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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (US 20120209398 A1), in view of Sharkey et al. (US 10729550 B2) and Lipman (US 5916270 A).
Regarding claim 1, Richardson discloses a dual mobility hip prosthesis (¶ 0008 discloses that the present invention may be applied to dual-mobility or bi-polar cups) comprising: an acetabular cup (200) defining an outer acetabulum fixing surface (211; ¶ 0025) and an inner fixing surface (¶ 0025; see fig. 5c annotated below); a fixed liner (212) defining an outer fixing surface configured for fixing to the inner fixing surface of the acetabular cup and an inner articular surface (¶ 0025; see fig. 5c annotated below); a bearing component (219) defining an outer articular surface configured for articulating against the inner articular surface of the fixed liner and an inner articular surface (see fig. 5c annotated below; ¶ 0025 discloses a acetabular cup with a rotatable bearing); a femoral component (31) comprising a neck engaging a head at a distal end of the neck (see fig. 5c), the head defining an exterior articular surface configured for articulating against the inner articular surface of the bearing component (¶ 0025; see fig. 5c), wherein: the acetabular cup defines an acetabular cup rim (see fig. 5c); and the liner defines liner rim (see fig. 5c). Richardson fails to disclose that the liner rim is recessed with respect to the acetabular cup rim so that an adjacent contact surface of the neck impinges the acetabular cup rim at extreme positions of the femoral component with respect to the acetabular cup without impinging the liner rim; the acetabular cup rim defines an inner contact face correspondingly angled to the adjacent contact surface of the neck at the extreme positions to reduce point contact loading between the acetabular cup rim and the adjacent contact surface of the neck.
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Sharkey also discloses a dual mobility hip prosthesis (1; see Abstract) comprising: an acetabular cup (20) defining an outer acetabulum fixing surface (24) and an inner fixing surface (26); a fixed liner (40) defining an outer fixing surface (42) configured for fixing to the inner fixing surface of the acetabular cup and an inner articular surface (col. 5 lines 62-67); a femoral component (col. 5 lines 26-29), wherein: the acetabular cup defines an acetabular cup rim; the liner defines liner rim (see fig. 10 below). Sharkey teaches that the liner rim is recessed with respect to the acetabular cup rim so that an adjacent contact surface of the neck is capable of impinging the acetabular cup rim at extreme positions of the femoral component with respect to the acetabular cup without impinging the liner rim (col. 7 lines 26-30 disclose that protruding parts of the liner rim are removed/recessed to solve the issue in prior art where a liner’s protruding rim collides with a neck stem causing micromotion and fretting corrosion; see col. 2 lines 25-28).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liner rim of Richardson in view of Sharkey such that the liner rim is flush with, recessed relative to, or less prominently extending beyond the acetabular cup rim, as doing so predictably reduces the potential for impingement, as Sharkey teaches that modifying the liner-cup geometry can reduce micromotion and mitigate fretting corrosion (Sharkey - col. 2 lines 25-28 and col. 7 lines 26-30).
Richardson in view of Sharkey fails to disclose that the acetabular cup rim defines an inner contact face correspondingly angled to the adjacent contact surface of the neck at the extreme positions to reduce point contact loading between the acetabular cup rim and the adjacent contact surface of the neck. Lipman also discloses a hip prosthesis (10) comprising: an acetabular cup (32) defining an outer acetabulum fixing surface and an inner fixing surface (see fig. 4 below); and a femoral component (40) comprising a neck (44) engaging a head (42) at a distal end of the neck (fig. 4), wherein: the acetabular cup (32) defines an acetabular cup rim (see fig. 4). Lipman teaches that the acetabular cup rim defines an inner contact face (36) correspondingly angled to the adjacent contact surface of the neck at the extreme positions and capable of reduce point contact loading between the acetabular cup rim and the adjacent contact surface of the neck (col. 3 lines 9-15; see figs. 3-6).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the acetabular rim of Richardson in view of Sharkey to include that the acetabular cup rim defines an inner contact face correspondingly angled to the adjacent contact surface of the neck at the extreme positions and capable of reduce point contact loading between the acetabular cup rim and the adjacent contact surface of the neck in order to reduce problems such as dislocation during extreme movements of the joint (col. 3 lines 9-15; see figs. 3-6).
