Opinion ID: 220600
Heading Depth: 3
Heading Rank: 1

Heading: Retainer Member

Text: BD argues that the district court erred when it concluded that the claimed retainer member and needle holder limitations need not be two separate parts. BD argues that the elements must be separate pieces because the asserted claims list the retainer member and needle holder as separate claim limitations and the specifications only describe a retainer member that is a separate part from the needle holder. BD argues that connecting two pieces via a tack weld, as disclosed in the bridge embodiment, is different from forming the elements as a single piece. To support that argument, BD points to the prosecution history, where the inventor allegedly represented to the U.S. Patent and Trademark Office (PTO) that the use of a tack weld to connect two pieces does not result in a one-piece structure. We disagree. The claims and the specifications indicate that the needle holder and retainer member need not be separately molded pieces. Claim 24 of the '733 patent, for example, claims a needle holder, where the head of the needle holder has a retainer member which can be separated from the head of the needle holder. Similarly, claim 43 of the '224 patent claims a needle holder having a head portion where the head portion of the needle holder further comprises an inner head, a continuous retainer member surrounding the inner head, and a bridging portion disposed between the continuous retainer member and the inner head. These claims allow the needle holder and retainer member to structurally overlap prior to separation and indicate that the two limitations need not be separate pieces. The specifications also indicate that the needle holder and the retainer member need not be separately molded pieces. The specifications state that the retainer member and the inner head of the needle holder can be connected by a weld, and retraction occurs when the weld is ruptured or separated. '733 patent, col.9 ll.7-13 (disclosing a tack weld); id. col.10 l.4 (stating that [s]onic welding could also be employed). As part of this disclosure, the specifications disclose forming a bridging portion that connects the retainer member and the needle holder head by welding the elements together to form the bridging portion, and retraction occurs when the weld at the bridging portion is ruptured, fractured or otherwise separated. Id. col.9 ll.38-41, col.9 ll.51-56. The specifications further disclose a method to couple the two structures by expos[ing] them to a temperature of about 120°C for twenty minutes or so to allow some diffusion or incipient melting to occur where they touch. Id. col.9 l.65-col.10 l.1. This passage suggests that the needle holder, retainer member, and bridging portion could be formed as an integral structure in the first instance. Thus, the specifications and the claims indicate that the retainer member and the needle holder need not be two separate pieces. See Linear Tech. Corp. v. Int'l Trade Comm'n, 566 F.3d 1049, 1055 (Fed. Cir.2009) (declining to construe second circuit and third circuit to require entirely separate and distinct circuits where nothing in the claim language or specification supported that construction and the specification disclosed that the circuits could share common circuit elements). The prosecution history does not compel a contrary result. During prosecution of the application that issued as the '224 patent, the inventor argued, among other things, that the outer wall of the needle assembly disclosed in Pressly was not part of a syringe made of a one-piece barrel because the outer wall was fixed to the barrel by ultrasonic welding means or other permanent attachment means following the installation of the retraction components as described in relation to FIGS. 11-13 [of Pressly]. July 17, 2000 Response and Amendment in Application Serial Number 09/617,868, at 43 (internal citations omitted). This statement by itself, however, is not sufficient to detract from the claim language and the written disclosure. The inventor's arguments relate to whether a barrel is made of one piece. The arguments do not address whether the needle assembly and retainer member, which are different syringe components that serve different purposes, can cover distinct structural portions of an integral structure. In addition, the asserted claims lack language that limits the needle holder or the retainer member to elements that are made of one piece. Ultimately, the inventor's statement, on its own, lacks the clarity required to exclude from the scope of the claims a needle holder and a retainer member that form distinct portions of a single structure. See Lazare Kaplan Int'l, Inc. v. Photoscribe Techs., Inc., 628 F.3d 1359, 1369-70 (Fed.Cir.2010); Phillips, 415 F.3d at 1317. Accordingly, the district court did not err in its construction of retainer member.