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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species A in the reply filed on 1/22/2026 and the interview from 4/9/2026 is acknowledged.
Claim(s) 10-13 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/22/2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/402885, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. 63/402885 fails to provide support for: the articulation surface comprises a substantially planar surface (as required by claim(s) 3-9); and a projection extending from a dorsal to a plantar surface of the implant (as required by claim(s) 8-9, 14) (it should be noted, within the specification for 63/40288 a fig. 5 is discussed which might provide support for the aforementioned features, however no fig. 5 is found within the drawings). Claim(s) 1-2 are awarded a priority date of August 31, 2022; claim(s) 3-19 are awarded a priority date of August 30, 2023.
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.
Claim(s) 3-9 is/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.
The term “substantially” in claim 3 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Please note: Applicant defined “substantially” within the specifications paragraph [0072]; however, even with the definition (“a quantity, property, or value that is present to a great or significant extent and less than, more than or equal to total”) it is unclear what defines “substantially planar”. What constitutes less than/ more than “substantially planar”? If something has a radius (which would make it not planar), what radius becomes “substantially planar”, or is it the size of the radius with respect to the size of the articulation surface/ articular section? It should be further noted, the “substantially planar” language within the specifications is not used to describe the articulation surface/ articular section (“substantially planar” is instead used to describe the tool used during the placement thereof). The articulation surface/ articular section is instead described as planar or having a radius. Claim(s) 4-9, which depend from claim 3, inherit the problems of claim 3.
Within claim 5, lines 2-3: Applicant claims, “an opposing articular surface of an adjacent bone”; it is unclear, and therefore indefinite, if this is the same as OR in addition to the articular surface of the resected bone (within claim 1, lines 1). Claim(s) 7-9, which depend from claim 5, inherit all the problems associated with claim 5.
Within claim 6, lines 2-3: Applicant claims, “one of ceramic or metal and is selected to be different than the articular surface”; it is unclear, and therefore indefinite, what has the ceramic/ metal – the articular surface (as required by the aforementioned claim requirement) OR the articular section (as required by claim 4, lines 1-2).
Within claim 7, lines 1-2: Applicant claims, “the projection is configured to mate with a recess formed in bone tissue”; it is unclear, and therefore indefinite, if this is the same as OR different from the resected bone (within claim 1, line 2). Claim(s) 8-9, which depend from claim 7, inherit all the problems associated with claim 7.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Deutchman et al. (US 2017/0258597 A1).
With respect to claim 1:
Deutchman et al. discloses a mid-foot arthroplasty system (orthopaedic implant capable of being implanted in the mid-foot), as can be seen in figs. 16A-16B, comprising an insert implant (either of elements 810 or 820) configured to be (capable of being) joined to an articular surface of a resected bone (paragraph [0075]), the insert implant (element 810 or 820) comprising one of ceramic on metal (bulk metal material with a ceramic coating) or metal on ceramic (paragraphs [0041, 0075]).
With respect to claim 2:
Wherein the insert implant (element 810 or 820) further comprises an articular section (surface 812 or 832), an osteo-interface section (surface opposite surface 812 or 832), and a projection (threaded projection in fig. 16A) extending from the osteo-interface section (surface opposite surface 812 or 832) (paragraph [0075]).
With respect to claim 3:
Wherein the articular section (surface 812 or 832) further comprises a substantially planar surface (a small subsection of the surface 812 or 832 is considered “substantially planar” as it has a large enough radius that it does not create a ball shape, or potentially the rim shown at the edge of the surface 832 in figs. 16A-16B) configured to articulate (capable of articulating) with an adjacent bone.
With respect to claim 4:
Wherein the articular section (surface 812 or 832) further comprises one of ceramic or metal (ceramic coating) (paragraph [0041, 0075]).
With respect to claim 5:
Wherein the osteo-interface section (surface opposite surface 812 or 832) further comprises a surface configured to (capable of being) interface with an opposing articular surface of an adjacent bone (paragraph [0075]).
With respect to claim 6:
Wherein the osteo-interface section (surface opposite surface 812 or 832) further comprises one of ceramic or metal (bulk metal) and is selected to be different than the articular surface (ceramic surface 812 or 832) (paragraph [0041]).
With respect to claim 7:
Wherein the projection (threaded projection in fig. 16A) is configured to mate with a recess formed in bone tissue and retain the insert implant (element 810 or 820) in a fixed position within the bone tissue (paragraph [0075]).
Claim(s) 14, 16-19 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Smith (US 2017/0095341 A1).
