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 Status
Applicant’s Remarks and Amendments filed 8 January 2026 have been entered. Claims 2 and 8-9 are cancelled. Claims 1, 3-7, and 10-17 are pending.
Response to Arguments
Applicant's arguments filed 8 January 2026 have been fully considered but they are not persuasive. Regarding Applicant’s argument that the combination of Gupta and Ishimizu does not disclose “the outer surface of the base located in the third region is exposed from the coating film” and that “the surface of the coating film in the second region has a surface roughness that is greater than a surface roughness of the outer surface in the third region” (pg. 7 of remarks), Examiner respectfully disagrees. Gupta teaches the outer surface of the base (Fig. 2, non-conductive surface 18) further comprises a third region (Fig. 2, bottom-most region of substrate 14)…the outer surface of the base (Fig. 2, non-conductive surface 18) located in the third region is exposed from the coating film (Fig. 2, osteoconductive coating 12 does not cover bottom-most region of substrate 14). As seen in Gupta’s Fig. 2, surface 18 within the bottom-most region of substrate 14 are not covered by the coating 12. This, in combination with Ishimizu which teaches the surface roughness of the surface of the coating film in the second region (Fig. 2, proximal first region 10) is larger than a surface roughness of the outer surface in the third region (Fig. 2, Example 1 comprises a surface roughness in the proximal first region 10 ranges from the same level of roughness as the distal side end region 7 to the same level of roughness as the base side second region 11 [0076] and a surface roughness in the distal end region 7 set to 27 µm, respectively [0053]) meets Applicant’s claim limitations.
Further Applicant’s argument that “Ishimizu’s surface roughness variations are between different coated regions on a stem, not between a coated region and an uncoated/exposed region on an acetabular cup” (pg. 7 of remarks) are not persuasive. Ishimizu teaches that the roughened portion of the implant provides frictional resistance immediately after insertion of the device into bone helping to better secure the device when implanted [0001-0004]. Ishimizu further discloses that the roughened coating may be applied via thermal spraying, which a person of ordinary skill in the art could use to apply to another portion of the implant, such as an acetabular cup. Therefore the combination of Gupta and Ishimizu teaches Applicant’s claim limitations and the rejection is maintained.
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.
Claims 1, 3-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (US 2011/0143127 A1), “Gupta” in view of Ishimizu et al. (WO 2020/040051 A1), “Ishimizu”.
Regarding claim 1, Gupta teaches an artificial joint shell (Fig. 1, acetabular cup medical implant 10) comprising: a base having a cup shape (Fig. 2, substrate 14), the base comprising an outer surface (Fig. 2, non-conductive surface 18), the outer surface comprising a first region (Fig. 2, region of non-conductive surface 18 covered by osteoconductive coating 12) and a second region adjacent to the first region (Fig. 2, region of non-conductive surface 18 covered by the bottom-most portion of the osteoconductive coating 12); and a coating film containing a calcium phosphate-based material (Fig. 2, osteoconductive coating 12 includes calcium phosphate or hydroxyapatite [0023) and an antimicrobial material (osteoconductive coating 12 may include antibiotics or be doped with silver ions [0024-0025]), the coating film being disposed across the first region and the second region of the outer surface of the base (Fig. 2, osteoconductive coating 12 is layered over non-conductive surface 18), and the second region (Fig. 2, region of non-conductive surface 18 covered by the bottom-most portion of the osteoconductive coating 12) is disposed between the first region (Fig. 2, region of non-conductive surface 18 covered by osteoconductive coating 12) and an opening portion of the base (Fig. 2, bottom-most region of substrate 14 covered by coating 12 is between underside of substrate 14 and the upper regions of substrate 14 covered by coating 12), the outer surface of the base (Fig. 2, non-conductive surface 18) further comprises a third region (Fig. 2, bottom-most region of substrate 14) located adjacent to the second region and between the second region and the opening portion (Fig. 2, bottom-most region of substrate 14 is between underside of substrate 14 and upper portion of substrate 14), the outer surface of the base (Fig. 2, non-conductive surface 18) located in the third region is exposed from the coating film (Fig. 2, osteoconductive coating 12 does not cover bottom-most region of substrate 14), but fails to teach wherein a surface roughness of a surface of the coating film in the first region is larger than a surface roughness of a surface of the coating film in the second region.
