USPTO Releases Revised Subject Matter Eligibility Guidance


On December 15th, 2014, the USPTO released its much anticipated revised subject matter eligibility examination guidance to assist patent examiners to evaluate inventions that may be related to any one of the three judicial exceptions to subject matter eligibility under 35 U.S.C. § 101 – law of nature, natural phenomena, and/or an abstract idea. 2014 Interim Guidance on Patent Subject Matter Eligibility (“Interim Guidance“). The Interim Guidance is to be published in the Federal Register on December 16th, 2014, and is to effective on that date. It is to be applied to all pending and newly filed applications.

This Interim Guidance, unlike the prior guidance of March 2014 (see my prior posts of March 5th and March 7th, 2014), encourages an evaluation of the claim as a whole. In addition, it does not consider a claim that is directed to a combination of natural products as per se ineligible because the individual elements separately are natural products. Continue reading this entry

Another Patent Challenge for Personalized Medicine


The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles ensue and to the benefit of the public, as further jurisprudence will bring more clarity to whether and how diagnostic technologies – critical to personalized medicine – can be patented in the United States.

Health Diagnostic Laboratory, Inc. (“HDL”) will be adding to this jurisprudence.  The company recently alleged that Boston Heart Diagnostic Corp. (“Boston Heart”) is infringing U.S. Patent No. 8,119,358 (the ‘ 358 Patent) entitled “Diabetes-related Biomarkers and Methods of Use Thereof.” Continue reading this entry

Canada Joins the Gene Patenting Debate


Canada has joined the gene patenting debate. Children’s Hospital of Eastern Ontario (“Children’s”) sued the University of Utah Research Foundation, Genzyme Genetics, and Yale University (“Defendants”) in Canada’s Federal Court asserting that 5 patents[1] assigned to Defendants (collectively the “Long QT Patents”) for compositions and methods useful in the diagnosis and/or assessment of Long QT syndrome (“Long QT”) in human patients are invalid and/or unenforceable. Continue reading this entry

Federal Circuit’s Post-Alice Eligibility Analysis of Business Methods


The Federal Circuit in Ultramercial, Inc. v. WildTangent, Inc., held that an “entrepreneurial” multi-step process for distributing copyrighted media products over the Internet to consumers is not patent-eligible under 35 U.S.C. § 101 even though the specific method of advertising and content distribution was neither previously known nor employed on the Internet. Although the patent in question is directed to a consumer-related business method, the Federal Circuit’s analysis of business-related discoveries is a must read for its view of patenting any technology that might be categorized as an “abstract idea” such as the analysis of patient-related data and management of clinical trials in the field of personalized medicine. Continue reading this entry

Supreme Court Asked to Review Standing in Stem Cell Challenge


The Public Patent Foundation and Consumer Watchdog (collectively “CW”) petitioned the U.S. Supreme Court on October 31, 2014, seeking reversal of the Federal Circuit’s dismissal of its appeal from a decision of the USPTO that upheld the validity of Wisconsin Alumni Research Foundation’s (WARF’s) patent regarding in vitro cultured human embryonic stem cells. The case will decide if a third party challenger, lacking a specific injury related to the underlying dispute, has standing to challenge the USPTO’s inter partes reexamination decision in the courts. Continue reading this entry