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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 February 2026 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 23 February 2026 have been entered. Claims 3 and 10 are cancelled. Claims 13-14 are new. Claims 1-2, 4-5, 7-9, and 11-14 are pending.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “clamping screw” of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 1 refers to a “clamping screw” that is not referenced in the specification.
Claim Objections
Claim 14 is objected to because of the following informalities: claim 14 states “the added ring being slit so can expand as the tightening screw is inserted” in lines 14-15 rather than “the added ring being slit so it can expand as the tightening screw is inserted”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-5, 7-9, and 11-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the attached ring" in line 13. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends amending this limitation to state the previously claimed “added ring”, rather than stating “attached ring”. Claims 2, 4-5, 7-9, and 11-12 are rejected by dependency.
Claim 1 recites the limitation “the clamping screw” in line 17. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the “clamping screw” and “tightening screw” are the same feature or two different components of the device. Further clarification is required. Claims 2, 4-5, 7-9, and 11-12 are rejected by dependency.
Claim 14 recites the limitation “the inserted ring” in line 14. There is insufficient antecedent basis for the limitation in the claim. It is unclear if the “inserted ring” and “added ring” are the same feature or two different components of the device. Further clarification is required.
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 Termanini (US 2021/0386561 A1), “Termanini”, and further 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), wherein the at least one added ring traps 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 wherein the attached ring comprises a clipping device to the main body, the clipping device comprises teeth having ends with fins which together form a groove, and a tab formed within a recess of the main body whose shape allows it to receive the groove formed by the teeth to allow the clipping of the attached ring, the fins being elastically deformable upon the passage of the clamping screw by bearing uniformly against an inner face of the recess of the main body, and the main body and joint outer surface being made of ceramic.
Termanini teaches total shoulder implant comprising a clipping device to the main body (Fig. 7, base part B comprises locking elements used to engage with head part A [0040]), the clipping device comprises teeth having ends with fins which together form a groove (Fig. 7, locking tabs 8 and circular disc 9 comprise space in between (i.e., groove) and interlock with circular groove 7 [0040]), and a tab formed within a recess of the main body whose shape allows it to receive the groove formed by the teeth to allow the clipping of the attached ring (Fig. 7, head part A comprises recessed circular groove 7 that mates with locking tabs 8 [0040]), the fins being elastically deformable upon the passage of the clamping screw by bearing uniformly against an inner face of the recess of the main body (Fig. 7, locking tabs 8 are deformable or bendable to provide a snap-fit between base part B and head part A of the implant [0040]). Termanini teaches that the locking elements provide a “snap-fit” that securely attaches the base with the head, forming a complete implantable humeral component [0040]. 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 added ring taught by Gargac with the clipping device taught by Termanini in order to more securely connect the components of the implant together to form a single implant for insertion. However, Gargac in view of Termanini fails to teach the main body and joint outer surface are 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 4, Gargac teaches wherein the added ring (Fig. 4, threaded member 264) comprises elastically a deformable peripheral device (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 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 Termanini (US 2021/0386561 A1), “Termanini”, 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 Gargac in view of Termanini and Cardon 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 Termanini (US 2021/0386561 A1), “Termanini”, 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 Gargac in view of Termanini and Cardon 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.
Claims 13-14 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 13, Gargac teaches a joint prosthesis implant (Fig. 4, glenoid implant 100) comprising: a main body (Fig. 4, glenosphere 116) and 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 in the main body (Fig. 4, threaded member 264) and forming with it a chamber (Fig. 4, internal cavity 292) trapping the head of the tightening screw (Fig. 4, proximal head 276 of 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 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 being configured to distribute homogeneously in the main body the mechanical stresses caused by tightening the tightening screw (col. 10-11, lines 53-4), but fails to teach the main body and joint outer surface are made of ceramic, and wherein the added ring comprises an elastically deformable peripheral device configured to deform as the tightening screw is inserted.
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)), and wherein the added ring comprises an elastically deformable peripheral device configured to deform as the tightening screw is inserted (Fig. 1, intermediate part 23 includes flanges 23.2 that are elastically deformable and engage with platform 20 due to forces from engaging locking member 50 (col. 6, par. 4)). Cardon discloses that the flanges axially interfere to prevent translation along the assembly axis in an axial direction in which the platform and articular component move away from one another (col. 2, lines 54-57). 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 added ring taught by Gargac with the ceramic material and peripheral device taught by Cardon in order to prevent separation of the implant components.
Regarding claim 14, Gargac teaches a joint prosthesis implant (Fig. 4, glenoid implant 100) comprising: a main body (Fig. 4, glenosphere 116) and 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 in the main body (Fig. 4, threaded member 264) and forming with it a chamber (Fig. 4, internal cavity 292) trapping the head of the tightening screw (Fig. 4, proximal head 276 of 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 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 being configured to distribute homogeneously in the main body the mechanical stresses caused by tightening the tightening screw (col. 10-11, lines 53-4), but fails to teach the main body and joint outer surface are made of ceramic, and wherein the inserted ring comprises a clipping device to the main body, the added ring being slit so can expand as the tightening screw is inserted.
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)), and wherein the inserted ring comprises a clipping device to the main body (Fig. 1, flanges 23.2), the added ring being slit so can expand as the tightening screw is inserted (Fig. 1, intermediate part 23 includes flanges 23.2 that form openings (i.e., slits) and are elastically deformable to engage with platform 20 due to forces from engaging locking member 50 (col. 6, par. 4)). Cardon discloses that the flanges axially interfere to prevent translation along the assembly axis in an axial direction in which the platform and articular component move away from one another (col. 2, lines 54-57). 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 added ring taught by Gargac with the ceramic material and clipping device taught by Cardon in order to prevent separation of the implant components.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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