Two Years in Wonderland: An Updated Look at Alice
By Scott Felder, Wiley Rein LLP
On June 19, 2014, the U.S. Supreme Court issued its decision in Alice Corp. Pty. Ltd. v. CLS Bank Int’l. More than two years later, courts, the U.S. Patent and Trademark Office (USPTO), and practitioners are still filling in the contours of the Court’s two-part test for patent eligibility.
Basic patent eligibility is defined by 35 U.S.C. § 101. In Diamond v. Chakrabarty, the Supreme Court reminded us that Congress intended § 101 to cover “anything under the sun that is made by man.” They cautioned, however, that it excludes “laws of nature, physical phenomena, and abstract ideas...”
In Alice, the Supreme Court reaffirmed the two-step framework it established in Mayo Collaborative Servs. v. Prometheus Labs., Inc. to determine whether an invention is directed to one these judicial exceptions to the scope of § 101. The first step considers whether the claims are directed to a law of nature, a physical phenomenon, or an abstract idea. If the claims are directed to one of these exclusions, the second step considers whether the claims’ elements, considered individually and as an ordered combination, add enough “to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.”
Although the Mayo/Alice test often is used as a sword to strike down business method patents, the framework is no less applicable to medical device research and development. Indeed, Mayo itself concluded that two patents directed to medical treatment methods were patent-ineligible laws of nature.
Likewise, as medical devices and procedures become more reliant on computers and technology, the question of whether a patent is directed to a patent-ineligible abstract idea becomes increasingly relevant. Thus, it is important for the medical device community to understand how to claim their innovations in a way that passes Mayo/Alice muster.
Unfortunately for those looking for guidance on what sorts of claims will survive a Mayo/Alice challenge, the majority of courts that have resolved patent eligibility questions on their merits have concluded that the patents before them are patent-ineligible. There are, however, a handful of paradigms useful in staving off a § 101 rejection during prosecution or challenge during litigation.
First, one can argue that the claims are not directed to a judicial exception (e.g., a law of nature, physical phenomenon, or abstract idea) in the first instance. For example, in Enfish, LLC v. Microsoft Corp., the Federal Circuit declined “to conclude that all claims directed to improvements in computer-related technology, including those related to software, are abstract and necessarily analyzed at the second step of Alice[.]” Instead, the court analyzed “whether the focus of the claims is on [a] specific asserted improvement in computer capabilities . . . or, instead, on a process that qualifies as an ‘abstract idea’ for which computers are invoked merely as a tool.”
Thus, if a claim can be characterized as a technological improvement, it may be found patent-eligible at the first step of the Mayo/Alice inquiry. One could envision such an argument being applied, for example, to claims directed to new software or hardware modules that improve the functioning of — or add features to — digital medical imaging or diagnostic equipment.
On the other hand, if a claim merely uses a computer as a tool, it likely will not be found patent-eligible at step one. A claim directed to software or hardware that does nothing more than automate a pre-existing process is likely to fall into this camp.
Often, it may be difficult to tell whether a claim is directed to a specific improvement or to an abstract idea where the computer is merely a tool. The Federal Circuit recognized the challenge of resolving such “close calls” in BASCOM Global Internet Servs. v. AT&T Mobility LLC.
One possible approach to resolving these close calls might be to read the claims without the computer elements. If the claim still makes sense, the computer is likely a mere tool. If, however, the claim is rendered incomprehensible by the deletions, it may be easier to argue that it is not directed to an abstract idea where the computer is nothing more than a tool.
In any event, even if an innovation is directed to a judicial exception, it can still be deemed patent-eligible if it satisfies the second part of the Mayo/Alice test. In this regard, the more specific a claim — even if each element is conventional standing alone — the more likely that claim is to overcome a § 101 rejection, or to survive a § 101 challenge.
For example, following the Federal Circuit’s decision in DDR Holdings, LLC v. Hotels.com, many courts have found claims that “provide a specific computing solution for a computing problem” or claims that are “necessarily rooted in computer technology in order to overcome a problem specifically arising in the realm of computer networks” patent-eligible. Thus, by arguing that a computerized medical innovation offers a solution “tethered to the technology that created the problem” in the first instance, one may be able to satisfy the second step of the Mayo/Alice test.
The USPTO also has issued patent eligibility guidance to its examining corps. At a high level of generality, this guidance is implemented as a flow chart that tracks the two-step Mayo/Alice test. In an effort to make it more user friendly for examiners (and applicants), however, the guidance includes several examples taken from and inspired by case law; each new iteration of the guidance (there have been three major iterations since Alice) includes more examples. One may be able to overcome a § 101 rejection during prosecution by finding an exemplary patent-eligible claim in the guidance and arguing that it is analogous to the claims under examination.
The Office’s eligibility guidance offers an additional approach to overcoming a § 101 rejection. Namely, the Office will conduct a “streamlined eligibility analysis . . . for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it.” For such claims, patent-eligibility is “self-evident.” For example, “a robotic arm assembly having a control system that operates using certain mathematical relationships” would be considered patent-eligible under the streamlined analysis, as would “an artificial hip prosthesis coated with a naturally occurring mineral.”
One can use this backdrop to survive a Mayo/Alice attack. During prosecution, one has the opportunity to shape the battlefield, ensuring that the claims include sufficient detail to divert into the Office’s streamlined analysis. One can also draft claims that mirror one or more of the Office’s exemplary patent-eligible claims.
Applicants also can draft their applications with an eye toward arguments, either in prosecution or in litigation, that the claims are not abstract (e.g., they fit into the Enfish paradigm), that they are deeply rooted in technology, and/or that they provide a technological solution to a uniquely technological problem (e.g., they fit into the DDR Holdings paradigm). Layered fallback positions (e.g., “even if the claims do not trigger the streamlined analysis, they still pass muster under the full § 101 analysis because . . .”) can be particularly advantageous.
For issued patents written pre-Mayo/Alice, one must go to war with the army one has. Lacking the ability to draft claims directly responsive to Mayo, Alice, and their progeny, the inevitable fight will be whether the claims are more likely the handful of patents that have survived § 101 challenges, or if they are instead like the mine run of patents that have fallen over the past two years, with only a slight reduction in the mortality rate in recent months.
To be certain, this area will continue to evolve, and it may be only a short while before the Supreme Court hears another patent eligibility case and reshuffles the deck again. In the meantime, innovators may find the strategies and guidance outlined here helpful when bracing for or addressing a § 101 rejection or challenge.
About The Author
Scott Felder is a partner at Wiley Rein LLP and the head of the firm’s Patent Prosecution practice. He counsels clients in connection with the acquisition, protection, management, and enforcement of intellectual property rights, including representing clients before the United States Patent and Trademark Office, including the Patent Trial and Appeal Board. Scott received his J.D. from the University of Virginia, Order of the Coif.