La decisión del Tribunal Federal de Apelaciones en el caso University of Florida Research Foundation contra General Electric plantea dudas sobre las directrices de elegibilidad de la materia objeto de la patente.

Subject matter eligibility jurisprudence under 35 U.S.C. § 101 has been in flux in recent years, following the Supreme Court’s decisions in Mayo v. Prometheus and Alice Corp. v. CLS Bank. On February 26, 2019, the Federal Circuit in University of Florida Research Foundation v. General Electric (available at: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1284.Opinion.2-26-2019.pdf ) held that the challenged claim(s) directed to systems and methods for compiling patient physiologic data from hospital bedside machines were invalid under § 101 as failing steps 2A and 2B under Alice/Mayo. While the decision represents the first Federal Circuit opinion since the publication of the USPTO’s recent guidance addressing invalidity under 35 U.S.C. § 101, it does not specifically address that guidance, neither adopting the two-prong analysis nor rejecting it. Additionally, some may argue that the court’s opinion appears inconsistent with training documents used by the USPTO regarding similar claims.

The courts and USPTO have applied a three-part test for determining subject matter eligibility of patent claims that has sometimes led to confusing and unpredictable results. The test requires Patent Examiners and courts to first determine whether a patent claim was directed to a statutory category (e.g., a process, machine, article of manufacture, or composition of manufacture) (step 1); then identify if the claim was “directed to a judicial exception,” such as a law of nature, natural phenomenon, or an abstract idea (step 2A); and finally, if the claim was directed to such an exception, then determine whether additional elements in the claim included “significantly more” than the exception (step 2B). However, the Supreme Court has expressly declined to define what constitutes an abstract idea or what qualifies as “significantly more,” setting the stage for inconsistent applications of the test.

On January 7, 2019, USPTO Director Andrei Iancu published new guidance for subject matter eligibility analysis in the Federal Register that attempted to clarify step 2A of the Mayo/Alice test, splitting this step into two prongs by: (1) providing explicit groupings of subject matter that is considered an abstract idea; and (2) clarifying that a claim is not directed to a judicial exception if the claim integrates the exception into a practical application of that exception. In the first prong (“step 2A(1)”), Examiners are directed to identify specific limitations in the claim that recite an abstract idea from the following groupings:

• mathematical concepts – mathematical relationships, mathematical formulas or equations, or mathematical calculations;
• certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
• mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion).

If a claim recites an abstract idea or other judicial exception, then under the second prong (“step 2A(2)”), Examiners must evaluate whether the recited exception is integrated into a practical application. If so, then the claim is not directed to the abstract idea and is eligible under 35 U.S.C. § 101 (though other rejections over prior art or written description may still apply). To apply this prong, Examiners are directed to identify any additional elements recited in the claim beyond the judicial exception, and evaluate those additional elements individually and in combination to determine whether they integrate the exception into a practical application. Examiners must consider all of the additional elements, regardless of whether they are considered well-understood, routine, or conventional.

However, the guidance only applies to the Patent Examining Corps and the USPTO’s own Patent Trial and Appeals Board (PTAB). In the instant Federal Circuit decision, the court does not address this guidance and arguably rules in a manner some may view as inconsistent with the USPTO’s § 101 training documents.

Specifically, the Federal Circuit considered eligibility of U.S. Patent No. 7,062,251, owned by the University of Florida Research Foundation, Inc. (UFRF). The ‘251 Patent, “Managing Critical Care Physiologic Data Using Data Synthesis Technology,” is directed to systems and methods for compiling patient physiologic data from hospital bedside machines, such as heart rate and blood pressure monitors. These machines typically have their own proprietary interfaces and communications protocols, and as a result, most health care facilities simply manually recorded the data on paper. This time-consuming and inefficient process can lead to transcription errors and treatment delays. The system described in the ‘251 Patent aimed to improve this process with a computing device with the ability to collect data and translate each of the proprietary protocols of the bedside machines into a standardized format. Claim 1 of the patent, which was considered to be representative, recited:

1. A method of integrating physiologic treatment data comprising the steps of:
   receiving physiologic treatment data from at least two bedside machines;
   converting said physiologic treatment data from a machine specific format into a machine independent format within a computing device remotely located from said bedside machines; performing at least one programmatic action involving said machine-independent data;
   and presenting results from said programmatic actions upon a bedside graphical user interface.

