Thoughts on Printed Matter
Does printed matter need to be printed? A panel of the United States Court of Appeals for the Federal Circuit doesn’t think so. The Federal Circuit has applied the “printed matter doctrine” – a doctrine that excludes patents on printed matter unless the printed matter is related to the functionality of what is being claimed – to “information” as such, on the theory that information is information, whether printed or not. This decision significantly expands the envelope of the printed matter doctrine, conflating it simultaneously with other patentable subject matter issues under 35 U.S.C. §101 and obviousness under 35 U.S.C. §103. Judge Newman issued a well-reasoned concurring opinion agreeing with the ultimate decision on the merits but disagreeing with the analysis.
The printed matter doctrine evolved in the nineteenth century in response to efforts to patent various types of paper stamps and forms. In general, the doctrine is considered to be a rule that protects the boundary between copyrights and patents. Printed matter of the type that would normally be protectable by copyright would not be entitled to patent protection. On the other hand, printed matter that acts in some functional way, such as by interaction with its “substrate”, may give rise to patentability. For example, digits printed according to a certain formula on a band were found to be functionally related to the substrate (the digits and the band jointly forming a math education device with each digit in a unique position relative to all the other digits) and thus the content and arrangement of the digits were given patentable weight. In re Gulack, 703 F.2d 1381, 1386 (Fed. Cir. 1983). Similarly, scales (volumetric indicia) printed on a measuring vessel in a manner that allowed easy calculation of partial recipes were given patentable weight in a claim directed to the measuring vessel.[1] In re Miller, 57 C.C.P.A. 809 (1969). However, in a claim to a kit that included a known reagent and printed instructions detailing a new method for normalizing and amplifying RNA, the printed method, although new, was not given patentable weight. The Federal Circuit explained that, unlike Gulack and Miller, “[h]ere, the printed matter in no way depends on the kit, and the kit does not depend on the printed matter. All that the printed matter does is teach a new use for an existing product.” Ultimately, the court held,
“Ngai is entitled to patent his invention of a new RNA extraction method, and the claims covering that invention were properly allowed. He is not, however, entitled to patent a known product by simply attaching a set of instructions to that product.” In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004).
As technology has evolved, the printed matter doctrine has been applied in the computer arts. In one such case, the Federal Circuit determined that a computer-based structural database was not printed matter – not because of the computer – but because the data structures “contain both information used by application programs and information regarding their physical interrelationships within a memory.” In re Lowry, 32 F.3d 1579, 1583-84 (Fed. Cir. 1994). On the other hand, in a claim to a computer including a memory, a limitation specifying that the memory stores, for example, a customer list, would likely not be given patentable weight under the printed matter doctrine.
The Federal Circuit provided a useful synopsis in In re DiStefano:
The common thread amongst all of these cases is that printed matter must be matter claimed for what it communicates. Only if the limitation in question is determined to be printed matter does one turn to the question of whether the printed matter nevertheless should be given patentable weight. Printed matter is given such weight if the claimed informational content has a functional or structural relation to the substrate. For example, in Gulack we determined that while a sequence of digits printed on a wrist band constituted printed matter, the sequence deserved patentable weight because the informational content of the sequence (what numbers were represented) was functionally related to the endless-band physical structure of the substrate. Similarly, in In re Miller, our predecessor court determined that while the text written on a measuring vessel was printed matter, it must be given patentable weight because there was a “functional relationship between a measuring receptacle, volumetric indicia thereon indicating volume in a certain ratio to actual volume, and a legend indicating the ratio, and in our judgment the appealed claims properly define this relationship.” Thus, as we have consistently held, once it is determined that the limitation is directed to printed matter, one must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is “no” is the printed matter owed no patentable weight.
In re DiStefano, 808 F.3d 845, 850-51 (Fed. Cir. 2015).
With this background in mind, we now turn to the Federal Circuit’s recent decision in Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP LTD.[2] This case is an appeal from an inter partes review decision by the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) finding claim 9 of Mallinckrodt’s patent “not unpatentable” and the remaining claims 1-8 and 10-11 unpatentable as obvious. The claims relate to methods for distributing nitric oxide gas cylinders for pharmaceutical applications. Nitric oxide is used to dilate blood vessels in the lungs and thereby improve blood oxygenation. Inhaled nitric acid is approved by the U.S. Food and Drug Administration for treating neonates with hypoxic respiratory failure. However, nitric oxide treatment may have serious side effects. In particular, the Mallinckrodt patent explains that patients with preexisting left ventricular dysfunction have an increased risk of severe adverse events including pulmonary edema. The patent advises that the risk/benefit should be evaluated on a case-by-case basis. The claims are, essentially, directed to providing a physician with the information needed to make this evaluation:
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.
