In ICU Medical Inc. v. Alaris Medical System, the Court of Appeals for the Federal Circuit (CAFC) affirmed the U.S. District Court for the District of California’s decision granting Alaris Medical System (Alaris) partial summary judgment of noninfringement and granting summary judgment of invalidity of ICU Medical Inc.’s (ICU) “spikeless” and “tube” claims for lack of written description under 35 U.S.C. § 112, ¶ 1 due to ICU’s subsequent broadening of its claims during prosecution. The CAFC also affirmed the granting of Attorney fees under 35 U.S.C. 285 and Rule 11 sanctions against ICU for multiple, repeated misrepresentations.

The device at issue is a needleless valve mechanism used to transmit intravenous fluids to a medical patient. Previously, needles were used to deliver fluid through a side port connecting to the main intravenous line, posing possible safety risks. ICU’s device instead uses a compressed seal on the valve to create a fluid pathway from the device through the valve and into the patent’s intravenous line without the use of a needle. ICU’s asserted claims can be categorized as either “spike” claims, “spikeless” or “spike-optional” claims, and “tube” claims. Initially, ICU filed a patent infringement complaint against Alaris based on U.S. Patent No. 6,682,509 and its spikeless claims. After the district court questioned the validity of those claims, ICU subsequently amended its complaint to assert spikeless claims from three additional patents (U.S. Patent Nos. 5,685,866; 5,873,862; and 6,572,592.)

The first issue, dealing with the “spiked claims,” turns on the definition of the word spike and whether the spike element must be pointed or shaped such that it can pierce the seal for fluid to be transmitted through the valve. The CAFC reviewed both the district court’s grant of summary judgment and the claim construction de novo. Alaris defines the word narrowly, arguing that a spike denotes a pointed instrument shaped such that it can pierce the seal for fluid to be transmitted through the valve, thereby limiting the breadth of ICU’s claims to use with such a pointed instrument. ICU defines the word broadly, asserting that it refers to an “upward projection” and therefore its claims including a spike are not limited to use with a pointed instrument. The CAFC, citing ordinary meaning and specific examples of usage in ICU’s claims and figures, agreed with Alaris that the word refers to a pointed instrument. The CAFC also noted that the specification “repeatedly and uniformly describes the spike as a pointed instrument for the purpose of piercing a seal inside the valve.” The CAFC points out that although it should not import limitations from the specification onto the claims, it should focus on how a person of ordinary skill in the art would understand the claim after reading the entire patent. As such, the CAFC held that that district court correctly construed spike as “an elongated structure having a pointed tip for piercing the seal, which tip may be sharp or slightly rounded,” thus affirming the district courts grant of summary judgment of noninfringement against Alaris with respect to the asserted spike claims.

The second issue is whether the later addition of the spikeless claims, while leaving the specification unchanged, broadens the claims by removing any initial spiked limitation, thereby constituting the addition of new matter rendering the claims invalid. The CAFC reviewed the district court’s grant of summary judgment of invalidity for lack of written description de novo. In interpreting the “written description” requirement of 35 U.S.C. § 112, ¶ 1, the CAFC relied on Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563–64 (Fed. Cir. 1991), which states that “[t]o satisfy the written description requirement, a patent applicant must ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.’” (emphasis in original) Alaris challenged the validity of ICU’s asserted spikeless claims on the basis that they lacked written description in the specification, arguing that the specification clearly limits ICU’s invention to valves with a spike and does not demonstrate that the inventor possessed a medical valve without a spike. ICU considers the claims to be spike-optional, arguing that because the claims contain no spike element, they cover both valves with a spike and valves without a spike. Additionally, ICU argues that the specification’s disclosure of a preslit seal demonstrates it had possession of an invention that was not dependent on a spike element.

The CAFC, relying on LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005), rejected ICU’s contention that the presence of the pre-slit seal combined with the figures and descriptions depicting spikes demonstrated that ICU possessed a medical valve that operated without a spike. The CAFC found that “ICU’s asserted spikeless claims are broader than its asserted spike claims because they do not include a spike limitation; these spikeless claims thus refer to medical valves generically – covering those valves that operate with a spike and those that operate without a spike. But the specification describes only medical valves with spikes.” Because the broader spikeless claims are not disclosed in the specification, the CAFC found that a person of ordinary skill in the art would not understand the inventor to have invented a spikeless medical valve, rendering the spikeless claims invalid under the written description requirement of § 112, ¶ 1.

The final points at issue are those of 35 U.S.C. 285 Attorney fees and Rule 11 sanctions against ICU. In determining whether attorney fees are warranted, the court must find the case to be “exceptional.” The CAFC, reviewing the issue de novo, found no clear error in district court’s finding that this case “was exceptional because ICU’s TRO/PI request and the amended complaint’s assertion of the spike claims were objectively baseless and brought in bad faith.” The district court found “multiple, repeated misrepresentations . . . to the Court regarding its own patents in an effort to conceal what are now characterized as errors in order to rescue the TRO/PI from denial.” Examples of such misrepresentations included double-patented claims, ICU’s misrepresentation of Federal Circuit authority, and misrepresentations relating to the spikeless embodiment. The CAFC held, “[h]aving determined that this case is exceptional, the district court appropriately exercised its discretion in awarding attorney fees only for that portion of the litigation ‘relating to: 1) the TRO/PI; 2) ICU’s assertion of the ‘spike’ claims; and 3) ICU’s construction of the term ‘spike’ at claim construction.’” With respect to the Rule 11 sanctions, the CAFC applied an abuse of discretion standard and agreed with the district court’s determination that ICU’s “frivolous construction and assertion of the ‘spike’ claims in the amended complaint, concurrently justified sanctions under Rule 11.”