Hi, Rabbi, Dr. Yosef Freedland, Surgeon and Patent Attorney on Medical Devices here.

So, returning to the renegade surgeon who misused your medical technology and writes an article on a singular experience:

Such a disaster can occur even when hundreds of clinical trials have proved your device to be efficacious, and that the flaw reported by the article is in fact a single occurrence that has no bearing on the overall efficacy of your product; for example where the surgeon explicitly failed to follow instructions clearly printed on the packaging brochure.

Examples of such cases, where single flaws that were later corrected spell the doom of any marketing in the United States are many. One such case occurred with a very viable product from a company we will refer to as Expanding IM Inc.

Expanding IM Inc. developed a unique expanding rod that installs in the intramedullary (IM) canal of a fractured long bone. The Expanding IM Inc. IM rod allows a surgeon to not only align a fracture in the long bone, but prevents torsion between fractured bone portions of the long bone when expanded.

There are a variety of already existing surgical devices on the market that prevent poor alignment between fractured bone portions of long bone.

For example there are rods that insert through the longitudinal axis of the long bone and have transverse lock screws in the upper and lower portions of the rod that prevent torsion between the Bone portions.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon and Patent Attorney signing off with the observation about cold weather, that:

At minus 80 degrees – Polar bears move south, Green Bay Packer (and Buffalo Bills) fans order hot cocoa at the game.

If it is cold where you live, remember the PLUS of freezing temperatures:

At Minus 90 degrees – Lawyers put their hands in their own pockets. ‘

AGAIN — Appelfeld Zer Fisher is an Israel patent attorney firm that provides patent drafting, filing and advice.

So let us continue:

The United States medical device market, possibly because of the tremendous rewards given in tort cases, is highly sensitive to flaws in medical device design.

As a result, a surgeon or physician who wishes to make his reputation may write an article on any single case that defines a flaw in a new medical device design. Such an article can provide reputation enhancement without all the costs associated with a full clinical and/or surgical of a device.

Because of the above noted tort rewards and the abhorrence of surgeons and physicians to be involved in the receiving end of cases of tort awards, such an article can spell a complete disaster for your medical device.

BTW at minus 100 degrees more positive developments occur – Hell freezes over, Clinton finally tells all. Kenneth Starr moves in with Monica. Alaskans button top button. Santa moves operations to Panama.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon and Patent Attorney signing off with the observation that the

Brain is an apparatus with which we think we think. Ambrose Bierce – American author and journalist 1842-1913

Appelfeld Zer Fisher is a patent firm that provides patent drafting, filing and prosecution of patent application. Additionally, Appelfeld Zer Fisher provides a unique service of providing good business advice on how to find investors and/or strategic partners for your unique inventions. As a part of this additional service, which happens to be highly important to all of our clients, I dedicate these next few posts.

Many fledgling medical device firms or inventors are posed with the question as to where it is best to introduce technology. For example, firms or inventors have the option to begin production and advertising in the United States. Alternatively, there are many other countries where such devices can be introduced.

Of course there are many factors that affect these decisions, but I would like to bring to your attention one very important issue in this blog with respect to product introduction.

The United States physicians and surgeons are exceptionally keen on writing articles about medical devices. Such an article may be an analysis of the efficacy of the product, which draws on a survey of several hundred uses of the product including clinical trials of several hundred patients.

Such a survey is of course fair and competent and can do your medical device a great service. This is particularly true if your medical device is a unique solution to a well known problem.

On the other hand it is often the case in the US that a reviewing physician or surgeon will publish an article regarding one surgical or medical experience in which the reviewer found a flaw in your device.  The article may enhance the reputation of the surgeon for finding “flaws” in your invention. But the article will spell the doom or your technology – no matter how “off base” the author is.

In other words, the US market is exceptionally sensitive to “untoward”, even completely unanticipated results that result from misuse of your devise.  It can be highly problematic to introduce an award-winning device in the US, only to have your success destroyed by a “renegade” article by a lone, perhaps incompetent, surgeon who failed to follow the guidelines of the instructions you included with your device.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon and Patent Attorney signing off with the advice that a great way to lose weight is to eat while you are naked and in front of a mirror. Restaurants will almost always throw you out before you can eat too much.

