A patent claim has three major sections, namely, a preamble, a transitional phrase, and a body. The body of the claim contains the elements which define the scope of patent protection as defined by that claim. The transitional phrase indicates whether incorporating other elements or components in an accused infringing device other than those elements recited in the body would avoid infringement of the claim. The preamble in general defines the environment (i.e., context) of the claimed invention but does not limit the claim unless the preamble breathes life into the claim. Shire Development LLC v. Watson Pharmaceuticals, Inc. (Fed. Cir. February 10, 2017) discusses the impact on the scope of claims when using a closed transitional phrase “consisting of.”
Three types of transitional phrases exist: “comprising,” “consisting of” and “consisting essentially of.” The transitional phrase “comprising” is referred to as an open transitional phrase because even if the accused infringing device includes additional components and elements, the accused infringing device will not avoid infringement as long as the accused infringing device incorporates all of the elements recited in the body of the claims or the claim elements.
The transitional phrases “consisting of” and “consisting essentially of” are respectively referred to as closed or partially closed transitional phrases. In particular, when a claim’s transitional phrase is either “consisting of” or “consisting essentially of,” adding an additional component or element to the accused infringing device may avoid infringement of the claim even if the accused infringing device incorporates all of the limitations and elements recited in the body of the claim. The issue decided in Shire Development turned on the scope of patent protection when the closed transitional phrase was used in the patent’s claim.
For a claim with the “consisting of” transitional phrase, if an added element is related to the invention then the accused infringing device does not infringe the claim. For a claim with the “consisting essentially of” transitional phrase, if the accused infringing device includes an added component or element that materially affects the basic and novel characteristic of the invention, then the accused infringing device does not infringe the claimed invention. On the other hand, if the accused infringing device includes an added component or element that does not materially affect the basic and novel characteristic of the invention and affects the basic and novel characteristic of the invention in a minor way, then the accused infringing device would still infringe the patent claim.
In Shire Development, the Federal Circuit compared a popular case relating to transitional phrases, namely, Norian. The Manual of Patent Examining Procedure (MPEP) § 2111.03 provides a detailed explanation of the three types of transitional phrases and utilizes the Norian case in explaining the scope of patent protection defined by a claim that utilizes a closed transitional phrase.
The invention claimed in Norian:
- Utilized the closed transitional phrase “consisting of”;
- The claimed invention was directed to a chemical kit; and
- The accused infringing device included a spatula.
The Court in Norian held that the accused infringing product infringed the claim. The accused infringing device did not avoid infringement of the claim because a spatula was unrelated to the claimed invention and had no interaction with the chemicals of the kit.
The instant case involved a claim that also used the closed “consisting of” transitional phrase. But, the accused infringer argued that the holding of Norian should be taken a step further.
The invention claimed in the instant case:
- Utilized the closed “consisting of” transitional phrase;
- The claimed invention was directed to an inner lipophilic matrix and an outer hydrophilic matrix; and
- The accused infringing product included an inner lipophilic matrix and an outer hydrophilic matrix with a small amount of a lipophilic substance in the outer hydrophilic matrix.
The District Court found that the accused infringing product infringed the patent claim. Upon appeal, the Federal Circuit disagreed.
The District Court had found that the lipophilic substance in the outer hydrophilic matrix still had a lipophilic influence on the outer hydrophilic matrix. The Federal Circuit held that the use of the closed transitional phrase, namely, “consisting of” and the related nature of the lipophilic substance in the outer hydrophilic matrix still had an influence that was lipophilic in nature. Hence, the Federal Circuit held that there was no infringement of the patent claim that utilized the closed transitional phrase.
Moreover, the Federal Circuit explained that to come to a different conclusion would do damage to the definition for the transitional phrase “consisting essentially of.” The transitional phrase “consisting essentially of” is defined as being partially closed. This transitional phrase allows for infringement if the added component in the accused infringing product was not material to the invention. The accused infringer wanted to broaden the scope of the closed transitional phrase “consisting of” to be equivalent to the partially closed transitional phrase “consisting essentially of.” For these reasons, the Federal Circuit reversed the District Court. The addition of a lipophilic substance in the outer hydrophilic matrix had an effect that was lipophilic in nature, and thus infringement was avoided. This is true even though the intended purpose of adding the lipophilic substance was for lubrication and not for its lipophilic characteristic (i.e., water dissolvability).
For the layperson, in the vast majority of patent cases, the claims should utilize the open transitional phrase “comprising” which is open-ended and avoids this issue altogether. However, during examination or patent prosecution, there may be times when utilizing the “consisting essentially of” or “consisting of” transitional phrases may be useful in overcoming a rejection made by the examiner. However, the ramifications for doing so should be explored before utilizing the closed or partially closed transitional phrases.
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