By Josue Rosario
The United States Constitution Section Article I, Section 8, Clause 8 states the importance of promoting and compensating innovation for American citizens. This gives Congress the power to give inventors and authors the legal right to protect their ideas and creations, which has been a key in promoting innovation among US citizens. This section is known as the Patent and Copyright Clause because it grants patents and copyright ownership to inventors and authors and allows them to receive incentives for their inventions. The Clause reads as follows:
“Congress shall have the power... To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."
Regarding patent law, Title 35, Section 101 of the United States Code (U.S.C.), a fundamental part of U.S. patent law is responsible for defining eligible inventions discovered that can be patented and outlines broad categories of patentable subject matter. The legal interpretation, controversy, and alteration surrounding Section 101 have been significant throughout the history of American patent law. Section 101 states:
“Whoever 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 therefor, subject to the conditions and requirements of this title.”
This U.S.C. provision lays out four statutory categories of inventions that could be eligible for patent protection, these are machines, processes, manufactures, and compositions of matter. The provision allows for patents on new inventions and useful improvements to any of these categories, which encourages the development of new technologies. Laws of nature, natural phenomena, and abstract ideas are the judicial exceptions held by the U.S. Supreme Court to the patent-eligible subject matter under section 101.
Examiners assigned to determine the eligibility of an invention follow the guidelines written in The Manual of Patent Examining Procedure (MPEP). This MPEP provides examiners, applicants, and attorneys with relevant reference work on case law and procedures. The MPEP also contains instructions for examiners to follow for patent prosecution. Although it does not have carry legal authority in US Courts, the MPEP presents the way the USPTO handles its cases. However, the language used in these provisions has caused legal and policy debates, leading to landmark Supreme Court decisions that have clarified and refined the boundaries of patent eligibility.
Over the past few years, there have been three important Supreme Court decisions related to patent-eligible subject matter. These rulings include Mayo v. Prometheus in 2012, Association for Molecular Pathology v. Myriad Genetics Inc. in 2013, and Alice Corp. v. CLS Bank International in 2014.
In 2012, the Supreme Court ruled in Mayo v. Prometheus that a personalized medical test was not eligible for patent protection because it relied on natural law (Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012)). The following year, in Association for Molecular Pathology v. Myriad Genetics Inc., the court unanimously decided that naturally occurring DNA segments are not eligible for patent protection. However, synthesized DNA is still patentable Assoc. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)). Finally, in Alice Corp. Pty. Ltd. v. CLS Bank International, the court ruled that computer-implemented business methods, even if patented, are not eligible for protection because they are abstract ideas implemented using generic computer systems and software (Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014)). These cases have had a significant impact on the patent landscape and continue to shape the way innovations are protected under the law.
The ruling on the Alice v. CLS case had such a big impact on the patentability of inventions, that the USPTO decided to create the two-step test for future patent applicants. The Alice/Mayo test, also known as the two-step test, is the current framework used to assess whether an invention is patentable and is derived from the landmark case we have already discussed. This test is used to determine whether an invention is patentable based on if the invention is directed to one of the judicial exceptions or if it represents an inventive application of the judicial exception. A flowchart presented by the USPTO shows the step-by-step analysis of the Alice/Mayo test.
The Alice/Mayo test has caused problems for courts and patent examiners, creating confusion around this area of law. There are concerns about the clarity and consistency of Section 101 application on cases. One of the main criticisms is that the test has become increasingly difficult for examiners to apply in a predictable way, especially regarding abstract ideas. To address the concern, the USPTO introduced new guidelines for patent eligibility in 2019 that were initially set forth in 2014 in the Interim Guidelines on Patent Subject Matter Eligibility. They were designed to address whether a patent claim or application falls under judicial exceptions, under section 101, such as laws of nature, natural phenomena, and abstract ideas (mathematical concepts, certain methods of organizing human activities, and mental processes).
The 2019 Revised Patent Subject Matter Eligibility Guidance brings about significant changes in the way examiners evaluate applicants' claims and the patentability of inventions with the Alice/Mayo test. The revised procedures categorize abstract ideas and clarify that a patent claim or application is not considered "directed to" a judicial exception if that exception is integrated into a practical application. With these changes, the USPTO aims to streamline the evaluation process and ensure that only truly inventive concepts are granted patent protection.