BoneChat call #10 - Greg Grissett - IP Strategy for Med Devices

So we are live with Greg Grissett. He's a patent attorney and he is going to demystify the world of IP strategy. He's going to give a very broad overview of everything you want to know about IP. But we can dive deep. We can dive deep. We can stop at any time and dive deep. So raise your hand if you have a question or drop a question in the chat, and I'm going to hand the mic over to Greg.

Okay, thank you, Tiger, for giving me the opportunity to speak about IP and IP strategy and medical devices. And thanks everybody for showing up. Showing up is It's a big part of life. Well, let's get right into it. 4 parts we're going to go through. One, IP overview. What are the basic forms of intellectual property protection and how those can be used on a new product? Some timing about filing for patent protection, just some, some pointers, some legal guideposts, but also just some practical considerations. Parts 3 and 4 are about how do you protect the revenue model with your patent strategy, and then avoiding patent risk. And these— the last two questions, they come up time and time and again, either from investors that are asking me to evaluate portfolios, or from executives that just want to make sure they're being diligent in, in protecting their, their IP. So we'll get started. Okay, there's really 4 types of intellectual property: trademarks, copyrights, trade secrets, patents. What you see is just a, a, a very brief overview of what it protects and how long the protection is. Trademarks, they are source identifiers. It's your brand. It could be a product name, it could be the name of the company, but its, its purpose is to identify a source. When we See, Apple, we know what we're getting. So it doesn't protect the underlying product, just a source identification. One of the things you may have seen, I'm sure you have, is the T and an M versus the R in the circle. A T and the M indicates a common law trademark, right? And that arises just by using it in commerce. You develop a product, you attach the logo or your brand to your literature, and you're using in commerce. And that, that's all you need to do to get a common law trademark, right? You can go one step further and file for a trademark registration, and that's what results in the R in a circle. So common law, TNM, or TNM superscript, registered is, is the R in a circle. We're not going to get into the details of, of the registration process other than, than what I've just shared, uh, but know that it's, it's a part of of intellectual property. Copyrights, I think, are going to become more important, um, as software makes its way into medical devices and, and our daily lives. Uh, but copyrights classically protect creative works, you know, uh, and expression. So, you know, songs, literature, art, your web page. But importantly, some aspects of software can be the subject copyright protection. So just keep that in the back of your mind. One other thing to know just about copyrights is they arise at the moment of creation. And I like to give this example: if I just draw a picture on my wall or write code on my wall, as soon as I put it on the wall, I become the author of the copyright and the owner of it. And if you take a screenshot of your, your monitor right now and try to use it, that's copyright infringement. That's basically all that needs to happen. So copyright infringement is about copying, really. But know that it's there. You can see the term. It is subject to change based on what Congress decides to do. Trade secrets, an important asset to consider. It basically protects information that isn't widely known and that's value derives from it not being widely known. Plus things that, that you've taken reasonable steps to maintain its secrecy. Tiger and I were talking about an example yesterday. I think he worked with a company that developed a type of composition and, and a process, and in, in, in his example he shared, there were 4 people who had access to the room where it's made and who knew all the details of it. That's a reasonable step to maintain its secrecy., and as long as it's not widely known, that protection lasts forever. Okay, so it's a pretty powerful right. There's a federal cause of action that was recently enacted a couple years ago that I think bolsters that. And then patents, where we're going to spend most of our time today, is protecting products, processes, devices, functions, uh, really the, the, the technology that's underlying what you're developing and introducing to the market. And you can see the, the patent term there. And so with that overview, we're just going to go into a sample product, and I'm going to summarize some of this. But basically, we have a health monitor, it has a sensor, it, it has a fancy communication system. Marketing calls it new device. It's got an ergonomic shape. Sleek design. You had to develop a new coding scheme, and that coding scheme was used to create software. Uh, there's some open source involved in there, and it also used this physiological data that was compiled by this company over many years. All right, so if we just look at how those four rights are applied to this, you can see your trademarks are going to be to your name. NuCo could be a trademark. New device could be a trademark. And again, remember, all you have to do is use it in commerce to get common law rights, and then you can take one extra step to get the R in the circle. Let's see, copyrights. The shape could be the subject of a copyright. The coding scheme, as I've discussed, and software. Open source I put here. It has copyright implications, but know that open source has It has limits on, on how you can use it and, and distribute it. And it's just being mindful of that going into using open source, of, of how you can distribute it moving forward. So patents, patents are all over this thing. The, the health monitor itself, or just the sensor, or, you know, the, the method of increasing data transfer rates, the ergonomic shape could be a design patent. We won't talk a lot about design patents, but know that's there. And available, the coding scheme and software. And then finally, if we look at trade secrets, that could be your software, it could be the physiological data. So with this, you can see how these different rights do interplay and overlap quite a bit. And so as you're developing an IP strategy, you really should be thinking about each, each, all 4 of these different rights and how they may overlap. You may choose trade secrets over patents. For, for different reasons that we'll, we'll touch on, you know, perhaps a little bit later in, in the talk. But that's just an example of how when I'm looking at a new product or a new business, where, where my mind is going as counsel to guide companies through developing an IP strategy and knowing that there's overlap and some interrelation here. Okay, we're gonna Pivot to patents mainly for the rest, um, of the presentation. And I, I want to just start out with some basics, meaning patents are, are really an exclusionary right. It, it, it's not a right that gives you permission to do something. What it does is give you a right to prevent others from doing very commercially relevant activities like making selling, offering for sale. So when you get this patent and it's granted, it gives you this ability to prevent others from doing a certain thing. It, it doesn't give you the right to do something without risk. And we'll touch on that more when we go into freedom to operate a little bit later. I, I, I put this slide, I, I love it mainly because patent claims are, are where it's at. It's why you hire a patent attorney. It's why you hire a patent searcher. Like Andrea to help evaluate patentability. It's the most important thing in the document, and it's the numbered sentences. And for, for those that haven't looked in detail at patents, this is an example of a patent claim. This is where we spend most of our time evaluating, getting claims, looking at other people's claims to see how we can get around them. It's the most important thing that, that there is. Okay, it defines the scope of the rights. This is like a deed, so to speak, of your property. The claim is very much like that. And valid claims— this seems basic, but it's worth mentioning— are novel and non-obvious over the prior art. Okay, we'll talk a little bit about what prior art is shortly. So two things that come to mind with patents is Developing a patent portfolio. And what this slide shows is just what is the difference between patentability and freedom to operate. Know that they are distinct, separate concepts. They may have underlying technological similarities because your patent application is going to describe, hopefully, what you're selling. But know when, when we're assessing patentability, we're looking at prior art, which is public— more or less publications patents available before a certain filing date or prior sales. That's generally what, what prior art is. Freedom to operate is all about your commercial product. It's what you're going to put in the box that you're going to sell, that you want that thing to avoid a third party's claims. All right, so we'll, we'll dig into that more, but know that patentability, freedom to operate, really separate, separate things not to be mixed. Okay, now moving on, just, just thinking about patents and, and how you might use them. You know, patents are— it's rare that a single patent is, is enough to build this impenetrable wall around your product or innovation. You know, really what you're doing is, is building fences, and it's a picket fence. And the more streamlined or more specific— I shouldn't say specific, but the more diligent you can be in developing your portfolio, the slats in between, the, the gap in between the slats can get more narrow and narrow, but never completely shut, is one way to look at it. Um, and that kind of leads to a question: well, what do you do? How do you focus on, on what to, to protect and, and what to look at. And I like to think of it in terms of, of must-haves. What are those things that, um, are, are really the technical linchpin that enables commercial success? You know, what is it that the market's wanting? What is this technical feature that, that is going to be— that everybody that wants to sell a similar product is going to have to do? Um, it may not be the entire product, it may just be one particular feature. I think Tiger gave an example of a particular joint in a type of implant. That was, you know, the, the one thing that, that helped them secure patent for meaningful patent protection. So just some, some more or less general guidelines there. Moving on, timing. This is a question that comes up quite a bit in, in my practice, is, is when do you start filing? When do you wait? When do you when should you call Patent Counsel? A couple of maybe basic guideposts is, is, and I think this is a good idea, I think you should do a patent search and, and contact Andrea and evaluate the patentability of your concept and then, and then file. Patentability searches do a lot. They streamline the application, they streamline the the drafting process. They streamline the patent prosecution process. It's the best approximation of what the Patent Office is going to do that you can do ahead of time to evaluate, you know, the invention.