So exactly how bad is this new ruling about obviousness?

Of course, as usual we need a little bit of background that may be “obvious” to those familiar with patent writing, but may not be “obvious” to the inventor reading the AZF blog.

First: Exactly who determines whether something is obvious? Traditionally this was a person who knows everything but has no creativity. However, one of the ways that the Supreme Court has made obviousness stricter is by alluding to the fact that a person who combines invention A with invention B may in fact possess some creativity.
Going back to our example of the orange juice squeezer on the pump: Let’s presume that you made a very unique formula comprising, for example, an epoxy. This epoxy is very efficient in securing a plastic orange juice squeezer to a wooden handle on an air pump. In this case, you might be able to apply and obtain a patent for this unique formula epoxy, but claiming the combination of an air pump and orange juice squeezer with the epoxy, might be deemed obvious, and hence would not be granted a patent. (I say “might” because there may be other “unique” issues involved AND I would not like to be cited in a decision that invalidates your invention of an orange juice squeezer and tire pump.

Second: how bad is it going to be for software patents?

Take a patent you’ve ever heard of which ‘does X over the internet’. Let’s say that X is an program that can unite accounting calculations that take place in multiple offices. So now it turns out that doing X, namely uniting multiple accounting calculations from a variety of locations has been known since the days of the horse and buggy. For example, on a given day the first stable only has two horses to attach to a four-horse buggy. So the first stable owner goes to a second stable to borrow two more horses.

On another day, the second stable only has one horse for a six-horse buggy so the second stable owner goes to the first stable and borrow five horses.
The accountants at both stables like to horse around and they calculate the amount of time and the number of horses that have been exchanged. In fact they compare their books and they combined their list together in a single accounting sheet.

Therefore, it turns out that combining accounting calculations from two separate locations has been around long before the Internet. So you come forward with a tremendously great software package that combines accounting calculations from separate locations by utilizing the Internet.
Based upon the new ruling of the Supreme Court, it may just be obvious that to utilize the Internet to combine accounting; even if you’re accounting package does more than calculate the number of horses exchanged between two stables. You might say that we are not in a very stable position because we don’t know the extent that the Supreme Court will apply this new ruling of obviousness.

For example, we may end up having some problems related to software. Let’s say that combining accounting software modules and physical machines like printers and monitors is not very easy; at least according to the complexity of your wonderful invention.

However, it may just be that the new ruling will be used to decide that the biggest nerd in the world who happens to know how to use a hand-held calculator may just have enough creativity to put together everything that you put together in your new invention.

The extent of the Supreme Court ruling intake in KSR versus Teleflex with respect to software patents will become more and more defined as time goes on and there are more rulings regarding software.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon, and Patent Attorney signing on how “Obviously” bad obviousness can be for invention.

KSR v. Teleflex, one of the Supreme Court patent decisions, has implications which are fairly far-reaching, affecting the “obviousness” of many patents.

A patent is granted to something we will call “a device” that is both novel and is not obvious.

A novel device means that the device has never been seen before in the world, nor described before anywhere in the world, and that it has industrial application. A device that is not obvious means that it does not combine two or more previously existing inventions.

I give an example of a novel device that is obvious and hence will not be granted a patent. Let’s say you take a hand pump to pump the tires on bicycles and or cars. And what you do is you attach an orange juice squeezer to the handle of the pump. Of course, this can be very useful because if in the middle of pumping up a tire, you get thirsty you can take a break and squeeze some orange juice and have a refreshing drink.

This combination of a pump and orange juice squeezer may be very useful in third world countries where pressurized pumps are not readily available. Someone who pumps tires all day, for example looking for air leaks, applying patches, and then pumping the tire to the normal pressure may have tremendous benefit from your combination pump and orange juice squeezer.

Your pump and orange juice squeezer is actually quite novel because you look throughout all the magazines and patents throughout the world and you see that nothing exists that allows a manual tire pumper to receive organic and fresh orange juice throughout the day.

