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 . Claims 1-14 are pending and examined below. Claims 15-21 is/are withdrawn.
Election/Restrictions
Applicant’s election without traverse of claims 1-14 in the reply filed on 05/21/2026 is acknowledged. The requirement is therefore made FINAL.
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 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitations “the fastening opening” in line 2 and “a fastening opening” in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if these are the same or different fastening openings.
Claim 2 recites the limitation “the proximal direction” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation “the proximal end” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5, & 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US 4938769 A) in view of Campbell (US 7771484 B2).
Regarding claim 1, Shaw teaches
a tibial component (10, Fig. 1, Shaw) of a knee joint endoprosthesis (Fig. 1, Shaw), comprising
a laterally extending tibial plate (12, Fig. 1, Shaw),
a distally projecting anchoring stem (13, Fig. 1, Shaw) with a shaft piece (shaft of 13, Fig. 1, Shaw), and
at least one laterally extending wing-like extension (81, Fig. 3, Shaw), wherein,
in an implantation state, the tibial plate (12, Fig. 1, Shaw) and the anchoring stem (13, Fig. 1, Shaw) are connected to one another by means of detachable fastening elements (connected at 23, 33, & 43, Fig. 1, Shaw), and wherein
the tibial plate (12, Fig. 1, Shaw) can be removed from the anchoring stem in an explantation state (removably attach to 13, Fig. 1, col. 4 line 35, Shaw).
Shaw does not teach at least one spacer that can be removed proximally is provided on the tibial plate. However, Campbell teaches a modular tibial implant (abstract, Campbell)
wherein at least one spacer (60, Fig. 1, Campbell) that can be removed proximally is provided on the tibial plate (54, Fig. 1, Campbell),
an end face (124, Fig. 1, Campbell) of which spacer (60, Fig. 1, Campbell) forms a stop for the extension (106, Fig. 1, Campbell) and is designed to create a slot-like free space (122, Fig. 14A, Campbell) with a defined minimum width.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw by incorporating the above teachings as taught by Campbell in order to enhance the locking force between the tibial baseplate 54 and the keel 56 (col. 7 lines 65-66, Campbell).
Regarding claim 2, Shaw teaches the fastening opening (67, Fig. 1, Shaw) but does not teach a width sufficient for passage of the spacer. However, Campbell teaches
wherein the fastening opening (82, Fig. 1, Campbell) has a width sufficient for passage of the spacer (60, Fig. 1, Campbell), wherein
the spacer is screwed into a fastening opening of the tibial plate in the implanted state (cam element is rotated, col. 7 line 23, Campbell), and wherein
the fastening opening is graduated with a width increasing in the proximal direction (width of 82 is increasing to accommodate 60 which has a wider top at 120 than at 124, Fig. 1 & 14C, Campbell).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw by incorporating the above teachings as taught by Campbell in order to enhance the locking force between the tibial baseplate 54 and the keel 56 (col. 7 lines 65-66, Campbell).
Regarding claim 3, Shaw does not teach the spacer has an external thread. However, Campbell
wherein the spacer has an external thread which engages in an internal thread of the fastening opening (80, 82 may be threaded, therefore 60 may have threads, col. 6 lines 5-6, Campbell).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw by incorporating the above teachings as taught by Campbell in order to enhance the locking force between the tibial baseplate 54 and the keel 56 (col. 7 lines 65-66, Campbell).
Regarding claim 4, Shaw teaches
a fastening screw (33, Fig. 1, Shaw), which is to be actuated from the proximal end and which connects the anchoring stem (13, Fig. 1, Shaw) to the tibial plate (12, Fig. 1, Shaw).
Shaw does not teach the spacer has a dual function and also functions as a mount for a fastening screw. However, Campbell teaches
wherein the spacer (60, Fig. 1, Campbell) has a dual function and also functions as a mount for a fastening screw (110, Fig. 8, Campbell), and which connects the anchoring stem (56, Fig. 1, Campbell) to the tibial plate (54, Fig. 1, Campbell).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw by incorporating the above teachings as taught by Campbell in order to enhance the locking force between the tibial baseplate 54 and the keel 56 (col. 7 lines 65-66, Campbell).
Regarding claim 5, Shaw does not teach the fastening screw is arranged coaxially in the spacer. However, Campbell teaches
wherein the fastening screw (110, Fig. 1, Campbell) is arranged coaxially in the spacer (60, Fig. 1, Campbell), wherein the fastening screw closes access to an actuating element (128, Fig. 14C, Campbell) of the spacer (60, Fig. 1, Campbell) in a mounted state.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw by incorporating the above teachings as taught by Campbell in order to ensure that the camming force remains exerted upon the tibial baseplate (col. 8 lines 15-16, Campbell).
Regarding claim 7, Shaw teaches
wherein the anchoring stem (13, Fig. 1, Shaw) has a planar upper side (Figs. 1 & 3, Shaw).
