Court Opinion

ID: 9497053
Source: CourtListenerOpinion
Date Created: 2023-08-05 16:42:21.829719+00
Date Added: 2024-06-11T17:57:58.730615
License: Public Domain

SCHALL, Circuit Judge,
eoncurring-in-part, dissenting-in-part.
I agree with the majority’s conclusions with respect to validity, the absence of a case or controversy regarding infringement of claim 18, breach of contract, enhanced damages, and the district court’s injunction. However, I respectfully dissent from the majority’s construction of claim 18 of the '658 patent. Because I think claim 13 covers only the correlation of elevated levels of homocysteine, I would remand the case for a recalculation of the damages resulting from indirect infringement.
Claim 13 of the '658 patent is an independent claim for a two-step method:
13. A method for detecting a deficiency of cobalamin or folate in warmblooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
Col. 41, ll. 58-65. Proper construction of the terms “correlating” and “elevated” is dispositive of the issue of infringement of claim 13. The district court construed “elevated” to mean “raised above the normal range,” and “correlating” as “to establish a mutual or reciprocal relationship between.” Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, No. 99-Z-870, slip op. at 2-3 (D.Colo. Nov. 29, 2000) (Markman Order). Disagreeing with neither of these constructions, the majority holds that when a patient’s homocysteine level is not “elevated,” claim 13 may nevertheless be infringed because “correlating” includes establishing both a mutual relationship and a reciprocal relationship. The majority states:
In essence, “correlating” means to relate the presence of an elevated total homocysteine level to either a cobalamin or folate deficiency, or both (i.e., a mutual relationship), and also to relate the absence of an elevated total homocy-steine level to a deficiency in neither *1373(i.e., a reciprocal relationship).... [T]he specification and prosecution history confirm that the claim language “correlating,” in the understanding of one of ordinary skill in this art field at the time of invention, includes both a mutual relationship between the presence of an elevated level of homocysteine and a vitamin deficiency and a reciprocal relationship between the absence of an elevated level of homocysteine and no vitamin deficiency.
In my view, the majority impermissibly expands the scope of claim 13 beyond the actual words of the claim.
I begin with what I see as the controlling principles of claim construction. When interpreting the claims of a patent, the court should look first to the intrinsic evidence of record: the claim, the specification, and, if in evidence, the prosecution history. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996). There exists within the intrinsic evidence a “hierarchy of analytical tools.” Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1344 (Fed.Cir.1998). First, the language of the claim should be considered— “[t]he actual words of the claim are the controlling focus.” Id. The claim language defines the bounds of claim scope. Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 619-20 (Fed.Cir.1995). Because the claims define the patentee’s right to exclude others, “the claim construction inquiry, therefore, begins and ends in all cases with the actual words of the claim.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed.Cir.1998).
If the meaning of a claim term is clear on its face, consideration of the remaining intrinsic evidence is restricted to determining if a deviation from the clear language of the claim is specified. Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed.Cir.2001). The court may consider the patent specification in construing whether the patentee has intended for the meaning of a claim term to deviate from its ordinary meaning. Vitronics, 90 F.3d at 1582. The court may also consider the prosecution history, if it is in the record, for evidence of an intentional deviation from the plain meaning of a claim term. Id.
Beginning with the ordinary meaning of the claim terms, I too do not disagree with the district court’s construction of the terms “elevated” and “correlating.” Nor do I disagree with the majority’s conclusion that the claim language does not require a further association between the level of total homocysteine and either a hematologic or neuropsychiatric abnormality or both. I cannot agree with the majority, however, that claim 13 is infringed when the test demonstrates that a patient’s homocysteine level is not “elevated.” The plain language of the claim requires “elevated” levels of homocysteine, and a heavy presumption weighs in favor of the ordinary and customary meaning of that term. CCS Fitness v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir.2002). As the district court properly construed the term, “elevated” requires a level of homocysteine that is “raised above the normal range.” Markman Order, slip op. at 2-3. Thus, for claim 13 to be infringed, the homocysteine assay must evince a level of homocysteine that is raised above the normal range. In short, in my view the majority disregards the explicit limitation in claim 13 that only an “elevated” level of homocysteine can be “correlated” with a vitamin deficiency.
There is no language in claim 13 addressing unelevated levels of homocy-steine, nor language that unelevated levels of homocysteine are to be correlated with the absence of a vitamin deficiency. Ordi*1374nary meaning thus dictates that a patient’s homocysteine level be “elevated” in order for a physician to practice claim 13. If the patient’s homocysteine levels are not “elevated,” by the plain language of the claim, there is no “correlating” to be done. The language of claim 13 does not suggest that the claim encompasses the correlation of unelevated levels with the absence of a deficiency, for the introductory phrase claims “a method for detecting a deficiency,” without addressing at all the detection of the absence of a deficiency. '658 patent, col. 41, ll. 58-59.
We have repeatedly stated that “[cjourts can neither broaden nor narrow claims to give the patentee something different than what he has set forth.” Tex. Instruments Inc. v. U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1171 (Fed.Cir.1993) (quoting Autogiro Co. v. United States, 181 Ct.Cl. 55, 384 F.2d 391, 396 (1967)); Oak Tech., Inc. v. Int’l Trade Comm’n, 248 F.3d 1316, 1329 (Fed.Cir.2001). In this case, however, the majority has permitted claim 13 to be infringed even when homocysteine assays result in unelevated levels. The majority thereby broadens claim 13 to also include, although it is not expressly claimed, correlating unelevated levels of homocysteine with the absence of a vitamin deficiency.
Relying on language from the specification and the prosecution history, the majority brings assays that demonstrate unelevated levels of homocysteine within the province of claim 13 by focusing its construction on the term “correlating.” The problem I have with this approach is that it ignores the term “elevated.” In addition, because the term “elevated” in claim 13 is unambiguous on its face, the specification and prosecution history of the '658 patent may be consulted only to determine if the patentee intended to deviate from ordinary meaning. Interactive Gift Express, 256 F.3d at 1331. There is no evidence before us that any deviation was intended. Throughout the specification, the term “elevated” is consistently used to refer to levels that are raised above average. For example, the specification explains that
The normal range for homocysteine in human serum is from about 7 to about 22 ¡xmol/liter. Homocysteine levels above these ranges are indicative of co-balamin and/or folate deficiency....
Hí # ❖ ❖ ‡
When homocysteine levels are elevated in individuals without inherited defects, at least one of folate or cobalamin is deficient.
'658 patent, col. 9, ll. 23-29, 38-40 (emphases added). Nor is there any evidence from the prosecution history that the pat-entee relinquished this claim construction in an amendment or in an argument to overcome or distinguish a prior art reference. Vitronics, 90 F.3d at 1582. Accordingly, I construe Claim 13 to require an assay that demonstrates an “elevated” ho-mocysteine level, or one “raised above the normal range,” in order for the claim to be practiced.
Pursuant to this claim construction, claim 13 is only infringed when the assays performed by LabCorp reveal elevated levels of homocysteine. As LabCorp explains, and as Metabolite does not dispute, approximately eighty to eighty-four percent of the assays LabCorp processes reveal unelevated levels of homocysteine. I would therefore vacate the jury’s verdict that the assays resulting in unelevated levels of homocysteine infringed claim 13, and further vacate and remand the jury’s verdict on damages for recalculation based only on those infringing assays that demonstrate elevated levels of homocysteine.