Patent application for computer analysis of clinical drug trials denied. IN RE: ROSENBERG

Patent application for computer analysis of clinical drug trials denied. IN RE: ROSENBERG

A patent is a set of exclusive rights granted to the inventor of a new invention. To gain a patent in the United States an inventor must file a patent application with the United States Patent and Trademark Office.  The patent application must describe the invention in detail and can claim the aspects of the invention which are new, useful and not obvious.  The United States Patent and Trademark Office will grant an application when the patent application demonstrates that all the requirements for patentability have been met.  A patent grants its owner the exclusive right to make, use, sell and import the invention in the United States.  If someone exercises one of these exclusive rights, without the authorization of the patent owner, that can be considered patent infringement.

Several different classes of inventions are eligible for patent protection. 35 U.S. Code § 101 states that, any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent.”  Software can be considered a computer implemented process and is eligible for patent protection in certain circumstances.

Whether computer software is eligible subject matter for patent protection is an evolving question.  Computer software typically takes algorithms, which can be considered an abstract idea, and applies these algorithms to perform a task.  The first United States patent on a piece of computer software was issued in April 23, 1968.  Since that time the definition of eligible subject matter has changed significantly, first enlarging and then shrinking the definition of what is considered patent eligible.  Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014) articulates the present test to determine if computer software is eligible for patent protection.  The first step in the Alice test is to determine whether the claims of the patent are directed to a patent-ineligible concept, like an abstract idea.  If the first step is true, then each patent claim is reviewed both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.  Understanding how the Alice test is applied can be difficult to grasp, therefore it is helpful to study case precedent.

IN RE: MICHAEL J. ROSENBERG, 2019-2251 (C.A.F.C. 2020) is a case where a patent application for computer software failed the meet the test for eligible subject matter.

This case begins with Patent Application No. 12/102,992 which was filed in 2012 by one Michael Rosenberg.  The ’992 Application describes a method and system to collect performance-related data about a clinical trial, analyze that data, and report on whether any adjustments should be made to the clinical trial based on the review of
the collected data.  The invention described in the patent application relates to conducting clinical trials in the medical field, as well as in other management systems, by providing a fully integrated ability to handle the many collection, analytic, and reporting functions.

The patent examiner rejected all pending claims under the abstract idea exception of § 101 and the Patent Trial and Appeal Board affirmed the rejection.  The Board found that invention performed the abstract processes of collecting and analyzing data and that the use of a generic computer to perform these processes did not amount to an inventive concept.  Rosenberg then appealed to the Court of Appeals for the Federal Circuit.

The Federal Circuit affirmed the Board’s decision.  The Federal Circuit reasoned that claiming the improved
speed or efficiency inherent with applying the abstract idea on a computer is insufficient to render claims of a patent eligible as an improvement.  Because the invention was directed to an abstract idea and because the invention did not disclose any thing other than conventional computer components to perform the abstract idea, the invention did not pass the Alice test.

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