what the current state of the law is for software and that relates to medical devices and that people want to know how to protect their medical devices by implementing it with a computer software application that runs the process or runs the device and that's something I think everybody's very interested in. So, what do you do? You have an idea. You start, square one. You want to protect your idea. The first thing you want to do is, anybody you tell or talk to about your idea, you want to have a non-disclosure with them. The worst thing you can do for an idea is disclose it because public use, public disclosure could harm your patent rights. Only certain countries allow what's called a grace period, which enables you to disclose it and still get patent protection. Most countries in the world are called absolute novelty standards, which basically says you disclose it, you lose it. But if you've already filed for an application in one country, you have a time period to protect it elsewhere and you're sort of in that window where you still can get patent protection in other countries. Now, for an NDA, most NDAs are boilerplate. When I say that is anybody you talk to will send you an NDA to sign. A couple of pretfalls or pitfalls in the NDA that you want to be careful about is that there always will be language in there that says, well, if the public knows this already, then we're not going to keep it confidential. Well, what does that mean? So, I think you've got to say when you provide things to a company, if you write on it, it's private, it's proprietary, this is not public knowledge. So, there's a little bit of a gray area there. What's public knowledge? What's not? But every boilerplate NDA will have that language in it, so you've got to be very careful about what the language of the NDA says. What is a patent? It doesn't provide you rights. It provides you a right to exclude people from making your claim device. So, it doesn't allow you to make the device, but it allows you to exclude others. What does that mean? Could you get a patent and infringe somebody else's patent? Yes. So, one of the things you heard Ray talk about was getting an improvement patent. Well, you can get a patent that improves somebody else's invention, but you can't make your device because you infringe their invention. But, conversely, they can't use your improvement. So, when you get in that situation, there are sometimes cross licenses that go to play where the owner of the underlying patent will want to license you, and vice versa, and there can be some agreements or contracts made in that way so you both benefit from it. Because if the improvement is really unique and worth it, the underlying owner of the patent will want to be able to implement that as well. Okay, what types of patents are out there? Well, there's a design patent. Design is just what the device looks like. If it's ornamental, not a useful aspect of what it is, and it's new, you can get a protection for what it looks like. A lot of furniture gets design patents. Plant patents. Types of flowers are patentable, things like that. New variety of a plant. And then, the most popular or most often associated with protecting medical devices or drugs or other things is a utility patent. You can protect the process of making it, the device itself, articles of manufacture, compositions of matter, and business methods, which is sort of where you get into the software link of business methods. And I'll explain that a little bit more later. What are the requirements? Well, there's really three statutory requirements. It has to be new, so if somebody made it 150 years ago, and even though nobody ever built the thing and sold it, you can't get a patent on it. It has to be useful. Everything's useful, so forget that one. Not obvious. This is the gray area out there which you have to overcome to get a patent. When I say something's not obvious, even though there's no other device out there like yours, if somebody has two things that they combine together and it makes your device, and somebody can say, well, anybody skilled in the art would know to put those things together, then that would prevent you from getting a patent. The patent office, the examiner, I've had them string together six references, seven references, and try to argue, well, if you took all of these prior art patents or publications, you put them together, anybody would know you could get your device. I say, well, that's great hindsight, and that's our argument. So, the argument is everything you're putting together looks good now because you see our invention. So, what's the number of references they can string together? There's no technical limit, but I've had a lot, and I've had a few, and I think if they string a number of them together, there's a good likelihood you're going to get a patent, because our arguments usually win on that one. So, you know, you have to evaluate the prior art. Now, when I, what I say that is you come up with your idea. So, you then, what do you do? Well, and I'm going to go a little bit, you have to look what's been done in the past to evaluate if what you've done is new or not obvious. Are all ideas patentable? They can be patentable, but they don't have to be great. As I said, you have a, they, in exchange for you giving your idea to the government basically is what you're doing. You're making it public. Everybody in the world can see it. Every country in the world can see it. There's an exchange. They'll grant you this right, this right to prevent others from making your device, selling it. You could literally, as Ray said, one of the things he's concerned about is licensing it and putting it in a drawer. You could theoretically get a patent, put it in a drawer, and stop the whole world from making it. And I don't know why you'd want to do that, but some people, how long is a patent life? Well, patent life is 20 years from the filing date. And it's an interesting thing. There are actually applications out there. I had one in particular that I filed in 2001, and I'm still trying to get it protected. And it's gone to appeal four times. The patent office laws have changed from the standpoint, and I explained that, with software. And each time we go back, they reject us. But then the law changes, so then the client appeals again. And they have an agreement with their licensee that as long as their application is pending, then they get a license. But the problem is going to be is when we patent issues, we're probably not going to have any term left in the patent, because you get 20 years from the filing date. So it's a really interesting question there. But that was done to prevent what was called submarine patents. And what