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 15 September 2025 have been entered. Claim 6 is cancelled. Claims 1-5 and 7-12 are pending.
Response to Arguments
Applicant's arguments filed 15 September 2025 have been fully considered but they are not persuasive. Gargac teaches that the compression washer 260 causes proximal head 276 of locking screw 256 to be in contact with a larger surface area of threaded member 264 (col. 11, lines 47-49) therefore meeting the limitation of amended claims 1 and 10.
Further, regarding the argument for reasoning to combine (page 7 of remarks), Cardon teaches that the articular component can be chosen by the surgeon during surgery or just before (abstract). The articular components are made from different respective materials including polymeric, metal, and ceramic (col. 4, lines 6-10). In order to provide an implant best suited to patient needs, it would have therefore been obvious to provide an implant main body formed of ceramic as claimed in this application, as stated in the previous Office Action.
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 1-4 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gargac et al. (US Pat. No. 11103357 B2) in view of Cardon et al. (US Pat. No. 10925745 B2), “Cardon”.
Regarding claim 1, Gargac teaches a joint prosthesis implant comprising: a main body (Fig. 4, glenosphere 116) comprising a joint outer surface (Fig. 4, articular surface 244), of concave or convex shape (Fig. 4, articular surface 244 is convex (col. 9, lines 14-15)), at least one tightening screw (Fig. 4, locking screw 256) configured to tighten the main body on the patient's bone or on an intermediate element attached to said bone (Fig. 4, threaded member 264 comprises internal and external threaded surfaces which engage with locking screw 256 (col. 9, lines 43-46)), at least one added ring (Fig. 4, threaded member 264) in the main body (Fig. 4, glenosphere 116) and forming with it a chamber (Fig. 4, internal cavity 292) trapping the head (Fig. 4, proximal head 276) of the tightening screw (Fig. 4, locking screw 256) and comprising a bearing surface forming a stop (Fig. 4, compression washer 260) for said head of the tightening screw (Fig. 4, proximal head 276), the added ring (Fig. 4, threaded member 264) being configured to be in contact with the tightening screw during said tightening (Fig. 4, threaded member 264 comprises internal and external threaded surfaces which engage with locking screw 256 (col. 9, lines 43-46)), the added ring (Fig. 4, threaded member 264) comprising a central hole crossed by the tightening screw (Fig. 4, locking screw 256 mates with internal threads 284 of threaded member 264 which comprises a hole (col. 9, lines 61-64)), the added ring (Fig. 4, threaded member 264) being configured to distribute homogeneously in the main body (Fig. 4, glenosphere 116) the mechanical stresses caused by tightening the tightening screw (col. 10-11, lines 53-4), and wherein the at least one added ring is in direct contact with a head of the at least one tightening screw (Fig. 4, compression washer 260 causes proximal head 276 of locking screw 256 to be in contact with a larger surface area of threaded member 264 (col. 11, lines 47-49)), but fails to teach the main body and joint outer surface being made of ceramic.
Cardon teaches articular components wherein the main body (Fig. 1, articular component 40) and joint outer surface (Fig. 1, articular surface 41) are made of ceramic (articular component 40 is made of ceramic (col. 7, lines 36-42)). Cardon discloses multiple articular components in a set that each vary in composition material (col. 7, lines 36-42). 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 joint prosthesis taught by Gargac with the ceramic material taught by Cardon in order to provide a range of options of implantable material to make the device more suited to patient needs.
Regarding claim 2, Gargac teaches wherein the added ring (Fig. 4, threaded member 264) comprises a threaded portion (Fig. 4, sidewall 288) and the main body (Fig. 4, glenosphere 116) comprises a corresponding tapped portion (Fig. 4, internal threaded surface 252), the threaded portion and the tapped portion being configured so that the added ring (Fig. 4, threaded member 264) can be screwed into the main body (Fig. 4, threaded member 264 includes sidewall 288 which is coupled with internal threaded surface 252 of glenosphere 116 (col. 10, lines 64-66)).
Regarding claim 3, Gargac teaches the added ring (Fig. 4, threaded member 264) and the main body (Fig. 4, glenosphere 116), but fails to teach a means for clipping.
Cardon teaches articular components having a means for clipping (projection 26 of the flange(s) 23.2 is snapped into the recess 35, 45). Cardon discloses that the projection axially interferes with the recesses to prevent translation between separate parts of the device (col. 8, lines 29-35). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the added ring taught by Gargac to reflect the clipping means taught by Cardon in order to prevent movement of individual parts within the device that could lead to implant failure during use.
Regarding claim 4, Gargac teaches wherein the added ring (Fig. 4, threaded member 264) comprises elastically deformable peripheral means (Fig. 4, compression washer 260) configured to deform (Fig. 4, compression washer 260 deforms with force of rotating locking screw 256 (col. 11, lines 27-30)) as said tightening screw (Fig. 4, locking screw 256) is inserted.
Regarding claim 7, Gargac teaches wherein the main body is a glenosphere (Fig. 4, glenosphere 116), the tightening screw (Fig. 4, locking screw 256) being configured to tighten the glenosphere (Fig. 4, glenosphere 116) onto a metaglene (Fig. 4, baseplate 108) attached to the patient's glenoid (Fig. 5, baseplate 108 includes a bone engaging surface 152 (col. 5, lines 52-53)).
Regarding claim 8, Gargac teaches the glenosphere (Fig. 4, glenosphere 116), but fails to explicitly teach the diameter is between 30 and 46 mm. However, Gargac does teach the diameter of the metaglene (Fig. 5, baseplate 108) being between 30 and 46 mm (Fig. 5, diameter of circular profile is between 20 mm and 40 mm (col. 6, lines 21-23) (i.e., glenosphere diameter must be larger than baseplate diameter since baseplate fits within glenosphere)).
