CLIENT ALERT – NEW USPTO 2014 Interim Guidance on Patent Subject Matter Eligibility


USPTO 2014 Interim Guidance on Patent Subject Matter Eligibility Update, Alice Corp. and In re BRCA Litigation

Last month the U.S. Patent and Trademark Office (“PTO”) released its 2014 Interim Guidance on Patent Subject Matter Eligibility (“Interim Eligibility Guidance”). The stated purpose of the Interim Eligibility Guidance is to set out the PTO’s interpretation of the subject matter eligibility requirements in view of the Mayo[1], Myriad[2] and Alice Corp.[3] decisions by the U.S. Supreme Court. Also discussed in this Client Alert is the latest opinion in the In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation[4] by the U.S. Court of Appeals for the Federal Circuit (CAFC).


In the last two years, the Supreme Court ruled on three cases (Mayo, Myriad and Alice Corp.) that addressed the scope of the judicial exceptions to patentability (inventions that do not qualify for a patent under U.S. patent law).  In 2012, the Supreme Court held in Mayo that a claim directed to a medical diagnostic method (giving a drug to a patient, measuring metabolites of that drug, and deciding to increase or decrease the dosage of the drugs) was a law of nature and not patent eligible subject matter. In mid-2013, the Supreme Court held in Myriad that naturally occurring DNA sequences, even when isolated from the body, were a product of nature and not patent eligible subject matter. And most recently in June of 2014, the Supreme Court held in Alice Corp. that merely implementing an abstract idea using a computer was not enough to transform that abstract idea into patent eligible subject matter. Furthermore, on December 17, 2014, the CAFC held in In re BRCA1 that Myriad did not confer patent eligibility on composition of matter claims directed to naturally occurring DNA strands, and that a DNA structure with a function similar to that found in nature can only be patent eligible as a composition of matter if it has a unique structure, different from anything found in nature.

The New Interim Eligibility Guidance

The Interim Eligibility Guidance for PTO Examiners supplements the “Preliminary Examination Instructions” published in June 2014 in view of Alice Corp., and supersedes the “Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products” published in March 2014.

The Interim Eligibility Guidance provides a revised, two-step framework for determining patent subject matter eligibility for patent claims. Step 1 inquires whether the claim, given its broadest reasonable interpretation, is directed to a statutory patentable subject matter (process, machine, manufacture or composition of matter). Step 2 inquires: (A) whether the claim is directed to a judicially recognized exception to patentability; and (B) whether the claim recites elements that amount to significantly more than the judicial exception itself.

A notable change from previous guidance includes the fact that all claims with a judicial exception are now subject to Step 2, which features the two-part analysis from Alice Corp (also called the Mayo test). The two parts of Step 2 of the Interim Eligibility Guidance determine whether a claim is “directed to” a judicially recognized exception (Step 2A), and if so, does it recite “elements that amount to significantly more.” (Step 2B). This is a change from previous guidelines which instead asked whether a claim “recites or involves” an exception, and whether it “recites something significantly different than” a judicial exception.

For claims found to be directed to a judicial exception under Step 2A, an additional analysis under Step 2B is required to determine whether the claim as a whole is directed to something that is “significantly more” than the exception itself. To be patent eligible, a claim that is directed to a judicial exception must “include additional features to ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception.”[5] The Interim Eligibility Guidance also reinforces the importance of considering the claim as a whole, even when individual elements viewed on their own may not appear to add significantly more to the claim.

For nature-based products, in Step 2A, the PTO continues to extend Myriad’s “markedly different characteristics” standard to determine whether the limitation recites a “product of nature” judicial exception. Upon the determination that a claim contains a limitation to a nature-based product, an inquiry must be made as to whether the claim recites subject matter that is “markedly different” based on structure, function, and/or properties when compared to the naturally occurring counterpart. If so, the claim is not directed to a judicial exception, and no further subject matter eligibility analysis is required. Examples of characteristics considered when determining whether there is a “markedly different characteristic” include: biological or pharmacological functions, chemical and physical properties, and chemical, genetic, or physical structures and forms. This is a considerable change from previous guidance that required the analysis and consideration of twelve different factors with six factors weighing towards eligibility and six factors weighing against eligibility.

With respect to computer or software related inventions, the Interim Eligibility Guidance requires that the invention involve “significantly more” than simply implementing an abstract idea with a computer. The Interim Eligibility Guidance lists some useful examples of limitations that may be enough to satisfy this requirement. These examples include improvements to another technology or technical field, improvements to the functioning of the computer itself, and effecting a transformation or reduction of a particular article to a different state or thing. If the claim as a whole does recite significantly more than the exception itself, the claim is patent eligible and the analysis is complete.

Following the subject matter eligibility analysis, a complete examination of the patent claims should be made regardless of whether a rejection based on subject matter eligibility is made (e.g., novelty, obviousness, etc.).

In re BRCA1- and BRCA2-Based Hereditary Cancer Test

In addition to the Interim Eligibility Guidance, the CAFC released its opinion in In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation. Together, the Interim Eligibility Guidance and In re BRCA-1 change the landscape for all software and biotechnology patent cases. In In re BRCA-1, the Court further limited patent eligible claims following the Supreme Court’s decisions in Myriad and Mayo. Specifically, the Court found invalid the broad claims to methods directed to detecting all BRCA-1 and 2 mutations using known methods. Essentially, the Court stated that the known methods (hybridizing a gene probe, detecting presence of hybridization product, amplification of the gene, and sequence of the amplified nucleic acids) did not add “enough” to “transform the nature of the claim” into a patent-eligible application.[6] The Court, however, did find claims directed to very specific mutations to be valid.

Initial Recommendations

In view of the Interim Eligibility Guidance and In re BRCA1 decision, the availability of protection for biotech and software-related inventions are now further limited. Applicants seeking protection for these types of inventions will most likely have to give up broad protection and focus claims on specific embodiments of the invention. Actions applicants can take to seek broader protection include:

  • Filing Continuation-in-Part (CIP) applications of existing pending applications as improvements and additional discoveries are made.
  • Providing more examples, variants, and details in the specification of the earliest filings.
  • Focusing on new and improved methods of detection and/or modifications in diagnostics and treatments.
  • Drafting claims of varying scope, with a combination of broad, intermediate and narrow claims that include very specific examples of, e.g., variants and mutations or novel implementations.

[1] Mayo Collaborative Serv. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).

[2] Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).

[3] Alice Corp. Pty. Ltd. v. CLS Bank Int’l., 134 S. Ct. 2347 (2014).

[4] In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litig. Univ. of Utah Research Found. v. Ambry Genetics Corp., 2014 U.S. App. LEXIS 23692 (Fed. Cir. 2014).

[5] 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74618, 74624 (Dec. 16, 2014) (37 C.F.R. Part 1).

[6] In re BRCA1- and BRCA2, 2014 U.S. App. LEXIS 23692 at 19, 20.