Ishimizu teaches a prosthetic joint with the outer surface comprising a first region (Fig. 1, proximal second region 11) and a second region adjacent to the first region (Fig. 1, proximal first region 10) and wherein a surface of the coating film in the first region has a surface roughness that is greater than a surface roughness of a surface of the coating film in the second region (Fig. 2, Example 1 comprises a surface roughness in the proximal second region set to 53 µm [0053] and a surface roughness in the proximal first region 10 ranges from the same level of roughness as the distal side end region 7 to the same level of roughness as the base side second region 11 [0076]), and the surface of the coating film in the second region (Fig. 2, proximal first region 10) has a surface roughness that is greater than a surface roughness of the outer surface in the third region (Fig. 2, Example 1 comprises a surface roughness in the proximal first region 10 ranges from the same level of roughness as the distal side end region 7 to the same level of roughness as the base side second region 11 [0076] and a surface roughness in the distal end region 7 set to 27 µm, respectively [0053]). Ishimizu discloses that the implant is sprayed with a thermal spray to form a rougher surface than on the distal end side of the stem portion and having a larger cross-sectional area than the distal end side of the stem portion [0053]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the coating film taught by Gupta with the roughness variations taught by Ishimizu in order to promote integration of the implant.
Regarding claim 3, Gupta teaches further comprising: a layered member (Fig. 2, electroconductive interlayer 16), the layered member being disposed in the first region (Fig. 2, region of non-conductive surface 18 covered by osteoconductive coating 12).
Regarding claim 4, Gupta teaches wherein the layered member is made of metal (Fig. 2, electroconductive interlayer 16 is deposited as metal or a metallic layer [0019]).
Regarding claim 5, Gupta teaches wherein the coating film (Fig. 2, osteoconductive coating 12) disposed in the first region is disposed on the layered member (Fig. 2, osteoconductive coating 12 covers electroconductive interlayer 16).
Regarding claim 6, Gupta teaches the layered member (Fig. 2, electroconductive interlayer 16), but fails to teach an edge having a lower height than a height of an inner portion of the layered member.
Ishimizu teaches a prosthetic joint comprising an edge having a lower height than a height of an inner portion of the layered member (Modified Fig. 2, base portion is wider than end portion). Ishimizu discloses that the inclined surface at the distal end of the roughen portion allows for increased stress handling and avoids breakage of the roughened portion [0083]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the coating film taught by Gupta with the roughness and inclined portions taught by Ishimizu in order to avoid implant malfunction from applied stresses.
Regarding claim 7, Gupta teaches wherein the coating film (Fig. 2, osteoconductive coating 12) is located in the second region (Fig. 2, region of non-conductive surface 18 covered by the bottom-most portion of the osteoconductive coating 12), but fails to teach an end portion and a base portion located closer to the first region than the end portion is to the first region, and a thickness of the base portion is greater than a thickness of the end portion.
Ishimizu teaches a prosthetic joint comprising an end portion (Modified Fig. 2 below, inclined portion 9 comprises end portion) and a base portion (Modified Fig. 2 below, inclined portion 9 comprises base portion) located closer to the first region than the end portion is to the first region (Modified Fig. 2 below, base portion is closer to proximal second region 11 than end portion is), and a thickness of the base portion is larger than a thickness of the end portion (Modified Fig. 2, base portion is wider than end portion). Ishimizu discloses that the inclined surface at the distal end of the roughen portion allows for increased stress handling and avoids breakage of the roughened portion [0083]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the coating film taught by Gupta with the roughness and inclined portions taught by Ishimizu in order to avoid implant malfunction from applied stresses.
