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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 January 2026 have been entered. Claim 21 is new. Claims 1-14 and 16-21 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 is amended to state “the bearing component to slide about linearly in two or more non-parallel directions”. This amendment introduces new matter that is not supported by Applicant’s disclosure. Applicant’s current specification only states that the bearing component “slide[s] about” the bearing surface, but mentions no other directional limitations. Applicant’s current Drawings present the bearing surface as convex or concave, i.e., having a curve or angle forming the surface. Any movement of the bearing component about the bearing surface would therefore technically not be linear. Further, since there is no clear support for this amendment it is unclear to Examiner if there is another intended meaning by this amendment. Regardless, without clear support the amendment is considered new matter. Claims 2-14 and 16-20 are rejected by dependency.
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 1-14 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Terrill et al. (US 2021/030552 A1), “Terrill” in view of Alain et al. (FR 2825263), “Alain”.
Regarding claim 1, Terrill teaches a glenoid implant system (Fig. 15, glenoid implant 2100) comprising: a tray component (Fig. 15, base component 2300) that comprises a bone-facing surface (Fig. 15, bottom of base component 2300 engaging with fixation members 2400) and a bearing-facing surface on opposite side of the bone-facing surface (Fig. 16, top of base component 2300 opposite fixation members 2400); and a bearing component (Fig. 15, bearing component 2200) that comprises an articulating surface that is concave or convex (Figs. 2 and 14, bearing component 2200 (similar to bearing component 200 [0047]) comprises bearing surface 202 which is concave [0032]) and a back side on opposite side of the articulating surface that is concave or convex (Figs. 3 and 14, bearing component 2200 (similar to bearing component 200 [0047]) comprises bone-contacting surface 204), wherein the articulating surface (Fig. 2, bearing surface 202) is configured for engaging a convex humeral head (Fig. 2, bearing surface 202 allows a humeral head to articulate against it [0032]) and the back side (Fig. 3, bone-contacting surface 204) is configured for engaging the bearing-facing surface of the tray component (Fig. 15, bone-contacting surface 204 engages with top of base component 2300 opposite fixation members 2400), but fails to teach enabling the bearing component to slide about in two or more non-parallel directions on the tray component while the convex humeral head articulates against the articulating surface.
Alain teaches a shoulder joint prosthesis enabling the bearing component to slide about linearly in two or more non-parallel directions on the tray component (Fig. 3B, movable plate 24 moves in any direction within a clearance between base 20 and said plate 24) while the convex humeral head articulates against the articulating surface (Fig. 1, support surface 26 of plate 24 articulates with head of humerus 12) and wherein the glenoid implant system further comprises a motion limiting feature that partially limits a range of motion of the bearing component sliding about the bearing-facing surface of the tray component linearly in the two or more non-parallel directions (Fig. 3B, bearing surface 32 of base 20 comprises rim 36 which creates a clearance which allows relative movement in any direction between the plate 24 and base 20). Alain discloses that the relative movement between the base and plate allows for a significant reduction in the shearing forces generated by the movement of the head of the humerus on the articulating surface (pg. 5, par. 2). 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 tray component and bearing component taught by Terrill to comprise the clearance, rim, and extending part of the plate taught by Alain which allow for relative movement between the two components in order to reduce the shearing forces acting upon the implant during its use and prolong the life of the implant.
Regarding claim 2, Terrill teaches wherein the tray component (Fig. 15, base component 2300) is formed of a metal (Fig. 15, base component 2300 is formed of metal [0007]).
Regarding claim 3, Terrill teaches wherein the bearing component (Fig. 15, bearing component 2200) is formed of a high-modulus polymer (Fig. 15, bearing component 2200 is formed of a polymer such as ultra-high-molecular-weight polyethylene (UHMWPE) [0032]).
Regarding claim 4, Terrill teaches wherein the bearing component (Fig. 15, bearing component 2200) is formed of high-modulus polyethylene (HMPE) or ultra-high-molecular-weight polyethylene (UHMWPE) (Fig. 15, bearing component 2200 is formed of a polymer such as ultra-high-molecular-weight polyethylene (UHMWPE) [0032]).
