In Retractable Technologies, Inc. v. Becton, Dickinson and Company, the Federal Circuit affirmed-in-part and reversed-in-part the district court’s finding that two of Becton, Dickinson’s retractable syringes infringed Retractable’s patents. The Federal Circuit found that one, but not both, of Becton, Dickinson’s syringes infringed the patents. For many, the conflicting approaches to claim construction espoused by Judge Lourie and Judge Plager on one hand and Judge Rader on the other will be more interesting than the conflict between Retractable and Becton, Dickinson.
The Patents At Issue
The patents at issue (U.S. 5,632,733, U.S. 6,090,077 and U.S. 7,351,224) are directed to retractable syringes that have a mechanism for retracting a syringe needle into the body of the syringes after use. Three syringe features were at the center of the dispute:
- Body. The claims recite a “body,” e.g., the outer casing of the syringes.
- Retainer Member. The claims recite a “retainer member,” which is a stationary piece inside the syringes that attaches to the inner part of the body. The retainer member surrounds a needle holder and connects to it at a point called the bridging portion. This connection prevents a compressed spring from prematurely forcing the needle holder (and the needle) into the cavity of the body.
- Mechanism for rupturing the bridging portion. Once the bridging portion is ruptured, breaking the connection between the needle holder and the retainer member, the spring is allowed to extend and forces the needle holder (and the needle) into the cavity of the body. At issue is whether “cutting” was disclaimed as a means for rupturing the bridging portion.
Becton, Dickinson’s Syringes
Becton, Dickinson had two syringes (a 3 mL syringe and a 1 mL syringe) in its Integra™ line that Retractable asserted infringed its patents. The relevant features of the syringes are:
- Body. The 3 mL syringe had a two-piece body and the 1 mL syringe had a one-piece body.
- Needle Assembly. Both the 3 mL and 1 mL syringes had a one-piece needle assembly containing a needle that fit within the syringe bodies.
- Mechanism for rupturing the bridging portion. Both syringes utilize a cutting feature to allow a compressed spring to expand and force part of the needle assembly (and the needle) into the body of the syringe.
The district court construed the claims in the following manner:
- “body” is not limited to a one-piece structure
- “retainer member” includes embodiments in which the retainer member is integrated with the needle holder to form a one-piece structure
- “cutting” was not disclaimed
Applying this claim construction, the jury found that both the 3 mL and 1 mL syringes infringed the asserted patents.
On appeal, Becton, Dickinson raised the following claim construction arguments, which the Federal Circuit reviewed de novo:
Becton, Dickinson argued that “body” should be limited to a one-piece structure, because the specifications describe “the invention” as including a one-piece body and also criticize prior art syringes that contain a two-piece body. For the ’224 patent, Becton, Dickinson asserted that these reasons overcome any different presumption due to claim differentiation (dependent claim 14 defines the syringe as having a “one-piece barrel” and dependent claim 57 expressly recites that “the body comprises a one-piece barrel”).
The Federal Circuit was split on this issue, with Judge Lourie and Judge Plager agreeing with Becton, Dickinson and Judge Rader dissenting. Writing for the court, Judge Lourie noted that the patent specifications focus on a one-piece body by expressly stating that “the invention” has a body constructed from one piece. The specifications also fail to disclose or suggest a multiple-piece body. The court found that the presumption of claim differentiation was overcome by “a contrary construction dictated by the written description,” in light of the specifications’ focus on a one-piece body and statements distinguishing prior art syringes that could not be molded as a one-piece body.
Under this claim construction, only Becton, Dickinson’s 1 mL syringe could meet the claim’s “body.”
Becton, Dickinson argued that the “retainer member” must be separate from the needle holder, because the claims list them as separate elements, the bridging portion necessarily connects two separate embodiments, and the inventor represented to the Patent Office during prosecution that the use of the bridging portion results in a separate retainer member and needle holder.
The Federal Circuit disagreed, citing claim language describing the “needle holder” as having a “retainer member which can be separated from the head of the needle holder” and “further comprises … a continuous retainer member.” The court noted the specifications’ description of the retainer member and needle holder as “an integral structure in the first instance,” due to a method of connecting the two components by melting and fusing them together at the bridging portion. The court noted further that the inventor’s statement was directed to the syringe “barrel” and not the retainer member, and so did not amount to a clear disclaimer of claim scope.
Mechanism for Rupturing the Bridging Portion
Becton, Dickinson relied on the specifications’ criticism of prior art syringes that do not use “friction” to release a compressed spring to support its argument that “cutting” was disclaimed.
The Federal Circuit disagreed, noting that statements about the difficulties and failures of the prior art, without more, do not disclaim claim scope. Instead, the specification must contain an “expression of manifest exclusion or restriction” in order to represent a clear disavowal of claim scope. The court also noted that the specifications describe the bridging portion as capable of being “ruptured, fractured or otherwise separated,” which inherently includes some forms of cutting.
Because the Federal Circuit upheld the district court’s construction of “body” as to the 1 mL syringe and upheld the district court’s construction of “retainer member” and conclusion that “cutting” was not disclaimed, the Federal Circuit found that Becton, Dickinson’s 1 mL syringe infringed Retractable’s patents.
Disagreement Over Claim Construction
The facts and decision here form the backdrop for the most interesting issue raised in this case: is the starting point for claim construction what is described the specification or the words used in the claims? Judges Lourie and Judge Plager favor the former approach, while Judge Rader dissented to take a divergent path.
What Did The Inventors Invent?
Judge Plager wrote a concurring opinion to drive home what he thinks is the crux of the majority’s decision, stating:
I write because, in the welter of all the claims in this case (both patent and litigation), the multiple patents at issue, the number of issues the parties have chosen to argue about (including the important claim construction issue), it would be easy to lose sight of a fundamental point so well made in the majority opinion:
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.
Judge Plager also cites another opinion authored by Judge Lourie, Arlington Industries, Inc. v. Bridgeport Fittings, Inc.:
[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.”
Judge Plager cautions trial judges not to be persuaded “by the siren song of litigation counsel to give the jury wide scope regarding what is claimed,” and encourages them to “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.”
What Do The Claims Recite?
Judge Rader wrote a dissenting opinion to express his disagreement with the “body” claim construction, based on the plain language of the claims:
This court construes “body” . . . to require a one-piece structure. Because the language of the claims make clear that “body” does not contain such a limitation, and it is improper to import limitations from the specification into the claims, I respectfully dissent.
Judge Rader cites Phillips v. AWH Corp., for the “bedrock principle of patent law” that the claims themselves, not the written description portion of the specification, define the patented invention. Turning to the case, Judge Rader found that the ordinary and customary meaning of the term “body” is “not limited to a one-piece structure,” particularly when neither the claims nor the specifications “envince intent by the patentee to limit the scope of ‘body’ to one-piece bodies.”
Judge Rader also placed greater emphasis on the Doctrine of Claim Differentiation, stating:
The only difference between independent claims 1 and 43 and dependent claims 14 and 57, respectively, is the addition of the “one-piece” limitation in the dependent claims, and appellants seek to read this “one-piece” limitation from the dependent claims into the independent claims. Such a reading would render the dependent claims completely superfluous.
The claim construction approach favored by Judge Lourie and Judge Plager brings to mind the analysis the court undertakes when addressing written description and enablement issues. There, too, the court looks to the specification to determine just what it is that the inventors invented.