ICU Medical, Inc. v. Alaris Medical Systems, Inc.

558 F.3d 1368, 90 U.S.P.Q. 2d (BNA) 1072, 2009 U.S. App. LEXIS 5271, 2009 WL 635630
CourtCourt of Appeals for the Federal Circuit
DecidedMarch 13, 2009
Docket2008-1077
StatusPublished
Cited by106 cases

This text of 558 F.3d 1368 (ICU Medical, Inc. v. Alaris Medical Systems, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
ICU Medical, Inc. v. Alaris Medical Systems, Inc., 558 F.3d 1368, 90 U.S.P.Q. 2d (BNA) 1072, 2009 U.S. App. LEXIS 5271, 2009 WL 635630 (Fed. Cir. 2009).

Opinion

MOORE, Circuit Judge.

ICU Medical, Inc. (ICU) appeals from various orders by the U.S. District Court for the Central District of California granting partial summary judgment of noninfringement, summary judgment of invalidity, and attorney fees and Rule 11 sanctions — all in favor of Alaris Medical Systems, Inc. (Alaris). ICU sued Alaris for infringement of four U.S. patents related to valves used in medical intravenous (IV) setups. The district court accepted Alaris’s proposed construction of the term “spike,” requiring pointed and piercing features, and granted partial summary judgment of noninfringement accordingly. The district court also granted summary judgment of invalidity under 35 U.S.C. § 112, ¶ 1 with respect to so-called “spike-less” and “tube” claims. Lastly, the district court awarded attorney fees and Rule 11 sanctions. For the reasons set forth below, we affirm.

BACKGROUND

The technology in this case concerns medical valves used in the transmission of fluids to or from a medical patient, such as when using an IV. Prior techniques involved the insertion of an external needle into a side port that connected to the main IV line. The problems associated with this practice included unintended detachment-of the needle, accidental needle sticks by medical personnel, and breaking off of pieces into the line upon insertion of the needle. Subsequent products offered alternatives to traditional needle ports, but these new products came with their own problems, including complex internal parts with increased risk of malfunction, dead space within the valve that made it difficult to deliver a precise volume of fluid, and the inability to support fluid flow in two directions. ICU attempted to overcome these problems by inventing a medical valve that receives fluid from a medical implement (e.g., a syringe) without the use of an external needle. The medical implement compresses a seal on the valve to create a fluid pathway from the medical implement through the valve and into a patient’s IV line.

ICU sued Alaris for patent infringement in June 2004, asserting only U.S. Patent No. 6,682,509 (the '509 patent) and its “spikeless claims” discussed below. ICU then filed an ex parte application for a temporary restraining order (TRO), which the district court denied. The district court explained that Alaris presented substantial questions of invalidity for the asserted spikeless claims of the '509 patent. ICU then amended its complaint to assert claims from three other patents: U.S. Patent Nos. 5,685,866; 5,873,862; and 6,572,-592 (the '866, '862, and '592 patents, respectively).

The asserted claims fall into three groups: the spike claims, 1 the spikeless (or spike-optional) claims, 2 and the tube *1373 claims. 3 Claims 9-12 of the '592 patent are representative of the asserted spike claims, for which an embodiment is depicted below.

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Dependent claims 10-12 further limit the claimed body, spike, and seal, respectively. The parties dispute whether the spike element must be pointed and whether the spike must be shaped such that it can pierce the seal for fluid to be transmitted through the valve. Claim 35 of the '592 patent is representative of the spikeless claims; it claims a needleless connector valve comprising a body and a seal. '592 patent col.18 11.40-63. Claim 17 of the '592 patent is representative of the tube claims. Id. col.161.57-C01.171.16.

After a series of detailed orders and findings, the district court granted summary judgment of noninfringement of the asserted spike claims; summary judgment of invalidity of the spikeless and tube claims for failure to satisfy the written description requirement; and attorney fees and Rule 11 sanctions. ICU appeals *1374 all three judgments, and we have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

DISCUSSION

I

We first consider the district court’s grant of summary judgment of non-infringement of the asserted spike claims, which we review de novo. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326 (Fed.Cir.2007). Summary judgment is appropriate when, drawing all justifiable inferences in the nonmovant’s favor, there exists no genuine issue of material fact and the movant is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The district court’s order, and ICU’s challenge, is premised on the district court’s construction of the term “spike.” We review determinations of claim construction de novo. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1455-56 (Fed.Cir.1998) (en banc).

We have consistently explained that claim terms should generally be given their ordinary and customary meaning and that such meaning is one “that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed.Cir.2005) (en banc). Moreover, “the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Id. at 1313. This last tenet derives from the fact that claims do not stand alone but rather “are part of ‘a fully integrated written instrument,’ consisting principally of a specification that concludes with the claims.” Id. at 1315 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed.Cir.1995) (en banc)). “The close kinship between the written description and the claims is enforced by the statutory requirement that the specification describe the claimed invention in ‘full, clear, concise, and exact terms.’ ” Id. at 1316 (quoting 35 U.S.C. § 112, ¶ 1). Thus not only is the written description helpful in construing claim terms, but it is also appropriate “to rely heavily on the written description for guidance as to the meaning of the claims.” Id. at 1317.

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558 F.3d 1368, 90 U.S.P.Q. 2d (BNA) 1072, 2009 U.S. App. LEXIS 5271, 2009 WL 635630, Counsel Stack Legal Research, https://law.counselstack.com/opinion/icu-medical-inc-v-alaris-medical-systems-inc-cafc-2009.