And so, Greg, would you do this when you have a kind of working prototype or wait until you have a commercializable product?

Right, somewhere— well, I think by the time you have a working prototype, I think you're ready. You know, if you've got a couple of components and you've got reasonable solid models and, you know, you know where it's going to be in the body and you have some sense of what technical feature that you're applying to that particular thing, I think you're ready to do a patent search. You may not be ready yet to draft a patent application. I think you can do a patent search a little earlier on. But, you know, it's somewhere on the earlier side, certainly. After you've drawn it on a napkin, but before or at have a prototype or reasonably good drawings, or you've thought through some of the structure that you're contemplating developing. Certainly, these are just basic guideposts: before public disclosure, before public use, before a trade show, before an offer for sale. That's not such an issue in the medical device industry if you need regulatory approval to market the device, but it's still, you know, something to, you know, something to keep in mind. And then the, the last piece I had, just before you share with any third party— and then I'll talk about who is a third party in just a second— but this is important for foreign patent rights. Now, I don't have a lot of on foreign patent rights, and we can talk about them. But when you disclose your invention to a third party in the absence of a non-disclosure agreement, you can foreclose some of the rights that you might be afforded otherwise in, say, Europe, Canada, China, Australia, if foreign patent protection makes sense, you know, at a given time. So who's a third party? It's that's, you know, the company, the entity, the employees, directors, maybe independent contractors depending on their nature, but they're not your advisors that are none of those. Okay, so even your advisors, they certainly should have a non-disclosure agreement or at least have some protection on file before you start sharing it. I see a lot of pitch decks with drawings or concepts that are included, and that's fine. What I've recommended and do recommend is you talk with patent counsel before you share that in a pitch deck to make sure it's protected, just so you preserve your foreign patent rights if you want to pursue them at a later time.

And you can, you can do that by just throwing it into provisional real quick, right?

