Last week, the Federal Circuit found all patent claims invalid for obviousness in an inter partes review, in Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd. But the Court did not render its decision without engendering a judicial disagreement between the majority and Judge Newman on the proper role of the printed matter doctrine in obviousness determinations.
Mallinckrodt's patent-in-IPR, U.S. Patent 8,846,112, was directed to methods for providing nitric oxide gas as a treatment for dilating pulmonary blood vessels in neonates. However, the art recognized a side effect, pulmonary edema, for which infants with pre-existing left ventricular dysfunction (LVD) were at particular risk. A diagnostic assay (pulmonary capillary wedge pressure, or "PCWP") having greater than a specific value was taught in Mallinckrodt's patent to exclude infants at risk for this side effect. Claim 1 is representative of the claims invalidated by the Patent Trial and Appeal Board, while Claim 9 was found nonobvious in the Board's Final Written Decision:
1. A method of providing pharmaceutically acceptable nitric oxide gas, the method comprising:
obtaining a cylinder containing compressed nitric oxide gas in the form of a gaseous blend of nitric oxide and nitrogen;
supplying the cylinder containing compressed nitric oxide gas to a medical provider responsible for treating neonates who have hypoxic respiratory failure, including some who do not have left ventricular dysfunction;
providing to the medical provider (i) information that a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure is 20 ppm nitric oxide and (ii) information that, in patients with preexisting left ventricular dysfunction, inhaled nitric oxide may increase pulmonary capillary wedge pressure (PCWP), leading to pulmonary edema, the information of (ii) being sufficient to cause a medical provider considering inhaled nitric oxide treatment for a plurality of neonatal patients who (a) are suffering from a condition for which inhaled nitric oxide is indicated, and (b) have pre-existing left ventricular dysfunction, to elect to avoid treating one or more of the plurality of patients with inhaled nitric oxide in order to avoid putting the one or more patients at risk of pulmonary edema. (italics denoting limitations found by the Board to implicate the printed matter doctrine)
9. The method of claim 7, further comprising:
performing at least one diagnostic process to identify a neonatal patient who has hypoxic respiratory failure and is a candidate for inhaled nitric oxide treatment;
determining prior to treatment with inhaled nitric oxide that the neonatal patient has pre-existing left ventricular dysfunction;
treating the neonatal patient with 20 ppm inhaled nitric oxide, whereupon the neonatal patient experiences pulmonary edema; and
in accordance with the recommendation of [claim 7], discontinuing the treatment with inhaled nitric oxide due to the neonatal patient's pulmonary edema.
(Italics denoting the limitations relied upon by the Board to find the claim non-obvious.)
The Board found claims 1-8, 10, and 11 to be obvious over a combination of four prior art references, but found claim 9 not to be obvious, its analysis for this claim resting on its construction of the phrase "in accordance with" (as discussed below).
The PTAB gave the limitations set forth in italics above to implicate the printed matter doctrine, insofar as they recited information transmitted to a doctor or other medical practitioner. These encompassed mental steps, according to the Board, and on these grounds were given no patentable weight in the Board's obviousness assessment. So construed, the Board found claims 1-8, 10, and 11 to be obvious because the skilled worker would have been motivated to combine the prior art, which disclosed the provisions of claim 1 having patentable weight (i.e., not disclosing the information regarding neonatal risk to nitric oxide (NO) administration). On the contrary the Board found claim 9 not obvious because the prior art did not teach excluding from NO treatment neonates identified using the method recited in the claim.
The Federal Circuit affirmed the Board's obviousness determination for claims 1-8, 10, and 11 and reversed the Board's finding that claim 9 was nonobvious, in a decision by Judge Lourie, joined by Chief Judge Prost and Judge Newman; Judge Newman filed a concurring opinion. As discussed in the opinion, Mallinckrodt argued that the Board's application of the printed matter doctrine for claim construction was improper and should be limited to determining whether the claims were invalid after the claims were construed. The Federal Circuit disagreed, holding that it was proper not to give printed matter patentable weight under these circumstances, and that the printed matter doctrine (and exclusion of these limitations) was proper when what the limitation recites is the content of the information provided according to the claims as recited here.
The Board and the panel majority did not apply the printed matter doctrine on grounds that the claims did not recite patent eligible subject matter under Section 101, but limited its consideration to obviousness, citing AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1064 (Fed. Cir. 2010), to the effect that merely adding an instruction sheet or other informational content to a drug product, even if required by the FDA for approval, is not sufficient to create a functional relationship that could form a basis for distinguishing the prior art.
The panel majority also rejected Mallinckrodt's further argument that considering whether the limitation encompassed "mental steps" was error, stating that the printed matter doctrine "and the §102 and §103 novelty and non-obviousness inquiries overlap," citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 90 (2012). The panel's analysis of claim 3 was relevant to patents interacting with thought by a medical practitioner, wherein:
[T]he potential benefit of treating the [neonatal patient] with 20 ppm inhaled nitric oxide vs. the potential risk that inhaled nitric oxide could cause an increase in PCWP leading to pulmonary edema in patients who have pre-existing [LVD], in order to arrive at a decision of whether or not to treat the [neonatal patient] with inhaled nitric oxide.
And this, according to the opinion, is equivalent to a doctor thinking about the information provided. Relevant to Judge Newman's concurrence (albeit not expressly directed to it), the opinion states that "adding an ineligible mental process to ineligible information still leaves the claim limitation directed to printed matter."
The opinion also rejected Mallinckrodt's argument that the term "pharmaceutically acceptable" incorporates the information contained in what the Board considered the printed matter. Instead, the Federal Circuit held that the term is related to "the physical condition of the gas" rather than how or to whom the gas is administered, and that this phrase does not impart a functional relationship with the information recited in the limitation excluded under the printed matter doctrine.
