The Theranos Story, ch. 59: there’s life left in the corporate corpse–patents! And no trial date in sight.

You can get blood out of this. Really! The US Patent and Trademark Office (USPTO) awarded five–count ’em, five!–patents to Theranos in March and April. All of them were filed between 2015 and 2016, when the whispers of fraud were getting louder, as were the legal threats.

The five patents are:

1. Systems, devices, and methods for bodily fluid sample collection, transport, and handling
2. Systems, devices, and methods for bodily fluid sample transport
3. Systems and methods for sample preparation using sonication
4. Systems and methods for sample preparation using sonication (cell disruption)
5. Rapid measurement of formed blood component sedimentation rate from small sample volumes

The CB Insights Research article has the details on what they cover, including patent application illustrations. It’s not stated, but looking back to TTA’s many articles, in this Editor’s judgment, the heir to these patents cannot be Elizabeth Holmes or her many investors now feeling the lint in their pockets, but the company holding the last note, the $65 million (not $100 million) loan from Fortress Investment Group LLC, part of Japan’s SoftBank Group [TTA 28 Dec 17]–collateralized by the portfolio of over 70 patents. Hat tip to HISTalk 19 April

If you hunger for a deep dive into the design of Theranos’ blood analyzers that never really worked, and can appreciate that the miniLab was what “one expert in laboratory medicine called “theater … not science”, this Design World article is for you: Schadenfreude for Theranos — and satisfaction in how engineering doesn’t lie

Meanwhile, back in the US District Court in San Jose, California, we learn that the trial of Ms. Holmes (now engaged to William “Billy” Evans, a 27-year-old heir to the Evans Hotel Group, which has three West Coast resort properties and who is also a techie) and former Theranos president Ramesh ‘Sunny’ Balwani has been delayed indefinitely. Originally reported to be summer entertainment with a start date of 8 July, the judge set the next status conference for the case for 1 July, but refused to set a trial date, which means that the trial may not begin till next year. According to the San Jose Mercury News, the defense is seeking materials from the FDA and CMS, which are, according to defense lawyer, lawyer Kevin Downey, are “in many instances exculpatory.”

Ms. Holmes’ lawyers are also seeking information on the communications between John Carreyrou of the Wall Street Journal, the FDA, and CMS. In a motion filed last week, they accused Mr. Carreyrou under the guise of investigative journalism of “exerting influence on the regulatory process in a way that appears to have warped the agencies’ focus on the company and possibly biased the agencies’ findings against it.” Stat

The bubbly Ms. Holmes and Not-So-Sunny Balwani are facing Federal charges of two counts of conspiracy to commit wire fraud and nine counts of wire fraud. They each face a maximum of 20 years in prison and up to $2.7 million in fines.

A review of digital health patent slugfests and Unintended Consequences

Mobihealthnews provides a recap of the past four years of patent actions pitting company against company in the hushed but deadly rings of the US Patent and Trademark Office (USPTO) and the US International Trade Commission. On the fight card: the never-ending American Well-Teladoc bout (Teladoc winning every decision so far by a knockout [TTA 18 June]–a second American Well patent being invalidated on 25 August); CardioNet vs MedTel, which the former won but has had to chase the latter out of the arena and down the street to collect; Fitbit-Jawbone which has gone both ways [TTA 27 July]; and the long trail of blood, sweat and Unintended Consequences around Bosch Healthcare’s heavyweight IP pursuit against mainly flyweight early-stage companies (not noting, as we did, their apparent ‘draws’ vs Philips and Viterion, then owned by Bayer).

The Reader will note our tracking Bosch’s activities go back to 2012 (here, here and here). Moreover, with Mr Tim Rowan of Home Care Technology, we broke the news of Bosch’s demise in June 2015, drawing the conclusion that their offense versus Cardiocom’s patents (now in Medtronic’s cardiac division) directly led to the invalidation of their key patents, IP–and the very basis of the company’s existence. See the 19 June 2015 article and our recap one year later in reviewing AW-Teladoc. (Any similar phrasing or conclusions within the Mobihealthnews article, we will leave to our Readers to decide!)

