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.
Election/Restrictions
Applicant’s election without traverse of Group I, Species A in the reply filed on June 30, 2026 is acknowledged.
Claims 10-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 30, 2026.
As an additional note, Applicant’s remarks filed April 6, 2026 and June 30, 2026, indicate that claims 11-18 should be included with invention 1 because they have been amended to include all of the features of independent claim 1. The restriction requirement mailed February 12, 2026, appears proper and has not contested by Applicant. The amendment places invention Group II in condition for consideration of rejoinder in the event that claim 1 is found allowable.
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 1-9 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.
When read in light of the original disclosure, it appears that the subtalar joint replacement device (preamble) comprises (1) a talar component; and (2) a calcaneal component. However, because no conjunction “and” or the like has been placed in between lines 6 and 7 of claim 1, this is unclear. The conjunctions in claim 1 appear to be used to delineate the subcomponents for each of the talar component and calcaneal component.
Claim 3 depends from claim 2, which depends from claim 1. Claim 3 recites the limitations “the first torus has a first articular radius; and the second torus has a second articular radius different from the first articular radius”. These limitations are unclear for at least the following reasons. First, there is insufficient nexus relating “the first torus” with a “first articular radius” as compared with the “surface of the portion of the first radius” (claim 2). Similarly, there is insufficient nexus relating “the second torus” with a “second articular radius” as compared with the “surface of the portion of the second radius”. Moreover, claim 3 requires the “first articular radius” to be “different from the second articular radius”. However, claim 1, upon which claim 3 depends requires “second shape to interface with the first shape of the talar articular surface to generate constraint across a subtalar joint” (claim 1, lines 10-11). Applicant’s originally filed disclosure discusses how same/similar first and second radii generate constraint across a subtalar joint, but how the level of constraint may be managed by the level of conformity between the radii (see originally filed specification at pages 12-13). Thus, it is unclear if the radii should be the same i.e., “generate constraint across a subtalar joint” (claim 1, line 11) or be different (claim 3). Moreover, it is unclear how claim 3 further limits claim 1.
Claim 4, line 2 is missing a preposition such as “of” between “an articular surface” and “a talus bone”. Similarly, claim 4, line 5 is missing a preposition such as “of” between “an articular surface” and “a calcaneus bone”. The intended preposition is unknown, therefore the claim is indefinite.
Claims 8 and 9 depend from independent claim 1. Claim 1 requires the limitation “the calcaneal articular surface…interfaces with… the talar articular surface…” (claim 1, lines 9-11). Claim 8 requires “a bearing insert configured to be positioned between the talar component and the calcaneal component”. When read in light of the original disclosure it is unclear how the talar and calcaneal components can interact as required by claim 1 if there is a bearing therebetween. Moreover, claim 9 requires, “the bearing insert is affixed to the talar articular surface or the calcaneal articular surface”. However, when read in light of the original disclosure, it is unclear how the bearing insert may be affixed to a surface that is required to, itself, “interface,” as required by independent claim 1, upon which claim 9 depends. Therefore, claims 8 and 9 are unclear and indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. See rejection of claim 3 under 35 U.S.C. 112(b) hereinabove. Claim 3 does not appear to further limit claim 1, upon which it depends because claim 1 requires the “second shape to interface with the first shape of the talar articular surface to generate constraint across a subtalar joint,” while claim 3 requires, “first articular radius” to be “different from the second articular radius.” See pages 12-13 of Applicant’s originally filed specification. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 8 and 9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. See rejection under 35 U.S.C. 112(b) as described hereinabove. Claim 1 requires “talar articular surface” and “calcaneal articular surface” to “interface” (claim 1, line 10). However, claims 8 and 9 require a bearing to lie between said interfacing surfaces or be attached thereto. Thus, claims 8 and 9 fail to further limit claim 1, upon which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-4 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanders et al. U.S. publication no. 2017/0304065 A1 (“Sanders”).
Regarding claim 1, Sanders discloses a subtalar joint replacement device (100, seq.), comprising: a talar component (102, seq.), comprising: a talar fixation surface (116, seq.; e.g., paragraphs [0075]-[0079], etc. figure 5, etc.); a talar articular surface (118, seq.) opposite the talar fixation surface (116, seq.) (e.g., paragraphs [0075]-[0078], etc.; figure 5, etc.), the talar articular surface (118, etc.) having a first shape (e.g., figure 5; and paragraphs [0075]-[0078, etc.); and one or more fixation devices (114, seq.) extending from the talar fixation surface (116, seq.) (e.g., paragraphs [0100]-[0102], etc.); and a calcaneal component (104, seq.), comprising: a calcaneal fixation surface (138, seq.) (e.g., figure 5, etc.; and paragraphs [0088]-[0092], etc.); a calcaneal articular surface (176, seq. or the like) opposite the calcaneal fixation surface (138, seq.) (e.g., figure 5, etc. and paragraphs [0086]-[0087], [0093], [0105], [0112], etc.), the calcaneal articular surface (176, seq.) having a second shape (e.g., paragraphs [0105], [0108], [0112], etc.) that interfaces with the first shape of the talar articular surface (118, seq.) to generate constraint across a sub-talar joint (figures 5-7; and paragraphs [0075]-[0078], [0105], [0108], [0112], etc.); and one or more fixation devices (136, seq.) extending from the calcaneal fixation surface (138, seq.) (e.g., see at least figure 5; and paragraphs [0095]-[0102], etc.).