Right. So provisional filing is a great way if you've got a meeting set up with with, you know, a high potential investor or a strategic, and you want to get— be able to talk about this innovation, then put a provisional together and get it on file. And then you've got some time after you file a provisional to update it after you refine the invention a bit more. So good practice, it's easy to do. I don't know, I wouldn't recommend necessarily just putting a slide deck as a provisional as a matter of course, but it can be done so that you can have that meeting and talk freely and, and feel— have some sense of protection as you're discussing it with people. All right, we, we talked a little bit about, about this already, but, um, when do you file? As you have a concept and some reasonable idea of its principle of operation, Certainly before any significant regulatory filing, whether that's an IDE, 510, you know, PMA, you do another review right before you hit send on these documents and make sure that you have some protection for what you're submitting to the FDA. Sometimes that can get lost in translation as you're developing portfolio on one side and working on your FDA, you know, documents on the other. Just do another check., you know, a couple of weeks before you're ready to hit send to the FDA and, and just make sure you've got everything, you know, buttoned up. And then, uh, this is, this is a harder one really, but when your development outpaces your original concept. So early on in, in BoneChat history, we, uh, Tiger Buford mentioned iterating over and over again. And to be honest, I kind of winced because I was nervous about what was lost between Iteration 1 and iteration 50, okay? You want to protect your final design. That's sort of the standard, okay? But there may be, say, iteration 35 or 36 or 37 might be something that your competitors could adopt. And you might want to have some defensive protection there. So it— the point really is just stay in contact with your patent counsel. For my clients, we usually meet quarterly at least, just to know, you know, what they're doing. And I'm sure I'm not seeing every, you know, every single, you know, design variation, but I am catching the ones that get them excited for sure. Okay, so that's another good—

yeah, go ahead.

Yeah, so Greg, so if you're iterating a design, let's just say you go through 50 iterations, and you, you're, you're trying things out and you're throwing them away. Can, can you patent things you don't put into the actual product and try to protect those?

Yes. Yes, you can. There, there's not a requirement for a, a working commercial product or a working prototype when you're filing patent protection. You, you do have to comply with a few things. You have to describe the invention and you have to enable it so someone of skill in the art can make and use it. Without undue experimentation. Um, you know, for an implant, for, you know, like a bone plate, for example, once you have your drawings and your CAD drawings, I mean, you're pretty much ready there from a patenting, you know, perspective. Um, when there's, you know, devices that have different moving parts and interactions of different things, those can change over time depending on what, what other kind of features that you want. And I'll just be mindful of of where you, where you want to go. And the, the idea isn't— I'm not advocating that you file a provisional that has 50 designs. You can. I don't think you need to. It's just a matter of having this discussion with patent counsel on an ongoing basis to make sure he or she knows what you're excited about and what your team is excited about. You know, usually I get the call when they've you know, put something in a pig or somewhere else, and they're like, wow, we need you down here, Greg. So usually you kind of know if you're excited about technology and excited about your product, you know when something is doing well, and certainly you need to pick up the phone and consider protecting it. So mainly it's communication and just keeping an open dialogue with your patent team. So if you're, if you're working on designs, you know, let's say you're actively iterating, um, does it make sense, you know, and at the same time, you know, you're talking with investors, um, through like, uh, the provisional route, is you said there's time to, you know, to update those or Yep. Does it make sense to file a provisional on, on kind of the first iteration, and then, and then is there a path to, you know, revise that through the year? Yeah, that's a great, that's a great question. Usually what I've seen is, is we may file on, you know, the first, you know, 3 or 4 concepts that come up with kind of early on. Yeah. And once you file the provisional, you have 1 year to do 2 things. Convert it to a regular utility application and preserve foreign patent rights. But in that intervening period, you're still plugging away and doing iterations, or you're scheduling meetings with investors. And what, what I've found is, is we may, we may file on concepts 1, 2, and 3, a provisional, and then, you know, 4 months later file on concepts 15, 16, 17. Okay. And in doing that, sometimes you will pick up some of the subject matter that made it through those iterations between, say, 4 and 14, you know, in my example. But, you know, usually I think, one, if you keep that in the back of your mind, there's things that make your team excited and that really gets you up earlier in the the next day. Yeah, is, is where you want to, you know, put, put some investment in, in that. And in this provisional phase, you can update it, as I said. So you may have one provisional for these first 3 concepts, a second provisional for another 3 or 4. You're quiet for 6 months, and then at close to that 1-year period, now we're, we're turning it into a regular patent application. We're thinking about what is the manufacturability, what really would be the commercial product if you can predict it at that point in time. It's a question I ask, you know, sometimes I get eye rolls when, when I do that, but it's, it's still worth asking and thinking about so that you can build that into the application and get some flexibility later on. Yeah, thank you for that.

Sure, great question. And a provisional is fairly cheap, and you can— you always have the option just to let it lapse if you don't want to invest more, right? Right.

It typically is— certainly the filing fees are, are really low. It's, I think, $260 now for a large— what they call a large entity. And it is, it is a cost-effective way to, to build an asset without having to necessarily comply with the entirety of the Patent Act in, in terms of building it for a regular patent application, you know. So we may not— you may not include 5,000 reference numbers in the provisional, or we may not— there's a couple of ways that you can, you can go about it. What I typically do and do recommend though in your provisional is We draft a set of claims, we get a good set of drawings, and, and put together a pretty brief description based on that. And why I like the claims is because the claims are the most important thing that we do. It's why you hire the patent attorney. But that claim language, once you have that written support in that provisional, that's going to give you the ability to kind of pick and choose and, and to draft claims at a later time. That, that may be important. Either you have to define over the prior art later or you want to go after a competitor. So there is a— there is provisionals are cost effective, but I'd recommend at least having some claims drafted and filed that will set you up later.

And are provisionals— when you do a patentability search or freedom to operate search, are provisionals searchable or are they not searchable because they haven't become a patent yet?

