DETAILED ACTION
This office action is responsive to the amendment filed October 22, 2025. By that amendment, claim 22 was amended; and claim 27 was canceled. Claims 22-26, 28, 29, and 31-41 stand 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 .
Response to Arguments
The outstanding rejection of claims 27-29 under 35 USC 112(b) was overcome by cancellation of claim 27.
The rejections of claims 22-24, 26, 27, 31, and 39-41 under 35 USC 102(a)(1) in view of Medoff (US 2009/0275991 A1) are discussed. In relevant part, it is argued that Medoff does not teach the curves of the plate configured to mate with the anatomy of the plantar aspect of the metatarsal bone; rather, Medoff teaches the plate is seated flush against he bone by a “flare’ at the terminal segment. This is not the same as what is claimed.
Examiner agrees that Medoff teaches the plate having a flared region to match the bone anatomy. However, examiner points to fig. 2C of Medoff, which clearly demonstrates the flared region 47 including two curves 50, and 52, which read on each of the claimed limitations. Therefore examiner disagrees that Medoff’s flared region is distinct from the claimed limitations.
The rejections of claims 25 and 32-38 under 35 USC 103 in view of Medoff; and claims 28 and 29 under 35 USC 103 in view of Medoff and Ramos Maza (US 2012/0010617 A1) are stated as being improper, with discussion of the term “tangent reverse curve” raised.
The arguments state that the instant specification provides “a plurality of examples” of the term “tangent reverse curve” and takes issue with the office stating that the curves 50/52 were what are being considered as a reverse curve. First – this comes up at only claim 35, where the recited limitation is a “reverse curve”, not tangent reverse curve, as argued. The word tangent is absent from the claims. The specification is reviewed, and two instances of the phrase “tangent reverse curve” occur at [0007] and [0025]. “Reverse curve” is found nowhere. The arguments point to an example of instant fig. 4 . Examiner does not find this clarification helpful in determining proper metes and bounds of the claimed term ‘reverse curve’. Is fig. 4 the only reverse curve which applicant believes falls within the scope of his claims? Which other ones do or don’t?
Examiner invites applicant to 1) demonstrate some of the additional examples of reverse curves to permit him to re-evaluate what should properly fall within and be excluded from the scope of the term; 2) claim the curve as was originally disclosed as a “tangent reverse curve”, in which case examiner would agree that the disclosure of [0007], [0025] and fig. 4 apply (which, as an aside, doesn’t really change examiner’s interpretation of the curve being simple two curves in two directions as shown at fig. 4; and doesn’t appear to change the scope of the claim understood by the examiner, but at least gets the same language used at all instances); and/or 3) provide a definition of the term which is known to those with ordinary skill in the art, by affidavit, evidence, or otherwise. Applicant’s assistance is requested. At present, the understanding taken in the prior office action is maintained.
The argument states that “to the extent that the cited art or Medoff implicitly references any number of bends, it remains unclear whether they are similar to the “tangent reverse curve” as claimed. Examiner is nearly persuaded that this is indeed an indefinite term, necessitating a 112 rejection, but at present, continues to believe it is merely enormously broad.
First – “reverse curve” is what is claimed, not “tangent reverse curve”. Is this broader in scope than a tangent reverse curve? Second, Medoff doesn’t implicitly reference bends – he clearly and explicitly demonstrates two at 50 and 52 in fig. 2C. Third, examiner is treating the term broadly, within the bounds of what is disclosed in the instant application, such that he disagrees that it is ‘unclear’ whether the curves are similar. Arguments which state that it is unclear whether the prior art is similar or not (as opposed to clearly distinct) will be treated as admission of indefiniteness in the instant claims in any future reply, and will be considered to require rejections under sections of 35 USC 112. Applicant’s assistance in this matter is solicited.
Any other aspects of the rejections of claims 25 and 32-38 under 35 USC 103 in view of Medoff; and claims 28 and 29 under 35 USC 103 in view of Medoff and Ramos Maza (US 2012/0010617 A1) are not particularly argued, and therefore are considered to fall or stand with the rejection of claim 1.
No other aspects are argued, and the claims are amended in the “interest of compact prosecution.”
Examiner agrees that the amendments overcome the rejection of record under 35 USC 102, but presents a new rejection under 35 USC 103 in view of previously presented references to Medoff and Ramos Maza, which rejection demonstrates that the amended claims are obvious in view of prior art.
See below.
Claim Interpretation
The understanding of the term “chamfer angle” taken in prior office actions continues to be taken, without repeating at this time. This interpretation can be found in the prior office actions.
Claim Objections
Claims 28 and 29 now recite dependence from cancelled claim 27. This is understood to be dependence from claim 22 for examination purposes. Correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 22-26, 28, 29, and 31-41 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 22 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 22 positively requires presence of the human bone at lines 15-16, where the claim is required to “mate with the anatomy of the plantar aspect of the metatarsal bone”. It is recommended that use of “configured to language” would overcome this rejection. The claim will be further examined assuming such amendment will be made.
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 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 mate with 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 matches 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” 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.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BATES/Primary Examiner, Art Unit 3799