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 .
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.
Claim Objections
Claim 16 is objected to because of the following informalities: “wherein the at least pocket” should read “wherein the at least one pocket”. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20180200066) in view of Wentorf (20130024001).
With regards to claim 1, Wang discloses a tibial prosthesis for a knee arthroplasty (FIG 10) comprising: a baseplate (312) comprising: a distal surface (314) sized and shaped to substantially cover a proximal resected surface of a tibia (FIG 11); a proximal surface opposite the distal surface (see annotated FIG 9 below), the proximal surface having a lateral compartment and a medial compartment opposite the lateral compartment (see annotated FIG 11 below); a periphery extending between the distal surface and the proximal surface (see annotated FIG 9 below); a first layer of porous material forming at least a majority of the distal surface and extending to the periphery (314; [0068]); and a second layer of non-porous or relatively less porous material ([0068], “If baseplate 312 has a partially porous area 314, the solid extension portions would extend therethrough to solid portions of the tibial baseplate 312”), and a tibial keel (316) extending distally from the distal surface to define a longitudinal tibial keel axis (FIG 10), but fails to disclose that the prosthesis has a plurality of reference features extending through the first layer, wherein the plurality of reference features form at least a portion of the distal surface.
Wentorf (20130024001) discloses a tibial prosthesis (FIG 4B) comprising a baseplate (12) with a distal surface (35) formed of a first layer and sized and shaped to substantially cover a proximal resected surface of a tibia (FIG 4B); a proximal surface opposite the distal surface (34), the proximal surface having a lateral compartment and a medial compartment opposite the lateral compartment (FIG 4A); a periphery extending between the distal surface and the proximal surface (FIG 4B). Wentorf teaches that the prosthesis has a plurality of reference features (70A, 70P) extending through the first layer (FIG 4B), wherein the plurality of reference features form at least a portion of the distal surface (FIG 4B). Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s tibial prosthesis to include a plurality of reference features extending through the first layer, wherein the plurality of reference features forms at least a portion of the distal surface, as taught by Wentorf, in order to better align the prosthesis ([0122]).
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With regards to claim 2, Wang as modified by Wentorf discloses the tibial prosthesis of claim 1, and further a plurality of fins (see annotated FIG 11 above) spanning a junction between the tibial keel and the distal surface (see annotated FIG 11 above).
With regards to claim 3, Wang as modified by Wentorf discloses the tibial prosthesis of claim 2, wherein the plurality of fins are angled anterior-posterior and medial-lateral to form a flute on a posterior of the tibial keel (see annotated FIG 11 above).
With regards to claim 4, Wang as modified by Wentorf discloses the tibial prosthesis of claim 3, wherein the tibial keel (316) includes a second flute and a third flute each extending to a distal tip of the tibial keel (FIG 11), wherein the second flute and the third flute are connected by an anterior fin on an anterior of the tibial keel (see annotated FIG 11 above).
With regards to claim 5, Wang as modified by Wentorf discloses the tibial prosthesis of claim 2, further comprising a plurality of pegs (330) extending distally from the distal surface (FIG 9), wherein one or both of the plurality of pegs (330) or the plurality of fins has a window formed of the porous material (332) therein (FIG 9).
With regards to claim 6, Wang as modified by Wentorf discloses the tibial prosthesis of claim 5, wherein the plurality of pegs (330) comprises four pegs located adjacent, respectively, a posterior-medial corner, a posterior-lateral corner, an anterior-lateral corner and an anterior-medial corner of the periphery (FIG 11).
With regards to claim 8, Wang as modified by Wentorf discloses the tibial prosthesis of claim 5, wherein the window extends entirely through at least one of the plurality of fins (FIG 11).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20180200066) and Wentorf (20130024001) as applied to claim 5 above, and further in view of Zappacosta (20220061998).
With regards to claim 7, Wang as modified by Wentorf discloses the tibial prosthesis of claim 5, but fails to disclose that the plurality of pegs (330) are one of square shaped or rectangular in cross-section and are configured to be press-fit into a round hole drilled into the tibia.
