Judges: Rader (dissenting-in-part), Plager (concurring), Lourie (author)

[Appealed from E.D. Tex., Chief Judge Folsom]

In Retractable Technologies, Inc. v. Becton, Dickinson & Co., No. 10-1402 (Fed. Cir. July 8, 2011), the Federal Circuit affirmed-in-part and reversed-in-part. The Court affirmed the district court’s construction of “retainer member” and “cutting” in the asserted claims, but reversed the district court’s construction of “body” in the same claims. The Court reversed the district court’s noninfringement decision with respect to one of Becton, Dickinson and Company’s (“BD”) devices, but affirmed with respect to another of BD’s devices. Additionally, the Court affirmed the district court’s exclusion of evidence of plaintiffs Retractable Technologies, Inc. and Thomas J. Shaw’s (collectively “RTI”) discovery responses and affirmed the district court’s decision that claim 25 of U.S. Patent No. 6,090,077 (“the ’077 patent”) was not invalid as anticipated or obvious.

RTI sued BD for infringement of the ’077 patent, U.S. Patent No. 5,632,733 (“the ’733 patent”), and U.S. Patent No. 7,351,224 (“the ’224 patent”). RTI and BD both design and sell retractable syringes, which are medical syringes having a needle that is retractable into the syringe body. Both parties agreed that retractable syringes have existed since at least the early 1990s, as evidenced by U.S. Patent Nos. 5,053,010 (“the ’010 patent”) and 5,211,629 (“the ’629 patent”). BD produces both 3 mL and 1 mL Integra™ syringes. Excluding a plunger, which includes a cutter to allow a spring to expand in order to retract the needle into the body, BD’s 3 mL Integra™ syringe contains two pieces: a syringe body and a needle assembly that screws into the body. BD’s 1 mL Integra™ syringe, on the other hand, is a onepiece syringe that includes the needle assembly.

The district court construed the claim terms “retainer member” and “needle holder” need not be two separate parts and that the claimed “body” was not limited to a one-piece structure. The district court also concluded that the patents did not disclaim the use of “cutting.” The jury found that BD infringed multiple claims of the asserted patents, and that BD failed to prove that any of the asserted claims were invalid. BD then moved for JMOL of noninfringement and invalidity, or, in the alternative, for a new trial. The district court denied the motions and entered judgment against BD.

On appeal, the Federal Circuit affirmed the district court’s claim construction of “retainer member,” but reversed as to the claimed “body.” Regarding the “retainer member,” BD argued that the “retainer member” must be separate from the “needle holder” because the asserted claims list them as separate claim limitations and because the specifications only describe a retainer member that is separate from the needle holder. The Federal Circuit, however, disagreed because the claims and the specification indicate that the “retainer member” need not be separately molded from the “needle holder” and that they can be integrally formed.

Regarding the claimed “body,” BD argued that “body” is limited to a one-piece structure, and the panel agreed. The Court noted that claim construction requires more than viewing the claim language in isolation, that claim language must always be read in view of the written description, and that any presumption created by the doctrine of claim differentiation will be overcome by a contrary construction dictated by the written description or prosecution history. Here, the specifications of the patents expressly state that each syringe embodiment contains a one-piece body and lacks any disclosure of a body having multiple pieces. Each figure also depicts a one-piece syringe body. Furthermore, the specifications note that the prior art fails to recognize a retractable syringe that can be molded as a onepiece outer body. The Court focused on the need to “capture the scope of the actual invention,” and reasoned that, in this case, while the claims leave open the possibility that the recited “body” may encompass a syringe body composed of multiple pieces, “the specification tells us otherwise.” Accordingly, the Federal Circuit reversed the district court and construed the claimed term “body” as comprising a one-piece body.

“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.” Slip op. at 17 (citing Phillips v. AWH Corp., 415 F.3d 1303, 1323-24 (Fed. Cir. 2005) (en banc)).

