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Abbott Laboratories & Surmodics, Inc. v. Church & Dwight Co.

December 22, 2008

ABBOTT LABORATORIES & SURMODICS, INC., PLAINTIFFS,
v.
CHURCH & DWIGHT CO., INC., DEFENDANT.



The opinion of the court was delivered by: Matthew F. Kennelly, District Judge

MEMORANDUM OPINION AND ORDER

Abbott Laboratories and Surmodics, Inc. (collectively Abbott) have sued Church & Dwight Co. (C&D) for infringement of two patents: U.S. Patent No. 5,654,162 ('162 patent) and U.S. Patent No. 6,020,147 ('147 patent). This case is before the Court for construction of disputed claim terms in the patents-in-suit. The parties submitted written briefs, and the Court held a claim construction hearing on December 12, 2008.

Background

The patents-in-suit, along with U.S. Patent No. 5,073,484 ('484 patent), are members of a family of patents dealing with technology that is used to detect the presence of a substance of interest within a liquid, such as urine or blood. The presence or absence of the substance of interest can be used to determine the condition of the individual utilizing the test. Home pregnancy tests are the best known practical application of this technology, as well as the basis for this litigation.

Specifically, Abbott alleges that home pregnancy tests manufactured by C&D infringe on the patents-in-suit. The claims at issue are claims 1, 7, 9, 10, 16, 11, 22, 28, and 29 of the '162 patent and claims 1, 6, 7, 11, and 12 of the '147 patent. Though each of the asserted claims differs in some respects, claim 9 of the '162 patent is representative of the disclosures made in the various claims:

A method for detecting the presence of an analyte in a carrier liquid suspected of containing said analyte, which method comprises;

a) providing a liquid permeable solid medium which defines a path for fluid flow capable of supporting capillary flow, along which are i) a site for application of the carrier liquid, ii) a diffusively bound labeled antibody specific for the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety, said antibody being capable of flow along the flow path, and iii) one or more zones spaced along said flow path, each zone having a predetermined amount of a reactant bound to it which is specific for either the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety

b) contacting said application site with said carrier liquid such that the liquid passes along the flow path by capillary flow such that analyte or reaction product of the analyte with another chemical moiety becomes bound to both the labeled antibody and the reactant bound to the solid medium; and

c) detecting the labeled antibody which, together with the reactant bound to the solid, medium, has sandwiched the analyte or chemical moiety as an indication of the presence of analyte.

Pl. Ex. A at 16:26-50. In the home pregnancy test embodiment, a urine sample is applied to a test strip to initiate the test. As it runs through the testing mechanism, the substance of interest in the urine, i.e., the hormone or other substance that will indicate the test user is pregnant, binds with antibodies and detector substances. The combination of those substances (or lack thereof) will indicate whether the test user is pregnant or not.

The family of patents at issue in this case has been the subject of extensive prior litigation, though not involving C&D. Some of the prior cases were settled, but others were litigated to final decisions that have resulted in written decisions. One case involved proceedings before the PTO that were appealed to the Federal Circuit. See In Re Swanson, 540 F.3d 1368 (Fed. Cir. 2008). Another case, to which the Court will refer as the Syntron litigation, resulted in a number of written decisions in the district court and on appeal. See, e.g., Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343 (Fed. Cir. 2003) (Syntron I); Abbott Labs. v. Syntron Bioresearch, Inc., No. 98 CV 2359, 2000 WL 968110 (S.D. Cal. June 29, 2000) (Syntron II); Abbott Labs. v. Syntron Bioresearch, Inc., No. 98 CV 2359, 2000 WL 33967724 (S.D. Cal. Sept. 28, 2000) (Syntron III). Where appropriate, the Court has consulted the courts' rulings and Abbott's statements made in other litigation involving the patents-in-suit and the related '484 patent.

Discussion

Construing the patent claims is the first step in a patent infringement case. See Mars, Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1373 (Fed. Cir. 2004). Claim construction is a question of law for the Court to decide. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-78 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). The Court begins its analysis by examining the claim language itself. See Hockerson-Halberstadt, Inc. v. Avia Group Intern., Inc., 222 F.3d 951, 955 (Fed. Cir. 2000). A claim term's ordinary and customary meaning, as understood by persons skilled in the relevant technology, is the default meaning. See id. The Court may also consider additional intrinsic evidence, which includes the other parts of the patent and the prosecution history of the patent. Phillips v. AWH Corp., 415 F.3d 1303, 1314-17 (Fed. Cir. 2005) (en banc)(citation omitted)

After the claim language, the most important type of intrinsic evidence is the patent's specification. The specification consists of "a written description of the invention, and of the manner and process of making and using it," as well as a description of "the best mode contemplated by the inventor of carrying out his invention," followed by "one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention." 35 U.S.C. § 112. The specification "is always highly relevant to the claim construction analysis . . . it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (citation omitted). The Federal Circuit has repeatedly emphasized that the claims of a patent "must be construed so as to be consistent with the specification." Merck & Co. v. Teva Pharmaceuticals USA, Inc., 347 F.3d 1367, 1371 (Fed. Cir. 2003).

The written description, however, does not limit the scope of the invention as described in the patent claim, because it sometimes describes just one way of practicing the invention -- the "preferred embodiment" of the invention. See Phillips, 415 F.3d at 1323; see also 35 U.S.C. § 112. A patent applicant is not required to include every conceivable embodiment of his invention. Sunrace Roots Enter. Co. v. SRAM Corp., 336 F.3d 1298, 1305 (Fed. Cir. 2003). For this reason, the Federal Circuit has cautioned that it is improper for a court to "import[ ] limitations from the specification into the claims absent a clear disclaimer of claim scope." Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1373 (Fed. Cir. 2007). The "clear disclaimer" requirement is satisfied only if there is "a clear disclosure that the patentee intended the claims to be limited as shown." MBO Labs., Inc. v. Becton Dickinson & Co., 474 F.3d 1323, 1334 (Fed. Cir. 2007); Phillips, 415 F.3d at 1323. In other words, a court cannot deviate from the ordinary meaning of a claim term simply by pointing to the written description or the identification of the "preferred embodiment" contained in the written description. Fuji Photo Film Co. v. Ficosa N. Am. Corp., 299 F.2d 1313, 1325 (Fed. Cir. 2002).

Another important source of intrinsic evidence is the prosecution history of the patent. Like the specification, "the prosecution history provides evidence of how the PTO and the inventor understood the patent." Phillips, 415 F.3d at 1317. Though often not as clear as the specification, the prosecution history can show "whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be." Id.

The Federal Circuit has authorized judges to rely on extrinsic evidence if the Court "deems it helpful in determining the true meaning of language used in the patent claims." Id. at 1318 (quotation omitted). Extrinsic evidence, however, is "less significant than the intrinsic record" for determining the meaning of the patent claims. Id. at 1317 (quotation omitted). Extrinsic evidence includes "all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980 (citation omitted). Extrinsic evidence, if used by a court, must be considered in the context of the intrinsic evidence. Phillips, 415 F.3d at 1319. The Federal Circuit has cautioned that flaws are inherent in each type of extrinsic evidence, e.g., dictionary definitions and expert testimony, and courts must assess that evidence accordingly. Id.

1. Analyte

The term analyte appears in every asserted claim of the patents-in-suit. Abbott contends that analyte means "the substance of interest, i.e., the substance that the test is designed to detect, if present in the liquid being tested"; C&D contends it means the "chemical moiety which is to be measured quantitatively." The primary distinction between these proposed constructions is the quantitative element. C&D's construction would limit analytes to substances measured quantitatively, whereas Abbott's ...


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