Zappacosta also discloses a tibial prosthesis for a knee arthroplasty (FIG 1) comprising: a baseplate (12) comprising: a distal surface (16) sized and shaped to substantially cover a proximal resected surface of a tibia (FIG. 18), and a plurality of pegs (34). Zappacosta teaches that the plurality of pegs (34) are one of square shaped or rectangular in cross-section ([0048]) and are configured to be press-fit into a round hole drilled into the tibia ([0048]). Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s plurality of pegs to be one of square shaped or rectangular in cross-section and configured to be press-fit into a round hole drilled into the tibia, as taught by Zappacosta, in order to maximizes the press fit of the peg with the bone ([0048]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20180200066) and Wentorf (20130024001) as applied to claim 2 above, and further in view of Unger (20100298947).
With regards to claim 9, Wang as modified by Wentorf discloses the tibial prosthesis of claim 2, but fails to disclose that one or more surfaces of at least one of the tibial keel or the plurality of fins is fabricated to be smoother than the distal surface to discourage bone ingrowth.
Unger also discloses a tibial prosthesis (FIG 1) with a distal surface (26), a keel element (18), and a plurality of fins (see annotated FIG 3 below) and teaches that the plurality of fins is fabricated to be smoother than the distal surface to discourage bone ingrowth ([0029], [0033]). Therefore, it would have been obvious for one having ordinary skill in the art at the effective time of filing to have modified Wang’s tibial prosthesis to include that one or more surfaces of at least one of the tibial keel or the plurality of fins is fabricated to be smoother than the distal surface to discourage bone ingrowth, as taught by Unger, in order to provide long term fixation that is not dependent on attachment of the keel ([0033]).
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Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20180200066) in view of Yoo (10172713).
With regards to claim 10, Wang discloses a tibial prosthesis system comprising: a prostheses including: a baseplate (312) comprising: a distal surface (314) sized and shaped to substantially cover a proximal resected surface of a tibia (FIG 9); a proximal surface (see annotated FIG 11 above) opposite the distal surface (314), the proximal surface having a lateral compartment and a medial compartment opposite the lateral compartment (see annotated FIG 11 above); a periphery extending between the distal surface and the proximal surface (see annotated FIG 11 above); and a plurality of pegs (330) extending distally from the distal surface (FIG 9); and a tibial keel (316) extending distally from the distal surface to a dome shaped distal tip (FIG 9), wherein the tibial keel has an elongate length as measured proximal-distal and defines a longitudinal tibial keel axis extending along the elongate length (FIG 9).
Wang fails to disclose a plurality of prosthesis, wherein a size of each of the plurality of prostheses differ with respect to the distal surface, the proximal surface and the periphery, and wherein the elongate length increases in a step-wise manner with an increase in the size the plurality of prostheses with respect to the distal surface, the proximal surface and the periphery.
Yoo discloses a tibial prosthesis (FIG 3A) with a baseplate (10), keel (50), and fins (50), and teaches a plurality of prosthesis (FIG 6), wherein a size of each of the plurality of prostheses differ with respect to the distal surface, the proximal surface and the periphery (FIG 6), and wherein the elongate length increases in a step-wise manner with an increase in the size the plurality of prostheses with respect to the distal surface, the proximal surface and the periphery (FIG 6). Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s tibia prosthesis to include a plurality of prostheses, wherein a size of each of the plurality of prostheses differ with respect to the distal surface, the proximal surface and the periphery, and wherein the elongate length increases in a step-wise manner with an increase in the size the plurality of prostheses with respect to the distal surface, the proximal surface and the periphery, as taught by Yoo, in order to be able to size more accurately to individual patients (col 2, line 9).
With regards to claim 11, Wang as modified by Yoo discloses the system of claim 10, further a plurality of fins (see annotated FIG 11 above) spanning a junction between the tibial keel and the distal surface (FIG 11).