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Modified Figure 2
Regarding claim 10, Gupta fails to teach the limitations of claim 10. However, Ishimizu teaches a prosthetic joint wherein a surface roughness of the outer surface in the first region is greater than a surface roughness of the outer surface in the second region (Fig. 2, Example 1 comprises a surface roughness in the proximal second region set to 53 µm [0053] and a surface roughness in the proximal first region 10 ranges from the same level of roughness as the distal side end region 7 to the same level of roughness as the base side second region 11 [0076]). Ishimizu discloses that the implant is sprayed with a thermal spray to form a rougher surface than on the distal end side of the stem portion and having a larger cross-sectional area than the distal end side of the stem portion [0053]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the coating film taught by Gupta with the roughness variations taught by Ishimizu in order to promote integration of the implant.
Regarding claim 11, Gupta fails to teach the limitations of claim 11. However, Ishimizu teaches a prosthetic joint wherein a surface roughness of the outer surface in the second region is greater than a surface roughness of the outer surface in the third region (Fig. 2, Example 1 comprises a surface roughness in the proximal first region 10 ranges from the same level of roughness as the distal side end region 7 to the same level of roughness as the base side second region 11 [0076] and a surface roughness in the distal end region 7 set to 27 µm, respectively [0053]). Ishimizu discloses that the implant is sprayed with a thermal spray to form a rougher surface than on the distal end side of the stem portion and having a larger cross-sectional area than the distal end side of the stem portion [0053]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the coating film taught by Gupta with the roughness variations taught by Ishimizu in order to promote integration of the implant.
Claims 12-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (US 2011/0143127 A1), “Gupta” in view of Ishimizu et al. (WO 2020/040051 A1), “Ishimizu” and further in view of Harwin et al. (US Pat. No. 5163961 A), “Harwin”.
Regarding claim 12, Gupta teaches the base (Fig. 2, substrate 14), but Gupta in view of Ishimizu fails to teach wherein the base comprises at least one through hole penetrating the outer surface and an inner surface of the base.
Harwin teaches a femur head prosthesis wherein the base (Fig. 4, acetabular component 3) comprises at least one through hole (Fig. 4, apertures 4a) penetrating the outer surface and an inner surface of the base (Fig. 4, apertures 4a extend through cup 4 for bone screws (col. 4, lines 19-23)). Harwin discloses that the apertures are to fit with bone screws to fasten the implant to the pelvis (col. 4, lines 19-23). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the base taught by Gupta with the through holes taught by Harwin in order to provide additional securing methods for the implant to avoid detachment from patient anatomy.
Regarding claim 13, Gupta in view of Ishimizu fails to teach the limitations of claim 13. However, Harwin teaches a femur head prosthesis wherein the outer surface of the base (Fig. 4, porous coating 12) further comprises a fourth region (Fig. 2, outer rims of apertures 4a) located adjacent to the first region (Fig. 4, regions of acetabular component 3 covered in porous coating 12) and between the first region and the at least one through hole (Fig. 4, outer rim of apertures 4a is between the open hole of apertures 4a and the regions of acetabular component 3 covered by porous coating 12), and a surface roughness of the outer surface located in the fourth region is smaller than the surface roughness of the surface of the coating film in the first region (Fig. 4, outer rim of apertures 4a are not covered by porous coating 12 (i.e., no roughness)). Harwin discloses that the apertures are to fit with bone screws to fasten the implant to the pelvis (col. 4, lines 19-23). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the base taught by Gupta with the through holes taught by Harwin in order to provide additional securing methods for the implant to avoid detachment from patient anatomy.
