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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/23/2026 has been entered.
Response to Arguments
Applicant's arguments filed 3/16/2026 and entered on 3/23/2026 have been fully considered. Applicant’s arguments regarding the combination of Winslow and Glien have been considered but they are not persuasive. Applicant disagrees that one of ordinary skill in the art would have combined Winslow, which is directed to a glenoid prosthesis, with the teachings of Glien, which is directed to a humeral prosthesis, to arrive at the shoulder implant assembly as recited in claim 9. This is not persuasive because both Winslow and Glien are directed to shoulder implants and the teachings of arms on a post to resist rotation as taught by Glien are applicable to essentially any implant comprising a post, as rotation within the bone is undesirable. This is a well-known feature in the art of prosthetics. The examiner maintains that one of ordinary skill in the art would have combined Winslow and the teachings of Glien since both are directed to shoulder implants and both have posts implanted in bone that would benefit from resisting rotation.
All other arguments are moot in view of the new grounds of rejection necessitated by the amendments.
Claim Objections
Claim 9 is objected to because of the following informalities: In claim 9, lines 13-14, “the end” is believed to be in error for --the second end--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 are rejected under 35 U.S.C. 103 as being unpatentable over Winslow et al. US 2009/0192621 (hereafter referred to as Winslow) in view of Lappin US 2012/0221112 (hereafter referred to as Lappin) and further in view of Kovacs et al. US 2016/0045323 (hereafter referred to as Kovacs).
Regarding claims 1 and 4, Winslow discloses a shoulder implant assembly comprising a first component 300 including a first portion including a plate 306 having a first face (face that faces the articulating component and away from the glenoid bone), a second face 326 disposed on an opposite side of the plate as the first face and configured to abut bone (figs.44B-47), and a periphery (the side surface of the plate as shown in fig.43), the plate defining a first plurality of apertures 316, and a second portion 328 extending from the second face of the plate to an end (fig.43), the second portion having a width dimension that is less than a width dimension of the periphery of the first portion (fig.43), wherein the first component defines an opening 304 that extends through the first portion and the second portion (fig.45 shows the central through opening), and wherein each aperture of the first plurality of apertures is disposed between the opening and the periphery (figs.43-44B), a first screw 302 of a first type sized and configured to be received in the opening and extend outwardly from the end of the second portion and to engage bone when disposed in the opening (fig.45), and a first screw of a second type 320 sized and configured to be received in at least one of the first plurality of apertures defined by the plate (fig.45). Winslow discloses the invention substantially as claimed but does not disclose that the first screw of the second type includes a threaded portion and an unthreaded portion terminating at a blunt tip, the threaded portion being disposed proximal of the unthreaded portion, or that the first screw of the second type includes a spherical head such that the first screw of the second type may be received in at least one of a plurality of apertures in a plurality of orientations.
Lappin teaches a shoulder implant assembly, in the same field of endeavor, wherein screws 34A, 34B include a spherical head to be matingly received in a concave seat 50 (fig.2) for the purpose of allowing the screws to be adjustable to any one of a variety of angles (par.27). Lappin further discloses the screws 34A, 34B have a threaded portion (proximal threaded portion shown in fig.2) and an unthreaded distal portion terminating at a blunt tip 56A, 56B (fig.2), the threaded portion being disposed proximal of the unthreaded portion (fig.2). Lappin par.31 incorporates Bouttens et al. US 6,953,478 for further features of the components and Bouttens teaches a smooth free end facilitates insertion of a screw (col.4, lines 57-59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second type of screws and their respective seats in the apertures of Winslow to include screws having a spherical head and corresponding concave seats in the apertures as taught by Lappin in order to allow for the screws to be adjustable to any one of a variety of angles. This provides flexibility to the surgeon to fasten the screws to optimal bone. It would have been further obvious to modify the screws of Winslow to have the smooth blunt terminal end taught by Lappin in order to provide a smooth atraumatic tip that facilitates insertion. The examiner notes that the instant application calls 123 (fig.3) a “blunt atraumatic tip 123” in par.39. This tip still has a somewhat pointed shape. The term “blunt” is interpreted to mean not sharp, therefore the curved tip taught by Lappin is considered blunt since it is rounded and not sharp. Winslow in view of Lappin discloses the invention substantially as claimed but does not disclose a second plurality of apertures, the apertures of the first plurality of apertures having a different size and a different shape than the apertures of the second plurality of apertures, wherein at least one aperture of the second plurality of apertures is disposed between adjacent apertures of the first plurality of apertures.
