DETAILED ACTION
This office action is responsive to the amendment and request for continued examination filed May 21, 2026. By that amendment, claim 4 was amended. Claims 4-10, 13-15, and 20-23 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 21, 2026, has been entered.
Response to Arguments
Applicant's arguments filed May 21, 2026, have been fully considered but they are not persuasive.
All arguments are based on the amended claim 4, and it is stated that the art of record does not motivate or suggest at least the newly added limitations. Basically, this was just a statement that this limitations is not there. No further evidence provided.
Examiner disagrees and points to why it is his position that the newly recited limitation is present in the prior art: See the rejection, below, modified to correlate to the amended claim language. Essentially, the amendment requires modifying the countersunk surface to correspond to an inferred countersunk head of an inferred fastener, such that the amendment is considered read upon by certain countersunk heads of certain fasteners.
The rejection of record is maintained.
Comment Regarding Limitation “Locking Feature”
For sake of brevity, the comment will not be repeated here. It is present in all office actions since March 7, 2025, and can be reviewed in any of those actions. The same understandings continue to be in effect.
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) 4-10, 13-15, and 20-23 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 4, Medoff teaches a method of forming a bone fusion plate. It is inherent that at some point in time, Medoff’s plate had to be manufactured, formed, or produced. The method includes
forming an elongate member 40 having an upper surface (down in fig. 2C) and a lower surface (up in fig. 2C) configured to mate with the anatomy of a plantar aspect of a metatarsal bone [0047], [0048];
arranging at least four fixation apertures 66 along the elongate member 40 to receive inferred fasteners for fastening the elongate member 40 to the plantar aspect;
forming a countersunk surface below the upper surface within each of the at least four fixation apertures [0046];
forming the countersunk surface includes configuring the countersunk surface such that an inferred countersunk head of some inferred fastener is capable of assuming a level that is flush with, or disposed below, the upper surface when the inferred fastener is tightened to hold the bone fusion plate against the metatarsal bone;
a longitudinal dimension of the plantar bone plate includes a first bend 50 with a first radius and a second bend 52 with a second radius, the second radius being smaller than the first radius as seen at fig. 2C;
configuring a compression slot 67 for compressing adjacent bone portions [0002, 0005] wherein the compression slot is configured to receive an inferred fastener at a right or oblique angle with respect to a plane of the plantar bone plate (depending on how the screw is driven) to encourage bone fusion; and
creating a curvature along the elongate member 40 to mate with the anatomy of the plantar aspect (curves 50 and 52 at fig. 2C; [0047] discusses modifying the radii of curvature to tailor the plate to particular sites of application, including a metatarsal) the curvature being configured to mate the bone plate with the specific anatomy of a bone to be treated (see e.g. figs. 11 and 12).
Medoff fails to teach the particular chamfer angle of the countersunk surfaces; or the chamfer angle being measured with respect to the countersunk surface and a centerline of each fixation aperture.
Ramos Maza teaches a configuration of a countersunk surface in an aperture in a bone plate. Ramos Maza teaches an angle a in his figures, which is described as being between about 30 to about 75 degrees. This results in the angle measured with respect to the countersunk surface and a centerline of the aperture being between 120 and 30 degrees. This range is considered to encompass each of the claimed chamfer angles. The measurement with respect to the countersunk surface and a centerline of the aperture is demonstrated in the marked up figure, below.
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It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Medoff apertures 66 with the claimed chamfer angles since Ramos Maza has taught that those angles are known to prevent rotation of the screws within the holes by providing normal forces which resist backout of the screw. (Ramos Maza, [0055]) Such a modification to the Medoff apertures would have resulted in reduced likelihood of screw backout after implantation of the plate and screws into a patient.
Regarding claim 5, Medoff makes no mention of an angle that the screw is received in the slot 67. It is inherent that a screw received through slot 67 will be either oblique or at a right angle with respect to a plane of the elongate member 40.
Regarding claim 6, the method includes forming a curvature that includes a first bend 50 and a second bend 52 along the elongate member 40.
Regarding claim 7, the curvature is configured for anatomy of a 5th metatarsal. This is considered to include a plantar anatomy. [0046-0047]
Regarding claim 8, the first bend 50 is concaved toward the upper surface as at fig. 2C and extending from a middle portion of elongate member 40.
Regarding claim 9, the second bend 52 is concaved toward the lower surface as at fig. 2C, and extending from the first bend to a proximal end 48 of the elongate member 40.
Regarding claim 10, as at [0047], the radii of curvature of 50 and 52 can be modified to any configuration for matching with a 5th metatarsal. This is considered to include a second bend 52 with smaller radius than the radius of the first bend 50.
Regarding claims 13-15, as at [0057], various materials suitable for immobilizing bone portions are taught, including medical grade polymers (known to include PEEK); and titanium (a biocompatible metal).
Regarding claim 20, the countersinks of the apertures 66 are considered to be formed as locking features for preventing loosening of the fastener (e.g. due to increased area of contact between the plate and screw head; [0055] of Ramos Maza).
Regarding claims 21-23, the curves 50 and 52 are substantially perpendicular to the length of the elongate member 40. These curves are taught in combination with curves parallel to the length of the elongate member 40 as at fig. 2E. These curves are formed for use on the anatomy of a 5th metatarsal [0047]. This anatomy includes a plantar anatomy.
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 W BATES/Primary Examiner, Art Unit 3799
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