people did in the past was people would file a patent application, and they would get a patent issued, but then they would follow what's called a continuation on a slight variation of the patent. And they would keep that alive, and they would try to broaden their claims and keep filing continuations. Meanwhile, day one started going longer and longer, and then the patent would issue nine years later. And then they would get 17 years. Well, the patent office said, wait a minute. This is not working. We have to go to a standard where we limit the entire terms of the patents. And the reason they went to 20 years from the filing date was to kill the submarine patents. Basically, for people continuing to file continuations on slight modifications and get their patent lives extended basically forever. And the rest of the world is in step with us on that. And design patents are 15 years. Where they pick that number, I don't know. Plant patents, same as utility patents. Types of patents. Well, you have a process patent, steps to perform a particular procedure, machines, pretty obvious, articles of manufacture, anything that's made, medical devices or articles of manufacture, compositions of matter, chemical compounds, formulations. So now you've come up with your idea. My recommendation is you don't tell anybody. You don't have to run to a patent attorney yet. But you can use all these free online sources and do your own searching. PTO has a very robust website. eSpacenet world patent searches, foreign patents, Google patents, very effective. And then path to PDF, you can get physical copies of the patents for free. So you just put the patent number in, download it, boom, you got it. So search, it's key terms. You got an idea. It's not the greatest search, but you can look at other prior patents and published applications and see whether anybody's working on what you're thinking about. Maybe you'll find it and you'll say, oh, well, that's not really an inventive idea. I don't need to spend any money. I don't need to go to a patent attorney. So you can do lots of free online searching. There's the methodology, subject matter, titles, you know, the patent number. If you know an inventor, you can use that. You can find people's patents. Dates, you can put in the countries of origin of the patents. Those are all in the search methodologies. Now you've done your own searching. You go, boy, I haven't found anything. What do you do? Then you go to a patent attorney. And the reason you go to a patent attorney is the patent attorney has better searchable databases in it. Like we use private databases that are worldwide, include China, everywhere, very detailed. And it's subject matter searching. What I mean by subject matter searching is patents issue what's called an international patent classification scheme. When the patent examiner gets your application, issues your patent, they put in a subject matter scheme for your patent. Beacons that show people where bombs are going to be dropped. Believe it or not, there's a subject matter classification set up in the international classification scheme that I can search every patent that issue that relates to these beacons that protect soldiers. Did something recently on that. And I put in the search subject matter classification and I can search that particular subclass. So I have more capable ways of doing it. And the reason you're doing all this searching is because when you file your application with the patent office, they're going to do the same search. And that's how they do their examination. They're going to do prior art search. They have the same databases. The proprietary database is very extensive. And so it's sort of like you want to know everything ahead of time. You don't want to be surprised after you file your patent application. What do you tell your patent attorney? You tell them everything about your idea. Because it's confidential, attorney-client privileged. You don't have to worry about anything. I've had clients ask me to sign NDAs. I'll sign them. It doesn't really matter. But it's protected because it's attorney-client privileged, licensed attorney. Patent attorneys are attorneys just like any other attorney. Costs. Every patent application is, I don't know if everybody's seen them, I'm sure I'm assuming you have, are different. So what is it going to cost? Ballpark. Patents can run from as little as $2,000 or $3,000 for very super simple devices to $50,000 for computer detailed software. There are 50 embodiments. $100,000. I've seen some of these patents from Apple or they're this thick and it's crazy. It's the hours to write them. The only thing that's standard in patent applications is format. It has to have a background. It has to have a summary of the invention. It has to have a detailed description of the invention. And then the magical claims. Everything rests in the claims. Claims is what your legal protection is. It explains your invention and what's in those claims is the most important. Your description can say anything in the world, but the protections, the claims, that's the most important thing. And we always joke that if the claim runs the length of a page, you don't get much of a patent because it's very narrow because you have to describe every single thing and if somebody doesn't have those components, they don't infringe your patent. Types of patents. What's a provisional application? I'm sure some of you have heard that. It's a holding card. Basically, you file an application. It's called a provisional. It doesn't have to have any claims. It's just a description. It's to prevent a disclosure. Tomorrow you're giving a talk and you go, oh my god, I'm going to tell everybody about my invention. You could run and file a provisional application. It's a holding card for one year. They'll give you a serial number. The patent office never examines it. It will never become a patent unless you convert that provisional by filing a non-provisional, which is a regular patent application within that one year period. The only caveat you want to know about is your foreign filing priority also is running from that original provisional filing date. So if you want to file abroad, you're starting with the provisional filing date to get the priority. Because if you've disclosed it the next day, then you have a disclosure. If you haven't disclosed it, then your provisional application filing date isn't as important as your non-provisional filing date. When I say non-provisional, that has to have claims with it, more detailed, and that's the one the patent office will examine. Now, what some people do, and a lot of universities do, is they file a provisional, and then three months later they file a second