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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 March 2026 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 13 March 2026 have been entered. Claims 19-38 are pending.
Response to Arguments
Applicant’s arguments with respect to claim 19 have been considered but are moot because the new ground of rejection does not rely on any reference 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 “inner edge” 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: Amended claim 1 refers to an “inner edge” that is not referenced in the specification.
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 19-29 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 2010/0125336 A1), “Johnson” in view of Kovacs et al. (US 2016/0045323 A1), “Kovacs” and further in view of Hodorek et al. (WO 2020/056419 A1), “Hodorek”.
Regarding claim 19, Johnson teaches a glenoid component (Fig. 9A, mounting member 130) for shoulder prosthesis (Fig. 1A), comprising: a glenoid coupling surface (Fig. 9B, base 123), for fixing to a bone (Fig. 9B, base 123 contacts and engages with scapula via mounting projection 129 [0085]) and comprising a first convex portion (Fig. 9A, mounting member 130 has convex surface [0085]) having a first outer edge (Fig. 9B, back edge 127) which defines a development plane (Fig. 9B, plane of base 123); a prosthetic coupling surface (Fig. 9A, top 128), opposite said glenoid coupling surface (Fig. 9B, base 123) for housing a second prosthetic component (Fig. 9A, top 128 comprises screw hole 143 which houses central screw (not shown)) of said shoulder prosthesis (Fig. 1A), said prosthetic coupling surface (Fig. 9A, top 128) comprising a second portion (Fig. 9A, top 128 and sidewalls 121 (opposite side of mounting member 130)) having a second outer edge (Fig. 9A, edge formed where top 128 and sidewalls 121 meet) which defines a reference plane (Fig. 9A, plane of top 128); a truncated cone-shaped glenoid coupling element (Fig. 9B, mounting projection 129 has chamfered edge 133 (i.e., mimics a truncated cone shape)), projecting from said glenoid coupling surface (Fig. 9B, base 123) and for coupling to a bone pin (Fig. 9A, mounting projection comprises screw hole 143 which extends through for a central screw (not shown) [0087]) of said shoulder prosthesis (Fig. 1), said glenoid coupling element (Fig. 9B, mounting projection 129) developing along an axis (Fig. 9C, longitudinal axis 122) which is perpendicular to said reference plane (Fig. 9C, longitudinal axis 122 is perpendicular to plane of top 128),; wherein said glenoid component (Fig. 9A, mounting member 130) provides a predetermined offset (Fig. 9A-B, distance between plane of base 123 and plane of top 128) between said development plane (Fig. 9B, plane of base 123) and said reference plane (Fig. 9A, plane of top 128), wherein said predetermined offset (Fig. 9A-B, distance between plane of base 123 and plane of top 128) is configured to vary a longitudinal distance along the perimeters of said first outer edge (Fig. 9B, back edge 127) and of said second outer edge (Fig. 9A, edge formed where top 128 and sidewalls 121 meet), wherein said first outer edge (Fig. 9B, back edge 127) of said glenoid coupling surface (Fig. 9B, base 123) is circular (Fig. 9B, back edge 127 forms a circle), and wherein said second outer edge (Fig. 9A, edge formed where top 128 and sidewalls 121 meet) of said prosthetic coupling surface (Fig. 9A, top 128) is circular (Fig. 9A, top 128 has edge which is circular), so as to allow an orientation of the glenoid component in a continuous way, covering all types of bone defects over 360° (Fig. 1B, scapula component 1 is mounted in the glenoid cavity on the patient’s scapula 8 [0062]), but fails to teach an angle between said development plane and said reference plane, said predetermined offset defining an increased thickness of said glenoid component for compensating a bone deficit, an inner edge which defines a circular recess, and wherein said glenoid coupling element is located within the circular recess such that the a gap exists between said first convex portion and said glenoid coupling element.