So if a patent could be granted to just on the basis of describing a “novel” invention, your pump and orange juice squeezer would be granted a patent, at least in the US.

The problem is that there is an issue of obviousness, which means that it would be obvious to someone who knows about tire pumps tires and orange juice squeezers to combine a manual air pump with a manual orange juice squeezer. In fact, the way you have combined the two objects is by taping the orange juice squeezer to the handle of the air pump. So there is nothing novel in the way that you have combined these two objects.

Since your orange juice squeezer and air pump represent an obvious combination, unfortunately you will not be granted patent.

In terms of legal implications of KSR versus Teleflex, the Supreme Court decided that when you combine invention A with invention B, to make invention C, the level of obviousness that will now exist is much stricter.

For example, if you have a distance sensor associated with an airplane and you modify it to work with an automobile, even if you make a few specific changes in the way the sensor attaches to the automobile over the way it attaches to the airplane; it may be an obvious invention.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon, and Patent Attorney signing on how “Obviously” bad obviousness can be for invention. Stay Tuned.

No break aways – no embolism.

In other words, your stents gets rid of those streaks in the skies – meteorites that burn up on hitting the atmosphere; at least those that might have been generated by the old type jacketed stent.

Specifically, you found that a polymer fiber having a diameter of between 5 and 10 microns completely eliminates instability in endothelial cells. Eliminate endothelial instability! Hmmm – Great idea.

In fact, this thinner fiber thickness allows all the patients with your jacketed stent to live without ANY Plavix for whatever life time is left after the roto-rooter cleans out the cardiac arteries and the NEW jacketed stent is in place.

Now there are plenty of patents out there that deal with stents that have jackets. Some patents claim that the jackets have a certain fiber diameter.

To be on the safe side, such patents give plenty of leeway as to the diameter of fiber.

So now you go take a look at some of the patents out there. Or maybe even a patent you wrote some time ago.

OOPS!

You find that some patents claim stent jackets made with polymer fibers having a diameter of between 2 and 40 microns in diameter.

Now “between 2 and 40 microns in diameter” includes your new discovery of between 5 and 10 microns. You know, like the math formulas we wrote a few years back (a few?):

2< (5-10) <40

Our middle set of numbers, (5 to 10), is greater than 2, but less than 40.

This creates a problem because your smaller-ranged fiber diameters have already been included in patents claiming broader-ranged fiber diameters.

Important: You gotta “think or thwim” or you won’t have nothin’, no matter how thwell the invention thounds.

And you find out that you still have an IP option — file a Patent of Selection.

Patent of Selection

Hmmmm. Patent of Selection. What’s that?

Glad you asked.

In our case, a Patent of Selection means that you have found that a limited range of numbers are patentable for a very special reason — even though they’re contained within a broader range of numbers in claims of a another patent.

The description of your Patent of Selection revolves around the totally unexpected novel results of no embolism generation by using polymer stent jackets with fibers between 5 and 10 microns in diameter.

Your Patent of Selection acknowledges that there are patents that claim jackets with fibers between 2 and 40 microns in diameter, but you carefully describe your invention, and include experimental data, that only this specific range of 5 to 10 micron fiber sizes results in stable endothelial cells.

After writing your description and including a section devoted to experiments that prove your thesis, you write a claim in your Patent of Selection that might read:

“A method of stenting, comprising implanting a stent assembly in a vessel of a subject, the stent assembly, including a stent jacket, comprising an expansible mesh structure, formed of fibers of a diameter between about 5 microns and about 10 microns, the diameter having a property of forming a substantially stable layer of endothelial cells, covering the fibers, thus reducing platelet aggregation…”

And guess what? You might just have a patentable new stent jacket.

And you can buy an island in the Bahamas and wait for a martini served by a French waiter coming in on a surfboard.

Of course the above-noted claim is not the only claim in your patent. In a future Blog, we may explore ways to expand the claims (and description) to get stronger protection.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon, and Patent Attorney signing off with one last sentence about a new flag invented by a newly-named banana republic, comprising:

A white stripe on a white background.

