PMD March 2005: Announcing the PedREST

In 2004 Pediatric Medical received notice that we were going to be granted our first patent – YEAH!!! We were finally ready to share our “creation” with the world

Our first opportunity came in March 2005 with something called the LifeSavers Conference. For those of you not familiar with it, Lifesavers is the premier national highway safety meeting in the United States dedicated to reducing the tragic toll of deaths and injuries on our nation’s roadways… The conference addresses a wide range of safety topics, from child passenger safety and occupant protection to roadway and vehicle safety and technology. It offers the latest information on advances in highway safety, highlights successful programs and draws attention to emerging safety issues.” It was to be held that year in North Carolina and seemed like the perfect place to “showcase” our new device. They even had a workshop scheduled on “transporting children on ambulances” being run by Dr. Marilyn Bull of Riley’s Children’s Hospital – well known for her work on ambulance safety. And for the icing on the cake – I had family in Charlotte – so I could attend the conference without having to rent a hotel room.

I made arrangements to attend the conference and not too long after drove to North Carolina for breakfast with my mother’s cousin and his girlfriend who worked for Britax (one of the most well-respected manufactures of child seats in the world – seriously what a coup)! Later that afternoon I met her over at the conference and she introduced me to the Britax folks in charge of new business development – who took one look at what we had and introduced us to SnugSeat – the company they partnered with to manufacture “specialty child seats”. Oh, and before I forget, while we were still at the Britax booth, some local EMS guys stopped by, saw our demo, and asked where they could get one. Can you say happy as a pig xxx xxxx??? (I’ll let you fill in the blanks)

Later that afternoon I attended the workshop on safe ambulance transport for kids. Unfortunately Dr Bull had been taken ill and could not attend herself – however her colleagues (Dr Judith Talty and Shayne Merritt) gave the presentation on her behalf. Their conclusion – which was no surprise to anyone, especially me – was that there really were no safe ways to transport little kids and that they hoped manufacturers would change this for the future.

At this point – totally “jazzed” – I waited until after the session and spoke with Dr Talty and Shayne. Both were floored by the PedREST presentation and asked me to please keep in touch and forward whatever I could to Dr Bull. Flying high I made the rounds of the other child seat manufacturers attending the conference (Graco, Evenflo, etc.) and finally, exhausted, headed for home.

5 days later I headed to Philadelphia for the EMS Today conference and there met with the top “players” in the EMS industry – Stryker, Ferno, Laerdal, Microtek Medical, Allied Health, etc. The response was tremendous, and the offers of encouragement and support, overwhelming! The PedREST was a hit!

Two weeks later, the following email arrived from Shayne Merritt:

Stephanie,

We will be passing this information on to Dr. Bull. In the meantime, if you have any photos or schematics that you could send for Dr. Bull, that would be helpful.

Your product is very intriguing and exciting since it’s success would fill an important need.

Shayne

As I look back on all of this, I can’t help but smile when I think about how on top of the world we were. The people we met…the welcome we received. I couldn’t have imagined a better way to start the next phase of our journey! Little did I know how much more of a journey lay ahead. To me, at that moment, the PedREST had officially arrived…

Until next time…

PMD 2004: And After Every Rain…A Rainbow

As you can probably tell, 2004 was a bit of a rollercoaster. And trust me when I say that after that disaster of a weekend, I was seriously ready for the cart to start rolling uphill again.

Sure enough Monday afternoon found us on a conference call with the examiner from the US patent office. See our patent had been already gone through 3 office actions and things were getting a little frustrating (not to mention expensive) so we decided to speak directly to the examiner to see if we could understand the rationale behind what he would and wouldn’t approve. Now having gone through this process several times, I feel obliged to tell you that unfortunately, in all likelihood a call like this will probably not leave you with a better understanding of how your examiner thinks.  What it can do however is provide you with insight into the one or two words or phrases that your examiner has a conflict with….and that can make all the difference in the world. Case in point: 

Our call began with our examiner showing us the “prior art” (i.e. other existing patents filed before ours) that he believed we would infringe upon with our current claim language. We went back and forth over a couple of minor points, made some small changes and then sat down to discuss what he considered to be the one “obstacle” we hadn’t yet overcome: a portable surgery tray that attached to a stretcher and kept the medical instruments secure – OR – as far as we could see – a cafeteria lunch tray with a strap running across it. (note – those of you who’ve been through this process are no-doubt chuckling because you’ve “lived the dream” of bizarre prior art references – for those of you whose jaws just hit the table, know that ours did too and we hadn’t even gotten to the best part).