Regarding claim 2, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 1. Lipman further discloses that the inner contact face is flat (see figs. 3-4).
Regarding claim 3, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 2. Lipman further teaches an inner contact surface having a width sufficient to engage the contact surface of a stem’s neck. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide acetabular rim comprising an inner contact surface width sufficient enough, e.g. of 2 mm, to contact the contact surface of a femoral components neck (see figs. 3-6) in order to minimize dislocation (Lipman - Abstract).
Regarding claim 4, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 1. Sharkey further teaches that the wherein the liner has a cross-sectional arc angle of greater than 170 degrees (fig. 10 illustrates a hemi-spherical liner 40, i.e. a liner with a cross-sectional arc angle of greater than 170 or 180 degrees).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified in liner of Richardson to include that the liner has a cross-sectional arc angle of greater than 70 degrees as taught by Sharkey as Sharkey demonstrates a liner having the claimed cross-sectional arc angle was known in the art before the effective filing date and suitable for use in an artificial hip joint/acetabular prosthesis. Furthermore, a person of ordinary skill in the art would have known to select the appropriate cross-sectional arc angle for a liner based on other design considerations, e.g. acetabular cup dimensions (e.g. depth, width, arc angle), femoral head coverage, range of motion, joint stability, or as disclosed in Sharkey to avoid dislocation issues of a femoral head due to mobile liners (see Sharkey - col. 2 lines 25-28 and col. 7 lines 26-30).
Regarding claim 5, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 1. Sharkey further teaches that the liner has a cross-sectional arc angle of approximately 180 degrees (fig. 10 illustrates a hemi-spherical liner 40, i.e. a liner with a cross-sectional arc angle of 180 degrees).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified in liner of Richardson to include that the liner has a cross-sectional arc angle of approximately 180 degrees as taught by Sharkey as Sharkey demonstrates a liner having the claimed cross-sectional arc angle was known in the art before the effective filing date and suitable for use in an artificial hip joint/acetabular prosthesis. Furthermore, a person of ordinary skill in the art would have known to select the appropriate cross-sectional arc angle for a liner based on other design considerations, e.g. acetabular cup dimensions (e.g. depth, width, arc angle), femoral head coverage, range of motion, joint stability, or as disclosed in Sharkey to avoid dislocation issues of a femoral head due to mobile liners (see Sharkey - col. 2 lines 25-28 and col. 7 lines 26-30).
Regarding claim 6, Richardson in view of Sharkey and Lipman disclose provides a liner rim that lies close to the inner contact surface of an acetabular rim, as Sharkey teaches Liners that do not protrude with respect to the rim of an acetabular cup in order to reduce micromotion and mitigate fretting corrosion and Lipman teaches an acetabular cup rim with an inner contact surface in order to reduce problems such as dislocation during extreme movements of the joint.
Regarding claim 7, Richardson in view of Sharkey and Lipman discloses a liner rim that lies within 2mm of the inner contact surface of an acetabular rim, as Sharkey teaches Liners that do not protrude and/or remain flush with respect to the surfaces of the acetabular rim of an acetabular cup in order to reduce micromotion and mitigate fretting corrosion and Lipman teaches an acetabular cup rim with an inner contact surface in order to reduce problems such as dislocation during extreme movements of the joint.
Regarding claim 8, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 1. Richardson further discloses that the liner is non-rotatably captured by the inner fixing surface of the acetabular cup (¶ 0025 discloses that the liner 212 is mounted into the acetabular cup/shell 210 and is captured/held by a screw 213 inserted into a threaded hole in the acetabular cup/shell 210; see fig. 5c).