Applying the two-part Alice/Mayo test, the Federal Circuit first contended that the claim merely recited automation of steps that were previously performed manually, and was thus directed to an abstract idea under step 2A: “[t]his is a quintessential ‘do it on a computer’ patent: it acknowledges that data from bedside machines was previously collected, analyzed, manipulated, and displayed manually, and it simply proposes doing so with a computer.” 2018-1284 at 8. In particular, the Federal Circuit noted the purely result-based functional language of the patent, stating that “[n]either the ‘251 patent, nor its claims, explains how the [device drivers written for the various bedside machines] do the conversion that UFRF points to… The ‘251 patent ‘fails to provide any technical details for the tangible components, . . . instead predominately describ[ing] the system and methods in purely functional terms.’” Id. at 9-10 (emphasis in original, internal citation omitted). Second, under step 2B, the court noted that the claim included no additional unconventional features beyond the use of generic computers, and therefore lacked any inventive concept beyond the abstract idea.

Although the Federal Circuit’s holding is likely not incompatible with the USPTO’s two-prong analysis—the claim at issue appears to lack any additional features that integrate the abstract idea into a practical exception that would provide eligibility under step 2A(2) of the USPTO’s guidance—the result may be viewed as inconsistent with training materials used internally by the USPTO. Specifically, along with the guidance, the USPTO provided example hypothetical claims and analysis regarding patent eligibility (available at: https://www.uspto.gov/sites/default/files/documents/101_examples_37to42_20190107.pdf). Example 42, Claim 1 is directed to a method related to medical records, and recites:

A method comprising:

a) storing information in a standardized format about a patient’s condition in a plurality of network-based non-transitory storage devices having a collection of medical records stored thereon;

b) providing remote access to users over a network so any one of the users can update the information about the patient’s condition in the collection of medical records in real time through a graphical user interface, wherein the one of the users provides the updated information in a non-standardized format dependent on the hardware and software platform used by the one of the users;

c) converting, by a content server, the non-standardized updated information into the standardized format,

d) storing the standardized updated information about the patient’s condition in the collection of medical records in the standardized format;

e) automatically generating a message containing the updated information about the patient’s condition by the content server whenever updated information has been stored; and

f) transmitting the message to all of the users over the computer network in real time, so that each user has immediate access to up-to-date patient information.

Some may view this Example Claim as similar to claim 1 of the ‘251 Patent at issue in the Federal Circuit decision, with steps of converting non-standardized information into a standardized format through the use of generic computing devices. Indeed, the USPTO’s analysis of the Example Claim notes that it recites an abstract idea, stating:

The claim as a whole recites a method of organizing human activity. The claimed invention is a method that allows for users to access patients’ medical records and receive updated patient information in real time from other users which is a method of managing interactions between people. Thus, the claim recites an abstract idea.

However, the analysis continues with step 2A(2), explaining that the Example Claim integrates the abstract idea into a practical application and is therefore eligible:

The claim recites a combination of additional elements including storing information, providing remote access over a network, converting updated information that was input by a user in a non-standardized form to a standardized format, automatically generating a message whenever updated information is stored, and transmitting the message to all of the users. The claim as a whole integrates the method of organizing human activity into a practical application. Specifically, the additional elements recite a specific improvement over prior art systems by allowing remote users to share information in real time in a standardized format regardless of the format in which the information was input by the user. Thus, the claim is eligible because it is not directed to the recited judicial exception (abstract idea). (emphasis added)

While the Example Claim includes several additional features of providing remote access, automatically generating update messages, and transmitting the update messages to users, and the USPTO’s analysis notes that these features allow the system to share information in real time, some commentators have suggested that it is not clear that the Federal Circuit would agree that this Example Claim is eligible. As with Claim 1 of the ‘251 Patent, the Example Claim is written in purely functional language, and does not recite any details of how the functions are performed. Similarly, other than the token recitation of generic computer components, the Example Claim does not include any limitations that were not previously performed by humans: data was stored in paper records and accessible by physicians (albeit slowly, frequently requiring physically carrying records throughout the facility); new information in non-standard formats could be translated and added in manually by staff; and physicians could be notified when new test results were added to the record. Implementing the improved system likely requires additional technical details as to how the system accomplishes the result but these features are not recited in the Example Claim, which instead merely focuses on the desired result to be achieved. Accordingly, it is possible that the Federal Circuit could find that the Example Claim is ineligible for the same reasons as the Claims of the ‘251 Patent.

The USPTO’s guidance is an important attempt to clarify subject matter eligibility and may reduce the number and difficulty of overcoming rejections during prosecution. However, it will be interesting to see to what extent the courts reach conclusions that may vary from the USPTO’s analysis. While the Federal Circuit did not discuss the guidance in this case, this may be due to the initial district court proceedings having occurred prior to the January 9^th publication of the guidance, as well as the application having been examined and granted under older subject matter eligibility jurisprudence (the ‘251 Patent was granted in 2004, four years prior to the Supreme Court’s decision in In re Bilski, and ten years prior to the Alice decision). Future cases addressing applications examined under the new guidance should be more informative as to their general consistency with court approaches.