provisional, six months later they file a third provisional, and they're still within that one year period. They then take all three, combine them into one non-provisional application because they keep improving it. They're doing more research, more development, and it's an effective way of filing one non-provisional, including you can put as many provisionals you want together. And you're protected along the way with that priority filing date. Foreign, I talked about that within one year. Now, every country has their own patent system. What do you do if you want protection in Europe, in the Far East, in every country? Well, there's a convention called the Patent and Cooperation Treaty, PCT, some of you have heard it. And what that does, that's another holding card application. Within one year of your filing date, you file this international application, it's called the PCT application, that gives you another term of roughly 18 months to decide whether you want to take that international application and enter into the countries or regions for additional protection. The costs of a provisional application run about $4,000, mostly filing fees, and they take your U.S. application, you attach it to a transmittal, the patent attorney does, file it with WIPO, International Patent Authority, and you have this international application sort of running along a timeline. You then say, okay, I've got a very successful device, I want protection in Europe. So you file, based on the PCT, a European application, a Canadian application, an application in Brazil, you know, 80 countries, but you have to pay for entry into each one of those countries, and the costs get expensive. You don't have to file in their home language, because that's one of the benefits, but you do have to file, you have to hire at that point, and the patent attorney has a system, we have a network worldwide, most patent attorneys do, of other attorneys in other countries, that will actually take your application and file entry, and it's sort of a reciprocal system. I do a lot of filing that come from Europe, from China, from all over, and I file in the United States for them, and then they revise our claims to be in conformity with their national or their regional requirements. What they'll do is they'll change the claims, because their rules are different, and I'm not being prejudiced, our rules are the best, and some of their rules are crazy, but you have to go along with them, because it's their system, and I can tell you right now, if you want to get a patent in China, good luck. If you're a U.S. company, they're not real friendly. So I talked about conversion, international patent protection, the PCT, patent cooperation treaty, patent structure, talked about that, this is what a patent looks like, I just threw Rays up there, sort of, it's always the same format, you always want to try to get the broadest claims you can, this is what a claim looks like, just format, where you just basically have a preamble, you could have components, you could have multiple components, so you try to get the broadest coverage, and the way it works with patent offices, you write a broad claim, they reject it, 90% of all applications are rejected on a first action, so don't be, oh my God, my patent's rejected, happens to almost every application filed, that's the game, the dance, I call it. We then respond, we rewrite the claims a little bit narrower, we call the examiner, have an interview, and I'm gonna wrap up soon. So, let's keep going, do I need a patent application before I license the idea? I would say at least a provisional, because you want to be protected, you want to basically have some right, so what's confidential, what's not, I talked about that, let's keep going, Ray did licensing, content, okay. The only other thing I wanted to quickly talk about, and I'll do it quickly, is software. So, everybody, you know, years ago, there was a Supreme Court case called State Street Bank, and State Street Bank said, you could protect patent software, and everybody said, oh my God, software, business methods, we can protect it, and every company filed thousands of patents, all the software companies, and they got the patents issued. And then the court said, that's not what we meant, and cases came down and basically invalidated probably 98% of those patents. They're still sitting on the record because they haven't been challenged, and really, the new system has sort of been evolving. Cases have been going to the Federal Circuit and the Supreme Court, changing the system, and I want to just give you one example, and then I'll be done quickly. So, you have a rideshare application like Uber or Lyft, and they filed the patent application, the patent application said, we want to share these rideshares between six people. And the computer program is going to tell the driver where all these six people are, and give them the route the person takes that's the shortest route to get to the same destination. And they had steps, you know, find the number of people, create the route to the shortest people, who do you pick up first, who do you pick up last, and they're all going to the same location. And the computer's going to do this, and it was pretty clever, and the software was pretty clever in figuring it out, and the driver then could pick up seven people to share the same ride to get to the same location. And they filed the patent application, the patent office said, sorry, not patentable. And they said, well, wait a minute, nobody's ever done this before. And they said, yeah, but you can do it by pen and paper, and because you can do it by pen and paper, not patentable, and it's not patentable. And the problem was is that, what is the machine doing that's different than you can do on pen and paper? If there's nothing that it's doing that's different, you're not getting a patent. That's the current state of the law. So if it can be done by pen and paper, then it's just an abstract idea, they said, and it's not patentable. And as the law stands right now, that's what it is. And I just wanted to sort of give you an example. So if you have a medical device, or if you have a medical machinery, or a robot that does that, and you say, well, I've developed software to tell it to, because it's better to move to point A than to point B. And then to do the next step, and the next step, and the next step, you're not going to get a patent on it. Because it's not really doing something more, and you need something more than just telling it the steps. So, well, thank you, and I'll be open for questions later, and I apologize for running over.

software law

medical devices

patents

prior art search

patent cost

software patenting