The U.S. Supreme Court recently decided a case resolving a patent dispute between two medical device companies, Hologic, Inc. and Minerva Surgical.  The opinion was closely watched because it raised the question of whether an inventor who has assigned a patent is legally prevented from later attacking the validity of that same patent — a doctrine historically referred to as “assignor estoppel.”

The Supreme Court’s opinion on June 29, 2021, upheld but limited this doctrine, defining its boundaries and emphasizing it is based on legal principles of equity and fair dealing.

In the case, Csaba Truckai was a listed inventor on a patent application, the rights to which were subsequently acquired by Hologic, Inc. Mr. Truckai then founded Minerva Surgical, Inc. and developed an endometrial ablation system.  Hologic sued Minerva for patent infringement of one of the assigned patents related to endometrial ablation.

In response to the claims of patent infringement, Minerva attacked the patent as allegedly invalid. In response, Hologic argued that, under assignor estoppel, Minerva should be prevented from attacking the patent’s validity because Minerva’s founder, Mr. Truckai, was an inventor on the same patent.

In deciding the case, the Court recognized the fairness principle of assignor estoppel — that an inventor shouldn’t be able to initially tout an invention to the patent office, only to later disclaim its worth after assigning it. However, the Court decided that the lower court had applied assignor estoppel too expansively to muzzle inventors.  Thus, the Court held that the doctrine applies only when an inventor makes statements (explicitly or implicitly) in assigning a patent, and later contradicts those statements in litigating against the owner of the patent. The Court reasoned that an assignment does carry an implied assurance of a patent’s validity, but where the assignor has not made explicit or implicit representations that contradict an invalidity defense, there is no ground for assignor estoppel.

To illustrate the boundaries of assignor estoppel, the Court provided three non-exhaustive examples of when assignor estoppel does not apply:

• First, when assignment occurs before an inventor can make a warranty of validity (e.g., “when an employee assigns to his employer patent rights in any future inventions he may develop during his employment”);
• Second, when a later legal development renders the warranty of validity irrelevant (such as a change in the law); and
• Third, when a change in patent claims occurs for an assigned application (e.g., “the new claims are materially broadened” during patent prosecution after the assignment takes place).

Nevertheless, each assignor’s and each company’s situation is unique, and the application of assignor estoppel depends on the particular situation. Medical device companies and others concerned about patents should seek the guidance of professional legal counsel when making any determination regarding whether assignor estoppel applies.

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On 2 July 2021, a hearing took place at the Federal Court of Australia in Melbourne, before Justice Jonathan Beach, in the matter of Stephen Thaler v Commissioner of Patents.  This case concerns the question of whether a patent may be granted for an invention that was devised by a machine, rather than by a human inventor.  Back in February, I reported on the refusal by the Australian Patent Office to accept as valid an Australian patent application naming an ‘artificial intelligence’ going by the name DABUS (‘Device for the Autonomous Bootstrapping of Unified Sentience’) as inventor.  And in March I reported that an application had been filed in the Federal Court for review of the Patent Office decision.

Regular readers will know my position on this issue – I do not consider it appropriate at this time (or, potentially, ever) to grant patents for inventions devised entirely by automated means, such that there is no human inventor.  I have written an article targeted to a more general audience, which has been published by InnovationAus, providing an overview of the Australian case, and broadly discussing my concerns.  Here I will be going into more detail of the arguments presented at the recent hearing, and why I think it would be very unfortunate if Justice Beach were to decide that this is a suitable case for judicial development of the law to embrace machine inventors, as he is being encouraged to do by Thaler.

I was able to attend the hearing virtually, since it was being held via web conference.  Thaler’s team, led by experienced and highly-regarded barrister David Shavin QC, appeared in person in the Melbourne courtroom with Justice Beach, while the Commissioner of Patents was represented by Hamish Bevan, appearing via video from Sydney (subject to restrictions, due to an ongoing COVID outbreak).  Although I disagree with the proposition, I thought that Mr Shavin presented a persuasive argument that the relevant provisions of the Australian Patents Act 1990 can, and should, be interpreted to encompass non-human inventors, and that Mr Bevan perhaps did not do enough to counter this argument.  I formed the impression that Justice Beach just might be minded to ‘develop’ the Australian law to permit patent applications having no human inventor, in part because he was not presented with any particularly good reasons not to do so.

