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 II, Species D, drawn to claims 10-16 in the reply filed on August 12, 2026 is acknowledged.
Allowable Subject Matter
Claims 12 and 13 are 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 fails to teach or disclose wherein the first and second side surfaces of the proximal femur replacement implant each include a recessed surface, the one or more screw fixation holes being formed in the recessed surface, the recessed surfaces being arranged and configured to be recessed a sufficient distance to reduce the extent that the secondary bone plate extends from an outer surface of the proximal femur replacement implant.
The prior art fails to teach or disclose wherein the secondary bone plate includes a first end, a second end, a central portion extending between the first and second ends, and a plurality of openings formed therein for receiving a fastener so that, in use the first end of the secondary bone plate is coupled to the first side surface of the proximal femur replacement implant via one or more fasteners passing through one of the openings formed in the first end of the secondary bone plate and into one of the screw fixation holes formed in the first side surface of the proximal femur replacement implant, the central portion of the secondary bone plate extends across a surface of the primary bone plate, and the second end of the secondary bone plate is coupled to the second side surface of the proximal femur replacement implant via one or more fasteners passing through one of the openings formed in the second end of the secondary bone plate and into one of the screw fixation holes formed in the second side surface of the proximal femur replacement implant.
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 10 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2020/0129297 to Haidukewych et al.
As to Claim 10, Haidukewych discloses a proximal femur replacement implant assembly arranged and configured to replace a head portion of a patient's proximal femur (600, Fig. 6, [0075]). The assembly comprises a proximal femur replacement implant (110) arranged and configured to be coupled to, or inserted into an intramedullary canal of, a remaining portion of a patient's femur [0054, 0075], the proximal femur replacement implant including a proximal end, a distal end, a first side surface, a second side surface, a medial side surface, and a lateral side surface (see annotated Fig. 6, below), a primary bone plate (612) arranged and configured to be coupled to a patient's bone [0075], and a secondary bone plate (634) arranged and configured to couple the primary bone plate (612) to the proximal femur replacement implant (110, Fig. 6, [0075]).
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As to Claim 14, Haidukewych discloses a proximal femur replacement implant assembly wherein the primary bone plate (612, analogous to 112 of Figs. 1A-1B) includes a hook-shaped plate (130) including one or more hooks formed on a proximal end thereof configured to engage a patient's proximal femur (conformity with 108 described in [0057], Figs. 1A-1B).
As to Claim 15, Haidukewych discloses a proximal femur replacement implant assembly wherein the secondary bone plate (634) is pressed- fitted to the primary bone plate (612, [0075]).
As to Claim 16, Haidukewych discloses a proximal femur replacement implant assembly arranged and configured to replace a head portion of a patient's proximal femur (600, Fig. 6, [0075]). The assembly comprises a proximal femur replacement implant (110) arranged and configured to be coupled to, or inserted into an intramedullary canal of, a remaining portion of a patient's femur [0054, 0075], the proximal femur replacement implant including a proximal end, a distal end, a first side surface, a second side surface, a medial side surface, and a lateral side surface (see annotated Fig. 6, above), and a customizable bone plate (612, analogous to 112 of Figs. 1A-1B) arranged and configured to be flexible (conformity with 108 described in [0057], Figs. 1A-1B), the bone plate arranged and configured to be coupled to a patient's bone [0057, 0075] and arranged and configured to coupled to the proximal femur replacement implant (coupled via 634, [0075]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0129297 to Haidukewych et al. in view of U.S. Patent Pub. No. 2009/0164026 to Mikami et al.
As to Claim 11, Haidukewych discloses a proximal femur replacement implant assembly wherein the proximal femur replacement implant (110) includes one or more screw fixation holes (receiving 251, Fig. 6, [0075]), each of the one or more screw fixation holes arranged and configured to receive a fastener or screw (251) for coupling the secondary bone plate (634) to the proximal femur replacement implant [0075].
As to Claim 11, Haidukewych discloses the claimed invention except for wherein the one or more screw fixation holes formed in the first and second side surfaces of the proximal femur replacement implant and being configured to receive a fastener or screw for coupling the secondary bone plate to the first and second side surfaces of the proximal femur replacement implant.
Mikami discloses a proximal femur replacement implant assembly (1, Fig. 1, [0058]) wherein one or more screw fixation holes (24) are formed in the first and second side surfaces (29) of the proximal femur replacement implant (22) and being configured to receive a fastener (6) for coupling the secondary bone plate (3) to the first and second side surfaces (29) of the proximal femur replacement implant (Figs. 1 and 2, [0066, 0080]) in order to allow for load to be distributed laterally to reduce chance of breakage of the implant while maintaining structural strength [0080-0081].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the proximal femur replacement implant assembly of Haidukewych with the fixation hole modification of Mikami in order to allow for load to be distributed laterally to reduce chance of breakage of the implant while maintaining structural strength.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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