Dependent claim 9 recited, inter alia:
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.
We shall set aside for the moment the question of whether a claim purporting to cover medical judgment – such as discontinuing a treatment when serious side effects are observed – should be patentable at all. Instead, we shall consider the manner in which the PTAB and the court interpreted these claims. Strangely, both the PTAB and the Federal Circuit treated these claims from the perspective of the printed matter doctrine.
The PTAB, during claim construction, interpreted the “providing information” limitations (the last two paragraphs of claim 1) under the printed matter doctrine, finding that the “information” was either printed matter or “mental steps” and lacked functional relationship with the other elements except as to the last element of claim 9 (discontinuing the treatment). So construed, and considering only the remaining limitations, the PTAB found that the prior art taught all elements that were given patentable weight, and found all but claim 9 invalid as obvious.
On appeal, Mallinckrodt argued the PTAB erred in applying the printed matter doctrine during claim construction rather than during the obviousness analysis and by extending it to cover mental steps. The Federal Circuit disagreed:
Like the information claimed by printed matter, mental steps or processes are not patent eligible subject matter. And while subject matter eligibility underlies the printed matter doctrine, many of our printed matter cases have arisen in the context of anticipation or obviousness. The printed matter doctrine thus raises an issue where the §101 patent-eligibility inquiry and the §102 and §103 novelty and nonobviousness inquiries overlap. Because 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. Accordingly, 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.
The evaluating limitation in claim 3 is directed to a mental step that is also printed matter. It requires a medical provider to weigh:
the 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.
‘112 patent col. 14 ll. 57-66. This limitation merely requires a medical provider to think about the information claimed in the providing information limitation of claim 1. But adding an ineligible mental process to ineligible information still leaves the claim limitation directed to printed matter. To hold otherwise would make the printed matter doctrine a dead letter, requiring no more than a “think about it” step to give patentable weight to a claim limitation directed to information content. There is no meaningful distinction between claim limitations directed to written information in Kao, Ngai, and AstraZeneca, verbal information in King, and mentally-processed information here. An applicant cannot “continue patenting a product indefinitely provided that they add a new instruction sheet,” Ngai, 367 F.3d at 1339, or as we now hold, information together with a purely mental step.
Id. at 12-13 (citations omitted). Ultimately, on this rationale, the court found all claims – including claim 9 – to be invalid as obvious. While it is hard to disagree with the ultimate finding, the rationale for using the printed matter doctrine is difficult to follow. If the claim recites mental steps, then there is a significant body of case law governing how to treat the claim under §101. If all elements of the claim are shown or rendered obvious by the prior art, there is no need for this analysis at all. The court’s statement, “the printed matter doctrine thus raises an issue where the §101 patent-eligibility inquiry and the §102 and §103 novelty and nonobviousness inquiries overlap” invites an unwelcome conflation of these distinct concepts. Treating any claim that recites “information” (a word that appears in many a claim) under the printed matter doctrine has the potential to add a new and unfortunate chapter to the statutory subject matter debate. Treating “mental steps” under the printed matter doctrine likewise seems an unnecessary excursion when ample case law guidance – albeit far from consistent – already exists in this area.
Judge Newman’s concurring opinion aptly and succinctly reflects the view of this author:
The “printed matter doctrine” does not apply to unprinted matter. My colleagues err in holding that “[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.” Maj. Op. at 12. Mental steps are mental, not printed. The printed matter doctrine is directed to printed matter, not information and not mental steps. This “doctrine” is not relevant to the claimed method of administering nitric oxide to infants with left ventricular dysfunction. The claimed method warrants analysis in accordance with the traditional grounds of sections 102, 103, and 112; not as a newly created category within section 101.
[1] Acting Chief Judge Rich famously wrote:
The disclosed invention has for its purpose the solving of the domestic culinary problem of measuring the ingredients from a cookbook recipe in something other than the full recipe. While it contemplates measuring out multiple recipes, for example a double recipe, it particularly contemplates solving the greater difficulty of measuring out fractional recipes, such as 1/3 or 1/2. Normally this would involve the calculation of such baffling measurements as 1/3 of 2/3 of a cup, which, it is assumed, would tax the mathematical abilities of many housewives. From the utility point of view, we will assume this to be so in the absence of any assertion by the Patent Office to the contrary. Indeed, we think we can judicially notice the fact.
[2] Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP LTD, 2018 U.S. App. LEXIS 12707 (Fed. Cir. May 16, 2018).
