Your Body and Your Brain “At Risk” – The Business of Recalling Biomedical Implants



Consumer electronics are “wants” bought by people who have purchasing power. These might range from human aids like calculators and robot vacuum cleaners to entertainment-driven electronics like smart TVs and tablets, to personal assistants like smart watches and fitness trackers. While most do not consider biomedical implants like heart pacemakers and brain pacemakers to be “consumer electronics”, by definition they are “a good bought for personal rather than commercial use”. The only paradox in this instance is that this suite of biomedical implantables are really “needs” as opposed to “wants”. Patients have a choice on whether or not to adopt this emerging technology, but most say that opting in is the only real option to maintaining their quality of life and longer-term wellbeing.

In the general consumer market, taking back a faulty product simply requires an original proof of purchase so an item can be validated as still being under warranty. In the case of biomedical implantables, a recipient simply cannot take back an implant for repair if it malfunctions. Biomedical implantables are willingly embedded in the body of a consumer by a surgical team, and require special expertise for removal, replacement or maintenance (i.e. upgrade). The manufacturer, for example, cannot conduct the removal process, but a surgeon with the right equipment and human resource support (e.g. nurses) can. In 2010, one supplier of pacemakers, Medtronic Inc., had to pay $268 million to settle thousands of lawsuits that patients filed after a 2007 recall of a faulty heart defibrillator wire that caused at least 13 deaths. In other cases, battery packs have failed causing disruption to consumer implants, and more recently we have witnessed software code security vulnerabilities in heart pacemakers which have meant that recipients had to undergo a firmware upgrade in a doctor’s office, a procedure that takes up to 5 minutes and is non-invasive.

On the one hand, these pacemakers are life-sustaining and life-enhancing to their recipients, on the other hand they place voluntary human implantees at some level of risk. The various types of risks will be considered in this presentation as will the impact of “recalls” on consumer implantees.

This Medtronic YouTube Video is shown in the context of this educational presentation under "fair use" rights. Gary's story demonstrates the positive and life-changing impact a DBS can have on one's life if they are suffering from Parkinson's Disease.

Now read about another Gary here. Two part interview will appear shortly in IEEE Consumer Electronics Magazine.

Warning: The contents of this video are disturbing.

Warning: The contents of this video are disturbing.

Citation: Katina Michael, May 18, 2018, "Your Body and Your Brain “At Risk” – The Business of Recalling Biomedical Implants", Innovations in Health Technology Panel at the Governance of Emerging Technologies and Sciences: Law, Policy and Ethics.

Brain Implant Electromagnetic Issues

Presentation delivered on Sunday April 15, 2018, 2.30pm.


Poster presentation at the 9th Annual International Conference on Ethics in Biology, Engineering, & Medicine in Miami, Florida.

Sunday April 15, 8:30am Breakfast and Registration Announcements/ Welcome

BIOENGINEERING ETHICS EDUCATION Session Chairs: Dr. Katina Michael & Dr. Subrata Saha

Mobile Alerts for People who Wander: Where RFID/NFC, Biometrics and GPS meet

Primary carers of people who wander have a substantial onus to keep their loved ones and clients safe. Though patterns of wandering differ between various stakeholder types in various contexts, the two main design points include:

  1. Ensuring an individual does not go beyond the perimeters of a home (in-building) or a facility (on-campus)
  2. Ensuring an individual who has wandered can be found quickly (usually traversing a public space).

Wandering about a public space is one of the freedoms people enjoy about being alive. Whether it is a brisk walk to the local park, a bus or train trip to the beach, or aeroplane travel to various parts of the world, we can all enjoy the world around us. Walking does not require any token, travel often requires a ticket such as a TravelPass, and flying a passport with an appropriate VISA. People who wander usually do so on foot or by public transport. This session tries to narrow in to the potential for using RFID/NFC, facial recognition, and GPS to trigger mobile alerts when someone has wandered outside a minimum bounded area.

Children with autism for example, have often escaped their homes, only to find themselves in danger, either from oncoming traffic or from deep waters. Those suffering from varying levels of dementia have found themselves on public transport or disoriented at the wheel. Quite often wanderers frequent paths they know well. Wanderers who are in urban centres can have a very different experience to those in regional or rural settings. Context awareness is paramount for a carer. Is there a lake nearby? Is their busy traffic outside the family home? Is the wanderer known to people in the local community like café owners or train station attendants?

Since the early 2000s, various kinds of technological solutions have attempted to help those in need in various markets. Though we are making major inroads into what we have termed hierarchical positioning systems, most systems seem to fall short and so we still have many reports of wanderers falling to their deaths, or drowning, or suffering some other plight. The anguish for carers is significant. There is no respite for them, and the responsibility takes a grave toll on individuals.

This session will explore how technologies could be utilized to monitor people in need within the family home or institutional facility (e.g. wearing RFID/NFC tags) and furthermore how once traversing a public space the wanderer can be located. A number of factors can impact findability: morphological conditions, the individual’s agreement to wear a device, how to respond to mobile alerts once a trigger has been executed.

Participants will learn about:

-          Individual wearer responses to wearable medic alert bracelets and tag technology

-          In-building and on-campus solutions offered by BLE and UWB

-          Advances in satellite-to-base chips (GPS sensors) used by the military

-          The role of visual analytics in near real-time analysis

-          Informed consent issues, duty of care, and getting privacy right

-          Patterns of analysis in human activity monitoring and what that can tell us

-          The importance of affordable solutions for primary carers who usually do not have a full time job while they are caring for loved ones who wander

-          Coordination with emergency services for assistance in finding a missing person

Presenter: Professor Katina Michael, Faculty of Engineering and Information Sciences, University of Wollongong

Collaborator: Dr Roba Abbas, honorary fellow, School of Computing and Information Technology, University of Wollongong

digital angel.png
hps 1 of 2.png
hps 2 of 2.png
 Source: Tee Chew and Katina Michael, 2005

Source: Tee Chew and Katina Michael, 2005

 Source: Tee Chew and Katina Michael, 2005

Source: Tee Chew and Katina Michael, 2005


Tragic stories involving wanderers

It's a devastating occurrence, but it's not rare.

About 20 times a month, a child with autism wanders off, according to national statistics tracked by the nonprofit Autism Speaks.

Two or three of those children die each month in the United States, the group’s numbers from 2017 show.

The most common cause of death will not surprise anyone who followed last weekend's disappearance of 4-year-old Chelsea Noel.

It's drowning.

Of these children, 74 percent run or wander from their own home or from someone else’s home, 40 percent run or wander from stores and 29 percent run or wander from schools. Close calls with traffic injuries were reported for 65 percent of the missing children and close calls with drowning were reported for 24 percent of the missing children. Running and wandering in children and teens with autism takes an enormous toll on families and caregivers, Schumer said: 56 percent of parents reported running as one of the most stressful behaviors they have had to cope with as caregivers of a child with autism. And 50 percent of parents reported receiving little guidance on preventing or addressing this common behavior.
— Autism Wandering Awareness Alerts Response and Education Collaboration and the National Autism Association

"Autistic children aged 14 years and younger are 40 times more likely to die from injury than the general pediatric population," Li said. Specifically, drowning accounts for 46% of all injury deaths among children with autism, which translates to 160 times the chance of dying from drowning compared to other children.

"The risk of drowning in autistic children peaks at age 5 to 7 years," Li said.

