DETAILED ACTION
This office action is responsive to the amendment filed May 27, 2026. By that amendment, claims 22 and 28 are amended. Claims 22-26, 28, 29, and 31-41 are pending.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 27, 2026, has been entered.
Response to Arguments
The outstanding objection to claims 28 and 29 are overcome by the amendments to the claims.
The outstanding rejection under 35 USC 101 was overcome by the amendment of May 27, 2026.
Applicant's arguments filed May 27, 2026, have been fully considered but they are not persuasive, even in view of the amendment.
Regarding the rejection of all claims under 35 USC 103 in view of Medoff (US 2009/0275991) and Ramos Maza (US 2012/0010617), it is argued that the combination plate does not teach the claimed tangent reverse curve. Examiner takes the same position he took when writing the rejection, that each claimed feature is present in the prior art, even as amended. No other substantive argument is made.
The term “tangent reverse curve” as now claimed is understood to mean what was disclosed at [0007] and [0025] and fig. 4 of the instant disclosure. Such arrangement is not agreed to be distinct from that cited in the art.
The rejection is maintained, as updated to correlate to the claim amendment, below.
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:
Claim(s) 22-26, 28, 29, and 31-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medoff (US 2009/0275991 A1) in view of Ramos Maza (US 2012/0010617 A1).
Regarding claim 22, Medoff teaches a bone fusion plate 40 [0015], comprising:\
a proximal end 43 and a distal end 48 with a curved portion (47/50/52) therebetween;
an elongate member 41 having an upper surface (down in fig. 2C) and a lower surface (up in fig. 2C);
at least four fixation apertures 66 arranged along the elongate member 41 (five seen clearly in fig. 2B). The fixation apertures 66 each include countersinks below the upper surface ([0046], see fig. 2D). Those countersinks are capable of permitting an (inferentially claimed) head of an (inferentially claimed) fastener to become countersunk to assume a level that is above, below, or flush with the upper surface when the fastener is tightened (e.g. by selection of an appropriate fastener with an appropriately dimensioned head);
a compression slot 67 for receiving a fastener [0046] at a right angle or at an oblique angle to compress adjacent bone portions;
a first bend 50 and a second bend 52 along the elongate member 41, the first and second bends forming a tangent reverse curve, configured to mate the lower surface with the anatomy of a plantar aspect of a metatarsal bone [0012], [0047], wherein the first bend 50 has a radius that is larger than the radius of the second bend 52 (as seen in fig. 2C; further it is contemplated to modify these radii of curvature as at [0047]), and wherein the radius and concavity of the first bend 50 and the radius of the concavity of the second bend 52 are configured to conform the lower surface of the bone fusion plate to the anatomy of the plantar aspect of the metatarsal bone [0047] and wherein the first bend is configured to have a curved portion extending from the first bend to the second bend (the entire regions 47 and 48 of Medoff’s plate are considered to be curves – note mathematical definition of ‘curve’ being considered to include a straight segment, below; the bends are capable of being modified [0047] such that it is clear the plate can mate with various bone sizes/shapes, such modification interpreted as modification of the curve in a region between 50 and 52, as well).
a top portion at proximal end 43 (downward facing surface in fig. 2C) is lower (in the upward direction) than a bottom portion at the distal end 48 in a longitudinal dimension (lower being “up” in fig. 2C); and
a curvature along a longitudinal or lateral dimension configured to match the anatomy of a bone to be treated (see e.g. fig. 2E; [0052])
The limitation “at an oblique angle” is considered to be a second alternative which the claim no longer requires once the perpendicular limitation is met.
“A curve” is defined in mathematics is described as “A smoothly flowing line (no sharp changes). In normal language a curve must bend (change direction), but in mathematics a straight line is also a curve” (www.mathisfun.com, 2007).
Medoff fails to teach the countersunk surface being configured to prevent the inferred fastener from backing out after being implanted into the metatarsal bone.
