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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dong et al. (US20070150068).
Regarding claim 17, Dong discloses an orthopedic implant (70, Fig. 12), comprising: an implant body defining a longitudinal axis extending in a direction of implantation of the orthopedic implant (see Fig. 12), the implant body having a first end portion (at 75) and a second end portion (at 73); the implant body having a thickness dimension (femoral stem thickness) defined perpendicular to the longitudinal axis, the thickness dimension of the implant body increasing in a direction along the longitudinal axis from the first end portion (75) to the second end portion (73) (see Fig. 12) and the implant body comprising a porous structure (foam structure 72) extending along the longitudinal axis, the porous structure (72) comprising a plurality of struts (see paragraph [0067]) arranged in a three-dimensional arrangement (forming webs 32, see Fig. 2), the porous structure comprising a transition zone in which the porous structure (72) gradually develops from a solid bulk material of the implant body (from solid stem 71) over a selected distance (see Fig. 12, [0106]).
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, 5, 11, 18, 20-21, 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dong in view of McTighe (US20030074079).
Regarding claim 1, Dong discloses an orthopedic implant (70; Fig. 12), comprising: an implant body defining a longitudinal axis (see Fig. 12) extending in a direction of implantation of the orthopedic implant (towards distal region 75 in Fig. 12), the implant body having a first end portion (73) and a second end portion (75); and a porous structure (72) extending circumferentially around the implant body (on surfaces of 71, thereby extending circumferentially as claimed; [0106]), the porous structure comprising a first circumferentially-extending zone exhibiting a first coefficient of friction with bone tissue (at 75) and a second circumferentially-extending zone exhibiting a second coefficient of friction with bone tissue (at 74), wherein the first circumferentially-extending zone (at 75) of the porous structure is offset from the second circumferentially-extending zone (at 74) along the longitudinal axis (Fig. 12) such that during implantation of the orthopedic implant, the first circumferentially-extending zone of the porous structure contacts bone before the second circumferentially-extending zone of the porous structure (distal region 75 would enter the bone tunnel before region 74 would enter the bone tunnel, thereby contacting bone before 74).
Dong fails to disclose the second coefficient of friction is greater than the first coefficient of friction. McTighe also discloses a femoral stem implant (10) with first (60) and second (intermediate region between 50 and 60) circumferentially extending zones offset along the longitudinal axis (see Fig.4) and teaches the different circumferentially extending zones each having a unique roughness (see paragraph [0054]). This difference in surface roughness results in the first circumferentially extending zone (60) exhibiting a first coefficient of friction with bone tissue (having a smooth surface) and the second extending zone (an intermediate region between 50 and 60) exhibiting a second coefficient of friction (having roughness of zone C). Due to the second circumferentially extending zone being rougher than the first circumferentially extending zone (see paragraph [0054]), the second coefficient of friction is greater than the first coefficient of friction (rough surfaces exhibit greater frictional forces than smoother surface when placed against the same third surface). 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 the first circumferentially extending zone and the second circumferentially extending zone of Dong such that the first circumferentially extending zone exhibits a first coefficient of friction with bone tissue and the second circumferentially extending zone exhibits a second coefficient of friction with bone tissue, wherein the second coefficient of friction is greater than the first coefficient of friction, as taught by McTighe, in order to allow for the implant to be easier to remove from the bone cavity and to increase torsional stability in the connection between the stem portion and the femur (see paragraph [0055]).
In an alternate interpretation, Dong discloses a porous bone implant (11; Fig. 4 and 8), comprising: an implant body defining a longitudinal axis (see Fig. 4) extending in a direction of implantation of the orthopedic implant (towards apex of the dome of the acetabular in Fig. 4), the implant body having a first end portion (52) and a second end portion (54); and a porous structure (P) extending circumferentially around the implant body (S), the porous structure comprising a first circumferentially-extending zone exhibiting a first coefficient of friction with bone tissue (at 61) and a second circumferentially-extending zone exhibiting a second coefficient of friction with bone tissue (at 62), wherein the first circumferentially-extending zone (at 61) of the porous structure is offset from the second circumferentially-extending zone (at 62) along the longitudinal axis (Fig. 4) such that during implantation of the orthopedic implant, the first circumferentially-extending zone of the porous structure contacts bone before the second circumferentially-extending zone of the porous structure (61 would enter the bone cavity before 62).
