DETAILED ACTION
The following is a non-final office action is response to communications received on 12/11/2023. Claims 1-18 are currently pending and addressed below.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, wherein the talar component has a continuous concave curvature (Claims 4, 11 & 14) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 11 & 14-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 4, lines 1-2 state wherein the superior surface of the talar component has a continuous concave curvature. After thoroughly examining the specification and drawings, it is unclear how the superior talar surface can be concave. It would appear, as shown in at least Fig 7, that the superior talar surface is convex. Claims 11 & 14 are similarly indefinite as they are directed to the same issue. For examination purposes, the examiner assumes that concave should read convex. Appropriate correction/clarification is required.
Claim Rejections - 35 USC § 102
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 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) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leemrijse et al. (US 10,952,865).
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Regarding Claim 1, Leemrijse teaches a partial ankle prosthesis (Fig 1) comprising: a tibial component (300) including at least one a peg (314) projecting outwardly from a superior surface and configured to be received in a hole formed in a lower end of a tibia; a poly (Col 6: lines 13-17) component (400) that is fixedly attached to the tibial component (Fig 1) and includes a concave inferior surface (Fig 1) of an anti-friction material (i.e., HDPE as taught in Col 6: lines 13-17); and a talar component (200) including an inferior surface configured to be attached to a patient’s talus and a single convex superior surface (201) configured to mate with the inferior surface of the poly component (Figs 1 & 2); wherein the partial ankle prosthesis is fully capable of being positioned within a unitary compartment of an ankle.
Regarding Claim 2, Leemrijse teaches wherein the superior surface of the tibial component includes two adjacent pegs (314A & 314B) configured to be received in corresponding holes formed in the lower tibia.
Regarding Claim 3, Leemrijse teaches wherein the inferior surface of the talar component (200) includes at least one peg (216) configured to be received in a corresponding hole formed in a talus bone.
Regarding Claim 4, as best understood (see 112 rejection supra), Leemrijse teaches wherein the superior surface of the talar component has a continuous convex curvature (201) between (i) anterior and posterior ends and (ii) medial and lateral sides.
Regarding Claim 5, Leemrijse teaches wherein the prosthesis further comprises a bioactive coating (Col 5: lines 9-18) on a surface of at least one of the tibial and the talar components.
Regarding Claim 6, Leemrijse teaches wherein an inferior surface of the talar component is curved (at 218 in Figs 7 & 10).
Regarding Claim 7, Leemrijse teaches wherein an inferior surface (207) of the talar component is substantially flat (Figs 2 & 3).
Regarding Claim 8, Leemrijse teaches wherein the talar component defines a notch (219) in at least one side surface (Fig 1) that is sized and oriented so as to provide a pilot for engagement with a portion of a surgical assembly tool (Col 17: lines 9-20) thereby allowing accurate alignment of the prosthesis by a surgeon.
Regarding Claim 9, Leemrijse teaches a partial ankle prosthesis comprising: a tibial component (300) including a superior surface having an outwardly projecting peg (314) configured to be received within a corresponding passageway formed in a portion of a distal tibia; a poly (Col 6: lines 13-17) component (400) that is fixedly attached to the tibial component and includes a concave inferior surface (Fig 1) of an anti-friction material (i.e., HDPE as taught in Col 6: lines 13-17); and a talar component (200) including an inferior surface having an outwardly projecting peg (216) configured to be received within a corresponding passageway formed in a portion of a talus and a single convex superior surface (201) configured to mate with the inferior surface of the poly component (Figs 1 & 2) and further defining a notch (219) in at least one side surface that is sized and oriented so as to provide a pilot for engagement with a portion of a surgical assembly tool (Col 17: lines 9-20) thereby allowing accurate alignment of the prosthesis by a surgeon in a single compartment of a patient’s ankle.
Regarding Claim 10, Leemrijse teaches wherein the anterior surface of the talar component (200) defines at least one groove (217 and/or 218) so as to provide additional surface area and thereby increase bone adhesion.
Regarding Claim 11, as best understood (see 112 rejection supra), Leemrijse teaches wherein the superior surface of the talar component has only one continuous convex curvature (201) between (i) anterior and posterior ends and (ii) between medial and lateral sides (Figs 1 & 6).
Regarding Claim 12, Leemrijse teaches wherein the prosthesis further comprises a bioactive coating (Col 5: lines 9-18) on at least one of a surface of the tibial component and the talar component that interfaces with bone.
Regarding Claim 13, Leemrijse teaches wherein an inferior surface of the talar component is complimentarily curved (at peg 216) to attach to a talar dome of the talus.
Regarding Claim 14, as best understood (see 112 rejection supra), Leemrijse teaches a partial ankle prosthesis (Fig 1) comprising: a tibial component300) including a superior surface configured to be attached to a lower portion of a tibia; a poly (Col 6: lines 13-17) component (400) that is fixedly attached to the tibial component and includes a concave inferior (Fig 1) surface of an anti-friction material (i.e., HDPE as taught in Col 6: lines 13-17); and a talar component (200) including an inferior surface configured to be attached to a patient’s talus and a single convex superior surface (201) having one continuous concave curvature both longitudinally between anterior and posterior ends and laterally between medial and lateral sides (Figs 1 & 6), and further defining a notch (219) in at least one side surface that is sized and oriented so as to provide a pilot for engagement with a portion of a surgical assembly tool (Col 17: lines 9-20) thereby allowing accurate alignment of the prosthesis by a surgeon in a single compartment of an ankle.
Regarding Claim 15, Leemrijse teaches wherein the superior surface of the tibial component (300) includes a peg (314) configured to be received with a hole in the lower tibia.
Regarding Claim 16, Leemrijse teaches wherein the anterior surface of the talar component includes a peg (216) configured to be received with a hole in a talus bone.
Regarding Claim 17, Leemrijse teaches wherein the prosthesis further comprises a bioactive coating (Col 5: lines 9-18) on a surface of the tibial component and/or the talar component that interfaces with a patient’s bone.
Regarding Claim 18, Leemrijse teaches wherein an inferior surface of the talar component is curved (at peg 216) and configured to attach to a talar dome of the talus bone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
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