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 .
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.
Response to Arguments
Applicant’s arguments, see amendment and remarks, filed February 10, 2026, with respect to rejection of claims 16 and 17 under 35 U.S.C. 103 as being unpatentable over Kofoed et al. U.S. publication no. 2014/0081413 A1 (“Kofoed”) have been fully considered and are persuasive. In particular, Examiner agrees that Kofoed is not directed to a fixed bearing type prosthesis. The rejection of claims 16 and 17 under 35 U.S.C. 103 as being unpatentable over Kofoed has been withdrawn.
On page 7 of the remarks, February 10, 2026, Applicant acknowledges a rejection of record under 35 U.S.C. 103 including prior art to Lee WO 2020/013901 in view of Goswami et al. U.S. publication no. 2011/0035019 (“Goswami”) and generally states that rejection of the claims is traversed. The rejection and Examiner remarks provided in the final action, mailed August 11, 2025, details how Lee and Goswami relates to all of claims 16-18 [although only claim 18 was new following the non-final rejection, while claims 16 and 17 were unamended]. However, Applicant’s amendment and remarks, filed February 10, 2026, fails to address the claims as they relate to prior art to Lee and Goswami in any detail. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. All claims are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Goswami. Details are found herein below.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: there is no antecedent basis/ support in the original disclosure for the subject matter in amended claim 16 for which there are new matter rejections detailed herein below [see 35 U.S.C. 112(a) rejection hereinbelow].
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 16 has been amended to recite “A two component fixed bearing prosthesis, comprising… a talar implant (first component); a tibial implant (second component); and a bearing component (third component).” Examiner is unable to find written description support in the original disclosure for the three-component prosthesis (see numbering of components above) for total ankle arthroplasty being a “two component” prosthesis as required by the amended independent claim. Thus, the claim contains new matter.
New claims 19 and 20 recite the limitations “a generally concave semi-circular form of radius 3mm-3.5mm” and “a generally convex semi-circular form of radius 3mm-3.5mm,” respectively. Examiner is unable to find written description support in the original disclosure for the concave/convex forms being of specifically a “semi-circular” shape or being specifically formed as a “half-circle” as required by the new claims. The claims constitute new matter.
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 16-20 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.
Independent claim 16 has been amended to recite “A two component fixed bearing prosthesis, comprising… a talar implant (first component); a tibial implant (second component); and a bearing component (third component).” It is unclear how the claimed three component prosthesis for total ankle arthroplasty is said to be a “two component” prosthesis as required by the amended independent claim.
Claim 16 recites the limitation “the axis of rotation” in line 16. There is lack of antecedent basis for this limitation in the 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 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee WIPO publication WO 2020/013901 A1 in view of Goswami et al. U.S. publication no. 2011/0035019 A1 (“Goswami”).
As best understood (see rejection under 35 U.S.C. 112(b) hereinabove), regarding claims 16-18, Lee discloses a ‘two component’ fixed bearing (e.g., see at least figures 9 and 10; and paragraph [0146], etc.) prosthesis (100, seq.) for total ankle arthroplasty, comprising: a talar implant (200, seq.); a tibial implant (110, seq.); and a bearing component (150, seq.) disposed between the tibial implant (110, seq.) and talar implant (200, seq.) (figures) and configured to slide relative to the talar implant (110, seq.) to facilitate motion of the prosthesis (100, seq.) (figures), wherein the bearing component (150, seq.) is fixed to the tibial implant (110, seq.) at a fixed connection (e.g., see at least figures 9 and 10; and paragraph [0146], seq., etc.) and wherein: the bearing component (150, seq.) and the talar implant (200, seq.) have corresponding sliding surfaces (162, 210; seq.- see figures); the corresponding sliding surfaces (162, 210; seq.) defining concentric cylindrical surfaces and an axis of rotation (figures); the concentric cylindrical surface (162) of the bearing component (150) has a ridge (182, seq.) configured to slide in a corresponding groove (222, seq.) in the concentric cylindrical surface (210) of the talar implant (200, seq.) (paragraph [0147], etc.); wherein a cross-section of the ridge (182, seq.) is defined by a first radius and a cross-section of the groove (222, seq.) is defined by a second radius (e.g., figures 10-14 and 17; and paragraphs [0147]-[0148], seq. etc.), wherein the first radius and the second radius are each substantially the same, such that the shape of the ridge (182, seq.) matches the shape of the groove (e.g., figures 10-14 and 17; and paragraphs [0147]-[0148], seq. etc.); an alignment of the bearing component (150, seq.) and the talar implant (200, seq.), along an axis of rotation is only due to an interaction of the ridge (182, seq.) and the groove (222, seq.) (figures and page 15, paragraph [0147], etc.); and a cross-section of the ridge defines a radius between 3 and 3.5mm, and wherein the groove (222, seq.) extends from a front edge to a back edge of the talar implant (200, seq.) (figures); and wherein the ridge (182, seq.) extends from a front edge to a back edge of the bearing component (150, seq.) (figures).