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One of the objectives of the Raising the Bar IP law reforms – most of which commenced on 15 April 2013 – was to reduce delays in the resolution of patent (and trade mark) applications.  The perceived problem with such delays was not that applicants were unhappy with the speed of processing of their applications (in fact, most choose to defer examination and acceptance of their patent applications), but rather that delays create uncertainty about whether a patent will be granted, and what scope the granted claims might have.  As noted in the Explanatory Memorandum to the Raising the Bar Bill, ‘[d]elay may suit the party, but it is not in the interests of the public, or the party’s competitors.’

There were four main features of the reforms that were expected to reduce delays and uncertainty:

1. reduction, from six months to two months, of the period within which an applicant is required to request examination, once directed to do so by the patent office;
2. reduction of the maximum period available for an applicant to obtain acceptance of a patent application, following issue of an initial examination report, from 21 months down to 12 months;
3. ‘tightening’ of the rules around when divisional applications can be validly filed, to reduce opportunities for what the Explanatory Memorandum describes as ‘abusive uses’; and
4. refinement of opposition proceedings, mostly in the form of more stringent criteria for obtaining extensions of time.

The reforms to opposition proceedings had an almost immediate impact, since they applied to all new oppositions filed on or after 15 April 2013, as well as (to a more limited degree) oppositions that were already in progress.  However, since over 99.5% of all accepted applications are not opposed, the reduction in opposition duration is irrelevant to the overwhelming majority of cases. 

It has taken longer to reach the point at which there is sufficient data to evaluate the effect of the change to the examination period, since this only applied to applications for which a request for examination was filed on or after 15 April 2013.  Many of these applications remained in the system for years.  Indeed, the last patent to be granted under the pre-Raising the Bar regime – without being additionally delayed by opposition proceedings – was no. 2010311063, which was derived from a PCT application that entered the national phase in Australia on 17 May 2012.  Examination was requested on 9 April 2013, and a first report issued on 7 August 2018 (after the application inadvertently lapsed and was restored).  The application was eventually accepted on 17 February 2020, and the patent granted on 18 June 2020.

I have now analysed nearly two decades worth of Australian patent examination data, spanning the period before and after commencement of the Raising the Bar reforms.  Further details and charts are below, but in summary I have found that:

1. reduction of the maximum examination period by nine months (from 21 to 12 months) has resulted in a drop of only a little over three months in the median period between initial examination and acceptance of successful applications;
2. the reforms have not, however, resulted in any lasting improvement in the pendency of the most ‘stubborn’ applications, which are only accepted following one or more divisional applications being filed for the purposes of continuing examination (for want of any better term, I call these ‘continuation divisionals’);
3. as a result, the ‘top’ 2% of cases are still pending for 900 days or more between an initial examination report being issued and an application finally being accepted;
4. perversely, following an initial temporary drop in the number of continuation divisionals, the reforms actually seem to have resulted in an increase in the proportion of divisional applications that are filed for the primary purpose of continuing examination;
5. on the other hand, however, the major use (i.e. over 60%) of divisional applications remains their primary purpose of pursuing alternative claims following acceptance of claims in a parent application.

Overall, reducing the examination period has had a relatively minimal effect on total pendency of patent applications – a reduction in the time prior to examination, i.e. between filing and a first examination report being issued, has been much more significant.  However, it appears to have had the unintended consequence of increasing the use of divisional applications to continue examination.

