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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 2026 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 13 January 2026 have been entered. Claims 24-27 are new. Claims 15-16 are cancelled. Claims 1-6, 8, and 17-27 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 15 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 § 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 1-6, 10-19, and 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (US 2014/0257495 A1), “Goldberg” in view of Winslow et al. (US 2011/0035013 A1), “Winslow” and further in view of Goldberg et al. (US 2017/0319348 A1), “Goldberg 348”.
Regarding claim 1, Goldberg teaches a replacement member for a shoulder joint replacement (Fig. 1A, glenoid component 100) comprising: an attachment face (Fig. 1C, bone-facing surface 106) on one side of the member, a concave joint surface (Fig. 2C, lateral articular surface 104) on a side of the replacement member opposite to the side of the attachment face (Fig. 2C, surface 104 is opposite to surface 106), and a circumferential face (Fig. 1B, peripheral wall 108) connecting the attachment face and the joint surface (Fig. 1B, peripheral wall 108 connects to both surfaces 104 and 106), wherein a portion of the concave joint surface (Fig. 2C, lateral articular surface 104) is connected to the circumferential face (Fig. 1B, peripheral wall 108) via a chamfered or rounded edge (Fig. 2C, inferior chamfer 130 connects peripheral wall 108 and surface 104 on one end of the implant) extending between the concave joint surface and the circumferential face (Fig. 2C, inferior chamfer 130 is placed between the lateral articular surface 104 and the peripheral wall 108 below), but fails to teach wherein the attachment face comprises a plurality of cylindrical protrusions.
Winslow teaches a glenoid component wherein the attachment face (Fig. 4A, coupling side 26) comprises a plurality of cylindrical protrusions (Fig. 4A, flanges 31 and central stem coupling mechanism 34), wherein the plurality of cylindrical protrusions comprise a first cylindrical protrusion (Fig. 4A, central stem coupling mechanism 34 further comprising central fixation stem 48 (Fig. 18B)) and at least three second cylindrical protrusions (Fig. 4A, flanges 31), wherein the first cylindrical protrusion comprises at least one annular recess (Fig. 4A, threaded aperture 36 comprises recesses/grooves from threading), wherein a first of the at least three second cylindrical protrusions is located in a cranial direction from the first cylindrical protrusion (Fig. 4A, flange 31 nearest top of glenoid prosthetic 20, above central stem coupling mechanism 34) and wherein both a second of the at least three second cylindrical protrusions and a third of the at least three second cylindrical protrusions are located in a caudal direction from the first cylindrical protrusion (Fig. 4A, flanges 31 nearest bottom of glenoid prosthetic 20, below central stem coupling mechanism 34). Winslow discloses that having multiple protrusions for anchoring the glenoid component increases its stability and security in the body [0005-0007]. 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 replacement member taught by Goldberg with the cylindrical protrusions taught by Winslow in order to increase stability of the implant when positioned in the glenoid fossa.
However, Goldberg in view of Winslow fails to teach at least one partial recess. Goldberg 348 teaches a glenoid component having protrusions (Fig. 12B, anchoring elements 3438, 3440) that each comprise at least one partial recess directed in a radial direction away from the first protrusion (Fig. 12D, anchoring elements 3438, 3440 comprise grooves 3462 which angle away from anchoring element 3442). Goldberg ‘348 teaches that the grooves are oriented to resist forces acting perpendicular to the back side of the glenoid component [0279]. 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 second cylindrical protrusions taught by Goldberg in view of Winslow to reflect the partial recess taught by Goldberg 348 in order to increase implant resistance to external forces after implantation.
Regarding claim 2, Goldberg teaches wherein the chamfered or rounded edge (Fig. 2C, inferior chamfer 130) is configured to be located at an adductive portion of the joint replacement (Fig. 1A, glenoid component 100) when the member is implanted in a body (Fig. 5B shows anterior view of the glenoid component 100).