The Court also agreed with the district court that the patents do not disclaim the use of “cutting.” BD argued that the specifications expressly criticize and distinguish prior art devices that operate by methods other than friction, thereby disclaiming devices that operate by cutting. Citing Epistar Corp. v. International Trade Commission, 566 F.3d 1321, 1335 (Fed. Cir. 2009), the Court disagreed that the claims should be construed to disclaim cutting, because in order to disavow claim scope, the specification must contain “expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” Slip op. at 18. Here, nothing in the claim language or the written description clearly excludes “cutting” from the scope of the claims.

Additionally, the Court reversed the district court’s decision of infringement of BD’s 3 mL Integra™ syringe, but affirmed the decision of infringement of BD’s 1 mL Integra™ syringe. Regarding the 3 mL syringe, which contains two pieces, BD argued that because the specifications of the patents criticize prior art syringes having multiple bodies, RTI cannot assert infringement under the DOE. Having construed the claimed “body” as a one-piece body, the Court agreed. When a specification excludes certain prior art alternatives from the literal scope of the claims and criticizes those alternatives, the patentee cannot then use the DOE to capture those alternatives. Regarding the 1 mL syringe, BD argued for noninfringement based on their construction of the claimed “retainer member” and because the patents exclude “cutting” from the scope of the claims. As discussed above, however, the Court disagreed with BD’s construction of the claimed “retainer member” and “cutting,” and therefore affirmed the district court’s determination of infringement of BD’s 1 mL Integra™ syringe.

Finally, the Court affirmed the district court’s decision that the patents were not invalid for anticipation or obviousness. BD argued that each of the ’010 and the ’629 patents disclose each limitation of claim 25, including the limitation for “lodging the thumb cap in the open back barrel.” RTI, however, provided expert testimony that neither the ’010 nor the ’629 patent discloses this “lodging” limitation. The jury agreed with RTI’s expert testimony and the Court held that substantial evidence supported the jury’s verdict. The Court disagreed, however, as to the holding of nonobviousness. RTI presented expert testimony that artisans of ordinary skill would not have been motivated to replace a “locking” mechanism disclosed by the ’010 and the ’629 patents with the “lodging” mechanism disclosed by UK Patent Application GB 2197792A. Thus, the Court held that substantial evidence supported the jury’s verdict of nonobviousness.

In a separate opinion, Judge Plager concurred with the majority. He wrote to reinforce a fundamental point made by the majority: that “the specification is the heart of the patent” and that the claims must be interpreted in light of the specification. Plager Concurrence at 2. Judge Plager noted that judges should not be persuaded by “the siren song of litigation counsel to give the jury wide scope regarding what is claimed,” because the primary obligation of patentees is to make full disclosure of what is actually invented, and to claim that and nothing more. Id. “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.” Id. (citations omitted).

Chief Judge Rader dissented-in-part because he would affirm the district court’s judgment that the 3 mL Integra™ syringe infringed the asserted claims. Rader Dissent at 5. Chief Judge Rader would adhere to the ‘“bedrock principle of patent law’ that the claims themselves, not the written description portion of the specification, define the patented invention.” Id. at 1-2 (quoting Phillips, 415 F.3d at 1312). In his view, the claimed term “body” has no special, technical meaning, and is not inherently a one-piece body. Id. at 2. Chief Judge Rader noted that under the doctrine of claim differentiation, the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim. Id. Applying this doctrine, the term “body” as recited in the independent claims of the patents cannot be interpreted as a one-piece body because of dependent claims, such as claim 14, which claim “[t]he syringe of claim 1 comprising a one-piece barrel.” Id. (alteration in original) (citation omitted). Chief Judge Rader further noted that there is no exclusion of a body having multiple pieces in the specification and that the continued use of the phrase “one-piece body” implies that the term “body,” standing alone, does not inherently contain a one-piece structural limitation. Id. at 4.