Regarding claim 2, Sanders discloses the first shape of the talar articular surface (118, seq.) conforms to a surface of a portion of a first torus (i.e., has a shape that follows a portion of a circular shape with a radius of curvature- e.g., see at least figures 5-7; and paragraphs [0075], [0077]-[0078], etc.); and the second shape of the calcaneal articular surface (176, seq.) conforms to a surface of a portion of a second torus (i.e., has a shape that follows a portion of a circular shape with a radius of curvature- e.g., see at least figures 5-7; and paragraphs [0105], [0112]-[0113], etc.).
Regarding claim 3, Sanders discloses the first torus (radius of curvature of 118, seq.) has a first articular radius; and the second torus (radius of curvature of 176) has a second articular radius different from the first articular radius (e.g., see at least paragraphs [0075], [0077]-[0078], [0105], [0112]-[0113], etc., especially paragraph [0112], wherein a kit includes at least two implant surfaces with different first and second radii of curvatures that are differently matched with respect to one another).
Regarding claim 4, Sanders discloses the talar fixation surface (116, seq.) is shaped to conform to native anatomy of an articular surface of a talus bone (figures 5-7; and paragraph [077], etc.); and the calcaneal fixation surface (138, seq.) is shaped to conform to native anatomy of an articular surface of a calcaneus bone (figures 5-7; and paragraph [0090], etc.).
Regarding claim 8, Sanders discloses the joint replacement device (100, seq.) further comprising a bearing insert (106, seq.) configured to be positioned between the talar component (102, seq.) and the calcaneal component (104, seq.) (e.g., figure 5, etc.).
Regarding claim 9, Sanders discloses the bearing insert (106, seq.) is affixed to calcaneal articular surface (e.g., figure 5, etc.).
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schon et al. U.S. publication no. 2015/0051706 A1 (“Schon”).
Regarding claim 1, Schon discloses a subtalar joint replacement device (1; figure 1), comprising: a talar component (2; figures 1A and B), comprising: a talar fixation surface (inner surface 8) (e.g., figures 1A and 5, etc.); a talar articular surface (outer surface 6) (e.g., figures 1B and 5, etc.) opposite the talar fixation surface (8) (e.g., figures 1 and 5, etc.), the talar articular surface (6) having a first [concave] shape (e.g., figures; and paragraph [0038]); and one or more fixation devices (protrusions 10) (figures) extending from the talar fixation surface (8) (e.g., figures 1 and 5); and a calcaneal component (4) (figures 2A and 2B), comprising: a calcaneal fixation surface (28) (e.g., figure 2A, paragraph [0046], etc.); a calcaneal articular surface (26) opposite the calcaneal fixation surface (figures 2B, etc.), the calcaneal articular surface (26) having a second [convex] shape that interfaces with the first [concave] shape of the talar articular surface (6) to generate constraint across a sub-talar joint (e.g., paragraph [0047], figures, etc.); and one or more fixation devices (30) extending from the calcaneal fixation surface (28) (e.g., see at least figures; and paragraph [0052], etc.).
Regarding claim 2, Schon discloses the first [concave] shape of the talar articular surface (6) conforms to a surface of a portion of a first torus (i.e., has a shape that follows a portion of a circular shape with a radius of curvature- e.g., see at least paragraph [0035], figures, etc.); and the second [convex] shape of the calcaneal articular surface (26) conforms to a surface of a portion of a second torus (i.e., has a shape that follows a portion of a circular shape with a radius of curvature- e.g., see at least figures; and paragraph [0053], etc.).
Regarding claim 3, Schon discloses the first torus (radius of curvature of 6) has a first articular radius; and the second torus (radius of curvature of 26) has a second articular radius different from the first articular radius (e.g., see at least paragraph [0047], i.e., R.sub.Co, and is “slightly larger than” the average radius, R.sub.To).
Regarding claims 4 and 5, Sanders discloses the talar fixation surface (6) is shaped to conform to native anatomy of an articular surface of a talus bone such that the talar fixation surface is shaped to conform to a surface of a section of a first cone (e.g., see at least figures; and paragraphs [0031]- [0035], etc.); and the calcaneal fixation surface (26) is shaped to conform to native anatomy of an articular surface of a calcaneus bone such that the calcaneal fixation surface is shaped to conform to a surface of a section of a second bone (e.g., see at least figures; and paragraphs [0046], [0065], etc.).
