SMITH & NEPHEW, INC. v. REA

OVERVIEW:

This case is related to a review of the Board of Patent Appeals and Interferences, where the Court of Appeals reversed the Board’s decision that the patent claims would have been unobvious in view of the prior art.

Synthes owns the US Patent No. 7,128,744, which is directed to a system for using plates to repair bone fractures in longer bones. The bone plate runs adjacent to the fractured bone and is attached by bone anchors (screws) that are inserted through holes in the plate and then into the bone. Claim 1 and FIGURE 1 of the 7,128,744 patent is reproduced below:

1. A bone plating system for improving the stability of a bone fracture in a long bone comprising:

a bone plate having:

an upper surface;

a lower surface;

a shaft portion having a width and a central longitudinal axis, the shaft portion configured and dimensioned to extend along at least a portion of a diaphysis of the bone and the lower surface of the shaft portion having a plurality of arched cut-outs extending transverse to the longitudinal axis; and

a head portion that flares outward from the shaft portion so as to have a width that is greater than the width of the shaft portion, the head portion curving upward from the shaft portion and having at least three bone anchor holes, the bone anchor holes being conically tapered from the upper surface to the lower surface, the at least three bone anchor holes having at least a portion that has a thread to engage a thread on a head of a bone anchor,

wherein the head portion has only bone anchor holes having the threaded portion, the shaft portion having a plurality of holes having at least a portion that has a thread to contact the thread on the head of a bone anchor.

 

In 2009, Smith & Nephew requested a reexamination of the ‘744 patent, where the Examiner rejected all 55 claims of the ‘744 patent as being obvious. Synthes appeals the rejections to the Board of patent appeals, where the board reversed the rejections of 24 of the ‘744 patent including independent claim 1. A crucial limitation of the claim is that all of the holes in the head portion are at least partially threaded to engage the threads on the head of a “locking” bone anchor. The central issue is whether it would have been obvious to design a bone plate in which ALL of the holes in the plate are conically tapered AND at least partially threaded. Apparently, there are two types of screws 1) non-locking compression screws (that have threaded shafts but unthreaded heads) to draw the bone and plate together, and 2) locking screws (which have threaded heads and threaded shafts) to fix the plate adjacent to the bone). The ‘744 patent is directed towards locking screws that is important when a bone is a weight-bearing bone that when subject to pressure can loosen the connection between the screws and the plate if only compression screws are used to attach the plate to the bone.

The ‘744 patent includes references to a plurality of prior art references that disclose 1) a plate that includes unthreaded holes designed for compression screws, 2) methods for use of locking screws, 3) a plate with 4 threaded holes and 2 unthreaded hole in the head portion, 4) an article that described using only conically tapered, threaded holes in the shaft and head portions of the plate, which stabilized the femur and did not compress or contact bone fragments directly.

The Court of Appeals stated that the essence of the Board’s reasoning was wrong, because the Board based its ruling on its conclusion that it would not have been obvious to use a standard compression screw in a threaded hole to obtain compression, but the claims of the ‘744 patent do not require that the head screws provide compression. More so, the Court of Appeals stated that, as an alternative to using all locking screws in the head holes, the specification of the ‘744 patent provides that non-locking screws can be substituted for locking screws if a surgeon elects. Therefore, providing compression in the head portion for all screws is not required by the language in the specification or the claims. Further, the Court of Appeals stated the a conically shaped screw could sit in the Haas reference holes within any rusk of protrusion, and the ‘747 patent recites “any surgical screw that has a non-threaded head… of an appropriate size and geometry for select pate holes of the bone plate can be used.” Therefore, the patent suggests that any screw design could be used, rather than a limiting choice.  The Court of Appeals further stated the ‘744 specification stated the ‘686 patent used non-locking screws in threaded holes. Therefore, the prior art demonstrated that non-locking screws could achieve compression in either type of hole, thus given the Court of Appeals reason to combine the references.

As such, the Court of Appeals reasoned that the patentability of the invention is directed towards the structure of the holes, and not the special nature of the non-locking screw that may be used in those holes because conical, partially threaded holes themselves were known in the art, as was the advantage of adding more of them to the head to lock the plate in place.

PATENT ATTORNEY TAKE-A-WAYS:

1)   Do not include specific references and/or what they disclose in a patent application. By doing so, Patent Attorneys allow more admitted application prior art. Additionally, as in this case, by stating what could and/could not be achieved with the prior art references, the Court of Appeals was able to construe what would or would have not been obvious to combine. Although it may be easier to obtain a patent by distinguishing specific references in a patent application, when it is time for claim construction and/or interpretation of the cited art by including more application admitted prior art, Applicants may have created unintentional arguments against themselves. It is for this reason, when writing applications, I try to keep the “background” section as short as possible, and let the Examiner decide what was prior art and/or what can or cannot be combined (or why). This may also come into play when inventors/companies want Patent Attorneys to include “the benefits of their patent over the prior art.” If my clients really wants you to state the benefits of their invention, I try to write only the benefits of their invention and not the limitations caused by what is currently available.

2)   This case shows how writing patent applications incredibly broad may limit what can be patented. In this case, the ‘744 patent described that pretty much any screw could be inserted into the threads based on a medical practitioners desire. If the ‘744 patent had omitted the broadening language, then at least an argument could have been made that only screws corresponding to the threads should be inserted.

3)   I would be interested to see if Synthes could argue/did argue the secondary considerations laid out in John Deere. Because this product was not previously used by others the commercial success, the failures by others, and need for the previously patent product may be decent arguments for Synthes. At least as fall back arguments. These secondary factors could especially be relevant because of the long discussions of the prior art in the ‘744 patent.

By | 2013-07-09T20:32:54+00:00 July 9th, 2013|Patent Attorney Takeaways|Comments Off on SMITH & NEPHEW, INC. v. REA