Right, they're, they're not. So they're held confidential with the Patent Office. So you can file a provisional, wait a year, let the date go by, and nobody will ever see the light of day of that provisional. What changes though, when you do file a provisional and that one year comes by and you file your, your utility application, about 4 months after filing, that will become publicly available and, and everybody will see it and have access to it. More or less. There are some ways to stop publication until it grants, but there's some drawbacks to that too. Good, good stuff. Okay, excuse me, we're going to switch to talking about how to, how, how to make sure your patents protect the revenue model. Um, And this, as I said, this is a question I get from investors who've hired us to evaluate portfolios. They want to know, is the technology protected? Is my revenue model protected? And as I mentioned earlier, what's the risk? What's the freedom to operate? So ensuring your patent protects the revenue model isn't necessarily a patentability question. You know, I'm kind of sidestepping that and just thinking practically about, okay, assuming patentability, what can we do to make sure that we're bolstering the IP? Two things you want to do generally is one, claim what is in the box and different parts of the value chain. We're going to go into that in some depth and then use continuations in a later stage in the patent process that we'll talk about. Continuations are fantastic. Tools. So covering what is in the box, and what I mean here is what you put in a package that goes in a box that you are getting, you are invoicing your customer for against a PO. That thing that goes from one dock, shipping dock, to another shipping dock. If your claim doesn't cover what's in the box, you're not covering what you're generating revenue for. Seems like a very simple statement, and it is, but it does take some intention to make sure that you're doing that. There's another issue that comes up when we think about drafting patent claims. We would like to have what we call direct infringers, meaning I want to— I want a patent claim that covers— this may not be the best example, but an iPhone. Um, I don't really want a patent claim that covers an iPhone plus me using it, because that way Apple then has— or we have to sue Apple plus me as a person. And trying to sue two people for patent infringement is harder than suing one. That's a paraphrase, basically. So claiming what's in the box helps you isolate who your direct infringer is. You know, your competitors are going to of course, try to match your technology and copy what you're doing, but they're gonna have to ship products in some way, and you wanna make sure to capture what they're gonna ship in their box to some extent. So what do I mean by this? If you're just an implant, but you're specifying sutures, you're not actually selling them and it's not in the box, then, you know, claim the implant only if you can. Um, what about implant plus sutures? You're bringing these into your distribution center, putting them in the box with your implant, and shipping all that, and invoicing all that, and receiving revenue for all that. Then claiming your implant plus the sutures is a way to protect your revenue model in a meaningful way. Claim implant and sutures. What about a robotic system? Well, you, you want to cover the robotic system and certainly aspects of it. Another example, and I don't know how prevalent this is, it's just a way to think about it. What if you lease the robotic system and charge a fee for using it? It's basically a license to use it, but the hospital doesn't own it actually. Well, a claim to a robotic system isn't really directly related to your revenue source. Because you're not— you're just selling the use of it. So in that case, a more relevant patent claim may be a method of using, of how this robotic system is being used and how a surgeon is engaging with it. Why do all this?

It—

but I don't know, I'm kind of belaboring the point here, but it's, it's about tying your patent claim to your revenue source. —your source. Your, yeah, your revenue.

And why is that important? I mean, why couldn't you have, you know, patents not related to your products that you're selling? Yeah, you can.

And I think the— if I'm looking at it from an investment perspective and just a maybe practical, you know, using a patent as a tool, remember the patent prevents others from doing these commercial things, making, selling, using, and importing that which is claimed. Okay, now if we fast forward a bit and go into— we're in patent litigation and we've established infringement and our patent's valid, we get to this damages phase. And there's a lot of effort that goes into mapping what, uh, products are actually covered by your patent claims. As a way to determine some of the damages base. All right.

So if you have— I see, that's, it's a measure. It's the measurable piece that you need.

Yeah, yeah, right, right. It's, it's a clean way to tie it to your actual market value or the value of the product in, in a sense. Okay, that's sort of practically what may happen in, in patent litigation. Now, taking a step back, before we're, we're not in, we're, we're just developing, we're investing in a company. And investors, they don't invest in a company just to have that company own patents, and they don't invest in the company just for the sake of them, of having patents. It's protection that people are after, and investors, in my view, are really investing in a revenue model at, at a later time, maybe, or this return. And this is, in, in my view, in my experience, the best way to tie your patent strategy back to that revenue model is the scrupulous application of what you're selling in the patent strategy and in the claim. Itself.

So, so you talked about what's in the box, but there's a lot of new, uh, products and services that are software, right? And the software's got algorithms and, you know, it's the, the software changes constantly. So how do you— I mean, I, I don't even know how to ask the question on how do you patent something that's changing all the time. Like software?

Well, I, it's that, that is, that is the most difficult thing that we do as, as patent professionals. You know, on one hand, we need to anticipate what we think people will do, and this is true for, uh, you know, hardware, you know, products in, in general. You know, what is it that— where is— where can we imagine the market is going? If we were to successfully introduce this product and build the market that we hope, that we hope that we do. You know, some of that is, is good, good patent lawyering, just anticipating in, in a software sense what, what will happen. A good example may be if, if you develop software that's running on a backend server that is pushing, you know, an application to a device in some, you know, in some way. The flow of data in those directions are important. You know, maybe in 15, 20 years there'll be no data centers in the US. Now that implicates how you may draft a claim because we can't necessarily capture foreign activities through a patent claim. All right. So some of it's anticipating that, but also just having these discussions with the innovators and saying, all right, you've been focused on this is my algorithm that I want to do, but, but we really need to talk about, well, if you came at this with a blank slate knowing what goal you wanted to, what, what would you do? And having that, that discussion, um, that's, I, I think, the best that you could do, you know, as your development changes. I— and this goes back to the timing of filing, you know, we have application 1 and then 18 months go by and now your product is, is pretty far afield from where you originally started. So what do you do? Well, I still think you have to file that which you're going to commercialize, but there, there, the decision to file is based on how much of a difference there is between what you're doing now versus what, what you're doing then, and then going through that that process again. And this can be done with provisionals too. I'm not suggesting that you deviate from that particular strategy. I don't know if that answered exactly what you asked, but yeah, it's just, um, it's a hard area.