Claims 1 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schweitzer et al. WIPO publication no. 2019/090022 A1 (“Schweitzer”).
Regarding claim 1, Schweitzer discloses a subtalar joint replacement device (100; figure 1), comprising: a talar component (10; figure 1), comprising: a talar fixation surface (12) (e.g., figure 1); a talar articular surface (e.g., figure 1) opposite the talar fixation surface (14) (e.g., figure 1), the talar articular surface having a first [concave] shape (e.g., figures); and one or more fixation devices (40) (figures 1 and 7) extending from the talar fixation surface (14) (e.g., figures 1 and 7; and paragraph [0071]); and a calcaneal component (30) (figure 1), comprising: a calcaneal fixation surface (32) (e.g., figure 1); a calcaneal articular surface opposite the calcaneal fixation surface (tray 34, figure 1), the calcaneal articular surface having a second [convex] shape that interfaces with the first [concave] shape of the talar articular surface to generate constraint across a sub-talar joint (e.g., paragraph [0071], figures, etc.); and one or more fixation devices (50) extending from the calcaneal fixation surface (e.g., see at least figures 4; and paragraph [0071], etc.). Schweitzer further teaches the first and second bearing surfaces 14, 24 have different radii of curvature (e.g., see at least paragraphs [0050], etc.).
Regarding claim 6, Schweitzer discloses at least one of the talar component and the calcaneal component has a non-uniform thickness (e.g., figures 1-3 and 5-7).
Regarding claim 7, Schweitzer discloses at least one of the talar component and the calcaneal component has a thickness that increases in a lateral direction and in an anterior direction. (e.g., see at least figures 1-3 and 5-7).
Regarding claim 8, Schweitzer discloses the joint replacement device (100, seq.) further comprising a bearing insert (106, seq.) configured to be positioned between the talar component (102, seq.) and the calcaneal component (104, seq.) (e.g., figure 5, etc.).
Regarding claim 9, Schweitzer discloses the bearing insert (106, seq.) is affixed to calcaneal articular surface (e.g., figure 5, etc.).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. U.S. publication no. 2017/0304065 A1 (“Sanders”) in view of Schon et al. U.S. publication no. 2015/0051706 A1 (“Schon”).
Regarding claim 5, as described supra, Sanders discloses the invention substantially as claimed. Sanders discloses the fixation surfaces may be formed as any shape that best optimizes the implant procedure (e.g., see at least paragraphs [0077] and [0090], etc.).
However, Sanders is silent regarding the talar fixation surface is specifically shaped to conform to a surface of a section of a first cone; and the calcaneal fixation surface is specifically shaped to conform to a surface of a section of a second bone substantially as claimed.
In the same field of endeavor, namely subtalar joint prosthesis, Schon teaches a talar fixation surface is shaped to conform to a surface of a section of a first cone; and the calcaneal fixation surface is shaped to conform to a surface of a section of a second bone (e.g., figures and paragraphs [0031]-[0035], [0046] and [0065], etc.).
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 fixation surfaces of Sanders such that the talar fixation surface is specifically shaped to conform to a surface of a section of a first cone; and the calcaneal fixation surface is specifically shaped to conform to a surface of a section of a second bone in order to allow for minimal bone resection with predictable results and a reasonable expectation of success.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. U.S. publication no. 2017/0304065 A1 (“Sanders”) in view of Schweitzer et al. WIPO publication no. 2019/090022 A1 (“Schweitzer”).
Regarding claims 6 and 7, as described supra, Sanders discloses the invention substantially as claimed. Throughout the disclosure, Sanders teaches selecting desired radii of curvature and component sizing in order to form a patient optimized prosthetic component (e.g., see at least paragraphs [0077]-[0078], [0090]-[0091], [0112]-[0113]). However, Sanders is silent regarding at least one of the talar component and the calcaneal component has a non-uniform thickness, wherein the non-uniform thickness increases in a lateral direction and in an anterior direction substantially as claimed.
In the same field of endeavor, namely subtalar joints, Schweitzer teaches at least one of the talar component and the calcaneal component has a non-uniform thickness, wherein the non-uniform thickness increases in a lateral direction and in an anterior direction (e.g., see at least figures).
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 vary the sizing and curvature of the implant such that at least one of the talar component and the calcaneal component has a non-uniform thickness, wherein the non-uniform thickness increases in a lateral direction and in an anterior direction in the invention of Sanders in order to optimize the implant for a particular patient’s need and/or surgical procedure with predictable results and a reasonable expectation of success.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774
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