Regarding claim 5, Terrill teaches wherein the bone-facing surface of the tray component (Fig. 15, bottom of base component 2300 engaging with fixation members 2400) comprises at least a portion that comprises a layer of a porous material that can promote bone in-growth (Fig. 15, base component 2300 (similar to base component 300 [0048]) includes porous metal to enhance bone growth [0036]).
Regarding claim 6, Terrill teaches wherein the bone-facing surface of the tray component (Fig. 15, bottom of base component 2300 engaging with fixation members 2400) comprises at least a portion that has a roughened surface that can accept bone cement for bonding with native bone (Fig. 17, base component 2300 comprises splaying member 2352 which include frictional engagement features 2354 (i.e., rough/textured surface) [0048]).
Regarding claim 7, Terrill teaches wherein the bone-facing surface (Fig. 15, bottom of base component 2300 engaging with fixation members 2400) further comprises one or more peripheral fixation features extending therefrom in a direction that is away from the bearing-facing surface (Fig. 15, base component 2300 comprises fixation members 2400 which extend away from top of base component 2300).
Regarding claim 8, Terrill teaches wherein the one or more peripheral fixation features is an annular ring (Fig. 3, circular rim 208 assists in mating to base 300 (base 2300) [0034]).
Regarding claim 9, Terrill teaches wherein the annular ring is configured into two or more segments (Fig. 3, circular rim 208 is formed in four semi-circular protrusions [0034]).
Regarding claim 10, Terrill teaches wherein the one or more peripheral fixation features are posts (Fig. 15, fixation members 2400 (similar to fixation members 400 [0047]) comprise threaded shaft (i.e., post) [0040]).
Regarding claim 11, Terrill teaches wherein the one or more peripheral fixation features further comprise one or more posts (Fig. 15, fixation members 2400 (similar to fixation members 400 [0047]) comprise threaded shaft (i.e., post) [0040]).
Regarding claim 12, Terrill teaches wherein the one or more posts extend from the annular ring (Fig. 15, fixation members 2400 extend from base component 2300 which is mated to bearing component 2200 by circular rim 208).
Regarding claim 13, Terrill teaches wherein the one or more peripheral fixation features (Fig. 15, fixation members 2400) comprise a layer of a porous material that can promote bone in-growth (Fig. 15, base component 300 (similar to base component 2300 which comprises fixation members 2400) is provided with enhanced bone ingrowth surfaces on all portions of the base component that contact bone [0036]).
Regarding claim 14, Terrill teaches wherein the back side of the bearing component (Figs. 3 and 14, bearing component 2200 (similar to bearing component 200 [0047]) comprises bone-contacting surface 204) is a spherical surface having a curvature defined by a first radius of curvature (Figs. 3 and 14, bearing component 2200 (similar to bearing component 200 [0047]) comprises bone-contacting surface 204).
Regarding claim 17, Terrill teaches the bearing-facing surface (Fig. 16, top of base component 2300 opposite fixation members 2400) and the bone-facing surface (Fig. 15, bottom of base component 2300 engaging with fixation members 2400), but fails to teach the motion limiting feature.
Alain teaches a shoulder joint prosthesis wherein the motion limiting feature comprises a continuous ridge that extends along the bearing-facing surface’s perimeter and is raised from the bearing-facing surface away from the bone-facing surface (Fig. 3B, rim 36 extends from and around second bearing surface 32 of base 20 and away from first bearing surface 30 of base 20). Alain discloses that the relative movement between the base and plate allows for a significant reduction in the shearing forces generated by the movement of the head of the humerus on the articulating surface (pg. 5, par. 2). 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 tray component and bearing component taught by Terrill to comprise the motion limiting feature taught by Alain which allows for relative movement between the two components in order to reduce the shearing forces acting upon the implant during its use and prolong the life of the implant. However, Terrill in view of Alain fails to teach radii of curvature.
Regarding claim 18, Terrill teaches the bearing-facing surface (Fig. 16, top of base component 2300 opposite fixation members 2400) and bone-facing surface (Fig. 15, bottom of base component 2300 engaging with fixation members 2400), but fails to teach the motion limiting feature.