Kovacs teaches a shoulder implant assembly, in the same field of endeavor, wherein a plate 12e, 12f (figs. 12A-12B) comprises a first plurality of apertures 36 for receiving screws (par.55) and a second plurality of apertures 90, 90f, the apertures 36 of the first plurality of apertures having a different size and a different shape than the apertures 90, 90f of the second plurality of apertures (fig.12A shows smaller, conical second apertures 90 and fig.12B shows larger, elongated second apertures), wherein at least one aperture of the second plurality of apertures is disposed between adjacent apertures of the first plurality of apertures (figs. 12A-12B) for the purpose of having the option to attach pegs or inserts to account for bone erosion and wear (par.90).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first component of Winslow in view of Lappin to include a second plurality of apertures, the apertures of the first plurality of apertures having a different size and a different shape than the apertures of the second plurality of apertures, wherein at least one aperture of the second plurality of apertures is disposed between adjacent apertures of the first plurality of apertures as taught by Kovacs in order to improve surgical implantation of the implant by accounting for erosion and wear patterns in the bone.
Regarding claims 2 and 3, see Winslow fig.43 which shows central screw 302 is longer than the second type of screws 320.
Regarding claim 7, see Winslow fig.45 for integrally formed first and second portions.
Claims 5, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Winslow in view of Lappin and Kovacs as applied to claim 1 above, and further in view of Glien et al. US 2004/0225367 (hereafter referred to as Glien).
Regarding claims 5, 6, and 8, Winslow in view of Lappin and Kovacs discloses the shoulder implant assembly of claim 1 as discussed above. Winslow further discloses the second portion includes a concave structure 328 extending from the second face of the plate, the second portion defining at least a portion of the opening (fig.45) but does not disclose that the second portion of the first component includes a plurality of arms extending radially outward about the opening, the plurality of arms extending from the concave structure, or wherein a plurality of projections extend from the second face of the plate, the plurality of projections disposed between the opening and the periphery and configured to engage bone to prevent rotation of the plate when the first component is implanted in bone.
Glien teaches a shoulder implant assembly, in the same field of endeavor, wherein a stem 10 that extends from a plate 16 includes a plurality of arms/projections 12 extending radially outward about the stem, the arms/projections 12 extending from the second face of the plate and are disposed between the stem and a periphery of the plate (figs. 7-10) for the purpose of resisting rotation (par.19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the arms/projections taught by Glien to the second portion of Winslow in view of Lappin and Kovacs in order to prevent rotation of the first component when the first component is implanted in bone.
Claims 9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Winslow in view of Glien, and further in view of Kovacs.
Regarding claims 9 and 11, Winslow discloses a shoulder implant assembly, comprising a first component 300 extending from a first end to a second end, the first component including a plate 306 having a first face (face that faces the articulating component) at the first end, a second face 326 disposed opposite the first face and capable of abutting a resected surface of a humerus (figs. 44B-47 show the second face abutting bone, “configured to abut a resected surface of a humerus” is directed to an intended use of the implant and the second face of the implant of Winslow is capable of abutting a resected surface of a humerus), and a periphery extending between the first face and the second face (the side surface of the plate as shown in fig.43), the plate defining a central aperture 304 and a plurality of openings 316 surrounding the central aperture (fig.43), and wherein the central aperture is sized and configured to receive a projection 338 for coupling an articular component 324, 326 to the first component (figs.45-47). Winslow further discloses a stem/concave structure 328 extending from the second surface of the plate which defines at least a portion of the central opening/aperture (fig.45). Winslow discloses the invention substantially as claimed but does not disclose a plurality of arms extending from the second face of the plate and terminating at the second end where the plurality of arms are joined together, the plurality of arms tapering along their length such that a width dimension of the plurality of arms adjacent to the plate is greater than a width dimension of the plurality of arms at the end, wherein the plurality of arms extend outwardly from the concave structure.