Regarding claim 9, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 8. Richardson further discloses that the liner is non-rotatably captured by the inner fixing surface of the acetabular cup without insertion of an intervening locking ring (¶ 0025 discloses that the liner 212 is mounted into the acetabular cup/shell 210 and is captured/held by a screw 213 inserted into a threaded hole in the acetabular cup/shell 210; see fig. 5c).
Regarding claim 10, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 8. Richardson further discloses that the liner exteriorly engages the acetabular cup at a polar region of the liner (fig. 5c illustrates and ¶ 0025 discloses that the liner 212 exteriorly engages the acetabular cup, being held by a screw 213, at the polar region of the liner).
Regarding claim 11, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 10. Richardson discloses that an acetabular cup (200) comprises a polar socket (209; see fig. 5a). Sharkey further teaches a liner (40) that comprises an integrally formed bung (46) protruding from the polar region (see fig. 7b) which inserts into the polar socket (64; fig. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liner of Richardson to include a liner that comprises an integrally formed bung protruding from the polar region which inserts into the polar socket as taught by Sharkey in order to provide a more stable connection of the liner to the acetabular cup and prevent rotation and separation of the liner (col. 7 lines 12-15).
Regarding claim 12, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 11. Sharkey further discloses that the bung is configured for frictional engagement with the polar socket (col. 7 lines 5-6 and lines 10-12 disclose that the bung 46 is connected to the socket 64 by a tapered interference/morse-taper fit, i.e. frictional engagement fit).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (US 20120209398 A1), in view of Sharkey et al. (US 10729550 B2) and Lipman (US 5916270 A), as applied to claim 12 above, and in further view of Meridew et al. (US 8123815 B2).
Regarding claim 13, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 12. Richardson discloses that the polar socket is threaded (see fig. 5a; 209). Richardson in view of Sharkey and Lipman fail to disclose that the bung comprises circumferential formations thereon which interfere with thread of the polar socket.
Meridew also a hip prosthesis (Abstract) comprising: an acetabular cup (302’); and a fixed liner (306’). Meridew teaches that a bung (342) comprises circumferential formations thereon which interfere with thread of the polar socket (see fig. 3d; col. 8 lines 44-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bung of Richardson in view of Sharkey and Lipman to include that the bung comprises circumferential formations thereon which interfere with thread of the polar socket as taught by Meridew in order to engage a connection portion in the acetabular cup (Meridew - Abstract).
Claims 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (US 20120209398 A1), in view of Sharkey et al. (US 10729550 B2) and Lipman (US 5916270 A), as applied above, and in further view of Sun et al. (US 9144497 B2).
Regarding claim 14, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 11. Richardson in view of Sharkey and Lipman fail to disclose that corresponding equatorial peripheries of the acetabular cup and the liner comprises a non-rotatably engaging frustoconical locking tapers.
Sun also discloses hip prosthesis (see Abstract) comprising: an acetabular cup (100); a fixed liner (Sun describes 200 as a bearing – However, see ENDO Indonesia Catalog Image below of Corentec Bencox Cup System from 09/21/2019 (“Corentec Bencox Cup System.” PT ENDO Indonesia, endo.id/catalog/product/corentec-bencox-cup-system. Accessed 8 June 2026) which discloses and illustrates a PE liner). Sun teaches that corresponding equatorial peripheries of the acetabular cup and the liner comprises a non-rotatably engaging frustoconical locking tapers (see fig. 4 tapers 101/201 and col. 4 lines 63-65; also see figs. below from ENDO Indonesia Catalog illustrating a PE liner with frustoconical taper locks).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the acetabular cup and the liner of Richardson in view of Sharkey and Lipman to include that corresponding equatorial peripheries of the acetabular cup and the liner comprises a non-rotatably engaging frustoconical locking tapers as taught by Sun in order to prevent micro-motion of the liner with respect to the acetabular cup (Sun - col. 5 lines 1-4).
Regarding claim 17, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 1. Richardson in view of Sharkey and Lipman fails to disclose that the acetabular cup rim defines inner anti-torsion recesses and wherein the liner rim comprises outer anti-torsion protrusions which correspondingly plug into the anti-torsion recesses.