He explained that children with the disorder often feel anxiety, and wandering, especially toward water, is one way they seek relief. With 100,000 children newly diagnosed with disorders each year in the US, he added, "the first concrete step parents and caregivers could take to reduce the exceptionally high risk of accidental drowning is to enroll these children in swimming classes."


People with autism are seven times more likely to encounter law enforcement; communication difficulties and atypical behavior can result in serious misunderstandings; people with autism are more likely to be victims of crimes; nearly 50 percent of people with autism wander or elope from safety; and accidental drowning accounts for approximately 90% of lethal wandering outcomes. To best address the safety needs of the community, Autism Speaks facilitates a two-pronged approach including Family Safety Fairs and Autism Awareness Training for First Responders.



A recent study showed 49 percent of parents with a child on the autism spectrum had reported that child had wandered away. Of those, 65 percent were in danger of a traffic accident, and 24 percent were in danger of drowning.1

"You can put the security systems, you can put locks on the door - not just where the doorknob is, but also up high and down low. You have security cameras, motion defectors in the middle of the night," Laxton said.

 Project LifeSaver

Project LifeSaver

"The national program partners with local first responders to connect caregivers of children and adults with cognitive disorders with wearable trackers.

Each device emits a unique frequency and a tracker can pick up a signal from it one to two miles away, which drastically reduces the time of a more “blind” search.

“For us, as a community, to have something like this, it truly is, has the capability of saving lives and being able to find people before it’s too late,” said assistant chief of police Brian Nugent.

In Hendricks County, the devices, which have a $350 up-front cost, are free for qualifying children and adults who tend to wander.

“Our goal is simply to reach out with these families, let them know this program is available and do everything in our power to facilitate that at absolutely no hassle or cost to them,” said Nugent.

Hendricks County first responders handle battery changes every 60 days and replacing cases and wristbands for free too.

The wearable isn’t just for when the wearer is in Hendricks County. The radio frequency transmitters can be picked up in another county too, as long as a nearby first responder has a tracker.

When families enrolled in the program leave the county for an extended period of time, the Project Lifesaver coordinator, Karen Hendershot, calls ahead to give the visiting county a proactive call with the wearer’s frequency information before they arrive.

No matter where the wearer is, the peace of mind gained by the caregiver relieves some of the burden of caring 24/7 for a person with a cognitive disorder, who tends to wander and is attracted to water.

“You could answer the phone or use the restroom,” said Denoon. “No matter what you try, there’s a possibility they could escape if they really want to. You can’t be with them 24/7 no matter how much you try.”

Other counties also offer the Project Lifesaver program, but many require parents or caregivers to pay at least part.

It’s only available in Hendricks County for free because of grants and donations."


3M™ One-Piece GPS Offender Tracking System integrates tracking, communication and mapping technologies. Operators can efficiently track offenders virtually anywhere, anytime, at varying levels of intensity through a single, compact body-worn unit.

One Piece GPS Tracking System product image
View the Product Brochure 390 KB PDF icon
The system features the ability to define inclusion and exclusion zones, animated and birds-eye-view mapping and the convenience of an offender wearing just one device on the leg. The system communicates certain events to the offender through vibrations and LED lights and can switch monitoring intensity modes remotely through software downloads, or automatically, per program rules definition.

3M™ One-Piece GPS Offender Tracking System features full house arrest supervision and will report technical events or violations of schedule restrictions, enabling agencies to apply home curfew restrictions in line with their program.

Key features:

Four supervision levels: active, alert, passive, and optional RF curfew monitoring
Multiple methods of offender communication: LED lights and vibration
Collects GPS points every 60 seconds (adjustable); once every 15 seconds when in zone violation
User configurable alerts and program rules
Continued tracking and offender alerts independent of communication availability
Multiple tracking technologies, back up location detection using LBS
Reliable data storage
Remote software upgrades and modifications
Functionality status indications
Multiple tamper detections
Securely fits on offender’s ankle using an adjustable, easy to install strap
Compact and lightweight
Hypoallergenic, waterproof and tamper resistant
36+ hour battery power
— 3M: Electronic Monitoring: One Piece GPS Tracking System
House arrest electronic monitoring uses radio frequency (RF) or GPS location technology to monitor the movement of offenders under home confinement. Electronic monitoring helps control costs by automating many routine supervision and recording tasks.
Integrated Monitoring Platform
Our Integrated Platform enables operators to integrate monitoring tools and software modules onto a single platform. The platform solution makes the most of technology benefits, allows tailoring to program needs, and enhances overall value by reducing initial investment, lowering installation and support costs, improving system management and maintenance capabilities, and reducing training, and minimizing inventory requirements.

Home Curfew RF Monitoring System
Our Home Curfew RF (Radio Frequency) Monitoring system monitors if the user is within a pre-set distance range during scheduled times. The system is highly configurable, flexible, tamper-resistant, and easy to use.
— 3M Public Safety - House Arrest Applications

 Austria also uses offender tracking systems

Austria also uses offender tracking systems

In early August the Department of Corrections revealed there were 18 people meant to be being tracked by the bracelets at large at once. Two more went on the run this weekend.

Child sex offender Daniel Livingstone is accused of breaking his electronic monitoring bracelet and going on the run.
Child sex offender Daniel Livingstone is accused of breaking his electronic monitoring bracelet and going on the run.

Multinational conglomerate 3M took over the electronic monitoring of offenders here in February in a five-year contract reportedly worth $80 million. Soon afterwards it received a “please explain” letter from Corrections when problems were discovered, documents reveal.

The firm was dumped as the supplier of a different anklet to the state of California in 2012 after flaws allowed paroled rapists and murderers to trick or remove their monitoring bracelets.

In 2013 the Los Angeles Times

reported that batteries in the bracelets used in California failed, GPS signals were vulnerable to illegal jamming devices, the signal could be diverted if the anklet was covered in tin foil, or disappeared if taken into cars or buildings, that cases cracked and GPS locations could be off by as much as almost five kilometres.

The 3M spokeswoman said on Sunday that a different “premium” product was used in New Zealand.

”The 3M GPS bracelet strap is designed to provide the highest level of tamper detection and meet health and safety standards that require these bracelets to be able to be readily removed in case of an emergency.

Around the world, 3M’s devices were used to monitor 200,000 offenders, and the company was confident in the integrity and quality of its products, a spokeswoman said.

Corrections figures show there were more than 15,500 breaches of electronic monitoring conditions between 2008 and August 2015.

Wandering Adults



Today’s wander management technologies are also more affordable—and increasingly discreet.

“Dignity and privacy are major concerns. The system should be designed in line with the high-end designs of assisted living communities, and should support the quiet environment trend,” says Jon Ross, general manager, HomeFree Systems, Milwaukee.

Increasingly, solutions that allow staff to set up “hot zones” are becoming more popular, according to Besecker, because staff can redirect residents who enter a predetermined off-limits zone. Exit alerts and off-campus alerts also can be set on or off for an individual or group of residents.

“The system also can trigger door locks and other mechanisms to reduce the risk of elopement,” Besecker says, adding that silent alerts delivered in real time to staff pagers, smart phones or any other voice or data device already in use in the facility can help ensure immediate action by staff, without the need for disruptive, dignity-robbing alarms.

Preventing dangerous wandering and elopement is indeed critical, but more operators are opting for technology that can offer a second line of defense. Cellular-based tracking solutions, which operate via residents who wear a watch-like device that can be precisely located virtually anywhere within an existing cellular network, is one example of this added layer of protection.

