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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phelps et al. (U.S. Publication No. 2021/0161676).
Schweitzer et al. discloses a prosthetic talus comprising: a base (120) having a top surface (126) and a bottom surface (124); and an articulating component (100) having a top surface (114) and a bottom surface (116, including recess), wherein the bottom surface of the articulating component is removably coupled to the top surface of the base (Figure 6), wherein the bottom surface of the articulating component includes a protrusion (screw 160a can be considered the protrusion when inserted), and wherein the top surface of the base includes a recess (132a) configured to receive the protrusion to thereby removably couple the articulating component to the base (Figure 17), wherein the articulating component includes a sidewall positioned between the top surface and the bottom surface (Figure 8), and wherein the sidewall includes a plurality of holes (140, paragraph 41).
Regarding claim 2, Phelps discloses a prosthetic talus comprising: a base (120) having a top surface (126) and a bottom surface (124); and an articulating component (100) having a top surface (114) and a bottom surface (116), wherein the bottom surface of the articulating component is removably coupled to the top surface of the base (Figure 17).
Regarding claim 3, the base comprises a first material, and wherein the articulating component comprises a second material that is different than the first material (Paragraph 30).
Regarding claim 4 the first material comprises a titanium alloy, and wherein the second material comprises a cobalt-chromium (CoCr) alloy (paragraph 30, states that any suitable combination may be used).
Regarding claim 5, the bottom surface of the articulating component includes a protrusion (screw 160a can be considered the protrusion when inserted), and wherein the top surface of the base includes a recess (132a) configured to receive the protrusion to thereby removably couple the articulating component to the base (Figure 17).
Regarding claim 11, the articulating component and/or the base include suture eyelets and/or drilled and tapped holes (140) configured to accept bone anchors for lateral ankle or deltoid instability.
Regarding claim 12, the base includes one or more holes (125) designed to allow for subtalar/ankle fusion or talonavicular fusion (considered capable of).
Regarding claim 13, the one or more holes are located on a neck of the base to allow for screw targeting from a calcaneus of a patient (Figure 11, lower right extension is considered a neck).
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.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phelps et al. in view of Liu et al. (U.S. Publication No. 2014/0093417).
Phelps et al. discloses the claimed invention except for at least a portion of an exterior surface of the bottom surface of the base includes a Zinc-Strontium (Zn—Sr) alloy and/or wherein at least a portion of an exterior surface of the top surface of the articulating component includes a Zn—Sr alloy.
Liu et al. teaches medical implants made from a Magnesium Zinc Strontium alloy. The alloys provide better degradation properties over just Magnesium implants and also further provide a cytocompatibility so that wear particles can be excreted or used in a metabolic process (Paragraphs 4-5). It would have been obvious to one skilled in the art to construct the device of Phelps et al. with at least a portion of the exterior surface of the base or top surface of the articulating component with a Zinc Strontium alloy to improve cytocompatibility.
Regarding claim 15, Liu et al. further teaches that the Zn—Sr alloy is selected from the group consisting of Zn—Sr, Zn-0.8Sr, Zn-0.6 Sr, Zn-0.5Sr, Zn-0.4Sr, Zn-0.2Sr, and Zn-0.1 Sr (paragraph 25).
Regarding claim 17, Liu et al further teaches that the ZN-Sr alloy further includes material selected from the group consisting of tricalcium phosphate, hydroxyapatite, and silicon (paragraph 23)
Allowable Subject Matter
Claims 6-10, 16, 18-20 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art alone or in combination fails to disclose patient specific talus implant having the structural and material limitations denoted the objected to claims.
Conclusion
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/ANDREW YANG/ Primary Examiner, Art Unit 3775
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