Judge Andrews on Friday accepted a defendant's argument that, during prosecution, the applicant had so clearly and unambiguously disclaimed the prior art that it warranted construing "comprising" as used in a claim element to mean "consisting essentially of"—a major narrowing of claim scope.
The claim involved an oral tablet that delivered multiple drugs, with a "barrier layer" between them. The barrier layer claim element included the word "comprising":
a barrier layer comprising hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide . . .
The portion after "comprising" in the claim element matches the composition of a commercially-available barrier layer called "Opadry ®White (YS-1-7003)."
The Court found disclaimer based on the applicant's statements about this this commercially-available product:
Applicants repeatedly and unambiguously disclaimed ingredients beyond Opadry ® White (YS-1-7003) by overcoming prior art references because of the unexpected and surprising results of the Opadry ®White (YS-1-7003) barrier layer.
The Court recognized that this limits the scope of the claim more than would be necessary to avoid the prior art at issue during prosecution:
Regarding the scope of the disclaimer, the Court agrees with Alkem that the Applicants put the public on notice that they were narrowing the scope of their claims to specify that the barrier layer is Opadry ® White (YS-1-7003), and the disclaimer should not be limited to the specific combination of elements presented by the prior art.
The Court did not discuss it, but "consisting essentially of" is a term of art with a very different claim scope than "comprising," as the Federal Circuit recently set forth in a case involving another Horizon entity:
The phrase “consisting essentially of” . . . is a transition phrase often used to signal a partially open claim [that] serves as a middle ground between closed-ended claims using the phrase “consisting of” and open-ended claims using the phrase “comprising.” . . . Accordingly, a drafter will generally include the phrase “consisting essentially of” before (a) a list of ingredients when dealing with a composition claim, or (b) a series of steps when dealing with a process claim. PPG. . . . By doing so, “the drafter signals that the invention necessarily includes the listed ingredients [but] is open to unlisted ingredients that do not materially affect the basic and novel properties of the invention.”
HZNP Meds. LLC v. Actavis Labs. UT, Inc., 940 F.3d 680, 692-93 (Fed. Cir. 2019) (citations omitted).
Judge Andrews' opinion doesn't say why the somewhat-open-ended "consisting essentially of" was used rather than the close-ended "consisting of," although it may not have been raised by the parties.
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