On August 26, 2014, Chief ALJ Charles E. Bullock issued Order No. 9 construing the disputed claim terms of the asserted patents in Certain Hemostatic Products and Components Thereof (Inv. No. 337-TA-913).
By way of background, this investigation is based on a complaint filed by Baxter International Inc., Baxter Healthcare Corporation, and Baxter Healthcare SA (collectively, "Baxter") alleging violation of Section 337 by Ethicon, Inc. and Ferrosan Medical Devices A/S (collectively, "Respondents") in the importation into the U.S. and sale of certain hemostatic products that infringe one or more claims of U.S. Patent Nos. 8,303,981 (the '981 patent); 8,512,729 (the '729 patent); 6,066,325 (the '325 patent); 8,357,378 (the '378 patent); and 8,603,511 (the '511 patent). See our March 5, 2014 and April 4, 2014 posts for more details on the complaint and Notice of Investigation, respectively.
As an initial matter, ALJ Bullock determined that a person of ordinary skill in the art "would possess a master's degree in chemistry, chemical engineering, biochemistry, materials science, polymer science, or a similar discipline with two or more years of experience working with polymeric compositions, including some experience with swellable polymers."
In the Order, ALJ Bullock construed two terms: (1) "hydrogel" and (2) "partially hydrated." ALJ Bullock also adopted the parties' proposed constructions for the remaining claim terms and construed the terms according to their agreed-upon definitions.
As to the first disputed claim term "hydrogel," the parties agreed that the first portion of the definition is "single phase aqueous colloid in which a biologic or non-biologic polymer absorbs water or an aqueous buffer" but disagreed on whether or not to include a "non-dry" requirement. Baxter argued that the word "aqueous" covered the concept that the hydrogel is not dry. Respondents argued that the specification teaches that in order to be a hydrogel the material must have a sufficiently high moisture content so that the material acts as a hydrogel and proposed the construction "single phase aqueous colloid in which a biologic or non-biologic polymer absorbs water or an aqueous buffer in an amount greater than or equal to 20% by weight." ALJ Bullock rejected Baxter's and Respondents' proposed constructions, finding The Commission Investigative Staff's ("OUII") arguments to be persuasive and construed hydrogel as "single phase aqueous colloid in which a biologic or non-biologic polymer absorbs water or an aqueous buffer in an amount sufficient to be swollen and not a free flowing powder." ALJ Bullock noted that all of the parties agreed that a "hydrogel" is not dry and that the adopted construction is consistent with the specification, which states that "[t]he term 'dry' will mean that the moisture content is sufficiently low, typically below 20% by weight water, so that the powder will be free-flowing and that the individual particles will not aggregate."
Regarding the second term, "partially hydrated," the parties agreed that the term refers to a hydration level falling between a "dry powder" and a "fully hydrated" hydrogel. The parties also agreed that upper boundary of the term is "having a moisture content greater than that corresponding to 95% of the equilibrium swell of the hydrogel or gelatin gel" which defines the term "fully hydrated" and that the only issue is how to distinguish between "dry" and "partially dry" material. ALJ Bullock found that this issue was substantively identical to the issue regarding the term "hydrogel," rejected Respondents' strict 20% test, and found that OUII's and Baxter's construction more adequately reflected the specification's discussion of "dry" compositions. Accordingly, ALJ Bullock construed "partially hydrated" to mean "having a moisture content sufficient to be swollen and not a free flowing powder, but less than or equal to the moisture content corresponding to 95% of the equilibrium swell of the hydrogel or gelatin gel."