With regards to claim 12, Wang as modified by Yoo discloses the system of claim 11, further comprising: a first layer of porous material forming at least a majority of the distal surface and extending to the periphery (314); and a second layer of non-porous or relatively less porous material forming a base ([0068], “If baseplate 312 has a partially porous area 314, the solid extension portions would extend therethrough to solid portions of the tibial baseplate 312”), wherein the plurality of pegs (330) are formed of both the porous material (332) and the non-porous or relatively less porous material (336) ([0068]).
With regards to claim 13, Wang as modified by Yoo discloses the system of claim 12, wherein the tibial keel (316) includes a first flute on a posterior side formed between the plurality of fins in addition to the tibial keel (see annotated FIG 11 above), and wherein the tibial keel includes a second flute and a third flute each extending to a distal tip of the tibial keel (see annotated FIG 11 above), wherein the second flute and the third flute are connected by a anterior fin on an anterior of the tibial keel (FIG 11).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20180200066) in view of Yoo (10172713) as applied to claim 11 above, and further in view of Wentorf (20130024001).
With regards to claim 14, Wang as modified by Yoo discloses the system of claim 12, but fails to disclose that the second layer of the non-porous or relatively less porous material has a plurality of reference features extending through the first layer, and wherein the plurality of reference features form at least a portion of the distal surface.
Wentorf also discloses a tibial prosthesis (FIG 4B) comprising a baseplate (12) with a distal surface (35) formed of a first layer and sized and shaped to substantially cover a proximal resected surface of a tibia (FIG 4B); a proximal surface opposite the distal surface (34), the proximal surface having a lateral compartment and a medial compartment opposite the lateral compartment (FIG 4A); a periphery extending between the distal surface and the proximal surface (FIG 4B). Wentorf teaches that the prosthesis has a plurality of reference features (70A, 70P) extending through the first layer (FIG 4B), wherein the plurality of reference features form at least a portion of the distal surface (FIG 4B). Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s tibial prosthesis to include a plurality of reference features extending through the first layer, wherein the plurality of reference features forms at least a portion of the distal surface, as taught by Wentorf, in order to better align the prosthesis ([0122]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20180200066) in view of Yoo (10172713) as applied to claim 10 above, and further in view of Unger (20100298947).
With regards to claim 15, Wang as modified by Yoo discloses the system of claim 10, but fails to disclose that one or more surfaces of at least one of the tibial keel or the plurality of fins is fabricated to be smoother than the distal surface to discourage bone ingrowth.
Unger also discloses a tibial prosthesis (FIG 1) with a distal surface (26), a keel element (18), and a plurality of fins (see annotated FIG 3 above), and teaches that the plurality of fins are fabricated to be smoother than the distal surface to discourage bone ingrowth ([0029], [0033]). Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s tibial prosthesis to include that one or more surfaces of at least one of the tibial keel or the plurality of fins is fabricated to be smoother than the distal surface to discourage bone ingrowth, as taught by Unger, in order to provide long term fixation that is not dependent on attachment of the keel ([0033]).
Claim(s) 16-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (20180200066) in view of Jones (20160262898) and Yoo (10172713).
With regards to claim 16, Wang discloses a tibial prosthesis system comprising: a first tibial prosthesis comprising: a first proximal surface (see annotated FIG 9 above); a first distal surface (314) opposite the first proximal surface, the first distal surface sized and shaped to substantially cover a proximal resected surface of a tibia (FIG 9); a plurality of pegs (330) extending distally from the second distal surface (FIG 9); a first layer of porous material forming at least a majority of the second distal surface (314); a second layer of nonporous material forming at least a portion of the second tibial prosthesis ([0068], “If baseplate 312 has a partially porous area 314, the solid extension portions would extend therethrough to solid portions of the tibial baseplate 312”), a first keel (316) extending distally from the first distal surface; and a first plurality of fins (see annotated FIG 11 above) spanning a junction between the first keel (316) and the first distal surface (314); but fails to disclose at least one pocket formed in the first tibial prosthesis and recessed from the first distal surface, wherein the at least one pocket is configured to receive a bone cement therein.