Regarding claim 3, Goldberg teaches wherein the concave joint surface face (Fig. 2C, lateral articular surface 104) has a curved profile (Fig. 2C, surface 104 is shaped to complement the humeral articular surface and is concave, planar, or convex [0073]), the curved profile being spherical, ellipsoidal, or ovoid shaped (Fig. 2C, lateral articular surface 104 is spherical [0073]).
Regarding claim 4, Goldberg teaches wherein the attachment face (Fig. 1C, bone-facing surface 106) is configured to fixedly attach the member to bone tissue or to another replacement member (Fig. 5B, surface 106 attaches to glenoid fossa 4).
Regarding claim 5, Goldberg teaches wherein the member is a glenoid replacement or a humeral replacement (Fig. 1A, glenoid component 100).
Regarding claim 6, Goldberg teaches wherein a section forming the joint surface comprises a composition of Vitamin E and UHMWPE (glenoid component 100 is fabricated from UHMWPE and other biodegradable materials (i.e., Vitamin E) [0116]).
Regarding claim 17, Goldberg teaches further comprising a first edge (Fig. 3B, upper edge of glenoid component 100) that surrounds the joint surface along its entire circumference (Figs. 3A-E, upper edge of glenoid component 100 extends around entire component), and a second edge (Fig. 3B, lower edge of glenoid component 100), the first edge (Fig. 3B, lower edge of glenoid component 100) comprising a first portion (Fig. 3C, upper edge surrounding glenoid component 100 above inferior chamfer 130) and a second portion (Fig. 3C, upper edge surrounding glenoid component 100 along inferior chamfer 130), the second portion connecting the joint surface with the surface of the chamfered or rounded edge (Fig. 3C, upper edge surrounding glenoid component 100 along inferior chamfer 130 connects with lateral articular surface 104), wherein the second portion (Fig. 3C, lower edge surrounding glenoid component 100 along inferior chamfer 130) is parallel to an axis defining the center of the chamfered or rounded edge (Fig. 3B, upper and lower edges of glenoid component 100 are parallel).
Regarding claim 19, Goldberg teaches wherein the chamfered or rounded edge (Fig. 2C, inferior chamfer 130) comprises a width, which tapers towards the two ends (Fig. 2C, width of inferior chamfer 130 surface narrows as it reaches anterior and posterior reliefs 134, 136).
Regarding claim 23, Goldberg teaches wherein the chamfered or rounded edge (Fig. 2C, inferior chamfer 130) extends between two ends (Fig. 2C, anterior relief 134 and posterior relief 136) thereof in a circumferential direction of the concave joint surface (Fig. 2C, inferior chamfer 130 extends across to both sides (anterior to posterior) of lateral articular surface 104), the chamfered or rounded edge (Fig. 2C, inferior chamfer 130) having a length in the circumferential direction (Fig. 2C, outer circumference of inferior chamfer 130) that is shorter than a circumferential length of the circumferential face and of the concave joint surface (Fig. 1A-B, peripheral wall 108 of lateral articular surface 104 extends around body 102 [0071] (i.e., is longer than inferior chamfer circumferential length)), wherein the chamfered or rounded edge (Fig. 2C, inferior chamfer 130) comprising a maximum width between the two ends (Fig. 3E, largest width of inferior chamfer 130 occurs closest to anterior and posterior reliefs 134, 136), wherein at least one of the two ends comprises a minimum width of the chamfered or rounded edge (Fig. 3E, center edge of inferior chamfer 130 comprises thinnest width), and wherein a surface of the chamfered or rounded edge corresponds to a surface of a truncated cone (Figs. 3B, D, inferior chamfer 130 is angled and cuts off, similar to a truncated cone (see Modified Figure 3D of Final Office Action dated 6 May 2025)).
Regarding claim 24, Goldberg fails to teach the limitations of claim 24. Winslow teaches a glenoid component wherein the second of the at least three second cylindrical protrusions and the third of the at least three second cylindrical protrusions (Fig. 4A, flanges 31 nearest bottom of glenoid prosthetic 20, below central stem coupling mechanism 34) are both offset from a straight line defined by the first cylindrical protrusion and the first of the at least three second cylindrical protrusions (Fig. 4A, bottom flanges 31 are spaced on either side of central stem coupling mechanism 34 and upper flange 31 which are in linear alignment). Winslow discloses that having multiple protrusions for anchoring the glenoid component increases its stability and security in the body [0005-0007]. 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 replacement member taught by Goldberg with the cylindrical protrusions taught by Winslow in order to increase stability of the implant when positioned in the glenoid fossa.