With regard to Mallinckrodt's assertion that the Board erred with regard to the secondary considerations of non-obviousness it asserted before the Board, the panel agreed that secondary considerations must be taken into account. Here, these were not relevant because the evidence for secondary considerations was based on the information that the Board and Federal Circuit determined had no patentable weight ("No patentable weight means no patentable weight.").
Turning to the question of the obviousness of claim 9, the opinion recognized this question turned on construction of the phrase "in accordance with," and whether there was a functional relationship between the "recommending" step and the "discontinuing treatment" step. For the purpose of deciding this question, the panel assumed the Board's construction was proper, stating that the claim "requires a medical provider to take a specific action, discontinuing treatment, as a result of the recommendation limitation," a construction that suffices to create a functional relationship which neither party nor the panel disputed. This "interrelating" the information with the "concrete step of discontinuing treatment meant to the panel that the Board had not erred in finding a functional relationship between the two limitations.
But that is not "the end of the inquiry," according to the opinion. The correct question was whether claim 9 as a whole would have been obvious, and the panel held that it is. The obviousness question regarding claim 9 was based on one reference, to Bernsasconi (A. Bernasconi & M. Beghetti, Inhaled Nitric Oxide Applications in Paediatric Practice, 4 Images in Paediatric Cardiology 4 (2002)), which disclosed that children with preexisting LDV were at risk when treated with nitric oxide and should be monitored to minimize severe adverse event occurrence. The Board found that the reference taught "that [nitric oxide] may be given to patients with LVD, as long as those patients are monitored carefully during treatment," which was contrary to the panel's interpretation of the claim language. The Federal Circuit held that this interpretation of the language of claim 9 was incorrect, and when properly understood the teachings of the Bernasconi reference was not contrary to what was claimed. The Board's error: "[t]he Board conflated excluding a patient with LVD from nitric oxide treatment and discontinuing nitric oxide treatment in a patient with LVD after that patient experiences a pulmonary edema," according to the opinion. The claim does not exclude patients from nitric oxide treatment, but provides that the treatment be discontinued if pulmonary edema ensues.
The Federal Circuit found that the factual bases for the Board's non-obviousness determination were not supported by substantial evidence. Moreover, remand was not necessary because "[t]he Board's uncontested findings regarding Bernasconi render claim 9 obvious under the proper reading of the claim." According to the opinion, the Bernasconi teachings of "careful observation and intensive monitoring during [nitric oxide] inhalation" include discontinuing treatment if pulmonary edema developed as a result of the treatment. The undisputed facts in the panel's opinion were that nitric oxide treatment was known in the art; that pulmonary edema in response to the treatment was known in the art; that pulmonary edema was known to be a potentially fatal side effect of treatment; and that "discontinuing a treatment in response to a serious side effect was known in the prior art." On these facts:
"[T]here is only one permissible factual finding," [citing] Corning v. Fast Felt Corp., 873 F.3d 896, 903 (Fed. Cir. 2017), that "careful observation and intensive monitoring" of patients with LVD treated with nitric oxide, motivated by the dangerous possibility of a pulmonary edema known to result from that treatment, includes or at least suggests to a person of ordinary skill discontinuing nitric oxide treatment after a patient with LVD administered nitric oxide suffers a pulmonary edema.
The panel also faulted the Board's reliance on secondary considerations, finding insufficient nexus to the claimed invention.
Judge Newman's concurrence disagreed with the majority's reliance on the printed matter doctrine, on the grounds that there is no printed matter recited in the claims, only information ("[b]ecause claim limitations directed to mental steps may attempt to capture informational content, they may be considered printed matter lacking patentable weight in an obviousness analysis," according to the majority opinion). Judge Newman perceived the conflation between mental steps and the printed matter doctrine by the Board as sanctioned by the majority to be another extension of patent eligibility considerations into what should be a straightforward obviousness analysis, with resulting doctrinal confusion. And this has practical consequences, because by denoting the limitations as having no patentable weight as printed matter the obviousness analysis can be performed as precedent expressly forbids it from being done:
[T]he form of analysis whereby limitations are removed from the claim before the claim is analyzed for patentability, is contrary to the patent statute, which requires determination of patentability of the claimed subject matter as a whole. It is improper to pluck limitations out of the claims, as of "no patentable weight," and then to review patentability of the remainder. See In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) ("Under section 103, the board cannot dissect a claim, excise the printed matter from it, and declare the remaining portion of the mutilated claim to be unpatentable. The claim must be read as a whole."). The Board stated that it afforded no patentable weight to the "providing information" and "evaluating" limitations, but gave patentable weight to the "recommendation" limitation in claim 9. Such piece-meal analysis does not impart precision to patentability analysis.
As is frequently the case, Judge Newman makes the better argument. Perhaps due to Section 101 fatigue or because the Supreme Court's penchant for ignoring the statutory silos of eligibility, anticipation, and obviousness is contagious, the majority's decision imports the incoherence of eligibility law into the obviousness context (doing little to clarify the standards in either). And by extending the application of the printed matter doctrine to claims that don't recite printed matter, this precedential decision has the capacity to make mischief (having the Court's imprimatur) until such time that another panel can creatively avoid its application or in the unlikely event that the Federal Circuit considers the question en banc (an eventuality that seems likely only if the Court becomes enamored with this approach to invalidating claims on eligibility grounds under the auspices of an obviousness determination). Neither possibility can be particularly comforting to the patent community.
Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd. (Fed. Cir. 2018)
Panel: Chief Judge Prost and Circuit Judges Newman and Lourie
Opinion for the court by Circuit Judge Lourie; opinion concurring in the judgment by Circuit Judge Newman
