Before Wallach, Taranto, and Stoll.  Appeal from the Patent Trial and Appeal Board.

Summary: The Federal Circuit determined that it had jurisdiction to hear an appeal from a Board decision in an IPR even though the Board erred in limiting the scope of the IPR by not instituting on all claims and grounds. 

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine’s Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain gene therapy products” will soon be able to qualify for fast track approval.[1]

Nike filed a lawsuit against Puma on May 3, 2018 in the District Court of Massachusetts accusing Puma of infringing over 40 claims of seven utility patents.  The complaint asserts that Puma is using Nike’s Flyknit®, Air®, and cleat assembly in several of Puma’s footwear products.  Footwear generally includes two primary elements, (1) an “upper,” which covers the foot, and (2) a “sole” structure, which is the portion located below the upper, between the foot and the ground.  Nike’s Flyknit technology appears to relate to footwear uppers, whereas its Air technology and cleat assembly appear to relate to footwear sole structures.

Before Lourie, Reyna, and Chen.  Appeal from the Patent Trial and Appeal Board (“PTAB”).

Summary: Nothing in § 41.41(b)(2) bars a reply brief from addressing new arguments raised in the examiner’s answer that are not articulated in the Final Office Action, regardless of whether the examiner designated the new argument as a new ground of rejection.

Before Prost, Newman, Lourie, Dyk, Moore, O’Malley, Reyna, Wallach, Taranto, Chen, Hughes, and Stoll.  On petition for rehearing en banc.

Summary:  Under step two of the Alice framework, whether a claim element or combination would have been well-understood, routine, and conventional is a question of fact.

Before Reyna, Taranto, and Hughes. Appeal from the Northern District of California.

Summary: Failure to use the word “means” creates a rebuttable presumption that the term is not a means-plus-function limitation invoking § 112 ¶ 6. That presumption was not overcome here because the challenger did not prove, by a preponderance of the evidence, that the claim terms failed to recite sufficiently definite structure.

DePuy Synthes, a part of the Johnson & Johnson Medical Devices Companies, announced recently that it has signed a definitive agreement to acquire the assets of Medical Enterprises Distribution, LLC, which includes the automated ME1000™ Surgical Impactor tool used in hip replacement surgery.  The two companies had previously formed an exclusive agreement to co-market the hip application of the ME1000™. 

Before Prost, Newman, and Wallach.  Appeal from the Patent Trial and Appeal Board.

Summary: An unsupported expert opinion does not constitute substantial evidence to contradict a prior art reference.

Before Newman, Dyk, and Chen.  Appeal from the District of Colorado.

Summary: (1) The Federal Circuit’s separate affirmance of a PTAB decision that a patent in suit is invalid renders an appeal from a district court on that patent moot due to collateral estoppel; and (2) an ongoing royalty determination should consider patentee’s improved bargaining position after the jury verdict.

On May 14, 2018, several important revisions to regulations of the Bayh-Dole Act (University and Small Business Patent Procedure Act of 1980, codified as 35 U.S.C. § 200) went into effect. The final revisions were published in the Federal Register of April 18, 2018.