Software iterates faster than hardware, and so it's, it's more challenging, right?

And software has its own challenges in, in the patent space. Um, it— the, the patent system right now is not friendly to to software developers, you know, for a number of reasons. What practically results from just changes in case law and policy is that software applications, software patents are going to be pretty specific to exactly what you're doing, you know, the algorithm that you're doing. Otherwise, you run the risk of it being deemed invalid. It's like a pendulum, like many other things, you know, 15 years ago you could get software that was broad that may you know, covered a certain activity. But now the Patent Office is requiring, you know, quite a bit of specificity, I think, in software. But it's a challenge. But remember that you also have copyright protection available for software too, as a supplement that could help. Um, okay, we're going to talk a little bit about, about the value chain, and this is just a basic you know, we have components, you have assembly, you've got a product, and it goes into a surgical use. At a minimum, in, in the— for the medco is, is getting a patent to the product, as indicated in, in the red box. This is sort of the bare minimum that you would need to do, I think, an understanding that you want to patent what's in the box. You know, as we've maybe seen in, in recent years, Um, you know, you may be developing these other things that make it attractive for a hospital system to purchase your product. Ancillary services is what I call it here. But what if you extended your patent protection to these ancillary services, to the product, and then to the surgical use too? We, we do benefit from being able to claim surgical methods in the United States, and I would take I would take advantage of that. So this is a bit, a bit more robust of, of a strategy. It— if your ancillary service is something like an inventory control system or some other software piece that, that goes along with your product and it helps you close that sale, then it makes sense to, to file patent protection on that because it's helped you build that revenue. Based on your product and these ancillary services. What this does also, you know, by implication, is really make it one more— it adds one more layer of difficulty for a customer to switch, okay? If you have patent protection on the surgical use, the product, and the ancillary services. Now, practically, in the medical device space, and certainly in the area that I've worked in, when you're working on— when you're drafting application on the product, there's always a discussion about its surgical use and where it's going in the body and how it's going in the body. So this isn't, this isn't a big lift to go from patenting the product to patenting the surgical use. It's just making sure that you're thinking through that, that surgical procedure in a meaningful way, matching to your instructions for use and matching to the indications that you're marketing to is, is really the, the substance of it. Now what if we go one step further and we go back into the assembly and, and maybe to the component? Now this is attractive if you're using a contract manufacturer. Now you're, you're, you're helping lock up your supply chain a bit and and at least giving your contract manufacturer pause to consider whether they want to, you know, help a competitor make something similar to your patents or not. Okay. So this is a pretty robust strategy. You know, I would say rare that you can go all the way back to, you know, components, you know, polymer types. You know, things of that sort. But it's worth looking at. There may be, there may be certain features, you know, certain components that you can get patent protection on. And it's just helping you establish protection for your up and down the supply chain and the value chain here. So things to think about as you're drafting this. One thing that this slide should by implication, you know, say is that this is, you want to have a thoughtful discussion with patent counsel about what commercialization looks like. And that's— this is pretty early on, so we're talking, you know, concepts 1 through 5. I'm having this discussion and wanting the client to be thinking about, all right, I'm going to make this here, here, and here. We may have this other thing there. And this is the surgical use that, that we're going to have. Are we going to make this ourselves? Are we going to do contract manufacturing? You know, what is— is there anything unique about the, the bits and pieces that you're acquiring to make your product? Okay, all things that, that really should be thought through as you're drafting those initial claims in that provisional application.

So the, in this chart, it looks like component vendors and product would be design patents, and maybe an assembly, ancillary services, surgical use would be methods patents.