“This cellular-based system can work indoors or outdoors, and can locate people quickly and precisely, even in buildings or places that would typically interfere with GPS locators,” says Jim Nalley, chief executive officer of EmFinders, Frisco, TX. The company’s EmSeeQ technology, developed in collaboration with law enforcement, is activated by a caregiver and utilizes the 9-1-1 emergency system.

Radio frequency identification and global position systems also are gaining momentum in the wander management segment.

“Extending the personal emergency response systems, there are systems on the market that can provide GPS tracking to help find individuals who end up wandering from a facility,” says Brian Jones, director, Aware Home Research Initiative, and senior research engineer for Georgia Tech’s Interactive Media Technology Center in Atlanta. “These technologies are more reliable than those we have seen in the past.”

Resident compliance is another critical factor. As sources explain, residents might try to tamper with or dismantle a wander management system, or they might attempt to remove the wristbands that track their location.

“Being able to know when the device is being worn or not is essential for any resident we want to feel secure,” says Besecker.

Because of the challenges associated with resident compliance, some vendors are now opting for GPS or RFID tags that can be easily and unobtrusively attached to a resident. The GPS or RFID device then alerts and guides the caregiver in the direction of the resident.

“Things like a departure alert placed above a doorway keeps track of [residents] and alerts a caregiver when there is unwanted wandering. Simple systems, such as mats that can be placed at doorways, also monitor resident wandering and prevent elopement,” Bingham says.

Safeguards needed
Even the best wander management solution won’t be worth its salt if caregivers fail to use it properly. For starters, batteries must be charged or replaced regularly to ensure that resident-worn bracelets or pendants are working as intended.

“Batteries are always an issue with any system that is truly wireless, and especially for the wearable components,” confirmed Jones, adding that active location monitoring and GPS tracking will drain a battery much faster than a simple button press that’s activated by the resident on a PERS device.

Vendors are doing their part to keep systems working properly by using extended-use batteries and building in alerts for low battery power. Still, many operators are adding their own safeguards by incorporating battery checks into their monthly safety checklists to prevent any devices from slipping through the cracks.

Today’s wander management solutions also are being designed with expandability in mind. More than ever, vendors are creating systems that support a range of applications, including remote health monitoring and fall prevention and detection.

“By being able to add this capability to their resident monitoring solution, assisted living operators are able to keep residents in their community longer than they did in the past,” reasoned Ross.

Innovations in resident health monitoring solutions, along with passive or “sensor” technologies that can be used in resident rooms to alert staff to potential problems or resident changes, are further allowing facilities to enhance resident safety and response. According to Besecker, these passive monitoring solutions are more effective when used in conjunction with an active solution—with positive identification and authentication of the person wearing the monitor.

“Passive monitors lose their effectiveness when there are multiple people in the environment as assumptions will need to be made about motion, door sensor indications, common activities and so on,” she says. “These types of issues can lead to inaccuracy in reporting status and [potentially inaccurate] conclusions about the data.”

Top 10 Solutions for Adults with Dementia who wander as listed by Alzheimer' here.

1. AngelSense

AngelSense provides caregivers a comprehensive view of their loved one’s activities, comings and goings. The device attaches to a loved one’s clothing and can only be removed by the caregiver. It provides a daily timeline of locations, routes and transit speed and sends an instant alert to caregivers if their loved one is in an unfamiliar place. Caregivers can listen in to hear what is happening around their loved one, can receive an alert if their loved one has not left for an appointment on time, allows caregivers to communicate with their loved one, and sends an alarm to locate your loved one – wherever they are.

1 angelsense.png

2. GPS Smart Sole

Similar to the GPS Shoe and from the same designers, the GPS Smart Sole fits into most shoes and allows caregivers to track their loved one from any smartphone, tablet or web browser. The shoe insert is enabled with GPS technology and allows real-time syncing, a detailed report of location history, and allows users to set up a safe radius for their loved one.



3. iTraq

iTraq is a tracking device that can be used to track pretty much anything – from loved ones to luggage, this tracker pairs with an app on a smartphone to find anyone and anything. For seniors, the device includes a motion or fall sensor and will send an alert if a fall is detected. It also has a temperature sensor. Their newest device, the iTraq Nano is marketed as the world’s smallest all-in-one tracking device that has global tracking, two months battery life, is water and dust resistant is able to be charged wirelessly. The device also has an SOS button that will send an instant alert to friends and family, notifying them of their loved one’s precise location.

4. MedicAlert Safely Home

This device was originally created to help emergency responders treat patients who could not speak for themselves. Today, the device also helps people with dementia who wander. The device is worn as a bracelet and when a loved one goes missing, caregivers can call the police and have the police call the 24-hour hotline to get the location of the missing person. Caregivers can also call the hotline themselves to get information. In addition to a tracking device, the bracelet has important medical information engraved upon it.



5. Mindme

Mindme offers two lifesaving devices, one is a location device, the other is an alarm. The alarm allows the user to alert a Mindme response center in case of a fall or other emergency. The locator device is specifically designed for people with dementia or other cognitive disabilities. The simple device works as a pendant that can be put in a bag or pocket and allows caregivers to track the user online at any time. Caregivers can also set a radius for the user and will be alerted if the person travels outside that zone.



6. PocketFinder

PocketFinder was founded in 2005 by a single parent who wanted to know the whereabouts of his young son, especially when he wasn’t there. Their slogan, “If you love it, locate it!” sums up their philosophy and service offerings. Tracking everything from luggage to pets to children to seniors, the company offers a wide range of emerging technological products. PocketFinder is designed to be the smallest tracker on the market and the device can fit in the palm of your hand. It has a battery life up to one week and allows caregivers to track wearers through a user-friendly app. The device was updated in January 2017 and now includes three location technologies including GPS, Cell ID and Google Wi-Fi Touch. It also now has an SOS button.



7. Project Lifesaver

The mission of Project Lifesaver is “to provide timely response to save lives and reduce potential injury for adults and children who wander due to Alzheimer’s, autism and other related condition or disorders.” Seniors who are enrolled in Project Lifesaver are given a personal transmitter that they wear around their ankle. If they wander, the caregiver calls a local Project Lifesaver agency and a trained team will respond. Recovery times average 30 minutes and many who wander are found within a few miles of their home. In addition to the location device, Project Lifesaver works with public safety agencies to train them on the risks associated with wandering.

 Source:  * 3402 rescued as of 10 April 2018


* 3402 rescued as of 10 April 2018

8. Revolutionary Tracker

Revolutionary Tracker has location-based systems to keep tabs on seniors who may wander. The company strives to “bring an unparalleled level of functionality, capability, ease of use and relevant presentation of information to give people the ability to extend communication, knowledge, protection and care for their loved ones.” Their GPS enabled personal tracker features an SOS button for emergencies and offers real-time tracking. This device allows multiple seniors to be tracked at the same time and syncs directly to a caregiver’s smart phone or computer.



9. Safe Link

Safe Link is another GPS tracking system available for people with Alzheimer’s or dementia. The product promises to “increase safety for the elderly, promote independent living and ultimately lead to a healthier lifestyle.” Safe Link is a small device carried by the person who may wander. The device periodically sends its geographic coordinates to central servers and family members and caregivers can view the wearer’s location via website. The device needs to be charged and worn at all times. All devices have an SOS button for emergencies.