Everything is still OK at the OK corral, and this is Post number 2 on stents.

Plavix

To avert the problem of embolism in jacketed stents, many people are given a drug for life which reduces platelet aggregation, for example Plavix. Less platelet aggregation means that when the endothelial cells separate from the polymer stent jacket, the platelets don’t tend to aggregate around the endothelial cells. No aggregation, no clumps — no clumps, no embolism.

The endothelial cells that break off generally do not gain the mass that becomes dangerous to your organs. Sort of like streaks of light that are evidence of tiny meteorites burning up in the atmosphere; endothelial cells without the combination of platelets generally “burn off” and do no harm to you.

Without Plavix, those tiny meteorites may clump together somewhere “out there” and form into an earth-killing planetoid or maybe even “The Eggplant that Ate Chicago”.

So the solution is to get a jacketed stent and take Plavix for life?

Not so quickly, Dicky!

Plavix is not a foolproof treatment for preventing an embolism because there may be a high percentage of Plavix receivers who do not develop sufficient reduction in platelet aggregation; and some of these people may end up with an embolism.

Then there are Plavix side-effects which include skin rashes, ulcers, loss of consciousness, and bone marrow disease.

So getting a jacketed stent and taking Plavix for life?

Si, Senior.

So it would be great if YOU

–  yes YOU, the person in the front row; with the plaid pants, polka dot shirt, striped bow tie, and fourteen pens in a shirt pocket plastic pocket protector – 

could invent a jacketed stent that gets rid of the need to take Plavix for life.

If YOU could invent such a stent, physicians would throw out:

i)                   bare metal stents, which have high chances of restenosis; and

ii)                 jacketed stents which cause embolism,

and switch to YOUR new jacketed stent.

If the doctor doesn’t like to throw things like stents out, the old stents can be recycled as Chinese hand cuffs for grasshopper legs so the children of the physicians can be amused by watching the grasshopper hop (or not hop) with their hopping legs encompassed by the stent.

For all those who are animal rights activists, I apologize. However I have not yet heard any opposition to placing heart stents on grasshopper legs; at least not to date. Please correct me if I am wrong.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon, and Patent Attorney signing off just before YOU find out the best invention since Pepsi Cola.

Up Next: Post 3, Almighty willing.

Let’s get down to some specific medical devices, for example cardiac stents, and how to write a patent on an invention in crowded terrain.

Before continuing, I must apologize to Ze’ev Fisher, of Appelfeld Zer Fisher, for writing this Blog in several posts; which is not the way Ze’ev Fisher prefers. However, this is the only way to go, in my humble opinion, in order to provide appropriate background related to the heart.

C’mon Ze’ev, have a heart.

Stent Background

Everybody, besides people in Kazakhstan like Borat Sagdiyev, are aware about stents.

For the sake of Borat, we will examine a bit about stents and specifically Cardiac Stents.

A stent is a mesh in a tubular configuration that is expanded in a hollow passage to open up an area that is blocked, usually by tissue. Cardiac stents are expanded in a heart artery to open up a partially blocked area of the artery.

There are two major types of cardiac stents as of this post: bare metal stents and jacketed stents.

Jacketed stents include a tubular stent frame covered by a jacket. The jacket often comprises a dense mesh of polymer fibers which prevents tissue from growing between the large holes in the stent frame.

Jacketed stents usually prevent restenosis but result in other problems.

These tissue cells, referred to as endothelial cells, can break away from the polymer fibers. Mobilized endothelial cells attract platelets, and form a large clump of dangerous cells, referred to as an embolism.

An embolism is a very nasty creature that can lodge in a blood vessel that feeds an organ with nourishment from blood and cause a portion of organ tissue to die.

Up to 2% of all jacketed stents eventually result in necrosis of vital organs as a result of mobilized endothelial cells that have formed into an embolism.

It is not very good to have dead tissue in an organ, particularly in the brain where the dead tissue causes a stroke. Then again, an embolism isn’t very good when it lodges in the heart, kidneys, or lungs, either. So the best idea is to stay away from things that can cause an embolism.

