Icu Medical, Inc. v. Alaris Medical Systems, Inc.

• Decision Date: 13 March 2009
• Docket Number: No. 2008-1077.,2008-1077.
• Citation: 558 F.3d 1368
• Parties: ICU MEDICAL, INC., Plaintiff-Appellant, v. ALARIS MEDICAL SYSTEMS, INC., Defendant-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

558 F.3d 1368

ICU MEDICAL, INC., Plaintiff-Appellant, v. ALARIS MEDICAL SYSTEMS, INC., Defendant-Appellee.

No. 2008-1077.

United States Court of Appeals, Federal Circuit.

March 13, 2009.

Frank E. Scherkenbach, Fish & Richardson P.C., of Boston, MA, argued for plaintiff-appellant. With him on the brief were Robert E. Hillman, and Jennifer K. Bush, and Craig E. Countryman, Fish & Richardson P.C., of San Diego, CA.

Timothy J. Malloy, McAndrews, Held & Malloy, Ltd., of Chicago, IL, argued for defendant-appellee. With him on the brief

were David D. Headrick, Scott P. McBride and Wilhelm L. Rao.

Before MICHEL, Chief Judge, PROST, and MOORE, Circuit Judges.

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 "spikeless" 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 claims.³ Claims 9-12 of the '592 patent are representative of the asserted spike claims, for which an embodiment is depicted below.

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

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 ll.40-63. Claim 17 of the '592 patent is representative of the tube claims. Id. col.16 l.57-col.17 l.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 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 noninfringement 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. With these principles in mind, we turn to the appropriate construction of the disputed spike term.

The district court construed spike to mean "an elongated structure having a pointed tip for piercing the seal, which tip may be sharp or slightly rounded." In doing so, the district court adopted Alaris's proposed construction and rejected ICU's broader proposal of "an upward projection." We agree with the district court's construction.

Independent claim 9 recites:

9. A valve, comprising:

a body having a cavity therein;

a spike located within said cavity in said body; and

a seal located on said spike, said seal comprising a series of O-ring elements.

'592 patent col. 16 ll.19-24 (emphasis added).

As the district court correctly noted, the specification "repeatedly and uniformly describes the spike as a pointed instrument for the purpose of piercing a seal inside the valve." For example:

"A two-way valve ... includes a seal which, upon being compressed by the medical implement, is pierced to open the valve and reseals upon being decompressed...." Id. col.1 ll.23-26 (background of the invention).

"A two-way valve is employed utilizing a reusable seal that may be repeatedly pierced by an enclosed, protected, non-metallic spike rather than an exposed metal needle." Id. col.2 ll.45-48 (summary of the invention).

"The spike need only be strong enough to penetrate the seal cap, or if necessary, to pierce a connecting septum." Id. col.10 ll.20-22.

"The delivery end or nose of the medical implement is inserted into the valve as depicted in FIG. 8, pushing the nose against the seal to compress the seal sufficiently to allow the tip of the spike to pierce the seal and enter said delivery end." Id. col. 15 ll.4-8 (operation).

It is true that we should not import limitations from the specification into the claims. Phillips, 415 F.3d at 1320, 1323. But "the line between construing terms and importing limitations can be discerned with reasonable certainty and predictability if the court's focus remains on understanding how a person of ordinary skill in the art would understand the claim terms." Id. at 1323. Indeed, the court should focus on how such a person would understand the claim term "after reading the entire patent." See id. at 1321. The specification never suggests that the spike can be anything other than pointed. As the district court noted, (1) each figure depicts the spike as elongated and pointed; (2) in each figure depicting an activated valve, the spike pierces the seal; and (3) the patents neither describe piercing as optional nor describe any non-piercing item as a spike.⁴ Moreover, ICU offers no support from any intrinsic or extrinsic source in support of its claim that the ordinary meaning of spike would include a non-pointed structure such as a tube or a straw.

ICU argues that the specification's disclosure of a spike with a hole at the tip precludes a construction that requires a pointed spike because a spike with a hole at the tip, according to ICU, would not then be pointed. The district court rejected this argument because (1) the construction it accepted "allow[s] for the possibility of a hole at the tip of the spike" and (2) "spikes featuring an angled...