10. Trax

Trax is touted as the world’s smallest and lightest live GPS tracker. The device sends position, speed, and direction through the cellular network directly to your app on a smartphone. Trax comes with a clip that is easy to attach to a loved one. The app allows caregivers to set “Geofences” and will send an alert if a loved one enters or leaves a predetermined area. Trax Geofences have no size limit, caregivers can create as many fence areas as needed, and can schedule when those virtual fences are in effect.



Alternate Technologies



Photo from Workshop at RFID2018. More here:

Total Farm Management Practices Using RFID: Two Australian Dairy Farm Case Studies

Radio-frequency identification (RFID) has been deployed in government mandated livestock identification schemes across the world since the 1990s. RFID in its basic function can help authorities identify animals, especially when traceability becomes paramount during disease outbreaks across regions. This session provides a view of how an RFID-enabled dairy farm can leverage mobile network infrastructure towards achieving total farm management. The data for the study was collected from two case studies, both NLIS (national livestock identification system) compliant dairy farms on the South Coast of New South Wales in Australia, soon after the NLIS was mandated. The Cochrane and Strong Farms were used as models to illustrate the core and auxiliary technology components of an RFID-enabled dairy farm. Beyond satisfying the regulations of government agencies for livestock to be a part of a national identification system for tracking purposes, farmers are now venturing beyond mere basic compliance systems. Once installed, farmers have begun to realize that their initial capital investment into an RFID system holds great strategic potential. The initial outlay while substantial is a once only cost that with a few more application-centric uses can yield a return on investment manifold. This workshop session provides an end-to-end view of the infrastructure and processes required to achieve an advanced RFID-enabled state-of-the-art dairy farm.

Participants will learn about:

  • Regulatory changes in the livestock industry: identification, traceability
  • Mandatory components for RFID-enabled dairy farms
    • RFID tags and boluses, herd management software, fixed RFID reader, digital network
    • Auxiliary components for RFID-enabled dairy farms
  • Portable readers, weight scales, automated feed-dropping controllers, milk meters, milking controller units, drafting gates, temperature monitoring, tracking, calf-feeding machines
  • Benefits of total farm management

Presenter: Professor Katina Michael, Faculty of Engineering and Information Sciences, University of Wollongong

Collaborator: Mr Adam Trevarthen, alumni of the University of Wollongong (for identification purposes only)

More here

Dealing with Dementia Gracefully

There are more than 413,106 Australians living with dementia. Australia's population is 24.13 million. Without a medical breakthrough, the number of people with dementia is expected to reach 1,100,890 by 2056. Currently around 244 people each day are joining the population with dementia. Dementia is the second leading cause of death of Australians contributing to 5.4% of all deaths in males and 10.6% of all deaths in females each year.


As we live longer due to medical breakthroughs as demonstrated by the average life expectancy (82.45 in Australia, compared to 83.84 in Japan and 78.74 in the USA) and are able to see more, our quality of life seems to be diminishing in other aspects. Futurists like Ray Kurzweil describe notions of the Singularity, and yet, families living with dementia face every day complexities today. Is there a solution to this growing problem? Transhumanists will say, yes!

In 2008, I had an article in the Illawarra Mercury that caught the attention of a gentle man, Kenneth Lea. Kenneth lived in Thirroul and we spent some time together discussing how location technologies might help carers with loved ones suffering from dementia. I visited Diggers in Corrimal with Kenneth to meet his beautiful wife. Kenneth had done everything to help his wife enjoy the comforts of home before the disease progressed and it was no longer safe for her to be there. I was heavily pregnant with my second child that year, but with Kenneth's handwritten letters I was moved to learn more about his story. With his patience, I was catapulted into what seemed a foreign world. I got to meet other carers also. They helped to formulate the opinions I have today with respect to how technology can aid sufferers and carers alike. There is also the wonderful work of Lyn Phillipson and her team at the Centre for Health Initiatives (CHI) at the University of Wollongong that I have always respected.

Some months ago I had the immense joy of meeting Suzi Jowsey Fetherstone. Her mother Patricia's story of Alzheimer's Disease (a form of dementia) was documented by AttitudeLive in 2014. I watched this episode last week for the first time. I was moved by many things. This is what I want to share with you when I see you at U3A. After watching this documentary aptly titled "Together Apart" you will understand the title of my presentation "Dealing with Dementia Gracefully". Perhaps, there is nothing graceful about dementia as a  'disease'. But how we honour, understand and respect our loved ones when they regress at their end of life stage, if they fall victim to dementia or Alzheimer's Disease can be graceful. Suzi Jowsey, and her father Victor, tell their intimate story. It is a celebration of Patricia's life, then and now. At my U3A presentation we will watch this documentary together and then have an open discussion about what we learnt from it.

Wearable and Implantables Panel at IEEE Life Sciences Conference 2017

IEEE Life Sciences Conference

Title of Panel: From Wearables to Implantables that Measure and Enhance Human Behaviour: What can we do already? And where are we headed?

Estimated Time: 1 hour

Structure: Each panellist will have 10 minutes to present their case. The moderator will then spent 20 minutes in discussion. Finally, the audience will be invited to ask questions for 10 minutes of each participant.

11.30am-12.30pm Thursday (14 Dec)

Moderator: Katina Michael

Biography: Katina Michael is a professor in the Faculty of Engineering and Information Sciences at the University of Wollongong. She is Editor in Chief of IEEE Technology and Society Magazine, and Senior Editor of IEEE Consumer Electronics Magazine. Katina has previously served as a representative of Consumers Federation of Australia between 2010 and 2016. She has been researching the socio-ethical implications of biomedical devices over the last 20 years.




Panelist 1: Ms Shanti Korporaal

 Ms Shanti Korporaal

Ms Shanti Korporaal

Shanti Korporaal is a Futurist, Serial Entrepreneur, Speaker, Facilitator, Whisky Chick and most of all, lives for Lightbulb moments. With her husband, Skeeve Stevens, she runs eight businesses with offices in two countries - Australia and Cambodia. In life and in business they make a great team, Skeeve is the visionary and ideas and Shanti is the practical tactical, implementer. She is co-founder and Director of Future Sumo, VR the World, Chip My Life, Niisch, eintellego Networks, eintellego Networks (Cambodia) and Elastic Venues (Cambodia). All of her companies are about empowering her clients to grow and flourish in their own businesses or department.

Panelist 2: Mr Meow Meow

 Mr Meow Meow

Mr Meow Meow

Meow is the founder of BioFoundry Inc Australia. He is a citizen scientist whose lab dabbles in wearable and implantable technology among other biohacking applications. His website is He has been featured in Bloomberg’s Hello World documentary in 2016. He was also the first person to implant and Opal card NFC device into his hand. He is a molecular biologist by qualifications and training.

Panelist 3: Rebecca Herold

 Ms Rebecca Herold

Ms Rebecca Herold

Rebecca has 25+ years of systems engineering, information security, privacy & compliance experience, is CEO of The Privacy Professor® consultancy she founded in 2004, and President of SIMBUS, LLC Information Security, Privacy, Technology & Compliance cloud services she founded in 2014. Rebecca engineered the SIMBUS architecture, including risk assessments, LMS, and breach calculator and management system, plus others.  Rebecca has authored 19 books, contributed to dozens of other books, and hundreds of articles. Rebecca led the NIST Smart Grid Privacy Subgroup for 7 years, was a co-founder/officer for IEEE P1912 Privacy and Security Architecture for Consumer Wireless Devices Working Group, and is on many advisory boards. Rebecca was Adjunct Professor for the Norwich University MSISA program for 9 years, has received numerous awards, and has provided keynotes on five continents. Rebecca appears regularly on the KCWI23 television show, and quoted in diverse publications.  Rebecca is based in Des Moines, Iowa, USA.