Dong fails to disclose the second coefficient of friction is greater than the first coefficient of friction. McTighe also discloses a porous bone implant (10) with first (60) and second (intermediate region between 50 and 60) circumferentially extending zones offset along the longitudinal axis (see Fig.4) and teaches the different circumferentially extending zones each having a unique surface roughness (see paragraph [0054]). This difference in surface roughness results in the first circumferentially extending zone (60) exhibiting a first coefficient of friction with bone tissue (having a smooth surface) and the second extending zone (an intermediate region between 50 and 60) exhibiting a second coefficient of friction (having roughness of zone C). Due to the second circumferentially extending zone being rougher than the first circumferentially extending zone (see paragraph [0054]), the second coefficient of friction is greater than the first coefficient of friction (rough surfaces exhibit greater frictional forces than smoother surface when placed against the same third surface). 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 the first circumferentially extending zone and the second circumferentially extending zone of Dong such that the first circumferentially extending zone exhibits a first coefficient of friction with bone tissue and the second circumferentially extending zone exhibits a second coefficient of friction with bone tissue, wherein the second coefficient of friction is greater than the first coefficient of friction, as taught by McTighe, in order to allow for the implant to be easier to remove from the bone cavity and to increase torsional stability in the connection between the implant and bone tissue (see paragraph [0055]).
Regarding claim 5, Dong as modified by McTighe, further discloses struts of the second circumferentially-extending zone (74) comprise a specified diameter along their lengths (struts have a diameter along their lengths; see Fig. 2).
Regarding claim 11, Dong, as modified by McTighe, discloses the orthopedic implant of claim 1. However, Dong, as modified by McTighe does not explicitly disclose wherein: the first circumferentially-extending zone of the porous structure exhibits a coefficient of friction with cancellous bone tissue of 0.2 to 0.5; and the second circumferentially-extending zone of the porous structure exhibits a coefficient of friction with cancellous bone tissue of 0.4 to 0.6, as required by the claim.
There is no evidence of record that establishes that changing the coefficients of friction of the first and second circumferentially-extending zones would result in a difference in function of the device disclosed by Dong, as modified by McTighe. Further, a person having ordinary skill in the art being faced with modifying the implant of Dong, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed coefficients of friction. Lastly, applicant has not disclosed that the claimed range solves any stated problem indicating that the coefficients of friction “can” be within the claimed range, and offering other acceptable ranges (e.g. 0.6 to 0.8 for the first zone and 0.8 to 1.0 for the second zone, specification paragraph [0060]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second circumferentially extending zones of the porous structure of Dong as modified by McTighe, to have a coefficient of friction with cancellous bone tissue between 0.2 to 0.5 and between 0.4 to 0.6 respectively as an obvious matter of design choice within the skill of the art.
Regarding claim 18, Dong discloses all the limitations as recited in claim 17. Dong further discloses the porous structure (72) having decreased porosity in the direction of implantation (see paragraph [0106]). Dong fails to disclose porous the structure exhibits a coefficient of friction with bone tissue that decreases along the porous structure in a direction of implantation of the orthopedic implant.
McTighe also discloses a femoral stem implant (10) and teaches different zones each having a unique roughness (see paragraph [0054]). This difference in surface roughness results in the first zone exhibits a first coefficient of friction with bone tissue (as different surface roughness would exhibit different friction coefficients) and the second zone (B+C) exhibiting a second coefficient of friction. Also, due to second zone (zone B+C) being rougher than the first zone (zone A) (see paragraph [0054]), the second coefficient of friction is greater than the first coefficient of friction (rough surfaces exhibit greater frictional forces than smoother surface when placed against the same third surface) resulting in the coefficient of friction for the femoral stem to decrease in the direction of implantation. 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 the porous structure (72) of Dong such that the porous structure exhibits a coefficient of friction with bone tissue that decreases along the porous structure in a direction of implantation of the orthopedic implant as taught by McTighe in order to allow for the implant to be easier to remove from the bone cavity and to increase torsional stability in the connection between the stem portion and the femur (see paragraph [0055]).
Regarding claim 20, Dong discloses all limitations as recited in claim 17. Dong further discloses wherein: the transition zone (75) is a first zone of the porous structure and the porous structure further comprises a second zone (74) and a third zone (73), the second zone (74) being offset from the first zone in the direction of implantation (74 is nearer to the ball that will be implanted into an acetabular cup than 75) and the third zone (73) being offset from the second zone in the direction of implantation (73 is nearest the ball that will be implanted into an acetabular cup than 74) such that the second zone is between the first zone and the third zone (74 is between 75 and 73), and such that the first zone contacts bone before the second zone of the porous structure during implantation (75 would enter the bone tunnel prior to 74).
