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USPTO Issues New Examination Guidelines for Patent Subject Matter Eligibility

April 16, 2014
Post by Blog Staff

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

Purpose

The attorneys of McKee, Voorhees & Sease, P.L.C. designed this blog as an informational and educational resource about intellectual property law for our clients, other attorneys, and the public as a whole. Our goal is to provide cutting-edge information about recent developments in intellectual property law, including relevant case law updates, proposed legislation, and intellectual property law in the news.

Disclaimer

McKee, Voorhees & Sease, P.L.C. provides this blog for general informational purposes only. By using this blog, you agree that the information on this blog does not constitute legal or other professional advice and no attorney-client or other relationship is created between you and McKee, Voorhees & Sease, P.L.C. Do not consider this blog to be a substitute for obtaining legal advice from a qualified, licensed attorney. While we try to revise this blog on a regular basis, it may not reflect the most current legal developments. We consciously refrain from expressing opinions on this blog and instead, offer it as a form of information and education, however if there appears an expression of opinion, realize that those views are indicative of the individual and not of the firm as a whole.

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