Glien teaches a shoulder implant assembly, in the same field of endeavor, wherein a stem 10 that extends from a plate 16 includes a plurality of arms 12 extending radially outward about the stem, the arms 12 extending from a second/lower face of the plate and terminating at an end where the plurality of arms are joined together (figs. 1-3 and 11-18 shows arms 12 joining directly together at the end), the plurality of arms tapering along their length such that a width dimension of the plurality of arms adjacent to the plate is greater than a width dimension of the plurality of arms at the end (figs. 1-3 and 7-18 show tapering arms) for the purpose of resisting rotation (par.19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the arms taught by Glien to the stem/concave structure of Winslow in order to prevent rotation of the first component when the first component is implanted in bone. Winslow in view of Glien discloses the invention substantially as claimed but does not disclose a plurality of anchor features surrounding the central aperture and disposed adjacent to the periphery, the plurality of anchor features having a different shape than the plurality of openings.
Kovacs teaches a shoulder implant assembly, in the same field of endeavor, wherein a plate 12e, 12f (figs. 12A-12B) comprises a plurality of openings 36 for receiving screws (par.55) and a plurality of anchor features 90, 90f surrounding a central aperture 48 and disposed adjacent/near to a periphery of the plate (fig.4 shows the reference number for the central aperture and figs. 12A-12B show the anchor features surrounding the central aperture adjacent the periphery), the plurality of anchor features 90, 90f having a different size and a different shape than the size and shape of the plurality of openings (fig.12A shows smaller, conical second apertures 90 and fig.12B shows larger, elongated second apertures), for the purpose of having the option to attach pegs or inserts to account for bone erosion and wear (par.90).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first component of Winslow in view of Glien to include a plurality of anchor features surrounding the central aperture and disposed adjacent to the periphery, the plurality of anchor features having a different shape than the plurality of openings as taught by Kovacs in order to improve surgical implantation of the implant by accounting for erosion and wear patterns in the bone. While the anchor features of Kovacs are not specifically disclosed as being used for sutures, this is an intended use and the anchor features/through holes taught by Kovacs are capable of receiving a suture therein. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 12-15, see Winslow fig.43 for first screw 302 configured to be received in the central aperture having a first length and first thread 312 and second screw 320 having a second length and a second thread 322, wherein the first length is longer than the second length and the first thread is different from the second thread.
Claim 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Winslow in view of Lewis et al. US 2007/0142922 (hereafter referred to as Lewis), in further view of Lappin, and in further view of Kovacs.
Regarding claim 16, Winslow discloses a shoulder implant assembly, comprising a plate 306 for coupling to a prepared surface of a bone, the plate comprising a first face (face that faces the articulating component), a second face 326 disposed on an opposite side of the plate as the first face (figs.44B-47), and a circular periphery (the side surface of the plate as shown in fig.43), wherein the plate defines an opening 304 and a plurality of apertures 316, the opening sized and configured to receive a projection 338 for coupling an articular component 324, 326 to the plate (figs. 45-47), and each aperture of the plurality of apertures is disposed between the opening and the circular periphery (fig.43), a first screw of a first type 302 having a first thread and a first length, the first screw of the first type sized and configured to be received in the opening and to engage bone (fig.45), and a plurality of screws of a second type 320, each screw of the second type of the plurality of screws of the second type having a second thread, a second length, and being sized and configured to be received in each aperture of the plurality of apertures (figs. 43 and 45). Winslow discloses the invention substantially as claimed but does not disclose the first screw has a third thread wherein the third thread engages a thread disposed within the opening.
Lewis teaches an implant 102 and screw 110, in the same field of endeavor, wherein a screw head has a thread 114 that engages a thread 116 disposed within an opening 104 of the implant and a thread 118 for engaging bone (fig.4), wherein the screw head is threaded for the purpose of providing rigid construction of the screw to the implant (par.94).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first screw of the first type and opening of the assembly of Winslow by adding threads to the screw head and opening as taught by Lewis in order to provide an improved rigid connection between the screw and plate. Threaded connections between screws and implants are well-known in the art for providing a secure connection. Winslow in view of Lewis discloses the invention substantially as claimed but does not disclose that the second type of screws are configured to be received in each aperture in a plurality of orientations.
