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August 18, 2006

Tissue Issues

Cook Biotech, exclusive licensee, and Purdue Research Foundation, owner of 5,554,389, sued ACell for infringement. In the appeal (CAFC 05-1458), there was a significant issue of claim construction, an interesting insight into seeking damages, and an applied corollary to the "all limitations" rule in figuring infringement under the doctrine of equivalents.

The ’389 patent, entitled “Urinary Bladder Submucosa Derived Tissue Graft,” issued on September 10, 1996. The ’389 patent is directed to a urinary bladder submucosa derived tissue graft composition comprising bladder submucosal tissue “delaminated from the abluminal muscle layers and at least the luminal portion of the tunica mucosa of the urinary bladder tissue,” ’389 patent, col. 1, ll. 56-58, that can be implanted to replace or support damaged or diseased tissues.


The jury had found '389 infringed, but then the trial court denied damages. The appeals court noted a mistake by the plaintiffs: only requesting lost profits damages, then failing to back it up with evidence.

With respect to damages, on the first day of trial, the district court granted ACell’s motion in limine seeking to preclude appellees from presenting lost profits damages to the jury because the district court found that appellees failed to establish an “appropriate record” with respect to damages sufficient to raise a jury issue. That ruling effectively precluded appellees from obtaining damages because they had sought only lost profits damages, and not a reasonable royalty. Thus, even though the jury returned a verdict in their favor, appellees were not awarded any damages.

Claim Construction

The appeals court ruled in this case that interpreting the specification was necessary to discern the non-ordinary meaning of the disputed claim term, and incorporated material was relevant to definition as well.

The main claim construction issue went to which tissue portions were included or excluded from the claim term “urinary bladder submucosa delaminated from . . . at least the luminal portion of the tunica mucosa,” relating to all claim terms, claim 1 being representative.

1. A composition comprising urinary bladder submucosa delaminated from both the abluminal muscle layers and at least the luminal portion of the tunica mucosa of a segment of a urinary bladder of a warm blooded vertebrate.

“[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs.” Phillips, 415 F.3d at 1316. We believe that this is exactly what the ’389 patentees did in this case.

Thus, while the composition clearly includes urinary bladder submucosa, it may also include other tissues, such as the non-luminal portion of the tunica mucosal layer. However, it cannot include that which was expressly excluded in the patentees’ definition, i.e., the “abluminal muscle cell layers and at least the luminal portion of the tunica mucosa.”

In divining the scope of the disputed claim term, the appeals court took stock of an incorporated reference, that "the ’389 patent specification expressly incorporates by reference the procedure for preparing intestinal submucosa from the ’508 patent."

“Incorporation by reference provides a method for integrating material from various documents into a host document . . . by citing such material in a manner that makes clear that the material is effectively part of the host document as if it were explicitly contained therein.” Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000) (citations omitted). “To incorporate material by reference, the host document must identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents.” Id. (citations omitted). Whether and to what extent material has been incorporated by reference into a host document is a question of law. Id.

Infringement Under the Doctrine of Equivalents

The CAFC reminded that infringement under the doctrine of equivalents was inapplicable because "the concept of equivalency cannot embrace a structure that is specifically excluded from the scope of the claims."

Appellees assert, however, that even if summary judgment of non-infringement is appropriate with respect to literal infringement, a new trial may be necessary on the question of infringement under the doctrine of equivalents. They argue that the evidence supports the theory that compositions that include lamina propria and submucosa are equivalent to compositions that consist essentially of submucosa because the two compositions perform the same function, in the same way, to achieve the same result.

ACell makes two arguments in response. First, it asserts that appellees did not preserve any argument under the doctrine of equivalents because they failed to assert any such theories of equivalents in the detailed portion of the pretrial order relating to infringement. Second, ACell argues that the “all limitations rule” bars the capture, under the doctrine of equivalents, of elements specifically excluded by a claim limitation.

Assuming that appellees could overcome their failure to preserve an issue with respect to infringement under the doctrine of equivalents, we conclude that applying appellees’ theory of equivalence with respect to asserted claims would violate “a corollary to the ‘all limitations rule[,]’ . . . that ‘the concept of equivalency cannot embrace a structure that is specifically excluded from the scope of the claims.’” Athletic Alternatives v. Prince Mfg., 73 F.3d 1573, 1582 (Fed. Cir. 1996) (quoting Dolly, Inc. v. Spalding & Evenflo Cos., Inc., 16 F.3d 394, 400 (Fed. Cir. 1994)). 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.” See supra Part II.B.1.b. A claim that specifically excludes an element cannot through a theory of equivalence be used to capture a composition that contains that expressly excluded element without violating the “all limitations rule.”

Posted by Patent Hawk at August 18, 2006 12:33 PM | Case Law