Conference Link:

Photos from the Panel

 Front: Katina Michael, Meow Meow, Shanti Korporaal. Background via Skype: Rebecca Herold

Front: Katina Michael, Meow Meow, Shanti Korporaal. Background via Skype: Rebecca Herold

Medical Device Commercialisation Training Program

Last week I had the pleasure of going to the medical device commercialisation training program (part 1) at Wollongong's Innovation Campus. It was a highly worthwhile day with lots of examples, a great deal of useful content, and application process information. As always I include the disclaimer at the top of this web page-- any errors in my note taking are my own. The notes are ill-formatted but I hope this does not detract from readability. I've tried to maintain some consistency throughout. The notes are my interpretation of what was said, notes from the board, and separate thoughts/reflections of my own on occasion.



Deep tech innovations


Redfern. 70 companies

Industry-agnostic, not just medical.

Life sciences, devices, diagnostics, robotics/hardware, enterprise software

500 patents in building

70 start ups

110M private and public funding


Incubator Process:




NSW Health (resmetal, next cochlear)


Ignition IP – base level skill (being informed)

Ignition Health – 12 week course (work in teams). Break down biases.

-          Customer discovery – finding the right business model

-          Team based

-          Experiential learning

-          Lots of customer interviews

-          Scientific method to the market

-          What are the assumptions making around

-          What are the pain points

Ignition CORE – Flagship. Run for 3 years. Intensive commercialisation course

-          Commercial aspects of building your medtech business

o   Intellectual property management

o   Market analyses and customer archetypes

o   Product development

o   Regulatory and reimbursement strategy

o   Financial modelling

o   Valuation

-          Ignition show case. 300 people. 950K of awards

50 graduates

11 companies

$20M in public/private funding


An Introduction to Intellectual Property

Gavin Recchia

Principal Patent Attorney

Davies Collision Cave (law firm)

-          Process, device, method

What is IP?

-          Trademarks etc

-          Innovation is only good as your ability to exploit it

-          How can you apply, an application, and a scenario that is used

-          Draw benefit to the exclusion of others

-          How is the public good best served by my work and its dissemination?

-          What is the public good?

o   Turning into clinical advance and turned into clinical setting

o   Not really to go to journal but what else?

o   IP protection and publication

§  Protect or perish ; publish or perish?

-          In the patent you are publishing in more detail than you can imagine.

o   Patent protect first, and then publish

-          Product of thought, creativity, and intellectual effort”

o   Industrial, scientific, literary, artistic fields

-          Intellectual property rights are those right available to protect knowledge

-          Intangible assets

o   More difficult to quantify and define but most important (as opposed to trucks)

§  Australia has invested in tangibles not intangibles OECD (share of GDP)

o   Not good on R&D and other intellectual property products

-          Seems to be a cultural things.

-          Patent filings: applications. Australia is flat. Zero growth.

-          AU medical device innovations

o   Health costs, population increases

§  Pressure to innovate in healthcare increases

o   Have skills and track record

o   Cochlear, REsMed (sleep medicine and non-invasive ventilation—sleep apnea), Compumedics (neurological), Optiscan, Impedimed (bio for lymphedema)

o   (1) Copyright, (2) trademarks, (3) industrial design, (4) patents

-          Copyright

o   Exists automatically. Protects literary and artistic

o   Dramatic works, musical works, Recordings and broadcast

o   Published editions

o   Protects the expression of something and not the idea itself

§  Demonstrate that they COPIED your work, not independent creation

§  In workplace it depends on your contract

o   Control over restricted acts (reproduction, sale, performance)

o   They are exclusive rights—right to stop someone else from reproducing

o   International in scope

o   Lifetime of the author +50-70 years after their death

o   Can be licensed like a key to a house

o   Protects expressions and not ideas

-          Branding

o   Trademarks

o   Logo

o   Registered names

o   Domain names

o   Copyright in and logos

o   Registered Trademark

§  One registered and the other asserted by common law

§  Stand out in the crowd

o   Trademarks:

§  Word, phrase, symbol, shape, color, scent, sound

·         Associates sign and image with a service

·         Coca-cola

§  Can be registrable

§  Threshold of distinctiveness

§  Lifetime – indefinite

§  Use or lose

·         Cadbury – colour purple- it work

·         BP tried to do it for green- did not work

·         Harley Davidson—sound of HD

·         Sound of lion in Metro Mayer (movie)

·         Apple symbol- woolworths, household goods, NO from apple

o   Apple was on green trucks of woollies and white in apple

§  Aldi is example of almost predatory

·         Against substantially identical or deceptively similar designs

·         Keep paying fees to that country

·         Different in each country (geographic)

·         Coca-cola—150 countries….

·         If not used for more than 3 years then it can be taken away from you

o   Demonstrate using it as a trademark

o   Sufficient reputation developed within


·         818621

·         Word: ResMed

·          Class 10

§  562396

·         Word: VPAP vPAP

·         Class: 10

·         Certain subset of goods and services

§  1158806

§  Samba

§  Class: 10

§  Different applications

o   Another trademark 796827 Samba, Bon Food Class:30 coffee

o   Samba x 2

o   Wind surfer, eski, Kleenex, hoover, windsurfer, post-it notes (3M)

§  Trademark rights on that word

§  SO familiar that they buy your product but not too familiar that they buy others also

o   Not Prima Facie Registrable

§  Kind, quality, quantity, intended purpose, value

§  Geographical origin, time of production, any characteristic of product

o   Advantages

§  Exclusive right to use trade mark and to obtain relief for infringement

§  Authorised use

§  Maintenance of trademark by renewal

§  Customs provisions

§  Deterrent effect of registration

§  Policing of trademarks register by Registrar of Trade Marks

§  Rights to assign/ record interest

o   Disadvantages

§  Procedure

§  Time and cost

§  Obligation to maintain and police registered trade mark

·         Non-use issues

·         Renewal requirements

§  Update changes

§  Pay fees to maintain each year

·         Apply -1-2K

o   Make your trademark stand out

§  Distinctive, memorable

·         Fanciful or coined terms, arbitrary marks

·         Avoid descriptive or generic terms

§  Gianturco-Rubin Stent, Taxus Stent, Taxus Liberte

o   Avoid generecising mark

o   TMs and Business names

§  Cannot register a business name unless y ou have done a trademark search. Because you can have a business name, a domain name, but trademark can belong to someone else.