Alain teaches a shoulder joint prosthesis wherein the motion limiting feature comprises a continuous ridge that extends along the bearing-facing surface’s perimeter and is raised from the bearing-facing surface away from the bone-facing surface (Fig. 3B, rim 36 extends from and around second bearing surface 32 of base 20 and away from first bearing surface 30 of base 20). Alain discloses that the relative movement between the base and plate allows for a significant reduction in the shearing forces generated by the movement of the head of the humerus on the articulating surface (pg. 5, par. 2). 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 tray component and bearing component taught by Terrill to comprise the motion limiting feature taught by Alain which allows for relative movement between the two components in order to reduce the shearing forces acting upon the implant during its use and prolong the life of the implant. However, Terrill in view of Alain fails to teach radii of curvature.
Terrill in view of Alain discloses the claimed invention except for two or more ridge segments. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to separate the perimeters forming the motion limiting feature into segments, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. MPEP 2144.04 (V-C).
Regarding claim 19, Terrill teaches the bearing component (Fig. 15, bearing component 2200), the tray component (Fig. 15, base component 2300), and the bearing-facing surface (Fig. 16, top of base component 2300 opposite fixation members 2400), but fails to teach the motion limiting feature.
Alain teaches a shoulder joint prosthesis wherein the motion limiting feature comprises a boss provided on the back side of the bearing component (Fig. 3B, plate 24 comprises part 40 extending from the underside) and a pocket provided on the bearing-facing surface of the tray component (Fig. 3B, base 20 comprises a clearance between rim 36 and part 40 of plate 24), wherein the pocket has an opening that is larger than the boss (Fig. 3B, base 20 comprises rim 36 which further comprises return 44 that is fitted within the clearance; groove 42 comprises additional clearance even when fitted with part 40 of plate 24). Alain discloses that the relative movement between the base and plate allows for a significant reduction in the shearing forces generated by the movement of the head of the humerus on the articulating surface (pg. 5, par. 2). 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 tray component and bearing component taught by Terrill to comprise the clearance, rim, and extending part of the plate taught by Alain which allow for relative movement between the two components in order to reduce the shearing forces acting upon the implant during its use and prolong the life of the implant.
Regarding claim 20, Terrill teaches the bearing-facing surface of the tray component (Fig. 16, top of base component 2300 opposite fixation members 2400) and the bearing component (Fig. 15, bearing component 2200), but fails to teach the motion limiting feature.
Alain teaches a shoulder prosthesis wherein the motion limiting feature comprises a pocket provided on the back side of the bearing component (Fig. 3B, plate 24 comprises groove 42 on the underside which mates with rim 36) and a boss provided on the bearing-facing surface of the tray component, wherein the pocket has an opening that is larger than the boss (Fig. 3B, base 20 comprises rim 36 which further comprises return 44 that is fitted with groove 42 of plate 24; groove 42 comprises additional clearance even when fitted with part 40 of plate 24). Alain discloses that the relative movement between the base and plate allows for a significant reduction in the shearing forces generated by the movement of the head of the humerus on the articulating surface (pg. 5, par. 2). 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 tray component and bearing component taught by Terrill to comprise the clearance, rim, and extending part of the plate taught by Alain which allow for relative movement between the two components in order to reduce the shearing forces acting upon the implant during its use and prolong the life of the implant.
Regarding claim 21, Terrill teaches a glenoid implant system (Fig. 15, glenoid implant 2100) comprising: a tray component (Fig. 15, base component 2300) that comprises a bone-facing surface (Fig. 15, bottom of base component 2300 engaging with fixation members 2400) and a bearing-facing surface on opposite side of the bone-facing surface (Fig. 16, top of base component 2300 opposite fixation members 2400); and a bearing component (Fig. 15, bearing component 2200) that comprises an articulating surface that is concave or convex (Figs. 2 and 14, bearing component 2200 (similar to bearing component 200 [0047]) comprises bearing surface 202 which is concave [0032]) and a back side on opposite side of the articulating surface that is concave or convex (Figs. 3 and 14, bearing component 2200 (similar to bearing component 200 [0047]) comprises bone-contacting surface 204), wherein the articulating surface (Fig. 2, bearing surface 202) is configured for engaging a convex humeral head (Fig. 2, bearing surface 202 allows a humeral head to articulate against it [0032]) and the back side (Fig. 3, bone-contacting surface 204) is configured for engaging the bearing-facing surface of the tray component (Fig. 15, bone-contacting surface 204 engages with top of base component 2300 opposite fixation members 2400), but fails to teach enabling the bearing component to slide about in two or more non-parallel directions on the tray component while the convex humeral head articulates against the articulating surface, and wherein the glenoid implant system further comprises a motion limiting feature that limits a range of motion of the bearing component sliding about the bearing-facing surface of the tray component, the motion limiting feature comprising a pocket provided on the back side of the bearing component and a boss provided on the bearing-facing surface of the tray component, wherein the pocket has an opening that is larger than the boss.
