(Doc. 286 at 48.) In support, J J cites Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1381 (Fed. Cir. 2007), Auto. Techs. Int'l, Inc. v. BMW of N. America, Inc., 501 F.3d 1274, 1284 (Fed. Cir. 2007), and AK Steel Corp. v. Sollac Ugine, 344 F.3d 1234, 1243-45 (Fed. Cir. 2003). J J cites to this case precedent for the proposition that when "the asserted claims are broad enough to cover [two embodiments], the patents must enable both embodiments."
A "consisting essentially of" claim occupies a middle ground between closed claims that are written in a "consisting of" format and fully open claims that are drafted in a "comprising" format. AK Steel Corp. v. Sollac and Ugine, 344 F.3d 1234, 1239 (Fed. Cir. 2003) ( citing PPG Industries, 156 F.3d at 1354). The phrase is commonly used to signal 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.
The phrase serves as a middle ground between closed-ended claims using the phrase "consisting of" and open-ended claims using the phrase "comprising." Id. ; AK Steel Corp. v. Sollac & Ugine , 344 F.3d 1234, 1239 (Fed. Cir. 2003). 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.
Facts supporting an invalidity conclusion must be shown by clear and convincing evidence. AK Steel Corp. v. Sollac & Ugine , 344 F.3d 1234, 1238–39 (Fed. Cir. 2003)."[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.
Fed.R.Civ.P. 56(c). Whether a claim satisfies the enablement requirement of 35 U.S.C. § 112, ¶ 1 is a question of law, reviewed de novo, based on underlying facts, which are reviewed for clear error. AK Steel Corp. v. Sollac, 344 F.3d 1234, 1238-39 (Fed. Cir. 2003). The evidentiary burden to show facts supporting a conclusion of invalidity is one of clear and convincing evidence because a patent is presumed valid.
Because a patent is presumed to be valid, the evidentiary burden to show facts supporting a conclusion of invalidity is one of clear and convincing evidence. AK Steel Corp. v. Sollac Ugine, 344 F.3d 1234, 1238-39 (Fed. Cir.2003). A. The Front-Loading 669 and 261 Patents
When, however, the "basic and novel properties" themselves are in dispute, courts have construed the term in order to define the "basic and novel properties" to delineate what must be shown for the purposes of infringement or invalidity. Id. *15-16 (citing AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1239-40 (Fed. Cir. 2003) (determining the basic and novel property of the invention by referring to the specification); L'Oréal S.A. v. Johnson & Johnson Consumer Cos., Inc., 2014 U.S. Dist. LEXIS 190268, *4 (D. Del. Nov. 5, 2014) ("As with claim construction, the court determines the basic and novel properties of an invention as a matter of law, while resorting to the same sources of evidence used for claim construction."). Accordingly, the Court will construe "consisting essentially of" in accordance with its well-established legal meaning, which is: "including the listed ingredients and open to unlisted ingredients that do not materially affect the basic and novel properties of the invention."
The party asserting lack of enablement of a patent bears the burden of proving the point by clear and convincing evidence.AK Steel Corp. v. Sollac, 344 F.3d 1234, 1238-39 (Fed. Cir. 2003). The "enablement requirement is satisfied when one skilled in the art, after reading the specification, could practice the claimed invention without undue experimentation."Id. at 1244.
The enablement requirement "is satisfied when one skilled in the art, after reading the specification, could practice the claimed invention without undue experimentation.'" Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008) (citing AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244 (Fed. Cir. 2003). However, the written description requirement is broader than requiring merely an explanation of "how to 'make and use'; the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
Claims that are not enabled by the patent's specification are invalid. See, e.g., AK Steel Corp. v. Sollac Ugine, 344 F.3d 1234, 1245 (Fed. Cir. 2003). "[A]s part of the quid pro quo of the patent bargain, the applicant's specification must enable one of ordinary skill in the art to practice the full scope of the claimed invention."