On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The draft guidance covers a wide range of issues, including cybersecurity device design, labeling, and documentation. The guidance is intended to provide medical device makers a road map on how to satisfy the FDA’s quality system and patient safety regulations and how to address cybersecurity considerations within their premarket submissions.

AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC.,

Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB).

Summary: Evidence of generic industry skepticism cannot, by itself, form the basis to preclude a finding of motivation to combine.

SUNOCO PARTNERS MARKETING v. U.S. VENTURE, INC.

Before Prost, Reyna, and Stoll. Appeal from the United States District Court for the Northern District of Illinois.

Summary: References to testing in an offer for sale do not necessarily trigger application of the experimental use exception to the on-sale bar defense.

ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of approximately AUD $100 million. ResApp directors announced a unanimous recommendation to sell, and their intent to vote their own shares accordingly. A shareholder vote is scheduled for June.

Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.” The company’s website states that their “mission is to enable manufacturers and their suppliers to develop and maintain products that aren’t just safe, but are also secure.”

APPLE INC. v. ZIPIT WIRELESS, INC. [OPINION]- PRECEDENTIAL
Before Hughes, Mayer and Stoll. Appeal from the United States District Court for the Northern District of California.

Summary: Notice letters and related communications may be sufficient to establish personal jurisdiction within a given forum.

NIAZI LICENSING CORPORATION v. ST. JUDE MEDICAL S.C., INC.

Before Taranto, Bryson, and Stoll.  Appeal from the U.S. District Court for the District of Minnesota.

Summary: Providing examples in the claim language and written description may provide definiteness to descriptive terms.   

ROCHE DIAGNOSTICS CORPORATION v. MESO SCALE DIAGNOSTICS, LLC
Before Newman, Prost, and Taranto. Appeal from the U.S. District Court for the District of Delaware.

Summary: A finding of inducing infringement requires knowledge that the induced acts constitute patent infringement, which can be established by a finding of ‘willful blindness’, a standard of limited scope that surpasses recklessness and negligence.

LITTELFUSE, INC. v. MERSEN USA EP CORP.
Before Prost, Bryson, and Stoll. Appeal from the U.S. District Court for the District of Massachusetts.

Summary: The Federal Circuit vacated a claim construction that violated the doctrine of claim differentiation by eliminating the scope of several dependent claims.

GENUINE ENABLING TECHNOLOGY LLC V. NINTENDO CO., LTD

Before Newman, Reyna, and Stoll. Appeal from the Western District of Washington.

Summary: A finding of prosecution disclaimer must be supported by an unambiguous disavowal within the intrinsic record.