Lee discloses “The central contact surface 182 may have, for example, a height ranging from approximately 1.5mm and 2mm” (paragraph [0147]). However, Lee is silent regarding the cross-section ridge radius of the central contact surface (i.e., claimed ridge). Thus, Lee is silent regarding a cross-section of the ridge defines a radius between 3 and 3.5mm substantially as claimed. Lee is likewise silent regarding the groove defines a radius of between 3mm and 3.5mm measured in a direction parallel to the axis of rotation substantially as claimed.
Formation of the cross-section of each of the ridge and groove with a radius in the range between 3 and 3.5mm measured in a direction parallel to the axis of rotation involves routine skill in the art, since these ranges appear within reasonable values for implantable human ankle prosthesis features (for example, see Goswami paragraphs [0055], [0056], [0070], [0071], [0076], etc.). Moreover, selecting these ranges merely involves discovering an optimum or workable range for the features of Lee’s disclosed device. Indeed, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Moreover, Applicant’s disclosure fails to show how the claimed ranges produce any unexpected results or are anything more than finding an optimum or workable range based on an analysis of stresses and features considered when forming an implantable prosthesis. See at least paragraphs [0014] and [0051] of Applicant’s filed disclosure.
Thus, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to form the cross-section of the ridge and groove each with a radius in the range between 3 and 3.5mm measured in a direction parallel to the axis of rotation in the invention of Lee in order to optimize the size of the device for handling the stresses of the implant and obtaining the desired disclosed articulation results with predictable results and a reasonable expectation of success.
Regarding claims 19-20, Lee discloses the groove comprises a generally concave semi-circular form of radius 3mm-3.5mm (e.g., figures); and the ridge comprises a generally convex semi-circular form of radius 3mm-3.5mm (e.g., figures).
Conclusion
The following prior art is made of record due to being pertinent to Applicant’s disclosure. However, this art is not expressly relied upon in the presented rejections.
Goswami et al. U.S. publication no. 2011/0035019 A1 (“Goswami”) discloses a prosthesis for total ankle arthroplasty comprising: a talar implant (130, seq.); a tibial implant (110, seq.); and a bearing component (120, seq.) disposed between the tibial implant (110, seq.) and talar implant (130, seq.) and configured to slide relative to the talar implant to facilitate motion of the prosthesis (e.g., figures, 1, 5, 10, 14, 18, 22 and 26), wherein: the bearing component (120, seq.) and the talar implant (130, seq.) have corresponding sliding surfaces (122 and 131, respectively, seq.) (e.g., figures, 1, 5, 10, 14, 18, 22 and 26), the corresponding sliding surfaces (122, 131; seq.) defining concentric cylindrical surfaces and an axis of rotation (e.g., figures, 1, 5, 10, 14, 18, 22 and 26, etc.); the concentric cylindrical surface (122, seq.) of the bearing component (120, seq.) has a groove configured to slide on a corresponding ridge in the concentric cylindrical surface (131, seq.) of the talar implant (130, seq.); an alignment of the bearing component (120, seq.) and the talar implant (130, seq.), along the axis of rotation, is only due to an interaction of the ridge and the groove (e.g., figures 1, 5, 10, 14, 18, 22 and 26, etc.). Goswami further evidences size ranges reasonable for features within an ankle joint including a range of 3 to 3.5mm (e.g., see at least paragraphs [0055], [0056], [0070], [0071], [0076], etc.).
Webster et al. U.S. patent no. 7,033,397 including col. 10, lines 35-39 evidences that metallic protrusions and polymeric grooves of bone prosthesis may be reversed as being within the routine skill of a worker in the art at the time of the effective filing date of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA LYNN WATKINS whose telephone number is (571)270-1456. The examiner can normally be reached Mon. & Tues. 3-8pm and Thurs. 12-6pm.
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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774
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