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 .
Election/Restrictions
Applicant’s election of Species A, claims 1-4 and 7-12, in the reply filed on September 3, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 13-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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 and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Thuliez (US 2016/0000570) in view of El-Hibri (US 2009/0131583).
Claim 1: Thuliez discloses a method of making an implantable component for an orthopedic prosthesis (¶¶ 46-48, 73). The method includes molding a first layer of a polymeric material to a second layer of polymeric material (¶¶ 73, 117) to form a composite (¶ 114; fig. 9; outer layer 904 and inner blank 902), forming the composite into a predetermined shape of the implantable component (¶¶ 49, 53-54, 62), wherein the implantable component has an articular layer and a support layer (¶¶ 46-48, 114; fig. 9), wherein the articular layer includes a PEEK homopolymer (¶¶ 46-50; fig. 9), wherein the support layer includes a polymer and a reinforcement fiber (¶¶ 12, 73, 84-85, 114).
Thuliez is silent as to the articular layer including a polysulfone. However, in the same field of endeavor of PEEK-based materials for bearing components, El-Hibri discloses an articular including a homopolymer, wherein the homopolymer includes a PEEK homopolymer and wherein the articular layer further includes a polysulfone (¶¶ 58, 75, 85; Table 1). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have utilized the PEEK/polysulfone material of El-Hibri in the articular layer of Thuliez to strengthen the region supporting the articular surface, consistent with Thuliez’s reinforcement teachings (¶¶ 84-85), and lower material cost while substantially retaining chemical resistance, as taught by El-Hibri (¶¶ 29-33).
Claims 7-9: El-Hibri discloses the PEEK being 80% and 90% (¶¶ 85; Table 1; E2, E1).
Claim 10: El-Hibri discloses the polysulfone being PPSU (¶¶ 58, 85; Table 1).
Claim 11: El-Hibri discloses the polysulfone being 20% (¶ 85, Table, E2).
Claim 12: El-Hibri discloses the polysulfone being 10% (¶ 85, Table, E1).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Thuliez (US 2016/0000570) in view of El-Hibri (US 2009/0131583), as applied to claim 1 above, further in view of King (US 2004/0210316).
Claim 2: Thuliez discloses the implantable component is an acetabular bearing (¶ 46), but is silent as to implanting into an acetabulum of a patient. However, King discloses a method of making an implantable component for an orthopedic prosthesis (abstract). The method includes molding a first layer of polymeric material to a second layer of polymeric material to form a composite (Ҟ¶ 29-32; fig. 1), and forming the composite into a predetermined shape of the implantable component which has an articular layer and a support layer (¶¶ 12-14; figs. 2-4), wherein the articular layer includes a homopolymer and the support layer includes a polymer (¶¶ 29-32), wherein forming the implantable component is an acetabular bearing which is adapted to be implanted into an acetabulum of a patient (¶¶ 19-22). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have configured the bone-facing side of the modified support with King’s respective fixation arrangement to secure the bearing at the intended anatomical site.
Claim 3: Thuliez discloses the implantable component is a glenoid bearing (¶ 46), and King discloses the implantable component being a glenoid bearing which is adapted to be implanted into a glenoid of a patient (¶ 19).
Claim 4: Thuliez discloses implantable component being a tibial bearing (¶¶ 46-48), and King discloses the implantable component being a tibial bearing which is adapted to be implanted into a tibia of a patient (¶ 19).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY THROWER whose telephone number is (571)270-5517. The examiner can normally be reached 9am-5pm MT M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Susan Leong can be reached at 571-270-1487. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LARRY W THROWER/Primary Examiner, Art Unit 1754