Ramos Maza teaches a countersunk surface 120 as best seen at fig. 5A. This surface is taught as an “anti-rotation surface”. The anti-rotation surfaces are described as cooperating with a head of a bolt inserted therein to prevent rotation of the bolt about a longitudinal axis of the bolt. [0054] Angles of the surfaces are selected to oppose rotation of a head of the bolt when in contact therewith, and sufficient to provide a secure contact between those surfaces [0055]. The surfaces are known in some situations to include friction enhancing features. [0056]
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Medoff plate with a total chamfer angle of any of the claimed range, as suggested by Ramos Maza. One would have done so in order to provide the Medoff plate with anti-rotation structures within the screw holes thereof to ensure secure contact between a tapered surface of a screw head and a countersunk bore [0054-0056]. The structure of the countersink cooperating with a screw head is considered to be a locking feature which prevents a fastener from loosening.
Regarding claim 23, the at least four apertures 66 are configured for receiving (inferentially claimed) fasteners suitable [0046] for fastening the bone fusion plate 40 to the plantar aspect of a metatarsal bone [0012], [0047].
Regarding claim 24, the bone fusion plate is comprised of a material having a tensile strength suitable for immobilizing adjacent bone portions of the metatarsal bone [0057].
Regarding claim 25, the combination suggests the limitations of claim 24, as above. Medoff further teaches use of “medical grade polymers” [0057].
However, Medoff does not specifically teach the plate formed of PEEK.
PEEK is known to be one type of medical grade polymer.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Medoff plate of PEEK based on the teaching that the plate could be formed of a medical grade polymer at [0057], and due to the fact that it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 26, Medoff teaches forming the plate of various biocompatible metals [0057].
Regarding claims 28 and 29, Ramos Maza teaches a chamfer angle of between 30 and 75 degrees [0055]. Examiner notes that this angle refers to an angle α as seen in fig. 5A. When angle α is converted to the claimed chamfer angle (as interpreted, previously), this correlates to a claimed chamfer angle in the range of 30-120 degrees. This disclosed range clearly encompasses the claimed ranges required by the claims.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Medoff plate with a chamfer angle of any of the claimed range, as suggested by Ramos Maza. One would have done so in order to provide the Medoff plate with anti-rotation structures within the screw holes thereof to ensure secure contact between a tapered surface of a screw head and a countersunk bore [0055]. The structure of the countersink cooperating with a screw head is considered to be a locking feature which prevents a fastener from loosening.
Regarding claim 31, the first bend 50 extends from a middle portion of the elongate member 41 and is concaved toward the upper surface (down in fig. 2C).
Regarding claims 32-38, the second bend 52 extends from the first bend. The second bend 52 is concaved toward the bottom surface (up in fig. 2C).
The second bend does not extend to the proximal end 43 of the plate in the demonstrated embodiment, such that a proximal portion is uncurved.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the plate with the claimed angles and locations of the curved portions. As at [0047], the angles and lengths of portions of the plate can be modified such that the plate conforms to other bones besides the fibula. In such a modification, the direction of concavity can be reversed and/or locations of the two bends can be reversed and/or the end declared to be proximal or distal can be reversed. Some of the alternative arrangements discussed will result in the claimed direction of concavity and location of the claimed bends relative to proximal and distal ends of the plate. One would have made the modification in order to form the bone plate to be specifically tailored for particular sites of application having a bone surface which flares proximate terminal ends of the plate. [0047]
The term “reverse curve” claimed at claim 35 is not a term of art known to the examiner, and is a term which is not particularly defined in the originally presented disclosure. As best understood, the reverse curve simply requires a first bend in a first direction, and second bend in a second direction. This understanding is supported from applicant’s figures. Curves 50 and 52 are considered to form a reverse curve. Examiner is unclear if this reverse curve limitation is contradictory to the ‘tangent reverse curve’ of claim 22, or in addition thereto. As written, this appears to be an additional limitation.
The plate having been configured for use on a 5th metatarsal [0047] is one of the modifications contemplated by Medoff.
Regarding claims 39-41, as best seen in fig. 2E, the curvature includes one or more curves arranged substantially perpendicularly to the length of the elongate member 41 [0052]. As noted above, curves 50 and 52 are also present which curves exist parallelly to the length of the elongate member 41 as seen in fig. 2C. The combination of curves is configured to mate the member to the 5th metatarsal [0047].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID BATES/Primary Examiner, Art Unit 3799
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