Dong fails to disclose the first zone exhibiting a first coefficient of friction with bone and the third zone exhibits a third coefficient of friction with bone tissue that is greater than a second coefficient of friction with bone tissue exhibited by the second zone. McTighe also discloses an orthopedic implant (10) with zones (see Fig.4, A, B, and C) and teaches the different zones each having a unique roughness (see paragraph [0054]). This difference in surface roughness results in the first zone exhibiting a first coefficient of friction with bone tissue (as different surface roughness would exhibit different friction coefficients), the second zone exhibiting a second coefficient of friction, and the third zone exhibiting a third coefficient of friction. Also, due to second zone (zone B) being rougher than the first zone (zone A) (see paragraph [0054]), the second coefficient of friction is greater than the first coefficient of friction (rough surfaces exhibit greater frictional forces than smoother surface when placed against the same third surface) resulting in the second coefficient of friction being greater than the first coefficient of friction and due to the third zone (zone C) having the roughest exterior of all three zones (see paragraph [0054]), it results in the third coefficient of friction being greater than the first and second coefficients of friction. 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 the porous structure (P) of Dong, using the technique taught by McTighe, such that the first zone exhibits a first coefficient of friction with bone and the third zone exhibiting a third coefficient of friction with bone tissue that is greater than a second coefficient of friction with bone tissue exhibited by the second zone in order to allow for the implant to be easier to remove from the bone cavity and to increase torsional stability in the connection between the stem portion and the femur (see paragraph [0055]).
Regarding claim 21, Dong as modified by McTighe, further discloses that the struts of the second zone (74) comprise a specified diameter along their length (struts have a diameter along their lengths; see Fig. 2).
Regarding claim 23, Dong, as modified by McTighe, discloses the orthopedic implant of claim 20. However, Dong, as modified by McTighe, does not explicitly disclose wherein the first zone of the porous structure exhibits a coefficient of friction with cancellous bone tissue of 0.2 to 0.5; the second zone of the porous structure exhibits a coefficient of friction with cancellous bone tissue of 0.4 to 0.6; and the third zone of the porous structure exhibits a coefficient of friction with cancellous bone tissue of 0.7 to 1.1, required by the claim.
There is no evidence of record that establishes that changing the coefficients of friction of the first, second, and third zones would result in a difference in function of the device disclosed by Dong, as modified by McTighe. Further, a person having ordinary skill in the art being faced with modifying the implant of Dong, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed coefficients of friction. Lastly, applicant has not disclosed that the claimed ranges solve any stated problem indicating that the coefficients of friction “can” be within the claimed range, and offering other acceptable ranges (e.g. 0.6 to 0.8 for the first zone, 0.8 to 1.0 for the second zone, and 0.8 or more for the third zone, specification paragraphs [0060] and [0070]) and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first, second, and third zones of the porous structure of Dong, as modified by McTighe, to have coefficients of friction with cancellous bone tissue between 0.2 to 0.5, 0.4 to 0.6, and 0.7 to 1.1 respectively, as an obvious matter of design choice within the skill of the art.
Regarding claim 24, Dong, as modified by McTighe, discloses all limitations as recited in claim 20. Dong further discloses the first zone (75), the second zone (74), and the third zone (73) of the porous structure (72) each extend at least partially around a perimeter of the implant body (see paragraph [0106] and Fig. 12).
Claim(s) 2-4, 6, 10, and 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dong in view of McTighe as applied to claim 1 above, and further in view of Gradinger et al (US5433750).
Regarding claim 2, Dong, as modified by McTighe, further discloses wherein: the porous structure (72) comprises a plurality of struts arranged in a three-dimensional arrangement (forming webs 32, see Fig. 2), but fails to disclose the first circumferentially-extending zone (75) comprises a transition zone in which a diameter of the struts decreases from a first diameter to a second diameter that is less than the first diameter.