Alain teaches a shoulder joint prosthesis enabling the bearing component to slide about linearly in two or more non-parallel directions on the tray component (Fig. 3B, movable plate 24 moves in any direction within a clearance between base 20 and said plate 24) while the convex humeral head articulates against the articulating surface (Fig. 1, support surface 26 of plate 24 articulates with head of humerus 12) and wherein the glenoid implant system further comprises a motion limiting feature that partially limits a range of motion of the bearing component sliding about the bearing-facing surface of the tray component linearly in the two or more non-parallel directions (Fig. 3B, bearing surface 32 of base 20 comprises rim 36 which creates a clearance which allows relative movement in any direction between the plate 24 and base 20), the motion limiting feature comprising a pocket provided on the back side of the bearing component (Fig. 3B, plate 24 comprises groove 42 on the underside which mates with rim 36) and a boss provided on the bearing-facing surface of the tray component, wherein the pocket has an opening that is larger than the boss (Fig. 3B, base 20 comprises rim 36 which further comprises return 44 that is fitted with groove 42 of plate 24; groove 42 comprises additional clearance even when fitted with part 40 of plate 24). Alain discloses that the relative movement between the base and plate allows for a significant reduction in the shearing forces generated by the movement of the head of the humerus on the articulating surface (pg. 5, par. 2). 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 tray component and bearing component taught by Terrill to comprise the clearance, rim, and extending part of the plate taught by Alain which allow for relative movement between the two components in order to reduce the shearing forces acting upon the implant during its use and prolong the life of the implant.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Terrill et al. (US 2021/030552 A1), “Terrill” in view of Alain et al. (FR 2825263), “Alain”, and further in view of Perego et al. (US 2020/214846 A1), “Perego”.
Regarding claim 16, Terrill teaches the bearing-facing surface (Fig. 16, top of base component 2300 opposite fixation members 2400), but fails to teach the motion limiting feature.
Alain teaches a shoulder joint prosthesis comprising a motion limiting feature (Fig. 3B, bearing surface 32 of base 20 comprises rim 36 which creates a clearance which allows relative movement in any direction between the plate 24 and base 20). Alain discloses that the relative movement between the base and plate allows for a significant reduction in the shearing forces generated by the movement of the head of the humerus on the articulating surface (pg. 5, par. 2). 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 tray component and bearing component taught by Terrill to comprise the motion limiting feature taught by Alain which allows for relative movement between the two components in order to reduce the shearing forces acting upon the implant during its use and prolong the life of the implant. However, Terrill in view of Alain fails to teach radii of curvature.
Perego teaches a shoulder prosthesis wherein the bearing-facing surface (Fig. 9a) being defined by more than one radii of curvature (Fig. 8b, glenoid insert 16 comprises two curvatures [0158]) wherein the bearing-facing surface (Fig. 9a) comprises: a central region that is a spherical surface having a curvature defined by the first radius of curvature (Fig. 17a, second radius RA-P); and a peripheral portion that is a spherical surface having a curvature defined by a second radius of curvature that is smaller (Fig. 17a, curvature profile 163 and curvature profile 164 are different (i.e., smaller or larger in size) [0158-0160]) than the first radius of curvature (Fig. 17a, first radius RI-S). Perego discloses that the two radiuses on the glenoid side allow for improved stability and articulation of the shoulder joint [0160]. 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 bearing-facing surface taught by Terrill with the radii of curvature taught by Perego in order to improve the stability and articulation of the shoulder joint.
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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