No Good Options

And this doesn’t leave a stent recipient with many good options: If you opt for a bare metal stent, you can get a re-blockage of the vessel.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon, and Patent Attorney signing off just before we finish explaining how bad the problem is that YOU are going to solve.

Getting back to your invention of the ultrasound probe that finds foreign bodies in people:

Alternatively, you have other suspicions about this fetal ultrasound probe. You suspect that even if the fetal ultrasound probe beams can be focused, the beams are limited to focusing at a maximum distance that is greater than your foreign body ultrasound probe.

Other ways to handle an unknown invention such as the fetal ultrasound probe is to add description and claims about how your invention can be focused to reflect off one object at a very short range and then modified to focus of a second object at a longer-range.

So in summary you write claims starting with the slug and then developing claims to the snail shell. you hope for the best, meaning that the first claim in its broadest form remains unchallenged. However you prepare for the worst meaning that you make plenty of backup claims supported by detailed description. With this hard shell protection, you are provided with multiple back up positions to allow us to protect your wonderful invention using items that are part and parcel your patent application, just like the snail shell that is part and parcel of a snail slug. So that winds it up for snails.

A hip young man goes out and buys the best car available: a 2009 Bugatti Veyron 16.4. It is the best and most expensive car in the world, and it sets him back $1.24M. He takes it out for a spin and, while doing so, stops for a red light. An old man on a moped (both looking about 90 years old) pulls up next to him. The old man looks over the sleek, shiny surface of the car and asks, “What kind of car ya’ got there, sonny?”

The young man replies “A 2009 Bugatti Veyron 16.4. It cost $1.24M.”

“That’s a lot of money” says the old man, shocked. “Why does it cost so much?”

“Because this car can do up to 320 miles an hour!” states the cool dude proudly.
The moped driver asks, “Can I take a look inside?”  “Sure,” replies the owner.

So, the old man pokes his head in the window and looks around. Leaning back on his moped, the old man says, “That’s a pretty nice car, all right!”

Just then, the light changes, so the guy decides to show the old man what his car can do. He floors it, and within 30 seconds the speedometer reads 320 MPH.

Suddenly, he notices a dot in his rear view mirror.  It seems to be getting closer! He slows down to see what it could be and suddenly, whhhoossh! Something whips by him, going much faster!

“What on earth could be going faster than my 16.4?” the young man asks himself.

Then, ahead of him, he sees a dot coming toward him. Whoooooosh! It goes by again, heading the opposite direction! And, it almost looked like the old man on the moped! “Couldn’t be,” thinks the guy. “How could a moped outrun a Bugatti?”

Again, he sees a dot in his rear view mirror!  Whooooosh Ka-BbblaMMM! It plows into the back of his car, demolishing the rear end. The young man jumps out, and good grief, it is the old man!!!  Of course the moped and the old man are hurting for certain. He runs up to the dying old man and says, “You’re hurt bad! Is there anything I can do for you?”

The old man groans and replies “Yes. Unhook my suspenders from your side-view mirror!”

BACK to our patent writing:

It was only after the patent was in its first draft that the client suddenly found an article about a “new” fetal ultrasound probe, perhaps without specific information on how it works. And since the patent for the fetal probe was unpublished, you couldn’t get any information on how the fetal probe works.

Just in case the fetal probe uses an array of transducers that produces and interprets beams having a short reflection, you decided to add claims about detecting hard objects AND, equally important, to add description about how your foreign body ultrasound probe makes this distinction.

It just so happens that your ultrasound probe includes a device that works similar to a durometer which is defined as “an instrument for measuring the degree of hardness; especially, an instrument for testing the relative hardness of steel rails and the like.”

We made sure that the description includes a definition of a durometer and a description of your durometer works in conjunction with out ultrasound probe. You also included figures that show how your ultrasound beams focus can be focused to cross at very close range or a farther range. This provides us with two backup positions by which to protect your invention. Of course the fetal ultrasound probe does not include a durometer. Additionally you suspect that the beams associated with the fetal ultrasound probe either cannot be focused.