Jones also discloses a tibial prosthesis (100) comprising a proximal surface (108), and a distal surface (110) opposite the proximal surface (FIG 2B), and teaches at least one pocket (130a, 130b) formed in the first tibial prosthesis and recessed from the first distal surface (Fig. 4), wherein the at least pocket is configured to receive a bone cement therein ([0051]). Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s tibial prosthesis to include at least one pocket formed in the first tibial prosthesis and recessed from the first distal surface, wherein the at least pocket is configured to receive a bone cement therein, as taught by Jones, in order to promote fixation ([0051]).
Wang as modified by Jones fails to disclose a second tibial prosthesis. Yoo also discloses a tibial prosthesis (FIG 3A) with a baseplate (10), keel (30), and fins (50), and teaches a plurality of prosthesis (FIG 6), wherein a size of each of the plurality of prostheses differ, but they contain the same structures. Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s tibial prosthesis system to include a second tibial prosthesis, as taught by Yoo, to be able to size more accurately to individual patients (col 2, line 9). The combination yields the second prosthesis comprising: a second proximal surface; a second distal surface opposite the second proximal surface, the second distal surface sized and shaped to substantially cover the proximal resected surface of the tibia; a plurality of pegs extending distally from the second distal surface; a first layer of porous material forming at least a majority of the second distal surface; a second layer of nonporous material forming at least a portion of the second tibial prosthesis; a second keel extending distally from the second distal surface; and a second plurality of fins spanning a junction between the second keel and the second distal surface; wherein the first keel and first plurality of fins share a substantially same geometry as the second keel and the second plurality of fins as disclosed by Wang since the second prosthesis has the same structures as the first prosthesis (see details above).
With regards to claim 17, Wang as modified by Yoo and Jones discloses the system of claim 16, but fails to disclose that the substantially same geometry includes at least two of: an elongate length as measured proximal-distal, a distal end profile, and a medial-lateral width.
Yoo further teaches that the substantially same geometry includes at least two of: an elongate length as measured proximal-distal, a distal end profile, and a medial-lateral width (col 8, line 39). Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s tibial prosthesis system to include that the substantially same geometry includes at least two of: an elongate length as measured proximal-distal, a distal end profile, and a medial-lateral width, as taught by Yoo, in order to have a standard (col 8, line 40).
With regards to claim 18, Wang as modified by Yoo and Jones discloses the system of claim 17, wherein the first plurality of fins are angled anterior-posterior and medial-lateral to form a first flute on a posterior of the first tibial keel (see annotated FIG 11 above), wherein the second plurality of fins are angled anterior-posterior and medial-lateral to form a first flute on a posterior of the second tibial keel (see annotated FIG 11 above), and wherein the first flute of the first tibial prosthesis and the first flute of the second tibial prosthesis have substantially a same angle (Yoo col 8, line 40, where this sizing does not change the angle).
With regards to claim 20, Wang as modified by Yoo and Jones discloses the system of claim 16, wherein the first tibial keel (316) includes a second flute and a third flute each extending to a distal tip of the first tibial keel (see annotated FIG 11 above), wherein the second tibial keel includes a second flute and a third flute each extending to a distal tip of the tibial keel (see annotated FIG 11 above), but fails to disclose that the second flute and the third flute of the first tibial keel share substantially a same geometry as the second flute and the third flute of the second tibial keel.
Yoo further teaches that the second flute and the third flute of the first tibial keel share substantially a same geometry as the second flute and the third flute of the second tibial keel (col 8, line 39). Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s tibial prosthesis system to include that the substantially same geometry includes at least two of: an elongate length as measured proximal-distal, a distal end profile, and a medial-lateral width, as taught by Yoo, in order to have a standard (col 8, line 40).
With regards to claim 19, Wang as modified by Yoo and Jones discloses the system of claim 16, but fails to disclose that the first plurality of fins are relatively thinner than the second plurality of fins.
Yoo further teaches that the first plurality of fins are relatively thinner than the second plurality of fins (50; FIG 3C, FIG 6). Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang’s first plurality of fins to be relatively thinner than the second plurality of fins, as taught by Yoo, in order to be able to size more accurately to individual patients (col 2, line 9).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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