Gradinger also discloses an orthopedic implant (10) with a porous open-mesh three-dimensional surface structure (1) that is also is divided into transition zones (A, B, and C). Gradinger teaches the struts decrease from a first diameter to a second diameter that is less than the first diameter in the transition zone (see Fig. 3 and col 2 lines 48-52). 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 the struts of the porous structure of Dong, as modified by McTighe, to have the diameter of the struts in the first transition zone decrease from a first diameter to a second diameter that is less than the first diameter, as taught by Gradinger, in order to improve the healing ability and long-term fixation properties of the implant (see col 1 lines 52-56).
In the alternate interpretation, Dong, as modified by McTighe, discloses the porous structure (P) of the porous bone implant (11) comprises a plurality of struts arranged in a three-dimensional arrangement (forming webs 32, see Fig. 2), but fails to disclose the first circumferentially-extending zone (61) comprises a transition zone in which a diameter of the struts decreases from a first diameter to a second diameter that is less than the first diameter.
Gradinger also discloses an orthopedic implant (10) with a porous open-mesh three-dimensional surface structure (1) that is also is divided into transition zones (A, B, and C). Gradinger teaches the struts decrease from a first diameter to a second diameter that is less than the first diameter in the transition zone (see Fig. 3 and col 2 lines 48-52). 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 the struts of the porous structure of Dong, as modified by McTighe, to have the diameter of the struts in the first transition zone decrease from a first diameter to a second diameter that is less than the first diameter, as taught by Gradinger, in order to improve the healing ability and long-term fixation properties of the implant (see col 1 lines 52-56).
Regarding claim 3, Dong as modified by McTighe and Gradinger further disclose the diameter of the struts decreases in a direction that is at an angle to the longitudinal axis of the implant body (see Gradinger Figs. 2-3, struts diameters increase as they farther away from the implant body and decrease when they are closer to the implant body).
Regarding claim 4, Dong as modified by McTighe and Gradinger further discloses wherein: the transition zone of the first circumferentially-extending zone is a first transition zone (see paragraph [0106], distal region 75); and the porous structure further comprises a second transition zone (see paragraph [0106], intermediate region 74), and a diameter of the struts in the second transition zone decreases in a different direction than in the first transition zone (Gradinger teaches the diameter of struts in the second transition zone (B) decreases in a different direction (towards the implant body) than the first transition zone (only towards the distal end of the implant body)).
Regarding claim 6, Dong as modified by McTighe and Gradinger discloses all the limitations as recited in claim 2 and Dong further teaches wherein the porous structure (72) further comprises a third circumferentially-extending zone (73) exhibiting a third coefficient of friction with bone, but fails to disclose that the third coefficient of friction is higher than the first coefficient of friction and higher than the second coefficient of friction.
McTighe further teaches the implant having a third circumferentially-extending zone (50) having a third coefficient of friction (having roughness of B+C) with bone that is higher than the first coefficient of friction (60 having a smooth surface) and higher than the second coefficient of friction (intermediate region between 50 and 60 having roughness of C). 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 the third circumferentially extending zone of Dong, as modified by McTighe and Gradinger, such that the third circumferentially-extending zone exhibits a third coefficient of friction with bone that is higher than the first coefficient of friction and higher than the second coefficient of friction, as further taught by McTighe, in order to allow for the implant to be easier to remove from the bone cavity and to increase torsional stability in the connection between the stem portion and the femur (see paragraph [0055]).
In the alternate interpretation, Dong as modified by McTighe and Gradinger discloses the porous bone implant (11) comprises all the limitations as recited in claim 2 and Dong further teaches wherein the porous structure (P) further comprises a third circumferentially-extending zone (see Fig.8, 63) exhibiting a third coefficient of friction with bone, but fails to disclose that the third coefficient of friction is higher than the first coefficient of friction and higher than the second coefficient of friction.
McTighe further teaches the implant having a third circumferentially-extending zone (50) having a third coefficient of friction (having roughness of B+C) with bone that is higher than the first coefficient of friction (60 having a smooth surface) and higher than the second coefficient of friction (intermediate region between 50 and 60 having roughness of C). 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 the third circumferentially extending zone of Dong, as modified by McTighe and Gradinger, such that the third circumferentially-extending zone exhibits a third coefficient of friction with bone that is higher than the first coefficient of friction and higher than the second coefficient of friction, as further taught by McTighe, in order to allow for the implant to be easier to remove from the bone cavity and to increase torsional stability in the connection between the implant and bone tissue (see paragraph [0055]).
