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Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd.

| Category: Intellectual Property News

On May 16, 2018, the United States Court of Appeals for the Federal Circuit ("Federal Circuit") affirmed in part, and reversed in part, the U.S. Patent and Trademark Office Patent Trial and Appeal Board's ("PTAB") application of the printed matter doctrine in the inter partes review ("IPR") of Praxair Distrib., Inc. v. Mallinckrodt Hosp. Prods. IP Ltd.

Mallinckrodt Hospital Products IP Ltd's ("Mallinckrodt") U.S. Patent 8,846,112 (the "`112 patent") was directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications.  In the final written decision, the PTAB held that all of the `112 patent's claims were obvious except for claim 9, which was held patentable. The PTAB found that cited prior art collectively taught each limitation of claims 1-8 and 10-19. Additionally, claim 9 stated that treatment with nitrous oxide should be discontinued in pediatric patients experiencing pulmonary edema. The PTAB found the cited prior art reference disclosed monitoring pediatric patients experiencing pulmonary edema while being treated with nitrous oxide, but did not teach or suggest discontinuing the treatment.  Therefore, the PTAB concluded that the cited prior reference did not teach or suggest the claimed features of claim 9.  Subsequently, Praxair appealed arguing that claim 9 was obvious in view of the cited prior art, and Mallinckrodt cross-appealed, arguing that the PTAB incorrectly applied the printed matter doctrine.

On appeal, the Federal Circuit addressed Mallinckrodt's first argument that the PTAB incorrectly applied the printed matter during claim construction. The Federal Circuit emphasized that mental steps or processes, like information claimed by printed matter, are not patent-eligible subject matter, unless functionally related to the substrate on which it is printed on.  Accordingly, the Federal Circuit determined that “printed matter must be interrelated to the rest of the claim and therefore, did not err in applying the printed matter doctrine during claim construction.”

Mallinckrodt next argued that the PTAB incorrectly extended the printed matter doctrine to include mental steps in order to determine obviousness.  Disagreeing, the Federal Circuit cited several printed matter cases that stemmed from obviousness and anticipation issues, and reasoned that "[b]ecause claim limitations directed to mental step may attempt to capture informational content, they may be considered printed matter lacking patentable weight in an obviousness analysis."  Therefore, the Federal Circuit concluded that the PTAB did not err in extending the printed matter doctrine when determining obviousness and correctly found claims 1-8 and 10-19 were unpatentable.

Subsequently, the Federal Circuit turned to Praxair’s argument that the PTAB incorrectly held claim 9 patentable as being non-obvious.  First, the Federal Circuit focused on the PTAB's construction of the phrase "in accordance with," as meaning "based on, or as a result of."  The Federal Circuit found the PTAB's construction was sufficient to create a functional relationship and therefore, the PTAB correctly gave the printed matter of claim 9 patentable weight. 

However, after analyzing the cited prior reference, the Federal Circuit, in agreement with Praxair, found that the PTAB erred in finding claim 9 non-obvious.  The Federal Circuit explained that the PTAB incorrectly read claim 9 as excluding a pediatric patient from the nitrous oxide treatment and emphasized that claim 9 should be interpreted as discontinuing the nitrous oxide treatment if pulmonary edema occurs.  Because the PTAB's secondary reasoning for finding claim 9 patentable was also based on this incorrect interpretation of claim 9, the Federal Circuit held that the PTAB's reasoning was not supported by substantial evidence. Therefore, the Federal Circuit concluded that the cited prior art reference did teach or suggest the claimed features of claim 9.

Ultimately, the Federal Circuit held limitations that merely claim information by incorporating that 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 it is printed on.  Furthermore, the Federal Circuit reaffirmed that the printed matter doctrine may be applied during claim construction, and for determining obviousness and anticipation.

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