This article helps you understand how to pass the FDA Refusal to Accept (RTA) screening process 510k submissions – updated Sept 2019 version. What is an RTA Checklist? The “RTA” in RTA Checklist stands for Refuse to Accept. The FDA uses this tool to determine if your 510(k) submissions will be accepted or not for […]

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A poor RTA response will cause a two-week delay, but an additional information request only gets one chance to avoid the dreaded NSE letter. An Additional Information Request (i.e. AI Request) is typically received just before the 60th day in a 90-day 510k review, while a Refusal to Accept (RTA) Hold is typically received on […]

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In 18 June 2021, a Full bench of the Federal Court of Australia (Middleton, Nicholas, and Burley JJ) unanimously upheld a decision of a single judge of the court (Beach J), finding that a method of detecting cell-free foetal DNA (cffDNA) in maternal blood serum comprises patent-eligible subject matter (i.e. a ‘manner of manufacture’) under Australian law: Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101.  The patent at issue is Australian patent no. 727,919, covering an invention originally developed by Oxford University researchers, and subsequently transferred to Sequenom Inc.  The patent expired in March 2018, however a live dispute remains because Ariosa Diagnostics licensed its ‘Harmony Test’ – which Sequenom says (and the Full Court has agreed) infringes the patent – for use in Australia since at least September 2015.

To my mind, the result in this case is neither particularly surprising nor contentious.  The patent claims are directed to a method of detecting cffDNA.  While the method is underpinned by the naturally occurring fact – not known until its discovery by the inventors prior to March 1997 – that cffDNA is present in maternal blood serum, a useful method of detecting a previously unknown natural phenomenon, having a practical application, has long been considered patentable.  Ariosa’s arguments that Sequenom’s claims were in substance directed to the ‘mere’ discovery itself, resulted only in the production of ‘information’, and therefore unpatentable, were unsuccessful.  And while the broad scope of the main claim in this case might raise other issues, such as obviousness or sufficiency of description, these matters have also been addressed at first instance and/or on appeal, and are separate from the question of subject matter eligibility. 

Nonetheless, this case will generate some interest, if only because the result in Australia is opposed to the outcome of equivalent litigation between Sequenom and Ariosa involving a corresponding patent in the United States.  In that case, a narrower claim than in Australia was found to be directed to an unpatentable natural phenomenon.  The result was controversial, not least because a number of judges on the US Court of Appeals for the Federal Circuit (CAFC) – including Judge Linn on the original panel (Ariosa Diagnostics, Inc.v. Sequenom, Inc. (Fed. Cir. 2015)) and Judges Lourie and Dyk in a decision refusing en banc rehearing – indicated that they felt bound by the Supreme Court precedents, but did not agree with the outcome.  There was therefore great disappointment when the US Supreme Court declined to hear an appeal.

The outcome of the Australian appeal is not all bad news for Ariosa, however, with the finding of the primary judge on infringement being partially reversed.  In particular, there were periods during which the Harmony Test was not carried out in Australia, but instead samples were sent to the US for testing by Ariosa, which the primary judge found also to be infringing actions.  The Full Court has disagreed, finding that ‘importing’ the information resulting from the tests into Australia did not comprise a relevant ‘exploitation’ of the claimed method, as it might have done were the product of the method a physical article.

Tokyo will see many firsts when it hosts the Games of the XXXII Olympiad. Not least, that the 2020 Games are being held a year later than planned and less than one year before the 2022 Winter Olympics in Beijing.

The worldwide pandemic also means that there will be no international visitors in Tokyo, but Olympic Broadcasting Services (OBS) will build on virtual-reality (VR) technology introduced in Rio in 2016 and PyeongChang’s 2018 Winter Olympics to make TV viewers feel a part of the Games from the comfort of their own homes.

OBS is the host broadcast organisation for the Olympic, Youth Olympic and Paralympic Games. It was created by the IOC in 2001. It provides broadcast content for use by all rights-holding broadcasters (e.g. the BBC, Eurosport) around the world, and it also helps broadcasters prepare for the Games; OBS oversees the fit-out of the International Broadcast Centre (IBC), which is the home of the broadcasting operations of the Games. It also prepares the compounds at each competition venue, where OBS and rights-holding broadcasters’ production and technical facilities are located and from where international television and radio signals will be produced.  

OBS expects to produce 56 live feeds and nearly 9,500 hours of content during the 17-day event, which consists of 339 events across 50 sporting disciplines. It has a team of nearly 8,000 people from more than 70 countries, with specialities and skills in different sports broadcasting.