We were quiet for a second and then our patent attorney who had joined us in the call proceeded to ask very calmly how the examiner thought this could be used to secure a child for safe transport to a hospital.  His answer – no joke – “well you could tape a baby to that tray”.

The silence was deafening…I mean seriously, how do you counter that??? Finally, after what seemed like minutes (ok, really only seconds) of silence I made a decision. No amount of intelligent discussion / arguing was going to change his opinion. I just needed to know where in his opinion we had gone wrong so that we could fix it.  So I sucked it up and asked…and to my surprise, he told me.  Not long after that we filed our final response with the USPTO.

For weeks I checked PAIR (the Patent Application Information Retrieval system for the USPTO) daily hoping for some kind of sign that we were finally done.  Thanksgiving morning (…and yes it really was Thanksgiving) I got one – our official “Notice of Allowance” was posted. 

I could follow this part of the story with a section on “what I learned” but I feel pretty confident that you all can figure that out on your own. I will say that after what felt like a torrential downpour I finally got my rainbow…

Until next time…with love from the “tape a baby corporation”

PMD: 2004 – Repeat After Me…Must Have CIP

By the end of 2003, we had received our first office action from the US patent office (USPTO), and filed an international PCT. Our attorney notified us that we would probably receive 2 more office actions before we were through and we should have our patent confirmed within 12 months – 17 on the outside.

Now for those of you beginning the patent process, I feel obligated to tell you that the words “office action” will likely become the bane of your existence. For reasons too numerous to count, it is almost unheard of that a patent will be approved when it is first submitted. But on a positive note, you’ll have a chance to improve your patent claims making your own patent stronger and more difficult to infringe. The downside is cost, so be prepared for this and budget in advance.

By March, we had filed our 2nd office action response as well as a “Continuation in Part”. It is here that I need to pause. A Continuation in Part or CIP is typically filed to add some new feature and/or better clarify some existing feature(s) previously disclosed – what it boils down to is that you have, for all intents and purposes, open claims on file with the patent office. It makes it very difficult for someone to take your patent – look for features you didn’t claim – and then design around it.

BTW – this is not a secret…big companies everywhere have been doing this for years to protect their intellectual property from other companies that might try to “borrow” their ideas. It’s us little guys – the individual inventors – that don’t know this…but we NEED to!  I have made a commitment and intend to honor it that if / when the PedREST makes it out to the market, I will take the next 6 months off to teach small inventors everywhere the mantra I repeat regularly: “Must Have CIP”.

In fact there were 2 key lessons that I’d like to share with any of you thinking about starting this process:

First…it requires a little extra paperwork (and funds), but if possible, when you file your patent application, file it in a way that DOES NOT allow it to be published until it is granted.

Second…at some point before your patent is finalized, search your specs for features you did not initially claim and any additional design modifications you’d like to make and FILE A CIP.

We didn’t do the first…fortunately for us, we did the second… And it saved us… Trust me when I say there will be more to come on this, but for now hopefully these 2 lessons will save you from some of the heartache my sister and I were soon to experience.

Until next time…

PMD 1997-98 – Let the “Giant Sucking Sound” Begin

It’s a rainy day here in Atlanta and I’m sitting here thinking back on everything that’s happened from the day my sister asked me to help her make her “little idea” a reality. Just about a year had passed since we started our journey and it was becoming painfully obvious that there was no way Suzanne and I were going to be able to bring this product to market on our own… The reality was that we were going to have to file some sort of patent application and neither of us had a clue as to where to begin. We would also need better drawings than the concept sketches Suzanne had created so off I went looking for a patent attorney and some engineers.