Regarding claim 9, Gargac teaches wherein the main body (Fig. 4, glenosphere 116) is a ceramic tibial plateau, a knee condyle, an anatomic glenoid, a hip acetabulum or a ceramic cup (Fig. 4 exhibits a glenoid implant 100 comprising glenosphere 116).
Regarding claim 10, Gargac teaches a joint prosthesis comprising an implant (Fig. 4, glenoid implant 100) comprising: a main body (Fig. 4, glenosphere 116) comprising a joint outer surface (Fig. 4, articular surface 244), of concave or convex shape (Fig. 4, articular surface 244 is convex (col. 9, lines 14-15)), at least one tightening screw (Fig. 4, locking screw 256) configured to tighten the main body on the patient's bone or on an intermediate element attached to said bone (Fig. 4, threaded member 264 comprises internal and external threaded surfaces which engage with locking screw 256 (col. 9, lines 43-46)), at least one added ring (Fig. 4, threaded member 264) in the main body (Fig. 4, glenosphere 116) and forming with it a chamber (Fig. 4, internal cavity 292) trapping the head (Fig. 4, proximal head 276) of the tightening screw (Fig. 4, locking screw 256) and comprising a bearing surface forming a stop (Fig. 4, compression washer 260) for said head of the tightening screw (Fig. 4, proximal head 276), the added ring (Fig. 4, threaded member 264) being configured to be in contact with the tightening screw during said tightening (Fig. 4, threaded member 264 comprises internal and external threaded surfaces which engage with locking screw 256 (col. 9, lines 43-46)), the added ring (Fig. 4, threaded member 264) comprising a central hole crossed by the tightening screw (Fig. 4, locking screw 256 mates with internal threads 284 of threaded member 264 which comprises a hole (col. 9, lines 61-64)), the added ring (Fig. 4, threaded member 264) being configured to distribute homogeneously in the main body the mechanical stresses caused by tightening the tightening screw (col. 10-11, lines 53-4), and wherein the at least one added ring is in direct contact with a head of the at least one tightening screw (Fig. 4, compression washer 260 causes proximal head 276 of locking screw 256 to be in contact with a larger surface area of threaded member 264 (col. 11, lines 47-49)), but fails to teach the main body and joint outer surface being made of ceramic.
Cardon teaches articular components wherein the main body (Fig. 1, articular component 40) and joint outer surface (Fig. 1, articular surface 41) are made of ceramic (articular component 40 is made of ceramic (col. 7, lines 36-42)). Cardon discloses multiple articular components in a set that each vary in composition material (col. 7, lines 36-42). 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 joint prosthesis taught by Gargac with the ceramic material taught by Cardon in order to provide a range of options of implantable material to make the device more suited to patient needs.
Regarding claim 11, Gargac teaches the added ring (Fig. 4, threaded member 264) and tightening screw (Fig. 4, locking screw 256) is inserted, but fails to explicitly teach the added ring is split. Gargac further teaches a second embodiment wherein the added ring is split (Fig. 6A, member 240A comprises ends 241, 242 that are spaced apart) so that it can expand (Fig. 6A, member 240A comprises ends 241, 242 which may be deflected causing widening of the member 240A (col. 8-9, lines 67-5)). Gargac discloses that the member prevents axial translation of the baseplate relative to the anchor member while also allowing for rotation (col. 9, lines 10-13). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the ring taught by Gargac to reflect the shape of the ring taught by Gargac in order to prevent unnecessary internal movement of individual parts of the implant that could lead to failure, but allow for internal rotation.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gargac et al. (US Pat. No. 11103357 B2) in view of Cardon et al. (US Pat. No. 10925745 B2), “Cardon” and further in view of Howling et al. (US 2010/0222889 A1), “Howling”.
Regarding claim 5, Gargac teaches the added ring (Fig. 4, threaded member 264) and the main body (Fig. 4, glenosphere 116), but fails to teach a thermally expansive material exerting expansion pressure on the main body.
Howling teaches a tibial implant comprising a thermally expansive material exerting expansion pressure (Fig. 4C, polymer material 35 is coupled to fixator 33 and when provided with energy (i.e., heat), the material 35 expands in various directions [0061]). Howling discloses that by deforming this heat activated polymer material, it is able to be wedged between the implant and bone so that the device may be fixed to the bone [0050]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the material of the added ring taught by Gargac to reflect the thermally expansive material taught by Howling in order to fix the implant to the bone more securely.
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gargac et al. (US Pat. No. 11103357 B2) in view of Cardon et al. (US Pat. No. 10925745 B2), “Cardon” and further in view of Juszczyk et al. (US 2020/0061238 A1), “Juszczyk”.
Regarding claim 12, Gargac teaches the added ring (Fig. 4, threaded member 264) and the main body (Fig. 4, glenosphere 116), but fails to teach wherein the added ring is added by brazing onto the main body.
Juszczyk teaches ceramic implant parts wherein the added ring (non-ceramic material [0056]) is added by brazing onto the main body (ceramic part can be welded to non-ceramic materials [0056]). Juszczyk discloses that bone welding is advantageous because the implant can be infiltrated by processing material and still further mechanically connected to other implant parts [0056]. 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 ring and main body taught by Gargac with the brazing methods taught by Juszczyk in order to allow for further treatment of the implant while maintaining mechanical capabilities.
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
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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