Yeah, I, I, I think that's, that's fair. I mean, if, uh, I do some work in interventional cardiology and there's some, you know, valves or, or sealing members or, or things like that, maybe that they, they may not be patentable in and of themselves. But it's worth looking at. They could be, you know, the components. Assembly would, would be a method of manufacturing or process. Products, product devices. And then surgical uses is, is really the surgical method. You know, how do you get into the anatomy? Where does it go? What does it do when it's there? And how does the surgeon engage with the patient in accomplishing that? Maybe there's instruments involved too. I mean, I'm not— I didn't put that here, but it's sort of presumed Sometimes you need, you need instruments, whether they're, they're going to be disposable or not, you know. Do we care? Do you care about instruments? You know, is that— are you getting reimbursed for them? Having these reimbursement discussions, you know, is, you know, is important. I have some clients that I think make really interesting instruments, but you don't really get a lot of money back for instruments. Um, so there's not, you know, there's not a lot I mean, right, a lot of times, especially plates and screws, we— it's tough to innovate in that space now. We innovate through the instruments, but our model in the US, you know, and that's what's interesting about sterile pack models now, is you can actually get reimbursed through that because you just, you know, you basically build it into the price. But I got a question real quick. It's interesting that you use the, uh, the suture on the plate. Example, because that describes exactly what I've launched. And I was curious if you could help me understand the surgical use a little bit more. So specifically, you know, what I have commercialized now, and I mean, the ship sailed on it, I can't go back, but anything forward, I'd like to kind of understand this surgical use, you know, that suture built into that plate is to neutralize soft tissue, and it's you know, it's all about, yeah, it's kind of just all about that. So is that when you say surgical use, is that what you're talking about, like the intended outcome of any particular feature or the intent? Yeah, I don't know if I would say the intended outcome, but in my mind when I'm thinking surgical use, I'm thinking who is the professional doing what to the product, to the patient? All right, that interface between, you know, making an incision, you know, securing a suture tail to a femur, and then positioning a plate in a particular way, you know, how— what is actually happening in the operating room? Okay. And how your product is being put in the body. That's what I mean by surgical use or surgical, you know, surgical method. And, and, you know, sometimes you'll see patent claims that say providing an implant and implanting said implant, um, and that's fine as far as it goes, but their method claims can be, you know, it can be quite broad because of how they're evaluated. Okay. And so, you know, inserting, you know, attaching a distal end of a SutureTail to, you know, the cortical tissue of a femur. Directional issues come up. We're thinking in 3-dimensional space about, you know, okay, where's the other suture going to be attached? How's the screw coming in? Is it coming in from a different orientation, you know, those are some of the things I would, I would think about. If you find— and this is an example I think we wrote about on Slack a little bit— like, if there's something in the operating environment that your product is enabling the surgeons, or is enabling saving of time and, and, and ease of use, then claiming those particular aspects of the process can be really important, mainly because they can be really strong patentability positions that aren't necessarily described elsewhere, but could help get you a relatively broad method claim. But that's what I mean, and literally what's happening with the implant and the suture and the anatomy and its interaction. Okay, yeah, I appreciate that. Thank you. All right, okay, I'm going to try to speed up a little bit. I do want to get to the FTO, but continuations, I'll, I'll run through. A continuation is you have your patent that you file, your regular utility application, it gets granted, and then right before it's granted, you can take the same document file it again at the Patent Office, claim priority to your first application. All right. And you can do that an unlimited amount of times up until the patent term expires. All right. So this is an example of two continuations based on, on a first application. In the situation— this example just illustrates what happens when you don't file a continuation. You got a patent, it covers your product or your method. That's great. 2 years later, you've got a competitor that just avoids your patent claims and you call the patent attorney. There's nothing you can really do with, with this because you don't have a continuation filed. So if we, if I advance here to the next slide, not much you can do there. But let's say you do, in this case, decide to file a continuation. We file continuation application B and application C. Now when you're calling your patent attorney, the patent attorney can check, says, look, we have a continuation filed, we can draft claims and react to the market and the product to cover that product that avoided the patent claims from Patent A and cover that in Application B and Application C. Strategists love this because it gives them flexibility. And Andrea's, you know, shaking her head, uh, the, the there's— I've worked with big companies and they will file continuations right up until expiration.

Okay, I was just gonna say, big companies love to do this kind of stuff, right? Because they'll— they'll— it basically allows them to, to create that picket fence as time goes on, right?

It, it's— it provides unbelievable flexibility in an otherwise static system. Okay, and anytime you can give your litigators and your business team some flexibility to react to the market, it— to me, this is, this is just, just good practice to do, you know. Um, continuations, you're talking $5,000, $6,000, $7,000 probably just to draft the claims. That might even be on, you know, on the high end, but The exercise is really just drafting claims. You're not rewriting a new application.

But again, when you were mentioning before whether you want to have different iterations, right, that, that might be one idea of why you would want to have all these iterations in your original application, because then you can go back and, and build claim, right, claims on those.

One, you bring up a good point. Earlier I said, well, maybe you don't want to file 50 iterations, but what if you did and now you have these continuations and you have competitors coming up all over the place? You can go back, reach back into that provisional, and pick and choose what you want to claim. Um, it's, it's a really powerful tool that I, I just recommend you, you consider and adopt moving forward. I'm going to skip ahead a little bit, um, and I, I want to go through freedom to operate before we run out of time and give some opportunity for questions. But how do you evaluate your product's risk position? Here's my slide again. I love it because it's an important distinction. Patentability, again, building patents, that's what we've talked about up until now. Freedom to operate is about the commercial product and about infringement. So basically, you develop a product, you haven't done a search. Well, you know, what do you do? What do we mean by this search? It's a freedom to operate. Study. And essentially, this is a— the, the task, and, and Andrea and your patent counsel would identify all the patents that are, that are relevant to your product, okay, to your, your product that you intend to sell. And then we're comparing that product to the relevant claims of those patents. That's essentially the exercise. And there's good reasons to do this. It's a good business tool. You just get to know, do I infringe or not? It's a legal tool. It does.

Yeah, Greg and Andrea, don't you do this before you've— your patent is settled down, when you have kind of a product concept and some draft claims? Or do you do it when once your patent is issued?