Regarding claim 10, Dong as modified by McTighe and Gradinger further discloses the strut members of the second circumferentially-extending zone (74) and/or the third circumferentially-extending zone (73) extend radially outwardly beyond strut members of the first circumferentially-extending zone (75; see Fig. 12, struts in second and third circumferentially extending zones extend farther from the longitudinal axis of the implant than the struts of the first circumferentially extending zone).
Regarding claim 12, Dong as modified by McTighe and Gradinger discloses the orthopedic implant of claim 6. However, Dong, as modified by McTighe does not explicitly disclose wherein the third circumferentially-extending zone of the porous structure exhibits a coefficient of friction with cancellous bone tissue of 0.7 to 1.1, as required by the claim.
There is no evidence of record that establishes that changing the coefficient of friction of the third circumferentially-extending zone would result in a difference in function of the device disclosed by Dong, as modified by McTighe and Gradinger. Further, a person having ordinary skill in the art being faced with modifying the implant of Dong, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed coefficients of friction. Lastly, applicant has not disclosed that the claimed range solves any stated problem indicating that the coefficient of friction “can” be within the claimed range, and offering other acceptable ranges (e.g. 0.8 or more, specification paragraph [0070]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the third circumferentially extending zone of the porous structure of Dong as modified by McTighe and Gradinger, to have a coefficient of friction with cancellous bone tissue between 0.7 to 1.1 as an obvious matter of design choice within the skill of the art.
Regarding claim 13, Dong, as modified by McTighe and Gradinger, discloses the bone implant comprises all the limitations as recited in claim 6. Dong further discloses the bone implant is an acetabular cup (see Fig. 8) and the third circumferentially-extending zone (63) of the porous structure (P) is disposed at least partially on the second end portion (54).
Regarding claim 14, Dong, as modified by McTighe and Gradinger, discloses the orthopedic implant of claim 13. However, Dong, as modified by McTighe does not explicitly disclose wherein a height of the third circumferentially- extending zone of the porous structure measured along the longitudinal axis is 10% to 40% of an overall height of the acetabular cup measured along the longitudinal axis.
There is no evidence of record that establishes that changing the height of third circumferentially-extending zone would result in a difference in function of the device disclosed by Dong, as modified by McTighe and Gradinger. Further, a person having ordinary skill in the art being faced with modifying the implant of Dong, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed percentage of overall height of the acetabular cup. Lastly, applicant has not disclosed that the claimed range solves any stated problem indicating that the height of the third circumferentially-extending zone of the porous structure “can” be within the claimed range, and offering other acceptable ranges (e.g., 5% to 50% of the overall length L, specification at paragraph [0129]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the third circumferentially extending zone of the porous structure of Dong as modified by McTighe and Gradinger, to have a height that is 10% to 40% of the overall height of the acetabular cup as measured along the longitudinal axis as an obvious matter of design choice within the skill of the art.
Regarding claim 15, Dong as modified by McTighe and Gradinger further discloses wherein the orthopedic implant is a femoral stem prosthesis (see Fig. 12, 70) and the third circumferentially-extending zone (73) of the porous structure (72) is at a proximal end of the porous structure (73 is the proximal region near the femoral ball 22).
Regarding claim 16, Dong as modified by McTighe and Gradinger discloses the orthopedic implant of claim 15. However, Dong, as modified by McTighe does not explicitly disclose wherein a height of the third circumferentially-extending zone of the porous structure measured in a direction of the strut diameter decrease in the transition zone is 10% to 40% of an overall height of the porous structure measured in the direction of the strut diameter decrease in the transition zone.
There is no evidence of record that establishes that changing the height of third circumferentially-extending zone would result in a difference in function of the device disclosed by Dong, as modified by McTighe. Further, a person having ordinary skill in the art being faced with modifying the implant of Dong, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed percentage of overall height of the porous structure. Lastly, applicant has not disclosed that the claimed range solves any stated problem indicating that the height of the third circumferentially extending zone of the porous structure “can” be within the claimed range, and offering other acceptable ranges (e.g., 5% to 50% of the overall length L, specification at paragraph [0129]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the third circumferentially extending zone of the porous structure of Dong as modified by McTighe and Gradinger, to have a height that is 10% to 40% of the overall height of the porous structure measured in the direction of the strut diameter decrease in the transition zone as an obvious matter of design choice within the skill of the art.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dong in view of McTighe and Gradinger as applied to claim 6 above, and further in view of Moore et al (US10098746).
