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 .
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-11 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2011/0035013 to Winslow et al. in view of U.S. Patent Pub. No. 2024/0307188 to Terrill et al.
As to Claim 1, Winslow discloses a glenoid implant (22, Fig. 1, [0033]). The glenoid implant comprises a liner (20) having a liner inner surface (24) and a liner outer surface (26, Fig. 1, 3A), the liner inner surface having a concave profile (seen in Fig. 3B) and configured to receive a corresponding convex surface of a humeral head or humeral implant [0033]. The implant comprises a screw (48) having a mantle portion (near 50, Fig. 6B, 8B) and a pedestal portion (near 48, Fig. 6B, 8B) extending distally from the mantle portion [0036], the mantle portion configured to be coupled with a distal portion of the liner outer surface (at 34) such that the screw extends distally from the liner [0035], the pedestal portion having one or more engagement features disposed thereabout configured to secure the implant to a glenoid fossa at an excision site thereof (e.g. 55, [0039]) , such that the glenoid implant is configured to be disposed entirely or substantially entirely within the excision site, thereby having an inlay configuration (Fig. 14, [0043]).
As to Claim 2, Winslow discloses a glenoid implant wherein one or both of the mantle portion and the pedestal portion comprise a porous material [0037-0038].
As to Claim 3, Winslow discloses a glenoid implant wherein the porous material comprises an open cell porosity structure, a closed cell porosity structure, or a combination thereof [0037-0038].
As to Claim 4, Winslow discloses a glenoid implant wherein the liner comprises an inner cavity portion about a distal portion of the liner inner surface (within body 38, Fig. 3A, [0035]).
As to Claim 5, Winslow discloses a glenoid implant wherein the inner cavity portion has a generally cylindrical shape (Figs. 3A-3B).
As to Claim 7, Winslow discloses a glenoid implant wherein the screw comprises a metal material [0038].
As to Claim 8, Winslow discloses a glenoid implant wherein the liner comprises a polyethylene material [0038].
As to Claim 9, Winslow discloses a glenoid implant further comprising an antioxidant material embedded in the polyethylene material (treatment described in [0038]).
As to Claim 10, Winslow discloses a glenoid implant further comprising a textured interface disposed between the screw and the liner [0047].
As to Claim 11, Winslow discloses a glenoid implant wherein the textured interface has a checkerboard texture (interface described in [0038-0039]).
As to Claim 22, Winslow discloses a glenoid implant wherein the liner (20) is configured to couple with the mantle portion (near 50, Fig. 6B, 8B) of the screw (48) through a threaded connection (via 36, [0035]).
As to Claim 23, Winslow discloses a glenoid implant wherein the liner (20) is configured to decouple from the mantle portion (near 50, Fig. 6B, 8B) of the screw (48) through rotation [0035-0036].
As to Claims 1-11 and 20-23, Winslow discloses the claimed invention except for the pedestal portion having one or more threads disposed thereabout configured to secure the implant to a glenoid fossa at an excision site thereof, wherein the inner cavity portion has a generally hexagonal prism shape, wherein the one or more threads comprise double helix threads, and wherein the one or more threads is configured to secure the implant to a glenoid fossa through rotation therein.
Terrill discloses a glenoid implant (100, Figs. 1A-1B, [0007]) wherein a pedestal portion (200) has one or more threads disposed thereabout configured to secure the implant to a glenoid fossa at an excision site thereof [0027, 0028, 0033], wherein the inner cavity portion (within 115, Fig. 3A) has a generally hexagonal prism shape (seen in Fig. 3A), wherein the one or more threads comprise double helix threads {described in [0028]), and wherein the one or more threads is configured to secure the implant to a glenoid fossa through rotation therein [0027] in order to retain the low stiffness of a polymer bearing with the high initial fixation power of screws [0025] while preventing backing out of the implant after insertion [0026].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the glenoid implant of Winslow with the threaded pedestal modification of Terrill in order to retain the low stiffness of a polymer bearing with the high initial fixation power of screws while preventing backing out of the implant after insertion.
Claims 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2011/0035013 to Winslow et al. in view of U.S. Patent Pub. No. 2024/0307188 to Terrill et al. in view of U.S. Patent Pub. No. 2014/0379089 to Bachmaier.
As to Claims 12-19, Winslow and Terrill disclose the claimed invention except for at least one notch disposed in the liner outer surface, wherein the at least one notch includes a first notch and a second notch disposed in the liner outer surface, further comprising a plurality of indents disposed in the liner outer surface, wherein the plurality of indents have a generally concave shape, wherein the plurality of indents have a generally convex indent surface, wherein the plurality of indents are disposed at least partially in the at least one notch, wherein the plurality of indents are arranged radial-symmetrically about a longitudinal axis of the glenoid implant, wherein the indents are configured to retain bone cement to adhere the glenoid implant to the glenoid fossa.
Bachmaier discloses a shoulder implant (100, [0042], Fig.6) including at least one notch (140) disposed in a liner outer surface (101, 012, 103, 104, 105, 106, [0043], Fig. 6), wherein the at least one notch includes a first notch and a second notch (multiple notches 140) disposed in the liner outer surface (Fig. 6, [0043]), further comprising a plurality of indents (121) disposed in the liner outer surface [0044], wherein the plurality of indents have a generally concave shape (seen best in Fig. 2), wherein the plurality of indents have a generally convex indent surface (indents 131, [0043]), wherein the plurality of indents are disposed at least partially in the at least one notch (between 122 amd 131/132, Fig. 1), wherein the plurality of indents are arranged radial-symmetrically about a longitudinal axis of the glenoid implant (Figs. 1 and 2), wherein the indents are configured to retain bone cement to adhere the glenoid implant to the glenoid fossa [0017] in order to enhance fixation between the implant and target bone site [0015, 0017].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the glenoid implant of Winslow and Terrill with the notch and indent modification of Bachmaier in order to enhance fixation between the implant and target bone site.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775