I don't I don't tie it to necessarily the, the patent issue or patent filing. You know, if it— to me, it depends on how much detail you have in your, in your product. I don't think you can do a very good FTO with a very broad idea, right? You do need some meat on the bones a little bit, okay, that to make it more meaningful. And, and one thing I, I will say, this isn't this isn't a one-and-done sort of thing. It is a process that you'll, you will continue, you know, over time as your product changes. All right, so think of it in terms of a process. It's a journey, not necessarily a, you know, a destination. You may get to the, your, your risk position, you know, early on, but it is this constant sort of, you know, updating. Um, I talk a little bit later, I will mention, and I'll just say it now, you know, in, in my mind, you, you do an FTO anytime you have a significant capital outlay that's coming up or a significant product change. So you certainly should have an FTO done before you submit a 510 or a you know, that's, that's probably on the further end of it. Um, I've had a, a referral or a good client of mine think about founding a company, and, and they're thinking about developing a product and had conducted— maybe it's more called a landscape study— just to see, all right, this is the lay of the land. It doesn't really tell you what the risk position is, but it gives you a sense of all right, here's the patent coverage in this area and in that area. And you could do that. That's a valuable, you know, that's a valuable exercise. This is a little bit more focused on I've got a product I'm about to sell, or I'm going to sell in the next 18 to 28, 24 months that I want to evaluate. Because once you've submitted your, your documents to the FDA, practically you're at a design freeze. It, you know, you're not typically changing things unless you absolutely have to in an ideal world.

So freedom to operate is you do it before you make a big commitment with cash or launch or regulatory filing.

Right, right, before you spend big money. And if you have, you know, an implant and a suture system and you've got solid models that you've got you know, I think you're probably ready. You can probably do one then and then update it as you do these further iterations down the road. But this is— excuse me— this is the, the sort of phases of a freedom to operate study. You, you find the patents in phase 1, then you study them to this to see does your product infringe the patents found in that phase. And you can see these pivot points If the products do infringe, that doesn't mean you have liability. We still have validity that we can look at. Is the patent valid? If it's not, of course you've got low freedom to op— a low risk and freedom to operate. If the patent— if you determine that the patent is valid, then you can secure a license or proceed in face of the risk or consider challenging, you know, the patent claim. So this is just an overview of what the process is and We'll dig a little bit more into Phase 1 and 2. And again, the name of the game is the claim. We look at Claim 1 as an example of a patent. I'll let you read this device. It's got a widget, a gizmo, an actuator, controller. Your first iteration is Product A. It has a brown— a brown widget, a gray gizmo, 2 actuators, and a controller. Product A still infringes the claim even if you added another, another actuator. That, that's not really the, the issue. Now we do some brainstorming and say, well, my technical team says a black gizmo is going to be better. Now in this example, Product B, a black gizmo is not a gray gizmo, so you don't infringe that claim, right? So that's, that's what happens in this Phase 1 and 2 of this Freedom to Operate study. You want to get to a point where you can either get— have some guideposts and say, this is where you can develop, you know, stay away from the gray gizmos and the brown widgets, focus on the black gizmo or the purple gizmo or the yellow widget and, you know, things of that sort. It's about guideposts really, and then proceeding development, you know, on that basis. Now what this slide also shows by implication is, well, product A was at time point 0, product B was at time point 1, you know, time point 2 you may have other product changes. Okay, so I don't, I don't think you need to do an FTO study for all 50 of your iterations. You're not going to commercialize all 50 of your iterations. You're going to commercialize one of them, but you want to make sure you're assessing FTO on what your most likely commercial product is. Over time and just update from time to time.

Talk about, uh, strong claims and weak claims. And I've always thought of strong claims as broad claims. Um, as an example, you know, one of the famous examples in orthopedics is Kaifan. So Kaifan, uh, got a patent on using a balloon to make a space and bone. It was a huge broad patent. It's worth a billion dollars. So, and then what, what's— talk about broad versus narrow, right?

Um, you know, broad, everybody likes a broad claim, um, but there, there are risks, you know. Now we have the Patent Trial and Appeal Board, we have extra ways of invalidating claims. So the broader your claim The easier it is to invalidate in litigation or before PTAB. And they do that with just finding prior art somewhere in the literature? Yeah, finding prior art. You know, the, you know, Andrew may agree with me here. A search is, you could do a search forever, theoretically. Okay. Now maybe you could, you, you could circumscribe, all right, I found most of the patents here, but did you find the dissertation sitting in a library in Germany that describes this particular implant? Or, you know, something. Maybe not. Patent examiner may not get it. You may not find it. Um, but if there's 7-figure patent litigation, you can rest assured the defendants will. And so broader claims are fine. What I like to tell people in the space is you really want— you want a broad claim, you want an intermediate scope claim, and then do the exercise to say, what is the narrowest claim I can draft that covers somebody else's commercial product? Because that makes it increasingly difficult to invalidate. You know, what are all the things that just have to be in there? That, that will enable use of this product. And, and I wouldn't shy away from those because in today's environment you really need a mix of focused claims and, and broad claims because it does give, you know, people pause when they see, you know, a claim that's pretty broad. I've had strategics not invest in companies because they didn't have a non-infringement position. We had a strong invalidity position because it was so broad, but they're like, look, infringement in district court is a preponderance of evidence standard. Invalidity is a clear and convincing evidence standard. That's a heightened standard. We don't want to touch it. Okay, so, you know, when, when we think about good patents or, or what is the ideal patent, I'm, I'm thinking of, of a claim that covers what's in the box, that is narrow but still covers exactly what's being sold. You know, I'm not advocating for a narrow strategy. I'm just saying you should have one claim in there that, that is really, you know, pretty focused and difficult to invalidate. That's what brings people to the table today, I think. We're— let's see, timing. We, we've talked a little bit about, about this. I'm, I'm basically finished. I know we're just a little bit over 4. Um, I'm happy to, to, to answer any, you know, any questions and, and, and discuss anything further with everybody. Thank you for your time. Oh man, I really appreciate this. This has been awesome for me. Do, do you have a minute just to, uh, um, help me understand continuation a little bit better? Are you— is— are you able to file continuations at any point during the life of the patent? Um, you can file it up until the day that the parent application issues. Okay. And that is always a date certain. You get a notice of allowance, then you pay the issue fee. And right now it takes about 3 or 4 weeks for the Patent Office to issue But you get an issue notification and it'll give you a date that says this patent will issue and you have to file a continuation before that issue date. You don't have to wait, but it needs to be during the pendency of an application. Gotcha. Thank you. Good question.

