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New 101 Guidance from USPTO – What Does It Change?

On January 4th, the USPTO announced revised guidance for subject matter eligibility (Section 101 Revised Guidance) and stated it would take effect when published on Monday, January 7, 2019....more

BSG Tech LLC v. BuySeasons, Inc.

In BSG Tech LLC v. BuySeasons, Inc., the Federal Circuit held that a patent claim is ineligible under § 101 when its only allegedly unconventional feature is an abstract idea. The Federal Circuit affirmed the judgment of the...more

FDA to Strengthen Cybersecurity Oversight

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the...more

Core Wireless Licensing v. Apple Inc.

Federal Circuit Summary - Before Reyna, Bryson, and Hughes. Appeal from the Northern District of California. Summary: Breach of a duty of disclosure to a standards-setting organization may constitute implied waiver,...more

FDA Unveils Update to Software Precertification Program

The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input....more

Improved User Interface Survives Section 101 Challenges

In Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc., the Federal Circuit held that user interface claims are patent eligible under 35 U.S.C. § 101 because they “recite a specific improvement over prior systems,...more

Arctic Cat Inc. v. Bombardier Recreational Products Inc.

Federal Circuit Summaries - Before Moore, Plager, and Stoll. Appeal from the United States District Court for the Southern District of Florida. Summary: In challenging compliance with the marking requirement of §...more

Standing to Appeal PTAB Decision to Federal Circuit is Measured for the Appellant, Not the Appellee

The Federal Circuit determined that Article III standing was not necessary for an appellee to participate in a judicial appeal of an IPR final written decision because the appellant had Article III standing in Personal Audio,...more

Healthcare Industry May Not Be Prepared For Internet of Things

A recent survey conducted by ZingBox, a Silicon Valley internet security startup, found that more than 90% of healthcare IT networks have Internet of Things (IoT) devices. The survey further found that more than 70% of IT...more

MedPlast Completes Acquisition of Vention Medical

MedPlast, Inc. recently announced that it has completed its acquisition of Vention Medical‘s device manufacturing services arm. The press release states that the acquisition “broadens MedPlast’s manufacturing capabilities...more

4/7/2017  /  Acquisitions , Medical Devices

Cuba an Untapped Market for Medical Device Exports

The United States is the world’s largest medical device exporter, according to reports accounting for $45 billion of over $140 billion in global exports in 2014. This is not surprising since it also produced the largest...more

6/20/2016  /  Cuba , Exports , Imports , Medical Devices

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

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