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PMD: 2004 – Repeat After Me…Must Have CIP

The PedREST storyBy 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 April 2004, we had filed our 2nd office action response as well as a “Provisional Application” – later to become our first “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 1999–2003: Learning to Walk

The PedREST storyAs I mentioned in my last PedREST post …by 1999 we had the first set of engineered “concept drawings” of our Pediatric Emergency Transport System – a.k.a. PETS. Our company was in what could probably best be described as a “toddler phase” – we were learning to walk before we could run – and walking meant refining our drawings and “officially” beginning the patent process.

I won’t bore you with all the details of the process we went through to create our patent (although for any of you starting this process, I’m happy to answer questions). Suffice it to say that we did a “prior art” search to make sure we wouldn’t overlap anyone else’s concepts and then worked with our attorneys to draft a patent that described in detail why the EMS community needed the PETS to save kids’ lives. There were multiple changes – both to the document and to the attorneys we were working with – but in the end, by September of 2002, Pediatric Medical had filed for its first U.S. patent. 🙂

By the end of the year things had started to pick up speed. A talented graphic artist / friend of mine by the name of Pete McKay created some logo options for us:

PETS logo 1PETS logo 3PETS logo 2

I met with a close family friend who was interested in helping us launch the product. With her on our side there was no way this couldn’t succeed. In business, she was a force to be reckoned with… to me, she was a mentor and a friend. …AND she wanted to help!

I emailed her our logo options and she responded – she HATED the name. Unbelievably frustrating (we loved it)…but unfortunately she had a point. People would either pronounce our name as “pets” or “peets” and neither really worked to our advantage or conveyed anything at all to do with child health or safety. I honestly couldn’t believe I had missed that, but really it’s very easy to get tunnel vision when you focus so intensely on something like this. Sometimes you need an objective opinion to see the forest through the trees.

So, point taken – lesson learned – and off we went to find a new name. By January of 2003 we had it: PedREST, a Pediatric Rapid Emergency Transport System AND a place for Peds patients to REST). It said it all and we were off and running…

Until next time…

PMD 1998-1999: Pinocchio becomes a “Real Boy”

I mentioned in my last post that fairly early on we realized we would need better drawings than Suzanne’s concept sketches – we needed to find The PedREST storysomeone who could take her ideas and turn them into something that could be built. In my mind this meant engineering drawings…trouble was, I didn’t know any engineers. So…where to start???

It is here that I’m proud to say I made one of the best decisions I’ve made in the 15+ years since this whole thing started. I say this because I’ve also made a lot of dumb ones…and I’ll share those with you too…but for now I’m going to share what turned out to be a terrific path for us to follow.

It’s July of 1998 and we need engineers…I’m thinking we should probably be looking for someone with a bio-engineering background (given the nature of our device)…oh, and did I mention we have very limited (think non-existent) funds? So I’m racking my brains (and questioning everyone I know) and it occurs to me that we have a great engineering school right here in Atlanta: Georgia Tech. I checked online and found the contact information for their engineering program and sent them a note:

Dear Sir or Madam:

I am a young entrepreneur who is working with a friend /colleague on a medical device that we believe will significantly impact the emergency medical care environment. As such, I am writing to request your assistance.

Having begun our patent process, we would like to secure engineering drawings of our concept and materials recommendations. As we are just starting out and operating on a “shoestring” budget, we were interested in obtaining the services of a talented graduate student. We are of course prepared to compensate him /her for time spent preparing the drafts, evaluating materials, etc. We were hoping this might be a project that could be of some interest to one of your students, and would gratefully appreciate if you could recommend one of your “best and brightest;” someone who might be willing to accept modest fees in exchange for “interesting resume material” (after the patent is secure).

Thank you in advance for any advice and/or assistance you can lend in this endeavor. Please feel free to contact me via e-mail or phone at your convenience.

Not long after I was contacted by Dr. Wepfer from the Woodruff School of Mechanical Engineering with suggestions of professors to contact who might have students with similar interests. After speaking with several of them I had received enough student recommendations to begin interviewing and not long after that we hired two of them.

I know that to some of you this may not have been the most exciting part of Pediatric Medical’s story…but for anyone undergoing the “invention” process, finding folks to work with that are both skilled and affordable can end a project before it even begins. Working with smart, creative grad students can be a win for both of you – not only can you access the talent you need to bring your ideas to life but in turn you can provide them with the one thing students usually lack when they enter the workforce…“real world experience”.

By the summer of 1999 we had our first set of drawings completed, PMD had incorporated and we had a new set of attorneys ready to help us get our patent out. Our chief engineer soon graduated and went on to work at JPL – a NASA research and design centers specializing in the construction and operation of robotic planetary spacecraft (thank you Wikipedia). We continued to work with him for a number of years, continuously innovating and improving on our original concepts. Looking back though, it was the events of that summer and the help of our “rocket scientist”…that finally brought Pediatric Medical to life.

Until next time…thanks for listening…

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 The PedREST storyasked 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)

I was also given some great “tips” from a friend whose brother was a trial attorney.
  • “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…

In the beginning, the PMD story: “Dying to Save the Lives of Kids”

I think it’s time…

PMD or Pediatric Medical Devices has been 15 years in the making. …or rather 15 years of my life. I kept thinking well when everything is done…when the PedREST finally comes out to the market…when we actually save a child’s life…then I’ll tell my story. But that hasn’t happened…at least not yet… and there’s no guarantee of when it will… so I think it’s time to tell this story to the best of my ability and hope someone gets to hear it…

The PedREST storyI probably should tell anyone who decides to stop by and read this that this is not “light reading” for a slow weekend. As I said at the start, it’s been 15 years. What I didn’t say was that during those 15 years, I’ve had someone close to me try and take controlling interest of the company, licensing negotiations fall through at the eleventh hour and trusted industry professionals “borrow” our ideas.

Truth be told it hasn’t been all bad. Because of this journey I’ve met some wonderful, truly selfless people without whom I would have lost faith a long time ago. And I founded this community – something I am very proud of…

But I’m getting ahead of myself. To really tell this right I need to go back to when it all began – September of 1995 when an EMT – my little sister – invented something she believed would save the lives of kids. I’m not going to retell her story since it’s already been told here. What I will say is that it started with a simple concept drawing on construction paper. Then in July of 1996 she came and asked me for my help…could I make her dream a reality? Of course I could…or so I thought.

People will always tell you things like …never give up… believe in your dreams and they’ll become a reality, …even “build it and they will come”. You know the sayings…and I listened to all of them. Bringing a new product to market is never easy…it’s also not inexpensive (as I soon discovered). It doesn’t care that the US has gone to war, or that we’re in a recession, or even that the job that pays the bills has come to a standstill. You just have to keep going and make tradeoffs…what will you give up this month so you can pay the attorneys, the engineers, the prototype guy? But you can only give so much before it crushes you and at one point it almost crushed me.

I am stronger now and rebuilding my life. And I think that’s why it feels like the right time to share this. … maybe someone can benefit from my mistakes …maybe someone who’s going through something like I did can take courage in knowing it is possible to come out the other side. For whatever it’s worth…my story begins here… until next week…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.

The PedRESTIn 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.Pediatric Rapid Emergency Safe Transport (PedREST)

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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