With respect to claim 14:
Smith discloses a mid-foot arthroplasty implant (rail fixing implant 122 used with tarsal joints), as can be seen in figs. 7 and 25 (paragraphs [0094, , 0100]), comprising: an articular surface (smooth articulation surface 12A) (paragraph [0095]), an osteo-interface surface (substrate interfacing element 14) (paragraph [0095]), and a projection (one of transverse rails 125) extending outward from the osteo-interface surface (substrate interfacing element 14) and extending from a dorsal to a plantar surface (the surfaces from which the leading element 125L and the pursuing element 125P originate from) of the implant (rail fixing implant 122) (paragraph [0098]).
With respect to claim 16:
Wherein the articular surface (smooth articulation surface 12A) is configured to (is capable of) articulate with an articular surface of an adjacent bone (paragraphs [0066-0067, 0095]).
With respect to claim 17:
Wherein the osteo-interface surface (substrate interfacing element 14) is configured to (is capable of) fixedly seat within a mating recess in bone tissue (grooves within substrate/ bone) (paragraphs [0090, 0101]).
With respect to claim 18:
Wherein the projection (one of transverse rails 125) is made of the same material as the osteo-interface surface (substrate interfacing element 14) (made from a singular material) (paragraph [0092]).
With respect to claim 19:
Wherein the articular surface (smooth articulation surface 12A) and the osteo-interface surface (substrate interfacing element 14) are fixedly joined to one another (when made from a singular material) (paragraph [0092]).
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) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deutchman et al. (US 2017/0258597 A1) in view of Smith (US 2017/0095341 A1).
With respect to claim(s) 8:
Deutchman et al. discloses the invention substantially as claimed, as discussed above. However, Deutchman et al. does not disclose the projection (threaded projection in fig. 16A) to be elongate and extending from a dorsal to a plantar surface of the insert implant (element 810 or 820).
Smith teaches a mid-foot arthroplasty implant (rail fixing implant 122 used with tarsal joints), as can be seen in figs. 7 and 25 (paragraphs [0094, 0100]), comprising: an articular surface (smooth articulation surface 12A) (paragraph [0095]), an osteo-interface surface (substrate interfacing element 14) (paragraph [0095]), and a projection (one of transverse rails 125) extending outward from the osteo-interface surface (substrate interfacing element 14) and extending from a dorsal to a plantar surface (the surfaces from which the leading element 125L and the pursuing element 125P originate from) of the implant (rail fixing implant 122) (paragraph [0098]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the projection (threaded projection in fig. 16A), as disclosed by Deutchman et al., with the projection (one of transverse rails 125) (which extends from a dorsal to a plantar surface (the surfaces from which the leading element 125L and the pursuing element 125P originate from)), as taught by Smith, as the two structures are used for the same purpose (both are used to attach an implant to resected bone) in the same area of the body (within the foot) and as such would be considered obvious substitutes for each other.
With respect to claim 9:
Wherein the projection (one of transverse rails 125), as taught by Smith, further comprises a same material (bulk metal) as the osteo-interface section (substrate interfacing element 14), as disclosed by Deutchman et al. (the materials thereof, are not modified by the shape/ structural changes made with respect to the rejection of claim 8 above).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2017/0095341 A1) in view of Deutchman et al. (US 2017/0258597 A1).
With respect to claim(s) 15:
Smith discloses the invention substantially as claimed, as discussed above. However, Smith does not disclose the mid-foot arthroplasty implant (rail fixing implant 122 used with tarsal joints) to comprise ceramic on metal materials, specifically a ceramic articular surface (smooth articulation surface 12A) and a metal osteo-interface surface (substrate interfacing element 14) to comprise metal.
Deutchman et al. teaches a mid-foot arthroplasty system (orthopaedic implant capable of being implanted in the mid-foot), as can be seen in figs. 16A-16B, comprising an insert implant (either of elements 810 or 820) configured to be (capable of being) joined to an articular surface of a resected bone (paragraph [0075]), the insert implant (element 810 or 820) comprising a ceramic articular section (surface 812 or 832) and a metal osteo-interface section (surface opposite surface 812 or 832) (paragraphs [0041, 0075]). The aforementioned combination of materials results in implants which have the high fracture resistance of the bulk metal and a wear resistant/ corrosion resistant/ self-lubricating articulation surface (paragraphs [0032-0033, 0035]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the materials, as taught by Deutchman et al., to make the mid-foot arthroplasty implant (rail fixing implant 122 used with tarsal joints), as disclosed by Smith (thereby resulting in a ceramic layer, as taught by Deutchman et al., making up the articular surface (smooth articulation surface 12A), as disclosed by Smith, and a bulk metal, as taught by Deutchman et al., making up the osteo-interface surface (substrate interfacing element 14), as disclosed by Smith) as the two structures are used for the same purpose (both are used to replace articulating joints) and materials, as taught by Deutchman et al., will result in an implant with high fracture resistance and high wear resistant/ corrosion resistant/ self-lubricating for articulation surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. HALES et al. (US 2022/0233324 A1) discloses a mid-foot arthroplasty system with a flat articulation surface.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774
Prosecution Insights