-          Industrial Design

o   Protects visual appearance of an article

§  Does not protect functionality

o   Monopoly over appearance

§  As indicated by representations

§  Lasts for about 10 years

o   Shape of a device (appl trademark ipads, syringes etc)

o   Shape, pattern, configuration, ornamentation

o   Cars, tyres, tyre treads

o   Protects appearance but NOT functionality (so you need a patent also)

o   Applied to medical devices, electronics, vehicles

o   Prevents direct reproduction of design

o   Can be obtained quickly

o   Add to commercial value of a product

§  Attractive and appealing, marketability

o   Catheter, wheel chairs, movement devices, stretches, stents, mesh, walking frames

o   TWO DESIGNS: AU 321356 vs AU 319213 (very similar). Swivel with steering variation.

o   Simply protects DIRECT COPYING

o   One thing to say you can do it, another to say it is WORTHWHILE endeavour to get IPx

-          Trade Secrets

o   Need to control disclosure or use of information

§  Technical data, business information..

o   Must be kept confidential

o   Not reverse engineerable

o   Are not property

o   Can suffer from leakage

o   Duration- as long as you keep the secret

o   Coca-cola… 2-3 people who know… cannot go on same plane… confidential

o   17 years (original patent)

-          Patent Overview

o   Protect functionality of products, methods or processes

o   Idea must be:

§  New: novel

§  Inventive: not obvious

§  Not excluded

·         Exclusionability of patents

o   Provides exclusive right to prevent others exploiting the invention

§  Does not provide freedom to operate

o   Philosophy

§  Promote R&D and innovation in industry

§  Offering a reward to the inventor

§  For the right to publish details of the invention

§  So the public may eventually use it

§  And other may work around it

·         Lasted 600 years

o   Monopoly of 20 years – limited duration

o   Contract between inventor and state – quid pro quo

o   Territorial in scope

o   Requirements

§  Patentable subject matter

§  Novelty

§  Inventive step/ innovative step

§  Specification

§  Utility

o   Formal application/ examination process

o   Difficult: novelty and inventiveness… to prove… this is the prior art

o   Innovation Patents

§  8 year monopoly right

§  Protect innovations

§  Obtained quickly 4-6 years

·         But these were new but not really INVENTIVE

o   Problem is that it was highjacked by big players not SME

§  Commercially useful assets

§  Barrier to entry

§  Likely to cease to exist given gov report

§  Road barrier court case

·         Substantial contribution to innovation (flexible road barrier)

o   Durapost vs Delnorth

o   Road post of spring steel with barb!

o   More difficult to invalidate than standard patent as no inventive step enquiry.

o   Useful for small things in increment

§  Lucentis by Novartis

·         Ranibizumab treating AMD macular degeneration

·         Prefilled syringes containing products with dosage amounts

·         Not chemical, not syringe but TWO THINGS

·         8 AU innovation patents ($500M sales in 2015)

·         Versus Bayer product [became a strong tool]

o   Patent-eligible Subject matter

§  New machines, devices

§  New compositions

§  New use of known object, substances etc

§  Methods of doing things

§  Processes for making things

·         Improved processes for making known things

§  Combinations of known things

·         Synergy or unexpected interaction

§  Can use SAME device for a different application (method patent)

o   Australia: NRDC case (1950s)

§  Artificially created state of affairs

§  In a field of economic endeavour

§  * cannot patent genes which are same as sequence in nature

§  Needs to be $

§  Can’t patent nature

o   Europe

§  Methods of treatment by surgery or therapy, and diagnostics, practiced on a human or animal body excluded

o   US

§  Anything made by man under the sun (1980s)

§  A beer barrel on a head

§  US Patent 5,443,036 (cat and beams)

·         Laser beam on a wall get cat to exercise

§  Just because you can get a patent it doesn’t mean you should.

-          If not an enforceable invention DO NOT patent it.

-          Does it align with business plans.

o   Must align with commercial objectives

-          Not always:

o   Medical treatments

o   Diagnostics

o   Software

o   Ecommerce and business methods

o   Gene sequnces

-          Typucally

o   Machines, devices, hardware

o   Processes, techniques, methods

o   Compositions, materials

o   GMOs (Except animals?)

-          Kit, collocation, working directions etc

o   Generally a kit of parts none of which are novel, is not patentable

o   Very important in diagnostics field

-          Case Study: B Braun Melsungen AG

o   Family business since 1839

o   Safety IV catheters

o   Invention borne out of AIDS treatment

o   Prevention of needlestick injuries

o   Sales in excess of $500M

-          Case Study: Ultimate Medical (Aussie)

o   Laryngeal masks and other airways management

o   T-Bag

o   Single use oxygen enhancement device

o   2013 acquired by Teleflex

-          Case study: Nurofen

o   Boots developed Ibuprofen (1961)

o   Launched in 1969

o   Patent expired in 1980s

o   Exclusivity in improvements

o   Value in trademark maximised


Different Types of IP and IP Rights

Why is IP important?

-          No one is giving the $ to you after the fact

-          Proprietary knowledge of a business

-          Most important asset owned

-          Large industries are founded on IP

-          Gives competitive edge in marketplace

-          Software: copyright in code

-          Pharmaceutical: Patents on drugs and their uses

-          Nike: Swoosh (nike label) Just do it.

-          Expensive process. Prevents copying and freeloaders. Recoup product costs

o   Feasibility study and market research

o   Prototyping and product development

o   Marketing

o   Developing manufacturing/ distribution capabilities

-          Example: cost of bringing pharmaceutical to market is $800 million

o   Dimasi, Hansen and Grabowski (2003)

-          Valley of death – lack of funding

-          As development goes up, funding goes down

-          Government funding initially and then private sector funding kicks in

-          Market monopoly

o   License invention to have a revenue stream

o   Negotiation tool

§  Offering cross licensing

-          Defence against other people’s rights

-          Directors’ Obligations

o   IP assets represent a disproportionate amount of a company’s value

o   Need to manage and take steps to protect IP in your company

o   A director may be personally liable if they direct an organisation to commit an infringement of third party IP


How to talk about your secret sauce without giving it away

Value, usefulness, monotone, who are you speaking to? Technical low-down, know your audience

-          What is the unique inventive step that needs to be protected

-          Know the boundaries

-          Everything else can be shared

-          Know your audience- craft the story.

-          Their pain points, their problems.

-          Customer vs physician.

-          Don’t care about the technology—but it is the impact.

-          What value do you create?

-          Potential investors, partners, buyers

o   Cook Medical

o   Meet people to work with

-          What’s in it for you?

-          What’s in it for them?

-          Can they replicate what you do?

-          To sign an NDA or not?

-          Medtronic or Boston Scientific

-          A lot of investors will NOT sign NDAs. No time.

-          VC – institutional seasonal investors. No opportunity to steal ideas and go elsewhere but Medtronic might.

o   With a larger corporate have an NDA.

o   Very first meeting you would not sign an NDA. Getting to know you.

o   Due diligence process… NDA would be signed.

o   If patent not granted yet, be low key (20 year monopoly)

-          Have a logical story. Share the vision.

o   Problem: how many, where, how bad?

o   Solution

o   Market: size and opportunity, service delivery

o   Traction

o   Defensibility

o   Business model

o   Pricing

o   Timeline

o   The Ask

o   * What is the impact—that is what it comes down to.

-          Business Model Canvas


-          Users (hospital, physician?)

-          Choosers (hospital, physician?)

-          Payers (admin, patient?)

-          * That jobs do they need to get done. Could be social or emotional jobs. Admin. What are KPIs you have to meet? Patient satisfaction rating.

-          Customer jobs: A, B, C. There are gains and there are pains.

-          Customer interviews that are face to face.

o   Body language is a big indicator.

Value Propositions:

-          What is your offering?

-          What pains are relieved?

-          What gains do you create?

-          *Is your solution a Vitamin vs Pain Killer


Match Value propositions to customers

-          Clayton christenssen, milk shakes, time….what wearing… with who?

