Opinion ID: 2719820
Heading Depth: 4
Heading Rank: 2

Heading: Active Disease

Text: Kennedy also contests the district court’s construction of the term “active disease,” as used in the ’442 patent. 7 Kennedy contends that the ’442 patent “explicitly defines” the term “active disease” to mean “‘the presence of six or criteria (duration of morning stiffness ≧45 minutes; ≧6 more swollen joints plus at least three of four secondary (ESR) ≧28 mm/hour; C-reactive protein (CRP) ≧20 tender or painful joints; erythrocyte sedimentation rate mg/l[)].’” Appellant’s Br. 32 (quoting ’442 Patent col. 20 ll. 35-39). In support of this argument, Kennedy points to the ’442 patent’s description of the T-14 study’s patient population: One hundred one (101) patients . . . who had . . . active disease (according to the criteria of the American College of Rheumatology) . . . were enrolled in the trial. Active disease was defined by the presence of six or more swollen joints plus at morning stiffness ≧45 minutes; ≧6 tender or pain- least three of four secondary criteria (duration of ≧28 mm/hour; C-reactive protein (CRP) ≧20 mg/l. ful joints; erythrocyte sedimentation rate (ESR) ’442 Patent col. 20 ll. 29-39. Kennedy relies on the prosecution history of the ’442 patent to support its desired claim construction argument. The examiner originally rejected the ’442 patent for indefiniteness, in part, because Kennedy did not sufficiently define the term “active disease.” In its response to 7 Claim 1 of the ’442 patent states: “A method of treating an individual suffering from rheumatoid arthritis whose active disease is incompletely controlled despite already receiving methotrexate . . . .” ’442 Patent col. 35 ll. 2-4. 20 ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY the examiner’s rejection, Kennedy stated that “active disease” is “defined by” the portion of the specification quoted above referring to the T-14 study. J.A. 5955. Thereafter, the examiner allowed the ’442 patent’s claims: “Given that [the] claimed methods are drawn to treating . . . patients who have already failed to respond to methotrexate or whose active disease has been incompletely controlled by previous treatment with methotrexate; the claimed methods of treating rheumatoid arthritis . . . due to unexpected results . . . are deemed to be an unobvious species.” J.A. 6007 (emphasis added). Kennedy argues that this prosecution history reveals that its more specific definition of active disease, in accordance with the definition set forth in the portion of the specification describing the T-14 study, was critical to the examiner’s allowance of the ’442 patent claims. AbbVie, on the other hand, contends that the quoted portion of the ’442 specification does not provide a single definition of active disease, but rather sets forth two definitions. Accordingly, AbbVie argues that the inventors cannot be viewed as having acted as their own lexicographers. See Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343, 1355 (Fed. Cir. 2003) (“Because the specification provides two alternative definitions for the term at issue, the specification does not define the claim term.”). Under such circumstances, AbbVie contends that the standard definition of active disease—“patients with continuing signs and symptoms of rheumatoid arthritis,” J.A. 92 ¶ 345—should apply here. This standard definition includes individuals in need of rheumatoid arthritis treatment, the definition used in the ’766 patent. We assume, without deciding, that Kennedy’s pro- posed construction of “active disease” was correct. The consequence is the genus claimed in the ’766 patent (treating all patients in need thereof) is broader than the species claimed in the ’442 patent (treating patients with ABBVIE INC. v. KENNEDY INST. OF RHEUMATOLOGY 21 “active disease,” i.e., particularly sick patients). Thus, assuming Kennedy’s construction of the term “active disease” is correct, we must decide whether a patent that claims to treat a subset of patients with more severe rheumatoid arthritis (the ’442 patent) is an obvious variant of a patent that claims treatment of rheumatoid arthritis patients generally (the ’766 patent).