Regarding claim 25, Goldberg fails to teach the limitations of claim 25. Winslow teaches a glenoid component wherein the first cylindrical protrusion extends further from the attachment face than each of the at least three second cylindrical protrusions (Figs. 16, 18B, and 20, central stem coupling mechanism 34 which further comprises central fixation peg 48 when implanted extends longer than flanges 31). Winslow discloses that having multiple protrusions for anchoring the glenoid component increases its stability and security in the body [0005-0007]. 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 replacement member taught by Goldberg with the cylindrical protrusions taught by Winslow in order to increase stability of the implant when positioned in the glenoid fossa.
Regarding claim 26, Goldberg fails to teach the limitations of claim 26. Winslow teaches a glenoid component comprising at least three second cylindrical protrusions (Fig. 4A, flanges 31) and the first cylindrical protrusion (Fig. 4A, central stem coupling mechanism 34 further comprising central fixation stem 48 (Fig. 18B)). Winslow discloses that having multiple protrusions for anchoring the glenoid component increases its stability and security in the body [0005-0007]. 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 replacement member taught by Goldberg with the cylindrical protrusions taught by Winslow in order to increase stability of the implant when positioned in the glenoid fossa. However, Goldberg in view of Winslow fails to teach each consist of two partial recesses directed in a radial direction away from the first cylindrical protrusion.
Goldberg 348 teaches a glenoid component having protrusions (Fig. 12B, anchoring elements 3438, 3440) that each comprise at least one partial recess directed in a radial direction away from the first protrusion (Fig. 12D, anchoring elements 3438, 3440 comprise grooves 3462 which angle away from anchoring element 3442). Goldberg discloses that the grooves are oriented to resist forces acting perpendicular to the back side of the glenoid component [0279]. 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 second cylindrical protrusions taught by Goldberg in view of Winslow to reflect the partial recess taught by Goldberg 348 in order to increase implant resistance to external forces after implantation.
Regarding claim 27, Goldberg fails to teach the limitations of claim 27. Winslow teaches a glenoid component wherein the first cylindrical protrusion consists of two annular recesses (Fig. 18B, central stem coupling mechanism 34 further comprises central fixation peg 48 which comprises 3 annular recesses). Winslow discloses that having multiple protrusions for anchoring the glenoid component increases its stability and security in the body [0005-0007]. 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 replacement member taught by Goldberg with the cylindrical protrusions taught by Winslow in order to increase stability of the implant when positioned in the glenoid fossa.
Claims 8 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (US 2014/0257495 A1), “Goldberg” in view of Winslow et al. (US 2011/0035013 A1), “Winslow” and Goldberg et al. (US 2017/0319348 A1), “Goldberg 348” and further in view of Hopkins (US 2018/0092747 A1), “Hopkins”.
Regarding claim 8, Goldberg teaches a shoulder joint replacement, comprising: a member of claim 1 (Fig. 1A, glenoid component 100), but Goldberg in view of Winslow and Goldberg 348 fails to teach an intermediate member, wherein the member and the intermediate member comprises a device attachment face configured to mate with a corresponding part of the member.
Hopkins teaches a convertible glenoid system comprising an intermediate member (Fig. 1B, baseplate 102), wherein the member (Fig. 3B, liner 332) and the intermediate member (Fig. 1B, baseplate 102) comprises a device attachment face (Fig. 1B, lateral-facing surface 104) configured to mate with a corresponding part of the member (Fig. 4, liner 332 and baseplate 102 are attached). Hopkins discloses that the baseplate can be treated to improve its fixation to the bone, such as surface blasting, hydroxyapatite coating, plasma spray, and more [0030]. 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 Goldberg with the baseplate taught by Hopkins in order to promote integration of the implant into the patient’s bone.