-          Staying in store? Innovators Dilemma

-          Half of milkshakes sold by 8.30am MCDONALDS

-          Nearly all had a long commute to work

-          Boring…stuck in traffic, peckish, limited by hands… (pain relievers)

o   Gains: quick, convenient, guilt-free MATCH (Gain creators)


PATENTS: What do I have to do?


-          Has this thing ever been done before?

-          Anywhere in the world before?

-          Prior art

-          Prior art must contain an “enabling disclosure”

-          Subject matter of patent application is compared against publications and prior use from anywhere in the world


-          The invention must involve creative thought or ingenuity

-          “If this exact thing hasn’t been done before (i.e. it is novel), what is the difference (i.e. step) from what was done before what is being done now? Is that step inventive?”

-          Is it obvious?

-          Non-obvious… but to whom?

o   Hypothetical person skilled in the art (PSA)

-          Thresholds differ in different jurisdictions


-          We look at common general knowledge

o   Would I directly be led to do this because I thought it was going to work


-          Reasonable expectation of success


-          Obvious to try


-          Invention must be fully described

-          Description must provide “best method” of performing the invention

-          Claims must not be too wide, considering what is disclosed in the specification

-          US: must enable the working of the invention, and show the applicant was “in possession” of it

Patent Claim

-          Describe the invention in ONE sentence

-          Think about the advance mad over the state of the art

-          Think about different possible embodiments to avoid being too narrow


A light emitting device compromising: an electricity conductive medium adapted to emit light when an electric current is passed therethrough


An electrical conductor adapted to emit light


EXERCISE: Fire, Candle, Gas Cylinder-à light bulb

Like a table cloth—do you trim to table… better to start bigger than small.


Don’t have to say it up front… JUS TNEW invention is!!

Google 23 and me…



Provisional (12 months)

-          Never published

-          Title, owner [secret document]

-          Can roll that over as often as you like

Complete (international application) - WIPO

-          Publication begins 6 months after… specification will be published

-          WIPO

-          18 months (preliminary search and opinon)

-          One person will assess but not 100% binding (knockouts at that point)

Then national phases

-          US, EP, AU, CA, JP, CN (national examination and grant)

-          Country level examined application and granted


PCT application

-          152 countries are covered

-          Gives you 18 month additional to choose countries in which to pursue patents

-          Official international search

-          Provisional patent is recognised internationally


-          Grace period for filing a patent application after public disclosure

-          Protect for self-disclosure

-          12 months to file complete patent

Patent application might be in process but DO NOT put a DESIGN application in because it will be disclosed within 6 months. While Patent applications is 12-18 months.


You can only claim for when it is granted.

Picket fences… broad

Modify… 20 + 20 years + 20 years… keep developing


Key points:

-          Should be filed before disclosure

-          Grace periods

-          Provisional 12 months… The clock is ticking… Complete 12 months (max)

-          Information/data collecting exercise is ongoing and subject to time pressures

-          Must include all subject matter

-          Must file in each country of interest

How much data?

-          In vitro vs in vivo data

-          Breadth of exemplification vs spectrum

-          Don’t have to test every single embodiment

-          In vivo data is not needed IF a sound prediction can be made

-          IN vivo data may be needed as support for examination

Depends on tech

Depends on stage of the patent process

Extrapolation is admissible


Useful starting point:

-          Would you be convinced of the claims made in light of the supporting data?

Cannibis. Medical cannabis.

Against the law

Reproducing a human.

Hold the patent from distribution. Socio-ethical legal issues.

Not against the law. Moral obligations for human harm.


Timing and Cost Management

-          Defer costs where possible

o   Combine applications where possible

-          Avoid unnecessary costs

o   Extension fees

-          Seek external funding

o   Government grants

o   Sensible country selection

§  Follow the money

·         Primary markets

·         Manufacturing

§  Consider patentability exclusions

o   Rationalise portfolio

Regular evaluation

-          Patent priority profiling

-          Deadline for internationalisation: 12 months after t

-          Deadlne for nationalisation: 30/31 months from beginning


Select what to patent

-          Business/commercial value

o   What is the lijely value of the technology

o   Will exclusivity provide a competitive advangtage

o   Does the technology align with commercial objectives

-          Legal strength

o   What is the inventive step over the prior art

-          The higher the regulatory bar to product approval to more the patent strategy is important

o   Timing

o   Countries

o   Disclosure over time

A balancing act:

1.       Cut your cloth and go broad

Broad: scope of potential monopoly, prior art against others, flexibility to change course, ability to bury lead idea

Narrow: simplar examination, greater certainty of ouotcome, reduced expeince, improved prospect of availability

Picket fences strategy:

CORE component (then expand)-- NUROFEN

BAYER: compound (termite protection). Expire patent and expand patent list.


-          Aggressive / licensed strategy

o   Patent everything

-          Blocking strategy

-          Defensive strategy

-          Fencing strategy

-          Land mines

-          Scorched earth

o   Put everything in and others cannot use it either


Discovery or invention

-          “Every scientific discovery if made technologically applicable, becomes an invention.

-          Continuous assessment of findings and developments

o   Checkpoints, e.g. group/lab meetings conference, manuscript

-          Do not try to evaluate inventiveness

-          Searching patent and non-patent literature

-          Invention disclosure forms (use it)

-          Consultation with patent attorney


What is an invention?

2.       Conception.

3.       Reduction to Practice

IN science it can be done in reverse… if engineerings 1-2 steps… or same time!


-          Formation in the mind

-          Definite and permanent idea

Reduction to Practice

-          Constructing invention

-          Testing

-          Testing of embodiments

-          The invention need not be perfect

-          Not all embodiments need to be tested

Constructive reduction to practice

-          Full clear concise and exact terms, to enable a person in the art relevant to it to make and use it

Who is entitled?

-          The inventor

-          Someone entitled through the inventor

-          Entitlement vs ownership

Inventorship matters:

-          Revoking a patent is almost impossible

-          Critical to identify inventors and ensure correct entitlement

Medical Device

-          Include software

-          Operations of a health system

-          A tool, diagnostic, device

-          Process

-          Public funding- ignition core… medical devices fund (state government fund) 6-8m$

WILL HIRD – Chemical Engineering

-          What constitutes inventorship?

-          “Conception is the touchstone to determining inventorship”

-          Without contribution the invention would not have been made


-          Material effect on invention

-          Part of a collaboration

-          Practical implementation of a mere idea

-          “But for”

-          Conception of the solution

Not indicators:

-          Using teaching of prior art

-          Normal skill in the art

Single inventor:

-          Fewer problems

-          Rarely applicable in modern high tech

Joint inventor:

-          Where two or more individuals collaborate on an invention

-          Each individual makes some but not all of the contribution

-          Owned in equal amounts

-          Subagreement about revenue on how to distribute among inventors entitled

Case Study:

-          HARRIS vs CSIRO

-          Collaborative project between D and H

-          H was considered to be an inventor.. materially affected the ultimate invention was

o   Entitlement

o   H challenged D…

Patent Owners:

-          Not normally the inventors

-          Chain of the title, normally from inventors to other entitites via:

o   Contract of employment

o   Assignment

o   Other legal contract or agreement

o   Check obligations

-          An inventor is always an inventor but owners come and go

-          Inventors are rewarded

Organisation IP Policy

-          Created by staff

Research (Organisation IP Policy)

-          Ensure ownership does not conflict with assessment of student


-          No true inventor was names

-          One or more additional inventors should have been named

-          No clear chain of title

-          CRC

-          Invention not conceived in course of employment


Case: Ethicon Inc v. U.S> Surgical Corp

-          Dr Yoon developed trocar equipped with safety device

-          Ethicon sued US Surgical

-          Mr Choi helped but not informed

-          US Surgical found out about Choi

-          Obtained a retroactive license

-          Corrected inventorship of patent

-          The US Surgical ended up on the patent

Perform inventorship determinations

-          Interview contributors

-          Collect collaborating evidence

-          Prepare time line/fact sheet

-          Obtain approval of fact sheet from contributors

Assess inventorship



-          Disclosing results of research to a company

-          NDA from the University

-          NDA for exchange of materials (MTA) materials transfer agreement

-          Complete invention disclosure form/ pre-disclosure form

-          Documented notebooks

Public disclosure

-          Kills off validity of payments

-          Europe, China doesn’t use a grace period (70%). Australia does.