Tokyo will be the first Olympic Games to be natively produced in ultra-high definition (UHD) – or 4K – and high dynamic range (HDR). UHD content has a resolution of 3,840 x 2,160 pixels, four times the number of pixels of full HD, to give more detail. HDR technology improves the contrast between black and white pixels for an accurate picture with more colour shades. Coverage of previous Games has been done in parallel coverage with broadcasters but this year will be the first time the native broadcast coverage for the OBS world feed will be produced directly as UHD and HDR across all competitions and ceremonies of this year’s Games.

Until recently there was no universal standard for UHD and the application of HDR was not a foregone conclusion, says Yiannis Exarchos, chief executive officer of OBS. He places great store on HDR in particular. “It brings, especially in outdoor sport, a level of detail, both in colour and light rotation, which really makes the images considerably more realistic than you get in HD; it’s not just about resolution.”

OBS has developed a standard which derives the best possible HDR output out of the UHD solution, making it more efficient and sustainable because OBS does not have to double up broadcast resources.

The closing ceremony will be broadcast in 8K to make the most of what are traditionally vibrant spectacles. 8K doubles 4K’s number of pixels to 7,680 x 4,320 and is 16 times greater than HD. Other sports (athletics, gymnastics, judo, and some > < swimming events) will be available in 8K in Japan, although other broadcasters may pick up the feed and experiment with trial transmissions. There are already plans for 8K broadcast by Chinese broadcasters for the 2022 Winter Olympics in Beijing.

Another Tokyo first will be immersive audio. All venues will deliver an immersive audio feed as discrete channels in a 5.1.4 format. This is five microphones placed front left, right and centre and either side or behind for surround sound, with one dedicated bass channel and four speakers above the source of noise. There will be 85 separate 5.1.4 audio feeds available for national broadcasters.

Immersive audio brings a three-dimensional experience to viewers or listeners. Exarchos says: “I am a huge audio fan because I believe that audio, in some sense, is the carrier of emotions... so I am happy that for the first time, across all sports, we will do 5.1.4 immersive audio.” Countries such as Japan, China, the US, Brazil, and most of Europe (via Discovery and Eurosport channels) will be able to experience 5.1.4 audio transmission.  

Bringing 3D quality of the Games to viewers from events held in arenas, OBS has partnered with Intel to bring its True View technology to Tokyo. TrueView is based on directors using images from virtual cameras all around a venue to deliver perspectives that cannot be seen by physical ones. It allows viewers to select the angle from which they want to see the camera, with options for three or six degrees of movement. It uses an array of high-resolution cameras positioned to capture the entire field of play, connected to on-site servers, based on Intel’s Xeon processors. Data from the cameras is sent to the cloud to be synchronised, analysed, and processed.

In the production suite, engineers can use virtual stationary and tracking cameras to create content focused on particular points in the game, maybe the most exciting action or sequences, for analysis by commentators. Images from the virtual cameras are rendered and converted into compressed digital video in the cloud. Up to 200 terabytes of raw data is processed per event, including height, width, depth, and relative attributes to create high-fidelity 3D video.

TrueView supports the common industry-standard video codecs (H.264, H.265, MPEG and AAC for audio) for use on different platforms and devices. The encoded video is converted into bit streams for live streaming. The bit streams are converted by the rights-holding broadcaster to decompress the video into a series of images, which are rendered sequentially and broadcast.

The output of volumetric content allows viewers to see all perspectives of the game, or to follow a particular player or see the play from any position on the field – including the referees.

In Tokyo, TrueView will be used for basketball games. It is, says Exarchos, one of the sports where it could be really outstanding, because of the three-dimensional nature of the sport. “It is also a very fast sport, that moves in many different directions and there is significant vertical movement.” OBS will produce five to seven volumetric replay clips for each game, which will be made available for directors to integrate into live coverage. “I’m pretty sure that some of these clips will go viral on social media platforms,” he adds.

Tokyo is the first step as broadcasters explore how to create exciting content. It could be someone ‘walking’ into the field of play, turning and watching the athletes around him or her, suggests Exarchos. He expects to see this develop and is looking forward to what will be broadcast at the 2024 Olympics in Paris.

An added benefit is that True View saves costs, and carbon footprint,  by not needing a camera crew to travel to the venue.