Kovacs teaches a glenoid implant comprising an angle between said development plane and said reference plane (Fig. 2A, implant 10 comprises surface 26 that is sloped to define an angle α between the articular side 20 (i.e., reference plane) and bone-engaging side 22 (i.e., development plane) [0054]), said predetermined offset defining an increased thickness of said glenoid component for compensating a bone deficit (Fig. 2A, angle α may be between zero degrees and thirty degrees and depth X may vary [0054] (i.e., component angle may vary based on bone deficit)). Kovacs discloses that this glenoid implant can replace or replicate an entire glenoid cavity or a portion thereof for shoulder joint replacements or fill a defect in the glenoid cavity due to severe wear [0049]. Therefore, it would have been obvious to one of ordinary skill in the art to combine the implant taught by Johnson with the sloped surface taught by Kovacs in order to replace various wear states of the glenoid cavity. However, Johnson in view of Kovacs fails to teach a circular recess, and wherein said glenoid coupling element is located within the circular recess such that a gap exists between said first convex portion and said glenoid coupling element.
Hodorek teaches a glenoid implant comprising an inner edge which defines a circular recess (Fig. 12, intermediate ring portion 204 defines fins 220 which creates circular recessed area 224), and wherein said glenoid coupling element is located within the circular recess (Fig. 12, post portion 206 is within circular recessed region 224) such that a gap exists between said first convex portion and said glenoid coupling element (Fig. 12, circular recessed portion 224 creates gap between tapered lower surface 210 and post portion 206). Hodorek discloses that the lower surface of the implant is configured to fit with the smooth surface of the glenoid cavity of the scapula [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 glenoid component taught by Johnson in view of Kovacs with the circular recess, first convex portion and gap taught by Hodorek in order to best fit the resected bone surface of the patient.
Regarding claim 20, Johnson fails to teach the limitations of claim 20. Kovacs teaches a glenoid implant wherein said angle is comprised between 2° and 30° (Fig. 2A, angle α may be between zero degrees and thirty degrees [0054]). Kovacs discloses that this glenoid implant can replace or replicate an entire glenoid cavity or a portion thereof for shoulder joint replacements or fill a defect in the glenoid cavity due to severe wear [0049]. Therefore, it would have been obvious to one of ordinary skill in the art to combine the implant taught by Johnson with the sloped surface taught by Kovacs in order to replace various wear states of the glenoid cavity.
Regarding claim 21, Johnson fails to teach the limitations of claim 21. Kovacs teaches a glenoid implant wherein said angle is comprised between 5° and 25° (Fig. 2A, angle α may be between zero degrees and thirty degrees [0054]). Kovacs discloses that this glenoid implant can replace or replicate an entire glenoid cavity or a portion thereof for shoulder joint replacements or fill a defect in the glenoid cavity due to severe wear [0049]. Therefore, it would have been obvious to one of ordinary skill in the art to combine the implant taught by Johnson with the sloped surface taught by Kovacs in order to replace various wear states of the glenoid cavity.
Regarding claim 22, Johnson fails to teach the limitations of claim 22. Kovacs teaches a glenoid implant wherein said angle is available with increases by 5° (Fig. 2A, angle α may be between zero degrees and thirty degrees and depth X may vary [0054] (i.e., component angle may vary based on bone deficit)). Kovacs discloses that this glenoid implant can replace or replicate an entire glenoid cavity or a portion thereof for shoulder joint replacements or fill a defect in the glenoid cavity due to severe wear [0049]. Therefore, it would have been obvious to one of ordinary skill in the art to combine the implant taught by Johnson with the sloped surface taught by Kovacs in order to replace various wear states of the glenoid cavity.
Regarding claim 23, Johnson teaches wherein said first convex portion (Fig. 9A, mounting member 130 has convex surface [0085]) provides a constant curvature radius (Fig. 9A, sidewalls 121 of mounting member 130 create a constant curvature).
Regarding claim 24, Johnson teaches wherein said second portion (Fig. 9A, top 128 and sidewalls 121 (opposite side of mounting member 130)) is concave (Fig. 9A, top 128 is concave [0085]).
Regarding claim 25, Johnson teaches wherein said constant curvature radius (Fig. 9A, sidewalls 121 of mounting member 130 create a constant curvature) is comprised between 25 and 35 mm (radius of curvature of spherical surface is between 10mm and 30mm [0026]).
Regarding claim 26, Johnson teaches wherein said constant curvature radius (Fig. 9A, sidewalls 121 of mounting member 130 create a constant curvature) is comprised between 27 and 30 mm (radius of curvature of spherical surface is between 10mm and 30mm [0026]).
