The U.S. Patent and Trademark Office (USPTO) released its revised Interim Guidance on Patent Subject Matter Eligibility under 35 U.S.C. 101 on Dec. 16, 2014. For the life sciences industry, the revised guidance provides significant relief from the previous guidance released March 4, 2014. However, just one day later, the joy that many life science patent practitioners felt from the revised guidance was tempered when the Court of Appeals for the Federal Circuit affirmed a district court’s holding of invalidity of several patent claims of Myriad Genetics based on patent subject matter ineligibility.

The good news

The revised guidance still employs a three-step analysis to determine subject matter eligibility, but has several notable changes. The first step of the analysis still questions if the claim is to a process, machine, manufacture or composition of matter as required by Section 101. However, the second step of the analysis questions if the claim is “directed to” a judicial exception, rather than the previous “involving” a judicial exception. As an example, the revised guidance notes that process claims that merely use a nature-based product are not necessarily subject to the analysis. Additionally, all claims — i.e., both products and processes — are subject to the same analysis.

Further, if a claim is identified as directed to a “product of nature” exception, the analysis compares the nature-based product to its naturally occurring counterpart to identify “markedly different” characteristics based on structure, function or properties. Only if there is no markedly different characteristic does the analysis proceed to the last step, which determines if the claim recites “significantly more” than the exception itself. Conversely, if a markedly different characteristic is found, the claim is determined patent subject matter eligible.

For claims directed to a judicial exception, i.e., a nature-based product that does not have markedly different characteristics, a law of nature, a natural phenomenon or an abstract idea, the claim must recite significantly more than the judicial exception itself. The revised guidance relies on various Supreme Court opinions to provide examples of what constitutes significantly more, including:

  • Improvements to another technology field
  • Iprovements to the functioning of a computer itself
  • Applying the judicial exception with or by use of a particular machine
  • Effecting a transformation or reduction of a particular article to a different state or thing
  • Adding a limitation that is other than what is well understood, routine and conventional in the field
  • Adding unconventional steps that confine the claim to a particular useful application
  • Other meaningful limitations beyond linking the use of the judicial exception to a particular technological environment

If the claim recites significantly more, it is patent subject matter eligible. Conversely, if the claim does not recite significantly more, it is not patent subject matter eligible.

The revised guidance acknowledges that certain claims, though reciting a judicial exception, when viewed as a whole clearly do not seek to tie up any judicial exception such that others cannot practice it. Such claims are subject to a “streamlined eligibility analysis” and do not need to pass through the full analysis outlined in the revised guidance as their eligibility will be self-evident. Examples in the revised guidance are a hip prosthesis including a coating of a naturally occurring mineral and a robotic arm assembly having a control system which employs a certain mathematical relationship.

As may be apparent, the revised guidance eliminates the complicated and cumbersome weighing of factors in favor of eligibility against factors in favor of ineligibility set forth in the previous guidance.

In addition to the revised guidance, the USPTO released examples of analyses of nature based products. The very first, Example 1, considers the subject matter eligibility of both gunpowder containing three naturally occurring materials and a firework containing the gunpowder in combination with other elements, which, infamously, in the previous guidance were subject to a complex analysis of patent eligibility. In current Example 1, the analysis of gunpowder recognizes there is no naturally occurring combination of the three materials and their combination has a markedly different property, namely, an explosive ability, as compared with each material individually, whereby the combination is not a product of nature exception and is patent eligible. The firework is analyzed under the streamlined eligibility analysis, as the claim is focused on the assembly of components, not the naturally based products, and it is not necessary to even apply the markedly different analysis.

Example 3 is also of particular interest. A claim to purified amazonic acid is determined patent ineligible on the basis that it is not markedly different from amazonic acid that occurs naturally in the leaves of the Amazonian cherry tree. On the other hand, a claim to a composition comprising a core of amazonic acid and a coating of another naturally occurring material that provides controlled release properties in vivo is patent eligible because the composition has different functional characteristics in vivo than either of the naturally occurring materials by themselves. Additionally, a claim to a stable aqueous solution of amazonic acid and a solubilizing agent is patent eligible because the naturally occurring amazonic acid is water insoluble, whereby the composition has a different property as compared with the naturally occurring product.

Finally, in Example 7, a fluorescently labelled nucleic acid is found patent eligible because the labeled nucleic acid has both a different structure and a different property from that found in nature.

Therefore, the revised guidance provides an easier analysis for determining patent eligible subject matter and, significantly, “markedly different” characteristics of claimed subject matter reciting natural-based materials may be based on structure, function or properties to find the subject matter patent eligible.

The step backward

Just one day after release of the USPTO’s revised guidance, the Federal Circuit affirmed a district court’s holding of invalidity based on patent subject matter ineligibility of several patent claims of Myriad Genetics directed to methods for screening germline of a human subject for an alteration of a BRCA1 gene. Claims directed to a pair of single stranded DNA primers derived from human chromosome 17q and to a pair of single stranded DNA primers isolated from human chromosome 13 were also affirmed as invalid based on patent subject matter ineligibility.

The method claims recited a first step of comparing a sequence from, inter alia, a tissue sample or derived from a tissue sample and the comparing step included, in one claim, hybridizing a probe to genomic DNA isolated from a sample and, in another claim, amplifying a gene from a sample using a set of produced primers. The court found the method claims “set forth well-understood, routine and conventional activity engaged in by scientists at the time of Myriad’s patent applications,” and “the claims contain no otherwise new process for designing or using probes, primers or arrays beyond the use of BRCA1 and BRCA2 sequences in those processes,” and “nothing is added by identifying the techniques to be used in making the comparison because those comparison techniques were the well-understood, routine and conventional techniques that a scientist would have thought of when instructed to compare two gene sequences.”

The court did not acknowledge, however, that it was not routine, conventional or well-understood to use these methods to identify cancer propensity-associated mutations in human DNA, because neither the genes nor the mutations were known at the time of the invention. The court also failed to acknowledge that the single stranded DNA primers differ from the naturally occurring double stranded DNA or that the function of the primers, hybridization, does not exist in vivo. Rather, the court’s opinion, like the previous USPTO guidance, found there must be a structural change to distinguish patent eligible subject matter from a product of nature.

The path forward

Though it is not clear if the USPTO will alter the revised guidance in view of the most recent Myriad decision, for the time being, the revised guidance provides the framework for the analysis of patent eligible subject matter in pending applications. It is unlikely that the USPTO will make any additional revisions before the last chapter on the patentability of the Myriad claims is written, which may not be for some time because the possibilities of a request for an en banc hearing or a writ of certiorari still exist.