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CAFC Finds One Becton, Dickinson Retractable Syringe Infringing, Another Noninfringing Since Specifications Limited Invention to a One-Piece 'Body'

July 8, 2011

The U.S. Court of Appeals for the Federal Circuit on July 8 found one Becton, Dickinson and Co. retractable syringe model infringing, but found that another two-piece model was noninfringing because the patent specifications limited the “body” of the invention to a one-piece structure (Retractable Technologies Inc. v. Becton, Dickinson and Co., Fed. Cir., No. 2010-1402, 7/8/11).

In a concurring opinion, Senior Judge S. Jay Plager agreed with that the Becton, Dickinson 3 mL model could not infringe the asserted patents, whose specifications, he said, “do not disclose a body that consists of multiple pieces or indicate that the body is anything other than a one-piece body.” Plager said that the specification ensures that patents meet their obligation of disclosing “what is actually invented, and to claim that and nothing more.”

However, citing the court’s en banc ruling in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005), Chief Judge Randall R. Rader dissented in part by arguing that the majority improperly limited the meaning of “body” to one-piece embodiments in the specifications.

District Court Found All Three Patents Infringed and Valid.

In 1995, Thomas Shaw filed a patent application for a “Tamperproof Retractable Syringe.” Shaw subsequently filed a series of continuation and continuation-in-part applications from the parent application, and these applications issued as three patents (5,632,733; 6,090,077; and 7,351,224) now owned by Retractable Technologies Inc. The company in this suit charged that Becton, Dickinson and Co.’s 1 mL and 3 mL Integra syringes infringed the patents.

A jury found that the ’733, ’077, and ’224 patents were infringed and not invalid for anticipation under Section 102 of the Patent Act, 35 U.S.C. §102, or for obviousness under Section 103 of the Patent Act, 35 U.S.C. §103. The district court then denied Becton, Dickinson’s post-trial motions as to invalidity and infringement.

Becton, Dickinson appealed.

‘Retainer Member’ Reading Upheld; Specifications Limit ‘Body’ to One Piece.

On appeal, Becton, Dickinson argued that the term “body” in the patents limited the invention to a one-piece structure, and there could not be infringement by the accused devices with multiple pieces. The district court construed “body” as “a hollow outer structure that houses the syringe’s components,” and concluded that the term “body” was not limited to a one-piece structure. Further, it argued that the district court erred when it concluded that the claimed “retainer member” and “needle holder” limitations need not be two separate parts.

“The proper construction of a patent’s claims is an issue of Federal Circuit law, and we review a district court’s claim construction de novo” Judge Alan D. Lourie said, citing the court’s en banc ruling in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, (Fed. Cir. 1998). Determining the scope and meaning of the asserted claims requires an examination of the words of the claims themselves, the specification, the prosecution history, and any relevant extrinsic evidence, he said, citing the en banc ruling in Phillips.

Within this framework, Lourie found that “needle holder” and “retainer member” need not be separately molded pieces based on the claims and specifications. He said that Claim 24 of the ‘733 patent and Claim 43 of the ‘224 patent allow the “needle holder” and “retainer member” to structurally overlap prior to separation and indicate that the two limitations need not be separate pieces. Further, he said that the prosecution history did not compel a different result. Accordingly, the Federal Circuit found no error in the district court’s reading of the “retainer member” limitation.

However, the appellate court did find error in the lower court’s construction of the “body” limitation, agreeing with Becton, Dickinson that the claimed “body” is limited to a one-piece structure in light of the specifications. Lourie conceded that “none of the claims expressly recite a body that contains multiple pieces.” Still, he said that while the claims can be read to imply that a “body” is not limited to a one-piece structure, “that implication is not a strong one.”

Lourie continued:

The specifications indicate that the claimed “body” refers to a one-piece body. In distinguishing prior art syringes comprised of multiple pieces, the specifications state that the prior art had failed to recognize a retractable syringe that “can be molded as one piece outer body.” … Consistent with this characterization of the prior art, the Summary of the Invention states that “[t]he invention is a retractable tamperproof syringe,” and that this syringe “features a one piece hollow body.” …

Similarly, the specifications, in describing the invention, expressly state that each syringe embodiment contains a one-piece body. … In addition, each figure that depicts a syringe body shows a one-piece body. In contrast, the specifications do not disclose a body that consists of multiple pieces or indicate that the body is anything other than a one-piece body.

There is a fine line between construing the claims in light of the specification and improperly importing a limitation from the specification into the claims. ... In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than strictly limit the scope of claims to disclosed embodiments or allow the claim language to become divorced from what the specification conveys is the invention.…

In this case, while the claims leave open the possibility that the recited “body” may encompass a syringe body composed of more than one piece, the specifications tell us otherwise. They expressly recite that “the invention” has a body constructed as a single structure, expressly distinguish the invention from the prior art based on this feature, and only disclose embodiments that are expressly limited to having a body that is a single piece. Thus, a construction of “body” that limits the term to a one-piece body is required to tether the claims to what the specifications indicate the inventor actually invented. Accordingly, the district court erred when it construed “body” as encompassing bodies composed of multiple pieces.

