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Clients seeking advice in establishing and maintaining patent portfolios worldwide in all areas of biotechnology and pharmaceuticals can benefit from the education and experience of Lynn L. Janulis, Ph.D. Her advanced graduate and post-doctoral scientific training in molecular and developmental biology, reproductive endocrinology and cancer, along with her legal experience, allow her to counsel clients in strategic management of their scientific intellectual property. She assists clients in obtaining worldwide patent rights with her experience in patent prosecution, opinions, due diligence analyses, and interference proceedings. Read full bio here.

The PTAB recently issued a final written decision in an inter partes review (IPR), refusing to cancel claims in Verinata Health, Inc.’s U.S. Patent No. 8,318,430.  Ariosa Diagnostics v. Verinata Health, Inc., Cases IPR2013-00276 and -00277 (P.T.A.B. Aug. 15, 2016). The claims are directed to methods for determining the presence or absence of fetal aneuploidy in a fetus.  This is the second such decision from the PTAB.  The first decision was the subject of an appeal to the Federal Circuit. Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015). In that appeal, which we previously discussed, the court vacated the PTAB’s prior conclusion of nonobviousness because the court could not discern from the appeal record that the PTAB properly considered the prior art. In its recent decision, the PTAB has considered that prior art, but nevertheless reaches the same conclusion of nonobviousness.
Continue Reading PTAB Accords Little Weight to Evidence without Analysis or Explanation

On June 30, 2016, lead APJ Jacqueline Wright Bonilla provided an overview of the new PTAB rules during the Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) Conference.  The final rule on Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board, which we have previously discussed [April 21, 2016 and August 20, 2015] was published on April 1, 2016, and was later revised in a correction to the final rule on April 27, 2016.  APJ Bonilla commented on the new rules relating to the standard for claim construction, preliminary responses by the patent owner, including testimonial evidence, word count, Rule 11-type certification, and motions for sanctions. 
Continue Reading An Overview of Amendments to the PTAB Rules

DNAThe Federal Circuit recently affirmed the Board’s IPR decision that IBS failed to satisfy its burden of demonstrating obviousness of the challenged claims of Illumina’s U.S. Patent No. 7,566,537 (“the ‘537 patent), and determined that the Board did not abuse its discretion in refusing to consider IBS’s reply brief.  Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., Case No. 2015-1693 (Fed. Cir. May 9, 2016). Illumina contended that its challenged claims, directed to a method of labeling nucleotides to determine their identity in a sequencing by synthesis (SBS) method, were nonobvious based on its use of a particular azidomethyl group as a 3′ OH blocking (or protecting) group.
Continue Reading Federal Circuit Upholds Rule that New Petitioner Arguments Cannot Be Raised in IPR Reply Briefs