Regarding claim 27, Johnson teaches further comprising at least two holes (Fig. 9A, four screw recesses 137) for receiving fixing screws (Fig. 9C, screw recesses and holes 139 receive screws 141) of said glenoid component (Fig. 9A, mounting member 130) of said shoulder prosthesis (Fig. 1A).
Regarding claim 29, Johnson teaches said predetermined offset (Fig. 9A-B, distance between plane of base 123 and plane of top 128) comprises a first offset (Modified Fig. 9C below, first offset) at said at least two holes (Fig. 9A, four screw recesses 137), and second offset (Modified Fig. 9C below, second offset) at a glenoid coupling element (Fig. 9B, mounting projection 129).
Regarding claim 37, Johnson teaches a shoulder prosthesis (Fig. 1A) comprising: a glenoid component (Fig. 9A, mounting member 130) according to claim 19; at least one second prosthetic component (Fig. 9A, top 128 comprises screw hole 143 which houses central screw (not shown)) connected to said glenoid component (Fig. 9A, mounting member 130).
Regarding claim 38, Johnson in view of Kovacs fails to teach the limitations of claim 28. Angibaud teaches an adjustable reverse shoulder prosthesis wherein said at least two holes are in connection with said circular recess (Fig. 6A, glenoid plate holes 122 are in contact with circular ring that engages with locking ring 130). Angibaud discloses that the screws engage with locking ring 130 to secure them and prevent the screws from backing out [0047]. 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 device taught by Johnson in view of Kovacs to include the locking screws taught by Angibaud in order to secure the screws in place upon implantation of the prosthesis.
Claims 28 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 2010/0125336 A1), “Johnson” in view of Kovacs et al. (US 2016/0045323 A1), “Kovacs” and Hodorek et al. (WO 2020/056419 A1), “Hodorek” and further in view of Angibaud et al. (US 2012/0209392 A1), “Angibaud”.
Regarding claim 28, Johnson teaches wherein said at least two holes (Fig. 9A, four screw recesses 137), but Johnson in view of Kovacs and Hodorek fails to teach housing respective angular locking screws.
Angibaud teaches an adjustable reverse shoulder prosthesis having an angular locking screw (Fig. 8B, polyaxial compression screws 114). Angibaud discloses that the screws engage with locking ring 130 to secure them and prevent the screws from backing out [0047]. 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 device taught by Johnson in view of Kovacs to include the locking screws taught by Angibaud in order to secure the screws in place upon implantation of the prosthesis.
Regarding claim 38, Johnson in view of Kovacs fails to teach the limitations of claim 28. Angibaud teaches an adjustable reverse shoulder prosthesis wherein said at least two holes are in connection with said circular recess (Fig. 6A, glenoid plate holes 122 are in contact with circular ring that engages with locking ring 130). Angibaud discloses that the screws engage with locking ring 130 to secure them and prevent the screws from backing out [0047]. 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 device taught by Johnson in view of Kovacs to include the locking screws taught by Angibaud in order to secure the screws in place upon implantation of the prosthesis.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 2010/0125336 A1), “Johnson” in view of Kovacs et al. (US 2016/0045323 A1), “Kovacs” and Hodorek et al. (WO 2020/056419 A1), “Hodorek” and further in view of Gargac et al. (US 2015/80305877 A1), “Gargac”.
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Modified Figure 9C
Regarding claim 30, Johnson teaches said first offset (Modified Fig. 9C above, first offset), but Johnson in view of Kovacs and Hodorek fails to teach a first threaded portion for housing a peripherally threaded closure element. Gargac teaches a reverse shoulder system having a first threaded portion for housing a peripherally threaded closure element (Fig. 4, internal threaded surface 252). Gargac discloses that internal threaded surface mates with an external threaded surface [0062]. 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 device taught by Johnson in view of Kovacs and Angibaud with the threading portions taught by Gargac in order to secure different pieces of the prosthesis together upon implantation.
