At the Federal Circuit
“A” Does Not Always Encompass “One”—Federal Circuit Reads “Population” into a Claim
If a claim recites a composition for inducing a desired effect in “a patient” and also recites that it does not produce a certain side effect, one might expect that the claim refers to a single person. If the desired effect occurred in that patient and the side effect did not, would the claim be satisfied? The Federal Circuit decided it would not in Braintree Laboratories, Inc. v. Novel Laboratories, Inc., __ F.3d __, 110 U.S.P.Q.2d 1525, 2014 WL 1584451 (Fed. Cir. 2014). The case concerned Braintree’s U.S. Patent No. 6,946,149 (“the ’149 patent”), which claims a composition used to help prepare patients for colonoscopies. The Federal Circuit construed a claim in the ’149 patent to require that a side effect not occur in a population of patients, even though the claim recited “a patient” (albeit in the preamble).
The colon needs to be visually clear during a colonoscopy. Therefore, patients typically drink several liters of a solution, such as an osmotic laxative, to purge the colon before the colonoscopy. An osmotic laxative may cause an electrolyte shift as a side effect. Asserted ’149 patent claim 15 reads as follows, in relevant part:
A composition for inducing purgation of the colon of a patient, the composition comprising . . . [a] solution comprising an effective amount of [three types of salt], wherein the composition does not produce any clinically significant electrolyte shifts . . . .Ex Parte Reexamination Certificate, ’149 patent, col. 2, ll. 23-30 (emphases added).
The parties did not dispute that “a patient” should be imported from the preamble into the limitation of not producing any clinically significant electrolyte shifts. The district court had construed “a patient” as meaning “one or more patients” in granting summary judgment of infringement, and Braintree supported this construction on appeal. Novel argued against this construction because it would mean that a composition could satisfy this limitation as long as one patient experienced no clinically significant electrolyte shifts, even if 99 patients out of 100 did.
In an opinion by Judge Prost, the Federal Circuit agreed with Novel and interpreted “‘a patient’ to mean the general class of persons to whom the patented compositions are directed, i.e., a patient population.” Braintree Labs., 110 U.S.P.Q.2d at 1530 (emphasis added). Interpreting “a patient” as one or more patients, the Court reasoned, “leads to the absurd result of infringement even if a composition causes clinically significant electrolyte shifts in a large percentage of patients,” but that the meaning of a patient population “is consistent with the invention the patentee intended to define and protect.” Id. (citation and internal quotation marks omitted). The Court noted that the specification stated the objective of finding “a well tolerated orally administered colonic purgative that . . . avoided the risks of upset of electrolyte balance in patients.” Id. at 1530-31 (quoting ’149 patent, col. 4, ll. 45–48). The Court also noted other statements in the specification referring to “patients” or “people.” See id. at 1531.
As a result, the Court found a genuine dispute as to whether the accused product avoids producing any clinically significant electrolyte shifts in a patient population. Accordingly, the Court vacated the lower court’s finding on summary judgment that Novel infringed Braintree’s claims and remanded the case back to the lower court for further proceedings. Id.
Dissenting, Judge Moore would have construed “a patient” as “one or more patients,” in agreement with Braintree and the district court. Id. at 1536 (Moore, J., dissenting). The dissent noted that “a” has been construed many times, and the Court has repeatedly held that “a,” when used in a “comprising” claim, means “one or more.” Id. at 1537. “The exceptions to this rule are extremely limited: a patentee must evince a clear intent to limit ‘a’ or ‘an’ to ‘one.’” Id. (quoting 01 Communique Lab., Inc. v. LogMeIn, Inc., 687 F.3d 1292, 1297 (Fed. Cir. 2012)). And “there is no plain meaning of ‘a’ that excludes the singular.” Id. Furthermore, she pointed out that the specification only sometimes used the word “patients” and also used the singular, e.g., stating a “purpose” of avoiding undesirable effects “on the recipient” of the solution. Id. (quoting ’149 patent, col. 3, ll. 32-38). Thus, Judge Moore concluded that Braintree’s construction was correct.
Although it may be rare going forward for judges to decide that construing “a” to include “one” gives absurd results, it seems prudent for innovators to consider guarding against undesired interpretations of claims with limitations on what the subject matter achieves. For example, a claim explicitly reciting that a composition does not produce a side effect in at least one patient may be less susceptible to the kind of construction in Braintree Laboratories. Also, a claim preamble is considered limiting if it is “necessary to give life, meaning, and vitality” to the claim. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (citations omitted). Specifying the entity subject to a recited effect outside of a claim’s preamble may reduce the risk of claim construction surprises related to this standard.
Additionally, obtaining a fallback claim that more specifically recites the basis for evaluating whether an effect occurred could have made the intended meaning clearer. Notably, such fallback claims might also be of increased value in light of the Supreme Court’s recent rejection of the Federal Circuit’s indefiniteness standard. Nautilus, Inc. v. Biosig Instruments, Inc., No. 13-369 (U.S. June 2, 2014). And, although perfect foresight is difficult to achieve, practitioners should avoid drafting specifications with language suggesting that a claimed invention involves an effect in a population rather than an individual.