Sun also discloses hip prosthesis (see Abstract) comprising: an acetabular cup (100); a fixed liner (Sun describes 200 as a bearing – However, see ENDO Indonesia Catalog Image below of Corentec Bencox Cup System from 09/21/2019 (“Corentec Bencox Cup System.” PT ENDO Indonesia, endo.id/catalog/product/corentec-bencox-cup-system. Accessed 8 June 2026) which discloses and illustrates a PE liner). Sun teaches that the acetabular cup rim defines inner anti-torsion recesses and wherein the liner rim comprises outer anti-torsion protrusions which correspondingly plug into the anti-torsion recesses (fig. 1 illustrates an acetabular cup 100 rim with recesses 150 and a liner 200 rim with protrusions 250 which once seated in the recesses 150 of the acetabular cup 100 the configuration would not permit torsion of the components with respect to one another, i.e. the assembly comprises anti-torsion recesses and protrusions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the acetabular cup rim and liner rim of Richardson in view of Sharkey and Lipman to include that the acetabular cup rim defines inner anti-torsion recesses and wherein the liner rim comprises outer anti-torsion protrusions which correspondingly plug into the anti-torsion recesses as taught by Sun in order to firmly affix the liner to the acetabular cup (Sun – col. 3 lines 3-4.)
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (US 20120209398 A1), in view of Sharkey et al. (US 10729550 B2) and Lipman (US 5916270 A), as applied to claim 1 above, and in further view of McEntire et al. (US 20130073050 A1).
Regarding claim 15, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 1. Richardson in view of Sharkey, and Lipman disclose an outer fixing surface of a line (see claim 1), but fails to disclose that the outer fixing surface of the liner comprises a DLC coating.
McEntire also discloses a hip prosthesis (¶ 0013) comprising: an acetabular cup (102) defining an outer acetabulum fixing surface (108) and an inner fixing surface (¶ 0013; 112); a femoral component (104) comprising a neck (114) engaging a head (116) at a distal end of the neck (see fig. 2), and the head defining an exterior articular surface (118). McEntire teaches that the outer fixing surfaces comprise a DLC coating (¶ 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liner’s outer surface of Richardson in view of Sharkey and Lipman to include that the liner’s outer surfaces comprise a DLC coating as taught by McEntire in order to increase the hardness of articulating interface surfaces, reduce the coefficient of friction between articulating components, decrease the effects of wearing at the articulating interface surfaces, and/or decrease the intensity of audible noises produced by the prosthesis during use (McEntire ¶ 0034).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (US 20120209398 A1), in view of Sharkey et al. (US 10729550 B2), Lipman (US 5916270 A), and Sun et al. (US 9144497 B2), as applied to claim 14 above, and in further view of McEntire et al. (US 20130073050 A1).
Regarding claim 16, Richardson in view of Sharkey and Lipman disclose the invention as claimed as discussed with respect to claim 14. Richardson in view of Sharkey, and Lipman disclose an outer fixing surface of a liner with tapers (see claim 14), but fails to disclose that the outer fixing surface of the liner comprises a DLC coating.
McEntire also discloses a hip prosthesis (¶ 0013) comprising: an acetabular cup (102) defining an outer acetabulum fixing surface (108) and an inner fixing surface (¶ 0013; 112); a femoral component (104) comprising a neck (114) engaging a head (116) at a distal end of the neck (see fig. 2), and the head defining an exterior articular surface (118). McEntire teaches that the outer fixing surfaces comprise a DLC coating (¶ 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the liner’s outer surface of Richardson in view of Sharkey and Lipman to include that the liner’s outer surfaces comprise a DLC coating at the tapers as taught by McEntire in order to increase the hardness of articulating interface surfaces, reduce the coefficient of friction between articulating components, decrease the effects of wearing at the articulating interface surfaces, and/or decrease the intensity of audible noises produced by the prosthesis during use (McEntire ¶ 0034).
Conclusion
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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