The patent attorney was not terribly hard to find…although little did I know that he was to be the first in a LONG LINE of patent attorneys we would eventually work our way through…(sorry…I mean work with). By the way – if I ever meet you and you hear this very faint “sucking sound” over my shoulder…that’s the sound of attorney and patent office fees sucking money out of your bank account …and I hate to tell you this, but once that sound starts it doesn’t EVER go away. On a positive note, you do get better at blocking it out…kind of like what happens when you live a few miles from a train track. But my apologies, I’m off topic…

So we needed a patent attorney (no way was I going to even try and file this on my own) and after speaking with a number of friends we were given several recommendations. I won’t bore you with the whole process we went through, but in case you ever find yourself in a similar situation, here are some of the questions we used in our evaluation:

1. Does your firm handle medical devices?
2. NDA’s: what’s needed and for whom (mechanical engineers? industry experts?)
3. Volume of patents submitted last year and would any of those clients be willing to be references?
4. Costs we can expect (“hourly rate” or by ”# of claims” or by “total project”)?
5. Overview of process : schedule and fees
6. Patent research / searches: what needs to be done before / during filing?
7. Path forward/options:  a) Make/Sell Product; b) Make/Sell Prototype; c) License Patent
   • Probability of success for each
   • Expected costs
   • Timeline
   • Role of attorney in each of these options (if any)

• “There’s a lawyer’s address book sort of – called the Martin Hubbell Directory. All law libraries have them as well as some city libraries. It will tell where a lawyer went to school and background info. A lawyer may be unimpressive in school but ELECTED to a position (i.e. president of the national trial lawyers association) by his/her peers. If the lawyers themselves elect someone that’s impressive”
• “Also check with their insurance company for how long they’ve been insured and how many times they’ve been sued and by whom. The court cases for lawsuits are on public record and you can read them at the court house…if they’ve made lots of stupid mistakes that got their cases thrown out of court, well then look elsewhere.”

In the end we chose an attorney from NYC that passed our due diligence with flying colors. It was from him that we learned some valuable lessons…

First – here’s what a “typical” patent process should look like.

• Begin with patent search for “prior art” to see if a patent is even worth pursuing). The search is based first on appearance of item and then claims and takes approximately a couple of weeks
• Choose materials you ultimately expect to use
• Establish the company / incorporate
• Contract with a patent draftsman You should end up with 2-3 sheets of drawings in approximately 1-2 weeks
• The patent application is drafted and submitted: …After 10 days you should be granted “Pending” status; it will take approximately 18 months – 2 years to Issue
• Create a business plan and begin “selling” to potential investors

Second – given the lack of regulation in the back of an ambulance, our device could likely be considered a “useful article of manufacturing” rather than a medical device…which could potentially save us years and hundreds of thousands of dollars in government approvals.

Finally – the process would cost approximately $6k for the initial filing with the assumption that 2 amendments would have to be filed at a total additional estimate of approximately $1.7k.

15 years, 2 US patents, 2 International patents (…and 2 others pending), a possible lawsuit and somewhere around $200,000 later, I have learned a valuable lesson:

When it comes to patents and lawyers – the word “approximately” has numerous definitions…the word “naïve” however is now perfectly clear.   

Until next time…thanks for listening…

A Public Meeting on Safe Transport for Kids on Ambulances

In the Federal Register, dated July 19, 2010, a notice and invitation was posted by the National Highway Traffic Safety Administration of the Department of Transportation (NHTSA). This Thursday – August 5th – NHTSA will be hosting a Public Meeting to hear comments regarding the newly-submitted draft recommendations for the safe transport of children in emergency ground ambulances.

What wonderful news! It’s about time that positive steps are finally being taken in the effort to establish consistent Federal guidelines for the safe transport of infants and children in emergency vehicles. This is most definitely a banner day for the Emergency Medical Service (EMS).