Regarding claim 21, Goldberg in view of Winslow and Goldberg 348 fails to teach the limitations of claim 21. Hopkins teaches a first embodiment of a convertible glenoid system wherein the device attachment face (Fig. 1, baseplate 102) comprises a first through hole (Fig. 4, recess 228 within middle peg 114 [0050]). Hopkins discloses that the baseplate can be treated to improve its fixation to the bone, such as surface blasting, hydroxyapatite coating, plasma spray, and more [0030]. 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 Goldberg with the baseplate taught by Hopkins in order to promote integration of the implant into the patient’s bone. However, the first embodiment of Hopkins fails to teach wherein a protrusion of the plurality of protrusions of the replacement member comprises an attachment structure that is configured to mate with a corresponding structure.
Hopkins further teaches a second embodiment of a convertible glenoid system wherein a protrusion of the plurality of protrusions (Fig. 7, middle peg 714) of the replacement member comprises an attachment structure (Fig. 7, male threads 754 at medial end of middle peg 714) that is configured to mate with a corresponding structure of the first through hole (Fig. 7, middle peg 714 comprises male threads 754 to mate with middle peg extension 752 [0063]). Hopkins discloses that the attachable middle peg extension allows for greater flexibility in selecting a configuration for the area of the extension that contacts bone to best match the anatomy of the patient [0064]. 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 Goldberg in view of Amis with the through hole and protrusions taught by Hopkins in order to create a more patient-specific implant.
Regarding claim 22, Goldberg in view of Winslow and Goldberg 348 fails to teach the limitations of claim 22. Hopkins teaches a first embodiment of a convertible glenoid component which comprises a snap-fit connection that is configured to snap into a corresponding connection part (Fig, 4, mating features snap into circumferential groove 120 [0035]). Hopkins discloses that the baseplate can be treated to improve its fixation to the bone, such as surface blasting, hydroxyapatite coating, plasma spray, and more [0030]. 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 Goldberg with the baseplate taught by Hopkins in order to promote integration of the implant into the patient’s bone. However, the first embodiment of Hopkins fails to teach the attachment structure and the first through hole.
Hopkins further teaches a second embodiment of the convertible glenoid component taught by Hopkins discloses the attachment structure (Fig. 7, male threads 754 at medial end of middle peg 714) and the first through hole (Fig. 7, middle peg 714 comprises male threads 754 to mate with middle peg extension 752 [0063]). Hopkins discloses that the attachable middle peg extension allows for greater flexibility in selecting a configuration for the area of the extension that contacts bone to best match the anatomy of the patient [0064]. 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 Goldberg in view of Amis with the snap-fit connections of the first embodiment taught by Hopkins and the attachment structure and holes taught by the second embodiment of Hopkins in order to create a more patient-specific implant.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Goldberg (US 2014/0257495 A1), “Goldberg” in view of Winslow et al. (US 2011/0035013 A1), “Winslow” and Goldberg et al. (US 2017/0319348 A1), “Goldberg 348” and further in view of Amis et al. (US 2018/0104065 A1), “Amis”.
Regarding claim 18, Goldberg teaches a chamfered or rounded edge (Fig. 2C, inferior chamfer 130), but Goldberg in view of Winslow and Goldberg 348 fails to teach wherein the maximum width of the chamfered or rounded edge is at least 3 mm; and wherein the minimum width of the chamfered or rounded edge is less than 3 mm.
Amis teaches a prosthetic glenoid component wherein the maximum width of the chamfered or rounded edge is at least 3 mm; and wherein the minimum width of the chamfered or rounded edge is less than 3 mm (Fig. 4, axis 20 defines component 10, and radius of curvature R1 defines the inferior end which is smaller, wherein Table 1 reflects a minimum width of the component 10 sizes to be 23 mm). Amis discloses that the measurements of Table 1 are exemplary approximate sizes wherein the width is defined as being the maximum dimension transverse to the defined axis [0086]. 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 size of the glenoid component taught by Goldberg to reflect the sizes taught by Amis in order to provide an implant that is best suited to a patient.
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
/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774