 show the undercut within item 8 under flange 17).
Regarding claim 31 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1substantially as is claimed,
wherein Ashby further discloses the coupling projection defines an axis of rotation in relation to which the meniscal and tibial components are rotatably mounted relative to one another in the coupling position (Figures 5-6 show the projection’s axis 8 around which the two components pivot when coupled in the configuration of Figure 10),
the coupling receptacle (26/27) has at least one undercut that is open in parallel to the bottom side of the meniscal component and surrounds the axis of rotation (Figure 4 item 28).
Regarding claim 32 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the apparatus comprises a rotation limiting device for limiting a rotation of the meniscal and tibial components relative to one another in the coupling position (Column 2 lines 1-4; Column 5 lines 5-10; while not specifically discussed, the internal faces of the receptacle inherently limit rotation to their boundaries).
Regarding claim 33 the Ashby Hayes Boschert Combination teaches the apparatus of claim 32 substantially as is claimed,
wherein Ashby further discloses the rotation limiting devices comprises at least one stop face formed on the tibial component and at least one second stop face on the meniscal component that cooperates with the first stop face, so that they abut against one another in a rotation position deflected from a base position by a maximum rotation angle (see the explanation regarding how the two components rotate relative to one another in the rejection to claim 32 above. The two components being limited to rotation when the receptacle of the meniscal component runs into the extent of the tibial component inherently matches this claim requirement).
Regarding claim 35 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
wherein Ashby further discloses the meniscal component has a top side (Figure 5 items 5/6) with medial and lateral joint faces (Figure 5 items 5/6).
Claims 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ashby in view of Hayes and Boschert as is applied above, or in the alternative, over Ashby, Hayes, Boschert, and further in view of Broshanan et al. (US 6123728 A) hereinafter known as Broshanan.
Regarding claim 34 the Ashby Hayes Boschert Combination teaches the apparatus of claim 33 substantially as is claimed,
wherein the first and second stop faces extend perpendicularly to the abutment plane (see the explanation in the rejection to claims 32-33 above; this is considered inherent as the two meet adjacent one another). Alternatively, see also Broschanan, who teaches an orthopedic apparatus in which top (Figure 1 item 28) and bottom (Figure 1 item 13) components are moveable relative to one another in a coupling position (Figure 17; Column 5 lines 4-10) which includes a rotation limiting device for limiting a rotation of the two components relative to one another in a coupling position (Column 4 lines 38-60; Figure 17 shows the limited rotation 41),
the rotation limiting device comprises a first stop face on the bottom component (tibial component of the Combination) and a second stop face that cooperates with the first stop face, being on the top component (meniscal component of the Combination),
wherein the two stops abut against one another in a rotation position deflected from a base position by a maximum rotation angle (see Column 4 lines 38-60 and Figure 17: the shape of the vertical channel 33 allows the limited movement 41: the shape of the two components 33 and 18 comprise the stops which limit the movement to that seen in Figure 17),
wherein the first and second stop face extend transversely to the abutment plane (see again the explanation in Column 4 lines 38-60 along with Figure 17 and 11 to see the slots which allow the limited movement.).
Ashby and Broshanan are involved in the same field of endeavor, namely tibial prosthetic implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the apparatus of the Ashby Hayes Boschert Combination to have stop faces which extend transversely to the abutment plane as is taught by Broshanan since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E).
Claims 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ashby, Hayes, and Boschert as is applied above, further in view of Claypool et al. (US 20120158152 A1) hereinafter known as Claypool.
Regarding claim 36 the Ashby Hayes Boschert Combination teaches the apparatus of claim 1 substantially as is claimed,
but is silent with regards to whether there is a femoral component.
However, regarding claim 36 Claypool teaches a knee joint endoprosthesis where there is a femoral component that cooperates with a tibial component ([0007]). Ashby and Claypool are involved in the same field of endeavor, namely joint replacements. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the apparatus of the Ashby Hayes Boschert Combination so that there is a cooperating femoral prosthesis as is taught by Claypool in order for the apparatus to be useful for a patient who requires a total knee replacement.
Regarding claim 37 the Ashby Hayes Boschert Claypool Combination teaches the apparatus of claim 36 substantially as is claimed,
wherein the Combination further teaches the femoral component which cooperates with the Combination can comprise medial and lateral femoral joint faces facing toward the meniscal component so that they abut against medial and lateral faces of the meniscal component in an implantation position of the apparatus, so that the medial and lateral femoral/meniscal joint faces cooperate upon the relative movement of the two components (Figure 6; [0061]).
Conclusion
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/29/26
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