‘Covid, travel bans and a postponement are challenges that should be used to advance broadcasting.’

While Exarchos is sworn to secrecy and cannot reveal details of the opening ceremony, he is able to confirm that it will be broadcast using multiple cameras for an immersive, virtual-reality experience.

VR is not new for the Olympic Games; it was used in 2016 at Rio and in 2018’s Winter Games in South Korea. For the opening ceremony, there will be six 180° camera systems and one 360° VR system. There will also be experimentation with 5G technology during the ceremony to ensure that content is quickly received at high resolutions and turned around for the worldwide audience.

“I believe that 5G can be a big game-​changer for broadcasting,” says Exarchos. “It can help us get rid of a lot of the technical constraints, equipment and regulatory needs, as well as permits for RF transmissions... We need to find a way that we can use all these interesting technologies in a way which is equally effective as we do with tools we have now.” VR has a huge bandwidth and 5G’s reduced latency could address synchronisation issues around live events. “5G provides ample bandwidth and also defeats the digital problems of latency to a very big extent,” he continues. There will also be opportunities for progress using mobile phone screens and the computational capabilities; “hence our collaboration with Intel,” Exarchos says.

The VR experience will be “significantly upgraded” compared to that used at PyeongChang, with coverage of 47 live events as well as between 50 and 100 pieces of VR highlights. “We have noticed that people tend to prefer to experience highlights on VR,” says Exarchos. “For Beijing, our common goal, with Intel, is to produce an 8K VR product.”

The 2018 Winter Games introduced Intel True VR, whereby OBS broadcast 30 events with live and video-on-demand VR events. There will be three to six camera viewpoints recording each event for content compatible with most commercially available VR headsets. Viewers can watch an immersive ‘VR Cast’, seen from different angles as well as graphics and picture-in-picture overlays. True VR can also be used for post-event highlights, and production teams can overlay statistics or picture-in-picture content.

The quest for stats by viewers has also led to Intel’s 3D Athlete Tracking (3DAT) being used at this year’s Games. Originally a coaching tool, it uses AI to identify 20 skeletal points on an athlete. Replaying the race these points indicate where pressure or stress is being exerted or to analyse moments of acceleration and deceleration. In Tokyo it will be used post-races for viewers to analyse the race in detail.

Intel’s director of sports performance technology, Jonathan Lee, explains how much data processing is involved. “We will track all eight or nine sprinters, so that’s nine videos at 60 frames per second for 10 to 12 seconds. It is not just the detection of athletes but tracking skeletal points... We use AI because the athletes are next to each other, so we may not be able to see the arm of the sprinter in lane five, for example,” he says. AI is used to differentiate which sprinter is which at any given moment.

Data that is of interest to an athlete and coach may be too detailed for a viewer but it is likely that statistics such as top speed, when a sprinter reaches that top speed and when they decelerate will be shown. 3DAT allows athletes and coaches to review a race and see that they maintain their top speed for say 20 or 30m and then start to decelerate at the 70m mark. “To be honest, to be able to digest all that information quickly, you’ll see colour indicators, almost like a heat map,” Lee says. The classic view of the sprinters racing towards the finish will be embellished with colours indicating their speed, moving from yellow to red and darker as they go faster, explains Lee. This in itself is a visual representation but post-production teams can overlay when a particular sprinter hits their top speed and what speed that is.

“We will work with broadcasters to understand how they use this type of content... perhaps some of the things coaches and athletes find interesting, we may find that fans find them compelling too, and we might start to weave them in as well,” suggests Lee. The technology is designed to complement the coverage of rights-holding broadcasters. The 3DAT clips with overlaid ‘heat maps’ can be used by commentators to examine what has happened.

Intel’s graphics partner receives the video from OBS, ingests the 3DAT data and renders the clips. AI processing happens in the cloud on Xeon scalable processors. It is turned around in less than 60 seconds.

“To be able to have volumetric replay, potentially also with analysis, and to be able to use it as a fourth or fifth replay after a race is a big deal,” says Exarchos. “I’m sure it will go faster and faster... and hopefully, we will do more in Beijing.”