MVS Filewrapper® Blog: USPTO Issues New Examination Guidelines for Patent Subject Matter Eligibility
The basic requirements for filing a U.S. utility patent are rather straightforward. Patents are granted for new, useful and non-obvious processes, products or compositions of matter. Similarly, any new, useful and non-obvious improvement to these categories of inventions may be granted a patent. Although seemingly straightforward, the three basic requirements for patentability are impacted by an evolving legal landscape which is largely dictated by court-created case law.
For much of the last thirty years, the case law addressing patent eligibility has had some consistency. However, a series of court decisions in recent years has changed the understanding of what is considered patent-eligible. As a result, the USPTO released guidelines last month providing an analytical framework to evaluate whether a patent claim meets these patent subject matter eligibility requirements (as set forth in 35 USC § 101). These guidelines titled "Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products" are particularly relevant for those dealing with patent applications (and portfolios) in the fields of biotechnology, chemistry and/or life sciences. Although subject matter eligibility is applicable for all fields of patenting, the guidelines were provided to patent examiners to specifically address examination of claims “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products” (i.e. applying the legal principles set forth in the Myriad and Prometheus decisions, see earlier FileWrapper postings for further detail).
A few key points to consider in light of the USPTO guidelines (available at http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf) include the following:
1. The guidelines apply to all claims (excluding "abstract ideas")
Any claims that “recite or involve laws of nature/natural principles, natural phenomena, and/or natural products” are to be examined using the new guidelines. The only exclusion is a claim which is alleged to recite an “abstract idea,” which will not be examined using the new guidelines.
2. Natural products are very broadly defined
The guidelines define natural products broadly, including “substances found in or derived from nature.” The take-home for patent Examiners is that claimed subject matter for a product must be non-naturally occurring to be subject matter eligible. In addition, to meet requirements of non-obviousness, the non-naturally occurring product must be “markedly different in structure from naturally occurring products.”
3. There is a 3-part eligibility test to be applied by Examiners
The guidelines provide Examiners with a decision tree for determining patent subject matter eligibility (reproduced at the beginning of this post). The first question asked by an examiner when evaluating a patent claim will be whether the claimed invention is directed to a statutory patent-eligible subject matter category (process, machine, manufacture, or composition of matter).
If the first threshold is met, the examiner will next question whether the claim recites or involves a judicial exception, which therefore precludes patentability. Examples of these exceptions include abstract ideas, laws of nature (i.e. natural principles), natural phenomena, and natural products.
Finally, the third question to be assessed by an examiner under the guidelines is whether the claim as a whole recites something "significantly different" than the mentioned judicial exception. The guidelines provide more extensive analysis of what constitutes a "significant" difference. Generally, there must be a showing that the product claimed has a marked difference from what exists in nature, or also recites a meaningful limitation to add something of significance to the patent claim.
We note that the guidelines were created by the USPTO for the USPTO examiners. Therefore, they are an interpretation of case law relating to subject matter eligibility. They are not binding law, and they are subject to change and/or judicial challenge. However, they can be helpful in navigating the area between patentable and unpatentable subject matter.