The issue of inconsistent guidelines for child emergency transport was first highlighted in a 1998 survey of state requirements for child safety restraints in ambulances, and the resulting report was the first to identify the many variations in guidelines existing from one state to another.

In 1999, a national consensus committee was convened to review EMS child transport practices. The resulting document, the “Do’s And Don’ts of Transporting Children in an Ambulance”, provided general guidance for EMS practitioners in the field. This document has remained the guide for the industry from then until now, even though protocols and practices remained inconsistent, often varied across jurisdictions and sometimes provided limited or inadequate guidance.

This problem is finally being publically recognized. The July 19th issue of the Federal Register states: “Currently there are no Federal standards or standard protocols among EMS and child safety professionals in the U.S. for how best to transport children safely in ground ambulances from the scene of a traffic crash or a medical emergency to a hospital or other facility. The absence of consistent national standards and protocols regarding the transportation of children in ground ambulances complicates the work of EMS professionals and may result in the improper and unsafe restraint of highly vulnerable child passengers. As a result, EMS agencies, advocates and academicians have turned to NHTSA for leadership on this issue.”

In September of 2008, in recognition of the need for improving child-oriented, safe, emergency ambulance transport, NHTSA initiated a project called: “Solutions To Safely Transport Children In Emergency Vehicles”, and formed a Working Group of experts in the field of Emergency Medical Services for the purpose of “drafting consistent national recommendations that will be embraced by local, state and national EMS organizations, enabling them to reduce the frequency of inappropriate and potentially unsafe transportation of ill, injured, or not sick/uninjured children in ground ambulances.”

In June of 2009, this website, Pediatric Safety.net was launched. This site made public awareness of the lack of safety guidelines and the use of inappropriately sized, non harness–equipped stretchers for child transport a primary concern. As a means of promoting awareness of the problem, pediatricsafety.net established a cause, ANSR (Ambulances Need Safety Regulations) for kids, which included a petition to be forwarded to each signer’s congressmen. The hope was that if enough people signed the petition, attention would force the government to play an active role in finding a viable solution to the problem.

In its “Innovation” section, pediatricsafety.net followed the development of the PedREST, a child-size safety transport system for infants and young children. From its humble beginnings as a crayon drawing concept idea, to a video prototype and now a physical prototype, the PedREST seemed to be a credible answer to the problem. Designed by an Emergency Medical Technician, it could, with a small amount of additional design modification by a qualified engineer, become this desperately needed safety transport device.

I am the cause advocate for Pediatric Safety. Two of my daughters were key in developing the PedREST. It took 15 years to get the PedREST through the patent process and the building of a prototype. Once created, it was disheartening to realize that companies were not falling all over themselves for the opportunity to take the idea and help commercialize it, so that it could be put to use as quickly as possible. What could be more important than protecting the life of an infant or small child already in the care of the very people committed to doing just that? What was even more upsetting was the fact that, even though so many articles had been written about the need for government intervention to establish industry guidelines, nothing had been publicly introduced over all these years to show that steps were at least being taken to that end.

Statistics say it all:*

1. Approximately 1 in 10 patient ambulance transports involve children. The result: 6 Million Children are transported by emergency medical vehicles each year
2. 3 out of every 100 transports involve children under 5 years of age. The result: approx. 1.8 million children are transported by emergency vehicles each year
3. 5,000 ambulance crashes per year with minor to fatal results. The result: approx. 4 child fatalities per year

I think the time has finally come for action!

• Participate in the public hearing concerning the draft recommendations on safe transport for children on ambulances. Register for the webinar by sending an email to: sandy.sinclair@dot.gov
• Please sign the ANSR petition and tell your congressman/woman that we require that our kids be transported safely on ambulances – anything else is unacceptable!

Help us help NHTSA pass formal regulations and guidelines to be used on local, state, and national levels to keep our kids safe when they need it the most.

With thanks from all my grandchildren, and from me.

Sandy Schnee

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Reference:

•  Dr Nadine Levick, MD/MPH, “Ambulance Transport Safety – Where is the State of the Art?”,  Child Passenger Safety Conference NHTSA Region II, Sept 26th, 2008

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