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No Infringement Under the Doctrine of Equivalents Where Claim Specifically Excluded Accused Product

August 18, 2006
Bianco, Krista E.

Decision icon Decision

Last Month at the Federal Circuit - September 2006

Judges: Newman, Lourie, Prost (author)

[Appealed from: N.D. Indiana]

In Cook Biotech Inc. v. ACell, Inc., Nos. 05-1458, -1558, -1559 (Fed. Cir. Aug. 18, 2006), the Federal Circuit reversed the district court’s claim construction and found that under the correct construction, ACell, Inc.’s (“ACell”) commercial product did not infringe Purdue Research Foundation’s (“PRF”) U.S. Patent No. 5,554,389 (“the ’389 patent”), either literally or under the DOE. The Federal Circuit also affirmed the district court’s grant of SJ that Dr. Badylak was not an inventor of ACell’s U.S. Patent No. 6,576,265 (“the ’265 patent”).

The ’389 patent generally relates to tissue compositions known as extracellular matrices that can be implanted torepair or support damaged or diseased tissue. The ’389 patent resulted from work Dr. Badylak and three other inventors completed while employed by Purdue University. Pursuant to his employment contract, Dr. Badylak assigned the ’389 patent rights to PRF, and on February 9, 2003, PRF granted Cook Biotech Inc. (“Cook”) an exclusive license.

After Dr. Badylak developed his urinary bladder submucosa-derived tissue graft composition, Dr. Spievack, a Harvard University professor and surgeon, also began testing techniques for removing various tissue layers of the bladder wall. When Dr. Spievack could not obtain a license from PRF, he formed ACell in 1999 to research and develop extracellular matrix technology. On December 1999, Dr. Spievack filed a provisional application relating to a matrix of urinary bladder tissues, an application which led to the issuance of the ’265 patent and lists Dr. Spievack as the sole inventor. While the ’265 patent was pending, PRF had asked the PTO to declare an interference, asserting four other individuals, including Dr. Badylak, were coinventors of the ’265 patent, since Dr. Spievack had visited Dr. Badylak at Purdue University and discussed his work on graft compositions during the time period of 1996 through the end of 1999.

Cook and PRF then sued ACell for patent infringement of claims 1, 7, and 8 of the ’389 patent, correction of inventorship for a number of issued patents, including the ’265 patent, and common law unjust enrichment for the research and inventions disclosed in the disputed patents. After construing the claims, the district court granted PRF and Cook’s motion for partial SJ that the only infringement issue left for the jury was whether ACell’s product contains any urinary bladder submucosa. The jury found ACell infringed claims 1, 7, and 8 of the ’389 patent, but that its infringement was not willful.

On appeal, the question of infringement of the ’389 patent hinged on the district court’s construction of the claim term “urinary bladder submucosa,” as recited in claim 1. Relying on Phillips, the Federal Circuit found that the specification defined “urinary bladder submucosa” as “urinary bladder submucosa delaminated from abluminal muscle cell layers and at least the luminal portion of the tunica mucosa of the urinary bladder tissue.” While the Federal Circuit noted the composition may include tissues other than urinary bladder submucosa, it cannot include what was expressly excluded by the inventors in their definition, i.e., the “abluminal muscle cell layers and at least the luminal portion of the tunica mucosa.”

The Federal Circuit next found that the ’389 patent specification defined the claim term “the luminal portion of the tunica mucosa” as “epithelial layers.” Since the term “epithelial layers” may arguably have two interpretations, the Federal Circuit chose the interpretation that was supported by a discussion of a procedure that was incorporated by reference into the ’389 patent. Based on this discussion, the Federal Circuit concluded that the “the luminal portion of the tunica mucosa” should be construed to mean “the lamina epithelialis mucosa (or transitional epithelium layer), the basement membrane, and the lamina propria.”

Having construed the claims, the Federal Circuit then reversed the judgment of literal infringement, holding that ACell’s product did not infringe claims 1, 7, and 8 of the ’389 patent. ACell’s product retains part of “the luminal portion of the tunica mucosa” of a segment of a urinary bladder and therefore lacks the claim limitation that the claimed compositions be delaminated.

Alternatively, in its appeal, PRF and Cook had also requested a new trial, arguing that ACell’s product infringes under the DOE since compositions that include lamina propria and submucosa are functionally equivalent to compositions that consist essentially of submucosa. Under a corollary to the “all limitations rule,” the Federal Circuit held no infringement existed under the DOE since “the concept of equivalency cannot embrace a structure that is specifically excluded from the scope of the claims.” Slip op. at 23. The ACell Vet product consists of basement membrane and tunica propria, two tissue layers specifically excluded from the claimed composition by delaminating “the luminal portion of the tunica mucosa.”

Addressing PRF’s cross appeal, the Federal Circuit affirmed the district court’s grant of SJ that Dr. Badylak was not an inventor of the ’265 patent, concluding that PRF failed to point to evidence sufficient to create a genuine issue of material fact that Dr. Badylak “contributed in some significant manner” to the conception of the invention claimed in the ’265 patent. The Federal Circuit found that Dr. Spievack’s testimony that he and Dr. Badylak had talked about “basement membrane stuff” in 1997 and 1998 was insufficient to overcome the presumption that named inventors are the actual inventors.