Regarding claim 14, Gupta in view of Ishimizu fails to teach the limitations of claim 14. However, Harwin teaches a femur head prosthesis wherein the at least one through hole (Fig. 2, apertures 4a) comprises: at least one screw hole disposed at a position further from the opening portion than other positions of other through holes of the at least one through hole (Fig. 2, acetabular cup 3 comprises an aperture 4a (used for bone screw (col. 2, lines 19-23)) at the central topmost point of the metal cup 4), and at least one counterbored hole (Fig. 2, apertures 4a other than central topmost aperture 4a) comprising a first penetrating portion (Modified Fig. 8 below, first penetrating portion) and a second penetrating portion (Modified Fig. 8 below, second penetrating portion), the second penetrating portion being connected to the first penetrating portion and the outer surface and having a narrower width than the first penetrating portion Modified Fig. 8 below, second penetrating portion is attached to first penetrating portion and is narrower in width). Harwin discloses that the apertures are to fit with bone screws to fasten the implant to the pelvis (col. 4, lines 19-23). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the base taught by Gupta with the through holes taught by Harwin in order to provide additional securing methods for the implant to avoid detachment from patient anatomy.
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Modified Figure 8
Regarding claim 15, Gupta in view of Ishimizu fails to teach the limitations of claim 15. However, Harwin teaches a femur head prosthesis wherein the coating film (Fig. 4, porous coating 12) is disposed at least a part of the outer surface in the fourth region (Fig. 2, outer rims of apertures 4a are surrounded by porous coating 12). Harwin discloses that the apertures are to fit with bone screws to fasten the implant to the pelvis (col. 4, lines 19-23). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the base taught by Gupta with the through holes taught by Harwin in order to provide additional securing methods for the implant to avoid detachment from patient anatomy.
Regarding claim 17, Gupta fails to teach the limitations of claim 17. However, Harwin teaches a femur head prosthesis wherein the fourth region (Fig. 2, outer rims of apertures 4a) is adjacent to the counterbored hole (Fig. 2, outer rims surround all apertures 4a). Harwin discloses that the apertures are to fit with bone screws to fasten the implant to the pelvis (col. 4, lines 19-23). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the base taught by Gupta with the through holes taught by Harwin in order to provide additional securing methods for the implant to avoid detachment from patient anatomy.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (US 2011/0143127 A1), “Gupta” in view of Ishimizu et al. (WO 2020/040051 A1), “Ishimizu” and Harwin et al. (US Pat. No. 5163961 A), “Harwin”, and further in view of Piecuch et al. (US 2019/0105177 A1), “Piecuch”.
Regarding claim 16, Gupta teaches the outer surface of the base (Fig. 2, non-conductive surface 18) and the coating film (Fig. 2, osteoconductive coating 12), but Gupta in view of Ishimizu fails to teach a fifth region located adjacent to the fourth region and between the fourth region and the screw hole, and the outer surface in the fifth region is fully exposed from the coating film.
Harwin teaches a femur head prosthesis comprising the fourth region (Fig. 2, outer rims of apertures 4a) and the screw hole (Fig. 2, acetabular cup 3 comprises an aperture 4a (used for bone screw (col. 2, lines 19-23)) at the central topmost point of the metal cup 4). Harwin discloses that the apertures are to fit with bone screws to fasten the implant to the pelvis (col. 4, lines 19-23). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the base taught by Gupta with the through holes taught by Harwin in order to provide additional securing methods for the implant to avoid detachment from patient anatomy. However, Gupta in view of Harwin fails to teach a fifth region located adjacent to the fourth region and between the fourth region and the screw hole, and the outer surface in the fifth region is fully exposed from the coating film.
Piecuch teaches an acetabular component comprising a fifth region (Modified Fig. 7 below, fifth region of rim feature 604) located adjacent to the fourth region (Modified Fig. 7 below, fourth region of rim feature 604) and between the fourth region and the screw hole (Modified Fig. 7 below, fifth region is between fourth region and hole 602), and the outer surface in the fifth region is fully exposed from the coating film (Modified Fig. 7 below, fifth region is not coated). Piechuch discloses that the rim feature in the acetabular component prevents interference between the securing components and the implant itself [0018]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the holes and fourth region taught by Harwin with the fifth region taught by Piecuch and the base taught by Gupta in order to limit interference of the implant with its connection features.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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