Lappin teaches a shoulder implant assembly, in the same field of endeavor, wherein screws 34A, 34B include a spherical head to be matingly received in a concave seat 50 (fig.2) for the purpose of allowing the screws to be adjustable to any one of a variety of angles (par.27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second type of screws and their respect seats in the apertures of Winslow to include screws having a spherical head and corresponding concave seats in the apertures as taught by Lappin in order to allow for the screws to be adjustable to any one of a variety of angles. This provides flexibility to the surgeon to fasten the screws to optimal bone.
Winslow in view of Lewis and Lappin discloses the invention substantially as claimed but does not disclose a second plurality of apertures, the apertures of the first plurality of apertures having a different size and a different shape than the apertures of the second plurality of apertures, wherein at least one aperture of the second plurality of apertures is disposed between adjacent apertures of the first plurality of apertures, and each of the second plurality of apertures is disposed between the opening and the periphery.
Kovacs teaches a shoulder implant assembly, in the same field of endeavor, wherein a plate 12e, 12f (figs. 12A-12B) comprises a first plurality of apertures 36 for receiving screws (par.55) and a second plurality of apertures 90, 90f, the apertures 36 of the first plurality of apertures having a different size and a different shape than the apertures 90, 90f of the second plurality of apertures (fig.12A shows smaller, conical second apertures 90 and fig.12B shows larger, elongated second apertures), wherein at least one aperture of the second plurality of apertures is disposed between adjacent apertures of the first plurality of apertures (figs. 12A-12B), and each of the second plurality of apertures is disposed between the opening and a periphery of the plate (figs. 12A-12B) for the purpose of having the option to attach pegs or inserts to account for bone erosion and wear (par.90).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first component of Winslow in view of Lewis and Lappin to include a second plurality of apertures, the apertures of the first plurality of apertures having a different size and a different shape than the apertures of the second plurality of apertures, wherein at least one aperture of the second plurality of apertures is disposed between adjacent apertures of the first plurality of apertures and each of the second plurality of apertures is disposed between the opening and the periphery of the plate as taught by Kovacs in order to improve surgical implantation of the implant by accounting for erosion and wear patterns in the bone.
Regarding claim 17, Winslow further discloses a concave structure 328 extending from the second face of the plate and terminating at an end, wherein the concave structure defines at least a portion of the opening 304 (fig.45).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Winslow in view of Lewis, Lappin, and Kovacs as applied to claim 17 above, and further in view of Glien.
Regarding claims 18-20, Winslow in view of Lewis, Lappin, and Kovacs discloses the shoulder implant assembly of claim 17 as discussed above, but Winslow in view of Lewis, Lappin, and Kovacs does not disclose that a plurality of projections extend from the second face of the plate, each projection of the plurality of projections is disposed between the concave structure and the circular periphery of the plate and is configured to engage bone to prevent rotation of the plate when the plate is implanted in bone, wherein the plurality of projections include a plurality of spaced apart arms, or wherein the plurality of spaced apart arms taper as they extend from the second face of the plate to the end such that a width dimension of the spaced apart arms adjacent to the second face of the plate is greater than a width dimension at the end.
Glien teaches a shoulder implant assembly, in the same field of endeavor, wherein a stem 10 that extends from a plate 16 includes a plurality of projections/arms 12 extending radially outward about the stem between the stem and a periphery of the plate, the projections/arms 12 extending from a second/lower face of the plate and tapering along their length such that a width dimension of the plurality of arms 12 adjacent to the plate is greater than a width dimension of the plurality of arms at an end (figs. 7-10) for the purpose of resisting rotation (par.19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the arms taught by Glien to the stem/concave structure of Winslow in view of Lewis, Lappin, and Kovacs in order to prevent rotation of the plate when the plate is implanted in bone.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lin US 5,376,126 discloses an implant comprising holes for screws and differently shaped and sized holes for sutures (fig.2b).
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774