Unintended consequences: American Well loses, loses patent, to Teladoc

On Tuesday, the Federal District Court of Massachusetts not only dismissed the American Well patent infringement lawsuit against Teladoc, but also invalidated American Well‘s patent, held by co-founder Dr. Roy Schoenberg since 2009. It was invalidated on the grounds that the claims in the patent were “too abstract” to be patentable and do not “amount to an inventive concept.” American Well is appealing the court decision.

Teladoc started this call-and-response in March 2015 by petitioning the USPTO (US Patent and Trademark Office) to invalidate several American Well patents. (AW claims to hold 28 patents and 22 pending applications). Shortly before Teladoc’s IPO on the New York Stock Exchange last June, American Well sued Teladoc on patent infringement. Those in the industry saw an effort to scupper the IPO. Our Editor Chrys at the time took a decidedly jaundiced view of American Well’s grounds for infringement:
This author is wondering who thought this was such a novel technology as to warrant a patent? What were they thinking? Having worked on developing unified messaging systems for a mobile phone operator at the turn of the century (now that’s a scary 15 years ago) I am just picking myself off the floor after reading this.
Surely all these functions are no more than what is in every instant messaging program, dating back to 1990s? Replace the words “medical service provider” by “friends” or “contacts” and “consultation” by “chat” or “call” it seems to me you get … Skype and Face Time and more! [TTA 9 June 15]
No matter, the result was yesterday’s double shot of a decision. In addition, three Teladoc complaints against American Well‘s patents to invalidate them are still in progress with the USPTO. A triple, anyone? MedCityNews, Teladoc press release, American Well press release
All this is despite the sobering facts that telemedicine has been unprofitable to date–and that IP wars have unintended consequences. (more…)

What’s news at the end of the week

Care Innovations harmonizes seniors, Panasonic adds diabetes, Jawbone and Fitbit bite, the first EHR/PHR Hack and Concussion in Cleveland. Converging its interests in remote patient monitoring with its long-time footprint in senior housing resident monitoring (QuietCare), Intel-GE Care Innovations is testing its Health Harmony remote patient monitoring system, partnering with two California-located Front Porch communities and the Front Porch Center for Innovation and Wellbeing. The residents selected have poor chronic condition management or have returned after a discharge from a skilled nursing facility. No disclosure on projected number or duration–and it doesn’t appear that QuietCare is part of the monitoring. Release….Panasonic just bought Bayer Healthcare’s diabetes/blood glucose monitoring device unit for $1.13 billion as Bayer continues to shed non-life science businesses. While old-school prick-and-bleed monitors are being eclipsed by continuous glucose monitors (CGMs) and mobile-based devices such as Telcare in the US and in Europe, there’s plenty of market remaining in the West, and new ones in Asia and the Middle East for simple devices. It joins Panasonic’s existing blood pressure monitors. MedCityNews….Jawbone and Fitbit continue to snap at each other in court, with the former on Wednesday filing a second lawsuit on patent infringement, specifically “a wellness application using data from a data-capable band”, with the added fillip of going to the International Trade Commission, which could ban the import of Fitbit products or component parts. The 28 May lawsuit was about Fitbit’s hiring of five former Jawbone employees who allegedly stole IP. The companies between them have hundreds of patents, and as this Editor has noted in previous IP and patent troll articles, the US Patent and Trademark Office (USPTO) is not especially rigorous in ensuring that patents are not overbroad. Wonderful for the IP attorneys, but not exactly what Fitbit wants as a runup to their expected IPO next week. Wall Street Journal….Now an EHR and PHR join Hackermania Running Wild. Medical Informatics Engineering reported Tuesday that in May their server was cyberattacked, exposing PHI of patients in five clients and separately information contained in the NoMoreClipboard PHR subsidiary. POLITICO reports that this is the first recorded instance of an EHR compromise. MIE ReleasePOLITICO Morning eHealth….If you are in the Cleveland, Ohio area and have an interest, Concussion: A National Challenge is a free, two-day event on detection and diagnosis sponsored by the National Academy of Engineering, the Institute of Medicine, Case Western Reserve University, Metro Health and Taipei Medical University. Advance registration required.