By Dennis Crouch
In re Bimeda Research & Development (Fed. Cir. 2013)
Bovine mastitis is udderly problematic. Since so many folks now want to buy antibiotic free milk, dairy owners are looking for new ways to address the issue. Bimeda's patent relates to one solution that can be used during a "dry period" – typically prior to a cow giving birth. See U.S. Patent No. 6,506,400. The offered solution essentially involves painting-on a waxy physical barrier to protect the mammary teat canal during the dry period. These seals are not new, but Bimeda's revolution is that its seals do not include any antiinfectives. In 2009, a competitor (Merial Ltd., a Sanofi compani) filed an ex parte reexamination request.
During reexamination, Bimeda added several new claims including a new limitation that the physical barrier seal is made of "an acriflavine-free" formulation. Acriflavine is well known to folks skilled in the art as a treatment for mastitis. However, the original specification does not mention acriflavine. The result is that the PTO Board found the claim unpatentable for failing to comply with the written description requirement of 35 U.S.C. 112. On appeal, the Federal Circuit affirms.
The original patent application must disclose the invention being claimed – otherwise the claim fails the written description requirement and is unpatentable. Written description issues arise most often when a patentee changes claim language during prosecution (as here) and adds new limitations in order to avoid prior art. Written description is often seen as a "technicality" requirement because it applies even when the added limitation would have been easy for someone of skill in the art to add without further instructions in the application specification. The point of the requirement is to make sure that patents are only granted to cover subject matter actually invented.
Here, Bimeda argued that it should be able to add the acriflavine-free limitation because (1) acriflavine is an antiinfective and the application described formulations that were antiinfective free and, the exemplary embodiment (Example 1) described a formulation that was acriflavine-free. Now, to be clear, the example did not spell out that the formulation was "acriflavine-free." Rather, acriflavine was simply not in the list of ingredients.
On appeal the Federal Circuit reviewed the factual question of written description for substantial evidence. Thus, the PTO wins if it can show more a mere scintilla of evidence in support of its findings. The court easily found sufficient evidence.
In this case, the Board found, inter alia, that claim 32 failed the written description requirement because the disclosure did not "describe a formulation excluding a specific species of the anti-infective genus, while permitting others to be present." On appeal, Bimeda counters this finding by arguing that the disclosure broadly claims a teat seal formulation utilizing a physical barrier, yet does not expressly exclude any particular antiinfective agents. Bimeda interprets this as tacit indifference to the presence or absence of specific antiinfectives, and contends that the disclosure therefore supports a claim which excludes one particular antiinfective (such as acriflavine) but permits the use of others (such as antibiotics).
Substantial evidence supports the Board's contrary interpretation because the disclosure is generally inconsistent with a formulation which, like claim 32, excludes acriflavine but could include antibiotics.
Judge Clevenger drafted the opinion for the court. Chief Judge Rader also filed a short concurring opinion noting that the usual catchphrase of "possession" is not the correct way to think about written description. In particular, according to Rader, possession makes no sense here where the focus is on a negative limitation. He writes that "the Board places the patentee into a Catch-22: to satisfy written description, the patentee must show possession of something it specifically claims it does not possess." Here, Judge Rader suggested an important element in this case is the fact that Acriflavine is a "well-known species of antiinfective that [has] been used in teat seals to treat bovine mastitis for over 75 years." Along these lines, it makes sense that you could later claim a "wheat-free" bread invention based upon a disclosed bread recipe that includes a list of ingredients for making the bread and where wheat is missing from the ingredient list. Of course