PTAB Finds Method Involving "Growing, Selecting, and Crossing" Sufficient for Integrating Genome Estimation Data Set Into Practical Application

Attorney: Nicholas Rosa, Ph.D.
September 17, 2024

The Patent Trial and Appeal Board (PTAB) recently reversed a final rejection based on § 101 by finding that a method for selecting individuals for a breeding program that recited the steps of “growing, selecting, and crossing” did integrate an “optimized [genome] estimation data set” judicial exception into practical application. These actionable steps and the distinct advantages the method represented over conventional breeding methods involving other types of genomic prediction described in the specification were instrumental in the PTAB’s findings. The inclusion of such actionable steps and description of the advantages of the subject matter of the application may be useful to support amendments that may be necessary to overcome § 101 rejections.<... Read more

Anything You (are Required to) Say May be Used Against You (as Prior Art): Federal Circuit Upholds Invalidity Based on Mandatory Publication of Clinical Trial Protocol

Attorney: Nicholas Rosa, Ph.D.
May 16, 2024

Clinical trials are a critical part of the development and approval process for drugs, biologics, and medical devices. The lengthy and public nature of clinical trials, however, can create challenges for protecting relevant IP.  A clinical trial is a study or investigation in humans to “evaluate the effect(s) of intervention(s) on biomedical or health-related outcomes.”  42 C.F.R. 11.  Interventions can take many forms that benefit from patent protection including drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); treatment strategies; prevention strategies; and diagnostic strategies. Id. <... Read more