Before Reyna, Wallach, and Hughes. Appeal from the United States District Court for the District of Nevada

Summary:  District Courts have jurisdiction to hear APA challenges to the PTO’s denial of a petition for rulemaking. An Examiner’s ability to reopen prosecution under a new ground does not deprive applicants of their right to maintain an appeal.

            On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards[1]. Currently, there are over 5,000 pharmaceutical sites worldwide. Of these sites, over 3000 are based outside of the United States. This large number of ex-U.S. sites requires a regulatory scheme that ensures both Current Good Manufacturing Practice (CGMP) and transparency regarding drug manufacturing.

Before Lourie, O’Malley, and Chen.  Appeal from the Patent Trial and Appeal Board.

Summary: When the ranges identified in a claimed composition overlap with the ranges disclosed in the prior art, the burden shifts to the patentee to come forward with evidence of nonobviousness.  This burden-shifting framework is applicable both in the context of district court cases and inter partes review proceedings.

Machine learning is one of the fastest growing categories of granted patents_[1].  However, there do not appear to be many examples of patent infringement lawsuits where machine learning claims have been analyzed by the courts under the patent-eligibility framework set forth in Alice_[2]. 

Before O’Malley, Reyna, and Taranto.  Appeal from the Patent Trial and Appeal Board.

Summary:  While obviousness of apparatus claims “capable of” a particular function may be shown by identifying a prior art reference that discloses an apparatus capable of performing the claimed function, obviousness of related method claims requires a motivation to actually use the prior art apparatus for the claimed function.

On September 10, 2018, the Federal Circuit decided Regents of the University of California v. Broad Institute, Inc., affirming the Patent Trial and Appeal Board (PTAB)’s determination of no interference-in-fact between the University of California (UC)’s application and the claims of twelve patents and one application owned by the Broad Institute.

Before O’Malley, Mayer, and Reyna. Appeal from the Patent Trial and Appeal Board.

Summary: Claims may be rejected under 35 § U.S.C. 103 based on implicit disclosures of a prior art reference.

Before O’Malley, Reyna, and Hughes.  Appeal from the Trademark Trial and Appeal Board.

Summary: Courts should not give too much weight to evidence purporting to show a lack of actual confusion in an ex parte proceeding. 

Before Newman, Dyk, and Taranto.  Appeal from the United States District Court for the District of Delaware.

Summary:  Pharmaceutical patents were obvious where the claims covered species of a genus taught by the prior art, the prior art taught achieving the claimed concentrations of the same compound but for a different indication, and a person of ordinary skill in the art would expect the claimed outcome.  Evidence of secondary considerations of nonobviousness such as long-felt need carried diminished weight because there was a blocking patent that may have deterred investment in the “blocked” invention.

Before Newman, Hughes, and Stoll. Appeal from the United States District Court for the District of Delaware

Summary: Objective indicia of nonobviousness cannot be dismissed merely because all the ingredients in a formulation were generally known and nothing prevented a skilled artisan from combining them.