Regarding claim 31, Johnson teaches said second offset (Modified Fig. 9C above, second offset), but Johnson in view of Kovacs and Hodorek fails to teach a second threaded portion for housing a head of a respective angular locking screw. Gargac teaches a reverse shoulder system having a second threaded portion for housing a head of a respective angular locking screw (Fig. 4, external threaded surface 272). Gargac discloses that internal threaded surface mates with an external threaded surface [0062]. 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 device taught by Johnson in view of Kovacs and Angibaud with the threading portions taught by Gargac in order to secure different pieces of the prosthesis together upon implantation.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 2010/0125336 A1), “Johnson” in view of Kovacs et al. (US 2016/0045323 A1), “Kovacs” and further in view of Gargac et al. (US 2015/80305877 A1), “Gargac”.
Regarding claim 32, Johnson teaches said glenoid coupling surface (Fig. 9B, base 123) and said glenoid component (Fig. 9A, mounting member 130), but Johnson in view of Kovacs fails to teach a trabecular porous structure for increasing stability and osteo-integration. Gargac teaches a reverse shoulder prosthesis comprising a trabecular porous structure for increasing stability and osteo-integration (Fig. 7D, porous material 304). Gargac discloses that the porous material promotes bony ingrowth wherein bone material can grow into the pores of the device [0073]. 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 device taught by Johnson in view of Kovacs with the porous material taught by Gargac in order to promote bone ingrowth and fast healing upon implantation of the device.
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 2010/0125336 A1), “Johnson” in view of Kovacs et al. (US 2016/0045323 A1), “Kovacs” and further in view of Winslow et al. (US 2018/0193150 A1), “Winslow”.
Regarding claim 33, Johnson teaches said prosthetic coupling surface (Fig. 9A, top 128), but Johnson in view of Kovacs fails to teach further comprising retentive elements protruding from said prosthetic coupling surface. Winslow teaches adjustable orthopedic connections including protruding retentive elements (Fig. 15, second interlocking portion 372). Winslow discloses that the interlocking portions inhibit rotational motion of the liner within the tray [0088]. 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 device taught by Johnson in view of Kovacs with the retentive elements taught by Winslow in order to limit unnecessary movement and wear of parts of the prosthesis.
Regarding claim 34, Johnson in view of Kovacs fails to teach said retentive elements are configured to house and retain an anatomic liner. Winslow teaches adjustable orthopedic connections including retentive elements (Fig. 15, second interlocking portion 372) that are configured to house and retain an anatomic liner (Fig. 15, liner 314). Winslow discloses that the interlocking portions inhibit rotational motion of the liner within the tray [0088]. 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 device taught by Johnson in view of Kovacs with the retentive elements taught by Winslow in order to limit unnecessary movement and wear of parts of the prosthesis.
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 2010/0125336 A1), “Johnson” in view of Kovacs et al. (US 2016/0045323 A1), “Kovacs” and further in view of Ondrla et al. (US 2006/0069445 A1), “Ondrla”.
Regarding claim 35, Johnson in view of Kovacs fails to teach a set of said glenoid components provides respective different predetermined offsets so as to define a plurality of different standard increased thicknesses for compensating different bone deficits. Ondrla teaches a set of said glenoid components (Fig. 6, shoulder arthroplasty kit 200) provides respective different predetermined offsets so as to define a plurality of different standard increased thicknesses for compensating different bone deficits (Fig. 6, shoulder arthroplasty kit 200 comprises multiple first members 104, 204, humeral heads, glenoid components, etc.). Ondrla discloses that the arthroplasty kit allows for use of different treatment methods while maintaining a common portion of the kit [0032]. 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 device taught by Johnson in view of Kovacs with the kit taught by Ondrla in order to offer a variety of treatment methods that vary from patient to patient.
Regarding claim 36, Johnson in view of Kovacs fails to teach each glenoid component of said set providing a respective predetermined offset, so as to define a plurality of standard increased thicknesses for compensating different bone deficits. Ondrla teaches each glenoid component of said set (Fig. 6, first members 104, 204, humeral heads, glenoid components, etc.) providing a respective predetermined offset, so as to define a plurality of standard increased thicknesses for compensating different bone deficits (Fig. 6, first members 104, 204, humeral heads, and glenoid components have varied angle offsets). Ondrla discloses that the shoulder kit allows for treatment of various rotator cuff injuries as conservatively as possible [0028-0029]. 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 device taught by Johnson in view of Kovacs with the kit taught by Ondrla in order to treat glenoid issues as conservatively as possible by providing various implant sizes or pieces.
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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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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