-          No public disclosure

-          Discrete about details of invention

-          Not publically disclosed prior to patent application

What happens when YouTube clips are made available for Kickstarter funding… courts put them up.

Cohen-Boyer patent (US 4237224)- public disclosure…

Commercialisation people wanting to hold back but academics want to impact

Computer related innovation

-          Patent protection

-          - function of a program, function of hardware

-          Protection of function and routine itself


                No need for registration

                Can protect source code, executable code

Circuit Layout


Example: Resmed AU2016204561: “System and method for determining sleep stage”

Example: AU2013319705

-          Contradiction between thought and feeling

-          Mental health care support device, system, method, program

o   “automatic thought and feeling inpuot unit

-          What is patentable

You can keep something away from public view (blackbox it)

-          E.g. trade secret for google rank page (patented, then IPO)

-          But today Google might not release the additional smarts


How can you stop someone else from doing something

Patent 1: patented compound

Patent 2: a new method of using the company (application of hair for minoxidil)

** Minoxidil (new use of a known substance)

n  Unexpected, needs to be inventive…

In the tech space: e.g. RFID and the use; Bluetooth


Right to exclude others from practicing invention

-          Making

-          Using

-          Selling

-          Offering to sell

-          Import

Relates to the patented invention

-          Looks to claims

-          Right to license or assign

-          Infringement action can only be brought after patent grant



Research use exemption

-          Experimentation

-          Experimental purposes

Regulatory exemption

Prior user rights

-          Secret use before priority date


If in the eye of public interest you can go forward and use the technology.


Patent Landscape

-          Patentability and freedom to operate are different things!

-          Different to protecting your intellectual property

-          ** Freedom to operate sometimes means you need to get a license to sell your process/product

Freedom to operate

-          Has nothing to do with whether or not you have a patent

-          Nothing to with the strength of your patent position

-          Relates to ability to commercialise your technology

o   Will you infringe some else’s patent right?

-          Determining FTO is not trivial


-          What markets are you interested in

-          Markets of partners/licensees?

-          What level of comfort do you want or need?

-          What level of comfort do inventors/licensees want or need?

-          What is your technology now?

-          What developments of your tech are your planning?


-          Specific patent search strategy

-          Patent claim analysis

-          - jurisdiction by jurisdiction analysis

1983 – Ben Lexin—wind keel (closed with blankets)


FTO—look if a patent has expired.


Dealing with someone else’s patent

-          Determine importance

-          Determine freedom to operate

-          Can I work around?

o   Identify elements of the claim that you can change or avoid

-          Invalidate the patent

o   Find prior art that invalidates problematic claims

§  “novelty KNOCK-OUT reference”

o   Ideally a single document or disclosure

-          License the patent


Patent searching

-          Should form part of any literature survey

-          Should form part of your R&D planning

-          Patent applications are published at about 18 months from filing

-          Searching is never 100% determinative- depends on searcher’s skills and expertise

o   Languages

-          Not one size fits all


Who are our competitors? Patent landscape

Where are the white spaces in R&D? Name

What is company X or inventor Y patenting? Patent family

IN which countries has patent protection been obtained or being pursued?

Is the claimed invention new?

Could we potentially be sued for patent infringement?

* atlasian



IP Australia

Google Patents




-          Purposeful. NGOs. Competitors.

-          Needs to be reproducible.

-          Identify the technical field.

-          Enable the invention to be repeated

Need to disclose everything or just keep it as a trade secret.

Scope of protection, clearly mark out territory

Japan, China, South Korea

Machine translation via Google

China’s move dramatic because gov funded innovation cycles


Patent Specification

-          Tech Field

-          Background

-          Summary of the Invention

-          Brief Description of Drawings

-          Detailed Description

-          Examples

-          Claims

-          Drawings

Patent claims are numbered

-          Preamble + characterising features

o   Define the invention

-          Claim set begins broad and narrows

-          Different claim types

Case: B Braun vs Multigate

                Retractable needle

-          Two different needle retraction devices. So broad claim meant that they could capture same thing differently… same function and different method.

Apple Samsung (IP barrister lawyers)


Exercise: drink carrying device

-          Prior art search: drink carrier

-          The drink carrier scenario

-          Drink carrier could fold into a small convenient size

-          Australian Patent: 2005289364

-          Breadth goes a lot further than normal requirement

-          Patent and design protection



-          Not about the product but descriptive of it sort of


Part 4

Everything that can be invented has been invented.

-          Cost

-          IP portfolio – what is it doing for you?

IP Services

-          IP creation and identification

o   Identify IP and its full potential

o   IP audits

o   IP mining

o   Branding development

-          Securing IP rights

o   Drafting and prosecuting patent applications

-          IP Agreements

o   CDAs/NDAs, licensee, assignments, MTAs, CRAs

-          IP enforcement


-          IP due diligence

-          IP portfolio enhancement for exit

-          Improved IP operational efficiency and effectiveness


Patent attorneys:

-          Draft a patent

-          Technical qualification (science, engineering, technical competence)

-          Drafting and prosecuting apps

-          searching

-          Advice / analysis

-          IP law specialists

-          70K in 3 countries (Europe, Asia, US); 7 apps 2-3K bills each; TOO MUCH $


Old School

-          Do research

-          Review Output (maybe)

-          Capture IP (if still can)

-          And then work out what we will do


Aligning R&D and IP

-          Tech and market are well understood

-          Business plan is in place

-          Commercial strategy is agreed

-          IP landscape is identified and analysed

-          Required IP portfolio is defined

-          R&D planned to create the IP portfolio required to achieve the strategy

IP Landscape

-          Raise awareness

-          Quick to file, quick to abandon

-          Proper management of non-patent IP

-          Patents splits by application to facilitate licensing

-          Strategic publication where appropriate

Conception and Technical Design

Anatomy of a patent portfolio

60% of patents collapse over time because they cannot afford the maintenance

-          High core value


Good idea?

-          Don’t tell anyone

-          Consider brief literature

-          Consider obligations

o   Employer, collaborator, sponsor

-          Report in invention disclosure


Tools and processes:

-          NDAs

-          Notebooks and journals

-          Invention disclosure

-          Right creation



-          Don’t talk to people’s lawyers, you should talk to people who are interested in the actual technology

-          Maintain detailed records

-          Date, diagonal line through page if blank

-          Ink only

-          Pre-disclosure forms