Regarding claim 8, Shaw teaches
wherein an opening (opening where 23 goes into, Fig. 1, Shaw) for a central screw (23, Fig. 1, Shaw) is provided on the tibial plate (12, Fig. 1, Shaw) with which the anchoring stem (13, Fig. 1, Shaw) is fastened to the tibial plate (12, Fig. 3, Shaw).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaw in view of Campbell, and further in view of Hazebrouck (US 20080091273 A1).
Regarding claim 6, Shaw teaches
wherein a second extension (82, Fig. 3, Shaw) is provided on the anchoring stem (13, Fig. 1, Shaw) opposite the extension stem (81, Fig. 3, Shaw), which interacts on the tibial plate (12, Fig. 1, Shaw) in a corresponding manner and a second fastening screw (43, Fig. 1, Shaw), wherein the extensions form an angle between 100° and 170° (Fig. 1, Shaw).
Shaw in view of Campbell does not teach a second spacer. However, Hazebrouck teaches a prosthetic knee system (abstract, Hazebrouck)
which interacts on the tibial plate in a corresponding manner with a second spacer (1466, Fig. 88, Hazebrouck).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw and Campbell by incorporating the above teachings as taught by Hazebrouck in order to secure the post 1461 to the tibial insert 1414 (¶0205, Hazebrouck).
Claim(s) 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaw in view of Campbell, and further in view of Zappacosta et al. (US 20220061998 A1) hereinafter, Zappacosta.
Regarding claim 9, Shaw does not teach the tibial plate is provided on its distal side with a porous structure. However, Zappacosta teaches a tibial implant for knee arthroplasty (abstract, Zappacosta)
wherein the tibial plate (12, Fig. 2, Zappacosta) is provided on its distal side (16, Fig. 2, Zappacosta) with a porous structure (distal surface 16 of the tibial plate 12 is porous, Fig. 2, ¶0049, Zappacosta), which comprises interconnected pores in a depth of the tibial plate (¶0049, Zappacosta), which has a width from 0.1 to 1.5 mm (1 mm to 1.5 mm). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw and Campbell by incorporating the above teachings as taught by Zappacosta in order to enable ingrowth of the bone into the tibial implant 10 after the tibial implant is placed on the bone to form a strong connection between the implant and the bone (¶0049, Zappacosta).
Regarding claim 10, Shaw does not teach the porous structure fully covers the distal side of the tibial plate. However, Zappacosta teaches
wherein the porous structure fully covers the distal side of the tibial plate (distal surface 16 of the tibial plate 12 is porous, Fig. 2, ¶0049, Zappacosta).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw and Campbell by incorporating the above teachings as taught by Zappacosta in order to enable ingrowth of the bone into the tibial implant 10 after the tibial implant is placed on the bone to form a strong connection between the implant and the bone (¶0049, Zappacosta).
Regarding claim 11, Shaw teaches
wherein protruding reinforcing ribs are provided on the distal side (55, Fig. 4, Shaw) of the tibial plate and extend radially from a central region to an edge of the tibial plate (see annotated Fig. 4 below, Shaw).
Regarding claim 12, Shaw teaches
wherein reinforcing ribs sunk (57, Fig. 4, Shaw) into the distal side of the tibial plate and extend radially from a central region to the edge of the tibial plate (see annotated Fig. 4 below, Shaw).
Shaw does not teach the porous structure is provided on the distal side of the tibial plate. However, Zappacosta teaches
the porous structure is provided on the distal side of the tibial plate (distal surface 16 of the tibial plate 12 is porous, Fig. 2, ¶0049, Zappacosta).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw and Campbell by incorporating the above teachings as taught by Zappacosta in order to enable ingrowth of the bone into the tibial implant 10 after the tibial implant is placed on the bone to form a strong connection between the implant and the bone (¶0049, Zappacosta).
Regarding claim 13, Shaw teaches
wherein a circumferential edge (56, Fig. 4, Shaw) is provided on the distal side (55, Fig. 4, Shaw) of the tibial plate.
Shaw does not teach the porous structure. However, Zappacosta teaches
the porous structure is provided on the distal side (distal surface 16 of the tibial plate 12 is porous, Fig. 2, ¶0049, Zappacosta).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw and Campbell by incorporating the above teachings as taught by Zappacosta in order to enable ingrowth of the bone into the tibial implant 10 after the tibial implant is placed on the bone to form a strong connection between the implant and the bone (¶0049, Zappacosta).
Regarding claim 14, Shaw teaches an edge (56, Fig. 4, Shaw) but he
does not disclose the width of the edge is only dimensioned in such a way that the porous structure covers at least half of a surface of the distal side of the tibial plate. However, Zappacosta teaches
wherein the width of the edge is only dimensioned in such a way that the porous structure covers at least half, more than 60%, of a surface of the distal side of the tibial plate (50%-80%, ¶0049, Zappacosta). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Shaw and Campbell by incorporating the above teachings as taught by Zappacosta in order to enable ingrowth of the bone into the tibial implant 10 after the tibial implant is placed on the bone to form a strong connection between the implant and the bone (¶0049, Zappacosta).
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Conclusion
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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