Regarding claim 7, Dong, as modified by McTighe and Gradinger, discloses all limitations as recited in claim 6, but fails to disclose wherein struts of the third circumferentially-extending zone comprise a plurality of prominences and recesses that increase the third coefficient of friction.
Moore also discloses a mesh of struts that can be applied to a region of an implant device (see Fig. 5A-B) and teaches the struts may comprise a plurality of prominences and recesses (see Fig. 5A-B, struts make up fins 500 that create peaks 520 and valleys in between 520s on the surface of the implant) that increase the coefficient of friction (see col 12, lines 3-6, struts help maintain the position of the implant in the bone and resist motion or change in position of the implant relative to bone). 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 the third circumferentially-extending zone of Dong, as modified by McTighe and Gradinger, to incorporate struts that comprise a plurality of prominences and recesses that increase the third coefficient of friction, as taught by Moore, in order to provide a strong mechanical bond between the implant and bone tissue (see col 1, lines 28-29).
Regarding claim 9, Dong, as modified by McTighe and Gradinger, discloses all the limitations as recited in claim 6, but fails to disclose wherein end portions of struts of the third circumferentially-extending zone are pointed.
Moore also discloses a surface mesh of struts that can be applied to a region of an implant device (see Figs. 5A-5B) and teaches the end portions of struts are pointed (at peaks 520). 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 the third circumferentially-extending zone of Dong, as modified by McTighe and Gradinger, to incorporate struts that have end portions that are pointed, as taught by Moore, in order to provide a strong mechanical bond between the implant and the surrounding bone tissue (see col 1, lines 28-29).
Claim(s) 8 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dong in view of McTighe as applied to claims 1 and 20 above, and further in view of Moore.
Regarding claim 8, Dong as modified by McTighe discloses all the limitations as recited claim 1, but fails to disclose wherein struts of the first circumferentially-extending zone and/or the second circumferentially-extending zone comprise rounded end portions.
Moore also discloses a surface mesh of struts (820) that can be applied to a region of an implant device (see Fig. 14) and teaches the end portions of the struts (820) are rounded (see Fig. 14). 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 the first and/or second circumferentially extending zones of Dong, as modified by McTighe, to incorporate struts that have end portions that are rounded, as taught by Moore, in order to provide a strong mechanical bond between the implant and the surrounding bone tissue (see col 1, lines 28-29).
Regarding claim 22, Dong as modified by McTighe discloses all limitations as recited in claim 20, but fails to disclose wherein struts of the third zone comprise a plurality of prominences and recesses that increase the third coefficient of friction.
Moore also discloses a mesh of struts that can be applied to a region of an implant device (see Fig. 5A-B) and teaches the struts may comprise a plurality of prominences and recesses (see Fig. 5A-B, struts make up fins 500 that create peaks 520 and valleys in between 520s on the surface of the implant) that increase the coefficient of friction (see col 12, lines 3-6, struts help maintain the position of the implant in the bone and resist motion or change in position of the implant relative to bone). 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 the third circumferentially-extending zone of Dong, as modified by McTighe, to incorporate struts that comprise a plurality of prominences and recesses that increase the third coefficient of friction, as taught by Moore, in order to provide a strong mechanical bond between the implant and bone tissue (see col 1, lines 28-29).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dong as applied to claim 17 above, and further in view of Gradinger.
Regarding claim 19, Dong fails to disclose wherein a diameter of the struts of the transition zone decreases in a direction that is at an angle to the longitudinal axis of the implant body.
Gradinger also discloses an orthopedic implant (10) with a porous open-mesh three-dimensional surface structure (1) that is also is divided into transition zones (A, B, and C). Gradinger teaches a diameter of the struts of the transition zone (A, B, or C) decreases in a direction that is at an angle to the longitudinal axis of the implant body (see Gradinger Figs. 2-3, struts diameters increase as they farther away from the implant body and decrease when they are closer to the implant body). 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 the struts of the porous structure of Dong to have a diameter of the struts of the transition zone decrease in a direction that is at an angle to the longitudinal axis of the implant body, as taught by Gradinger, in order to improve the healing ability and long-term fixation properties of the implant (see col 1 lines 52-56).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN ZHI-DE YAO whose telephone number is (571)272-5449. The examiner can normally be reached Monday - Friday 8:00 am to 5:00 pm.
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/JUSTIN ZHI-DE YAO/Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774