On December 15, 2014, the U.S. Patent and Trademark Office issued its long-awaited Interim Guidance on Patent Subject Matter Eligibility (published in the Federal Register on December 16, link here: [(79 Fed. Reg. 74618)]). The Guidance supersedes the guidelines for determining patent eligibility for life sciences claims in view of the Supreme Court’s Myriad and Mayo decisions, and supplements the June 25 Examination Instructions for software claims in view of the Supreme Court’s Alice decision.

On initial review, the new Eligibility Guidance presents a welcome shift from the highly burdensome, detrimental, and legally flawed guidelines initially proposed by the Patent Office in response to the Myriad and Mayo decisions. It is evident from the Patent Office commentary regarding the new Guidance, as well as from the guidelines themselves, that the drastic revisions were heavily influenced by comments and criticism from the public, including Sutherland, as unduly limiting the scope of patent-eligible subject matter in the life sciences.

Some of the most significant changes for determining subject matter eligibility under the new Guidance are summarized below.

  1. The new guidelines have done away with the initially proposed “12-factor weighing” test for determining subject matter eligibility, thereby also eliminating the numerous hypothetical claims examples of patentable and unpatentable subject matter under the initially proposed test.
  2. Although the guidelines again categorize “products of nature” as an “exception” to patent-eligible subject matter broadly defined by 35 U.S.C. § 101, the test for determining whether a claim is directed to a so-called “product of nature exception” has been separated from the analysis required to determine whether a claim includes significantly more than one of the judicial exceptions (law of nature, natural phenomenon, or abstract idea). Application of the overall analysis is now to be based on whether a claim is actually “directed to,” rather than merely “involving,” one of the judicially defined exceptions above. Thus, for example, process claims merely reciting (using) a nature-based product should not necessarily be subject to an analysis for “markedly different” characteristics.
  3. The Guidelines clarify that the characteristics relevant to the “markedly different” analysis may include a product’s structure, function, and/or other properties that differ from its naturally occurring counterpart in the natural state.

Patent owners of computer-implemented technologies will not find as many relevant revisions to the original June 25 examining instructions. The reason for this is that numerous courts have found various software and business method-related patents invalid since the Supreme Court’s Alice decision. In fact, only recently, on December 8, did the Federal Circuit uphold the validity of an internet-based patent in DDR Holdings.

Sutherland was one of six law firms that submitted comments in response to the initially proposed guidelines, which are available on the Patent Office website [http://www.uspto.gov/patents/law/comments/mm-d-sutherland20140801.pdf]. Sutherland’s comments, authored by Jana Nelson (Washington, D.C.), were highly critical of the March 4 life sciences guidelines, emphasizing the apparent consensus of life sciences experts and patent practitioners that the initially proposed guidelines were “based on an incorrect and overly broad interpretation of what no longer may be deemed patent-eligible subject matter based on relevant Supreme Court decisions.” In quoting the very words of the Mayo court, the comments reminded the Patent Office that the Supreme Court has “repeatedly emphasized a concern that law not inhibit future discovery by improperly tying up the use of laws of nature and the like” and that instead “[r]ewarding with patents those who discover laws of nature might encourage their discovery.” The Sutherland comments further noted that: “In addition to the Guidance being based on a fundamentally flawed analytical framework, it directly conflicts with the USPTO’s constitutional mandate to promote science and the useful arts. Notably, by restricting the scope of patent-eligible subject matter the Guidance threatens to effectively suppress innovation in industries relating to biotechnology and biopharmaceuticals.”

The Patent Office issued the new guidelines as “Interim Guidance,” as it is again seeking public comments thereon over a 90-day period, including suggestions of claim examples that could assist examiners and practitioners in determining patent eligibility of life sciences, software, and business method claims going forward. The Patent Office will also hold a public forum (currently projected for January 21, 2015) to discuss the new Guidance.