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USPTO Relaxes Guidelines on Biochemical Inventions
USPTO Relaxes Guidelines on Biochemical Inventions

Since the Supreme Court’s Myriad decision of 2013 (see Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107), inventors and patent owners have struggled with trying to protect inventions that were suddenly declared patent-ineligible laws of nature or natural phenomena. On Dec. 16, 2014, the United States Patent and Trademark Office (“USPTO”) formally released a new set of guidelines for judging patent eligibility. These guidelines are based on the Supreme Court’s recent decisions in Myriad and two other cases, and replace earlier guidelines released in March (see Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)).

U.S. patent law, specifically 35 U.S.C. § 101, states that a patent may be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Courts have long recognized three judicially-created exceptions to these broad categories of patent-eligible subject matter, namely, “laws of nature, natural phenomena, and abstract ideas.” Unfortunately, these three exceptions are not clearly defined.

Guidelines released by the USPTO in March received criticism from the patent community for forcing too many patent applications into an analysis of whether their claimed inventions were directed to patent-eligible subject matter. Patent examiners were instructed to analyze the patent eligibility of claims involving one of the three exceptions. In the new guidelines, examiners are only instructed to analyze patent eligibility of claims directed to one of the three exceptions, indicating that the USPTO intends to be less aggressive at finding eligibility problems.

The new guidelines provide additional clarity regarding the exception for “natural phenomena.” In the March guidelines, patent examiners were advised that combinations of naturally occurring products were unlikely to be patent eligible. In the current guidelines, the USPTO notes that a combination of naturally occurring products may be patent eligible if the combined product has markedly different characteristics than what exists in nature. In the biological and chemical fields, changes in chemical structure, physical form or chemical/physical properties of a product, as compared to the product’s natural counterpart, can demonstrate markedly different characteristics.

While these new guidelines may provide some clarity and comfort to those in the biological and chemical fields regarding patent eligibility, those in the software field have received little additional guidance. Case law remains unsettled on the proper method for determining whether software constitutes a patent-ineligible abstract idea. We suggest that software developers use extra effort to provide a broad, thorough, and detailed specification in any patent application. Once filed, the specification of an application cannot be amended to include new matter. As the law changes and hopefully clarifies, and further guidance is issued by the USPTO, it may be necessary to amend the claims in the application to adapt to the changes. A strong specification will help ensure that support is available for any amendments which may become necessary.

If you have any questions regarding these or other patent matters, please contact Dr. Brian W. Chellgren or another patent attorney at Bingham Greenebaum Doll LLP.

To learn more about Dr. Brian W. Chellgren and his practice, visit his profile.

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  • Partner

    Brian is an attorney in the firm's Lexington office, a member of the firm's Business Services Department, and Chair of the Intellectual Property Practice Group. A registered patent attorney with degrees in molecular biology (B.S ...



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