Praxair Distribution v. Mallinckrodt Hosp. Prods. IP , Nos. 2016-2616, 2016-2656, 2018 (Fed. Cir. May 16, 2018) (Before Prost, C.J., Newman, and Lourie, J.) (Opinion for the court, Lourie, J.) (Concurring opinion, Newman, J.)

Mallinckrodt owns the ’112 patent, which is directed to methods of distributing nitric oxide cylinders for pharmaceutical operations. Praxair petitioned for inter partes review of claims 1-19 of the ’112 patent, which the Board instituted. The Board held that claims 1-8 and 10-19 would have been obvious over four prior art references. However, claim 9 survived. Praxair appealed from the Board’s decision regarding claim 9, and Mallinckrodt cross-appealed regarding claims 1-8 and 10-11.

The claims included a “recommendation that, if pulmonary edema occurs in a patient who has pre-existing … LVD [left ventricular dysfunction] and is treated with inhaled nitric oxide, the treatment with inhaled nitric oxide should be discontinued.”

The Board applied the printed matter doctrine to this requirement of the claims. This doctrine provides that no patentable weight should be given to the content of information recorded in a substrate, such as the information in a database. The Board interpreted the providing information, evaluating, and recommendation steps in the claims to be either printed matter or purely mental steps, in either case not entitled to patentable weight, because they lacked a functional relationship to the other claim limitations. However, for claim 9, the Board interpreted “in accordance with” to mean “based on, or as a result of” the recommendation to discontinue nitric oxide treatment, “thereby establishing a functional relationship to the recommendation limitation.”

Claim limitations directed to printed matter are not entitled to patentable weight unless the printed matter is functionally related to the substrate on which the printed matter is applied. “Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004). Merely adding an instruction sheet or other informational content to a drug product is not sufficient to create a functional relationship, even if the information is required by the FDA for approval. Instead, the printed matter must be interrelated with the rest of the claim.

Here, the Board properly addressed the printed matter doctrine. “The Board’s printed matter analysis only required analyzing and interpreting the meaning of the claim language. That is claim construction, which is ultimately a legal inquiry.”

The Court then addressed whether the Board erred at the first step of the printed matter analysis. The Court held that, “[l]ike the information claimed by printed matter, mental steps or processes are not patent-eligible subject matter.” A limitation that merely claims information by incorporating that information into a mental step will receive patentable weight only if the limitation is functionally related to the substrate. In this context the Board held that the ordinary meaning of “pharmaceutically acceptable” in the preambles of independent claims 1 and 7 refers to the physical condition of the gas, not prescribing information that may accompany it. The Court agreed. The Board did not err either in construing “pharmaceutically acceptable” or in concluding that the term did not create a functional relationship.

The Court affirmed the Board’s decision holding claims 1-8 and 10 unpatentable as obvious.

Next, Praxair argued that the Board improperly construed “in accordance with” in claim 9. The Board found a functional relationship by interpreting “in accordance with” to mean “based on, or as a result of” the recommendation to discontinue nitric oxide treatment. According to Praxair there is no functional relationship between the discontinuing step of claim 9 and the recommendation limitation.

The Court “assume[d] that the Board properly construed the term ‘in accordance with’ as meaning ‘based on, or as a result of.’” Under the Board’s construction, claim 9 requires a medical provider to take a specific action, discontinuing treatment, as a result of the recommendation limitation. The Court, and both parties, agreed that this sufficed to create a functional relationship. Therefore, the Court found that the Board did not err in concluding that the printed matter in claim 9 has a functional relationship to the rest of the claim and giving the printed matter patentable weight.

This did not end the inquiry, because the Court still had to consider whether the claim as a whole would have been obvious to a person of ordinary skill at the time of the invention. First, in addressing the differences between the prior art and claim 9, the Board found that the Bernasconi reference did not teach or suggest that treatment should be discontinued in pediatric patients with LVD that experience pulmonary edema, as required by claim 9. Instead, Bernasconi taught “that [nitric oxide] may be given to patients with LVD, as long as those patients are monitored carefully during treatment.” The Board’s reading of Bernasconi conflated excluding a patient with LVD from treatment with discontinuing treatment after that patient experiences a pulmonary edema. Claim 9 does not address excluding patients with LVD from nitric oxide treatment. It recites that nitric oxide be given to patients with LVD, and be discontinued if a pulmonary edema occurs. Therefore, “Bernasconi’s teaching that patients with LVD could be treated with nitric oxide if carefully monitored is not contrary to the claim language, and the Board erred by interpreting claim 9 otherwise.”

The Board also found “compelling” Mallinckrodt’s evidence of secondary considerations that “patients were not excluded” from an INOT22 study, despite the known relationship between the nitric oxide treatment and pulmonary edema for patients with LVD. However, because the Court concluded that claim 9 requires administering nitric oxide to patients with LVD, Mallinckrodt’s evidence of secondary considerations regarding the failure of researchers to exclude such patients from the INOT22 study lacked sufficient nexus to the claim. Both the Board’s findings regarding the differences between the prior art and claim 9 and its findings on secondary considerations depended on an incorrect interpretation of that claim. Thus, the Court reversed the Board’s decision that claim 9 is not unpatentable as obvious.

Judge Newman concurred in judgment of unpatentability of claims 1-11, but disagreed with the Court’s view of the “printed matter doctrine” and its application to “information” and “mental steps.” She argued that the majority improperly expanded the application of the printed matter doctrine, explaining that the doctrine is limited to “printed matter, not information and not mental steps.”

Take Away

A claim limitation that incorporates information into a mental step or process is not entitled to patentable weight under the printed matter doctrine, unless the limitation is functionally related to the substrate to which the printed matter is applied.

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