However, the Federal Circuit did agree with the district court’s finding that devices that operate by “cutting” were not excluded from the scope of these patents. It found nothing in the claims disavowing “cutting” and said that the specifications in fact disclose a “bridge” embodiment, in which the needle retracts when the weld at the bridge portion is “ruptured, fractured or otherwise separated.”

3mL Integra Syringes Not Infringing.

Based on these claim constructions, the Federal Circuit next turned to the infringement rulings. Having found that the specifications require a one-piece “body,” it reversed the district court’s judgment that the two-piece 3 mL Integra syringe infringed Claims 43, 55, 60, and 61 of the ’224 patent and Claim 25 of the ’077 patent.

It then upheld the ruling that Becton, Dickinson’s one-piece 1 mL syringe featuring a cutter within the needle assembly infringed Claims 43, 55, and 60 of the ’244 patent and Claims 1 and 24 of the ‘733 patent.

Finally, the appellate court affirmed the rejection of Becton, Dickinson’s arguments on invalidity for anticipation and obviousness.

The opinion was joined by Senior Judge S. Jay Plager, and joined in part by Chief Judge Randall R. Rader.

Judge Plager Concurring: The Specification Describes What Was Invented.

In his concurring opinion, Plager credited Lourie for his “thorough and well-reasoned” opinion. He underscored Lourie’s statement here that: “In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than . . . allow the claim language to become divorced from what the specification conveys is the invention.”

Stressing the importance of the specification in claim construction, Plager also praised Lourie’s analysis in Arlington Industries Inc. v. Bridgeport Fittings Inc., 632 F.3d 1246 (Fed. Cir. 2011), stating:

Judge Lourie articulated that idea more fully in his excellent concurring/dissenting opinion in Arlington Industries, Inc. v. Bridgeport Fittings, Inc, where he said: “[T]he basic mandate is for claims to be interpreted in light of the specification of which they are a part because the specification describes what the inventors invented. The specification is the heart of the patent. In colloquial terms, ‘you should get what you disclose.’” …

However much desired by the claim drafters, who want claims that serve as business weapons and litigation threats …, the claims cannot go beyond the actual invention that entitles the inventor to a patent. For that we look to the written description. See 35 U.S.C. § 112. I have written elsewhere about the curse of indefinite and ambiguous claims, divorced from the written description, that we regularly are asked to construe, and the need for more stringent rules to control the curse. … .

I understand how a perfectly competent trial judge can be persuaded by the siren song of litigation counsel to give the jury wide scope regarding what is claimed. But it is a song to which courts should turn a deaf ear if patents are to serve the purposes for which they exist, including the obligation to make full disclosure of what is actually invented, and to claim that and nothing more.

Rader in Dissent: Majority Improperly Narrowed ‘Body’ to Embodiments in Specification.

Dissenting in part, Chief Judge Randall R. Rader argued that the majority improperly read “body” to be a one-piece structure by relying on embodiments in the specification and that the infringement ruling as to the 3mL Integra should have been affirmed. “It is improper to import limitations from the specification into the claims, and this court has expressly and repeatedly warned against confining claims to specific embodiments of the invention set forth in the specification,” Rader said, citing the en banc decision in Phillips.

In Rader’s view, there was no manifest disavowal of claim scope here by Shaw consistent with Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367 (Fed. Cir. 2005). He wrote:

While portions of the specifications reference a “one piece hollow outer body,”… these references do not rise to the level of an expression of manifest exclusion or an express disclaimer of claim scope. … In fact, the inventor’s consistent use of the modifier “one piece” (or “one-piece”) both in the claims and in the written description when he intended to describe a syringe with a one-piece body strongly implies that “body,” standing alone, does not inherently contain a one-piece structural limitation. … When the inventor intended to impose a one-piece structural limitation, he did so explicitly, as shown by dependent claims 14 and 57 in the ’224 patent. Consequently, this court should not impose such a structural limitation on claims that merely use the term “body” without a “one- piece” modifier. Such a construction is contrary to the ordinary and customary meaning of the word “body,” violates the doctrine of claim differentiation, and lacks support in the patents at issue.

Retractable Technologies was represented by Roy W. Hardin of Locke, Lord, Bissell & Liddell, Dallas.

Becton, Dickinson was represented by William F. Lee of Wilmer, Cutler, Pickering, Hale, and Dorr, Boston.

Read the decision in Retractable Technologies Inc. v. Becton, Dickinson and Co.

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