Can you talk about method patents a little bit? My understanding— I'm no expert by any means, but Matt, if you have 10 steps in a surgery or 10 steps in a procedure, uh, and you patent that method patent, the competition can just reorder the steps and get around a method patent. Is that true?

It's yes and yes and no. So the general rule is that the order in which the steps are in the claim isn't limiting. Okay, unless the claim through its structure requires it. So an example might be I have, you know, an implant with a distal end that gets inserted next to bone, and then the second step is the proximal end of the implant is placed next to a different part of the bone. Well, to get to the second step, you necessarily have to do the first step. You know, that's the, the claim requires an order of operations, but sometimes it may not be. It could be, um, providing an implant, inserting the implant, inserting screws in the holes of the implant. All right, inserting screws in the holes of the implant could happen at any stage. It's, it's not necessarily required, right? That's a good question though. Interesting. Excuse me.

Well, we're a little past the hour. Any other questions, or— go ahead.

I got a quick one, Tiger. Hey, Greg, that was great. Thank you. Um, I'm, I'm downstream in the beginning on the, on the manufacturing side. I— how do we— we work— we're working on some pretty, um I don't know, we think pretty innovative stuff in the forging space. How do we get a, you know, like we're working on a titanium femur that we're doing in one strike, you know, so I don't know if you're familiar with forging, but anyways, it's so Is there a way to protect those type of things from the process side, you know, the patent side for processing? Yeah, absolutely. You know, so any, any time you have a, well, the product necessarily may not have to be new or non-obvious, but if the way that you're making the product is new or non-obvious, then you have the ability to secure patent protection for it. And sometimes what, what I like to do when we're looking at, at manufacturing processes, especially in, in things like forging or thermoforming or, you know, things like that, it may be, you know, breaking down the, the, the process— and you probably do this for some other reason— into the, the sort of incremental steps as possible, and then evaluate, all right, what's the What's the most critical thing here? What is it that along this process? And build out your process claims that way. You know, certainly if you're in the manufacturing business, having a process-oriented patent is going to be directly relevant to your business and your business model. But there's, you know, I wouldn't not consider, you know, patent protection just because you've, you know, you're at a more downstream, you know, process. There's certainly innovations that can happen at that phase that you may be observing and experiencing now.

So couldn't Frank, like, patent the forging process that's different than anybody else, or the material properties that are different than anybody else's There's kind of two ways it could go, right?

Right. All those are, you know, all, all those are possible. You know, if the— there's a couple of things, you know, the, the, the forging process, you know, what new machines or equipment or, or other structures that you had to create to enable this process that are, that are part of it could be the subject of of a patent application. I've done some work with manufacturers similarly situated where you may have a process patent that, you know, covers step A, B, and C, but sometimes you can have, you know, a machine that comprises X, Y, and Z that does the things that you intended to do. So there's, there's two ways I would look at it. You know, what is the equipment that you're using? Is there something innovative and new there? And then how your product is interacting with, with that equipment in, in terms of steps in the process. All right, that makes sense. Thank you.

Great, great question, Frank. So hey, Dave Johnson joined late. He's got his hand raised.

Hey guys, um, thanks for this. This is, uh, this is really, really interesting, really helpful. Uh, so I have a question on FTO. And, um, so we, we've had our patent attorney draft opinion letters for us. Um, what— at what point does it become an FTO? And at what, at what point does it actually carry weight and be, be it, you know, is it certified in some way, um, with some backing that's, you know, can you insure that or something, right? And, um, you know, what is that line? And then also, what is the— what would someone expect to pay for an FTO?

Right, that's a good— that's a good question. Um, there's— there, I would say there's a spectrum of types of FTO letters. You know, on one end, I would say one is called an FTO survey. And an FTO survey may be, I found 5 patents or 5 patent applications and I'm able to identify one element of the claim that just is just not there. You know, you sell sutures and the claim requires an implant. It's just, you know, that sort of basic. It's just an FDA survey that says you're clear of these things. Uh, that's a useful business tool. Um, on the other end of the, the spec— the, the spectrum, and this is where I, I you know, more or less, I think strategics do this. Some of the clients I've worked with in the past, you want to prepare what's called an opinion of counsel. And those are two different things. So an opinion of counsel is, is what you would use to mitigate a willful infringement determination in patent litigation. So just to take a step back, you get sued for patent infringement They prove infringement. You don't prove that the patent's invalid, and damages have been applied, say $2 million. The patent owner says, you willfully infringed, you dirty rascal. I'm tripling damages. Hmm. An opinion of counsel is submitted as evidence to reduce that damages award as an indication of your reasonableness in relying on counsel. And, and the reasonableness of your invalidity argument or your non-infringement. There's certain requirements that make an opinion of counsel an opinion of counsel. So I, I don't— there's not a certifying body that would certify it, but there are basic requirements that are required, that, that are needed in, in an opinion of counsel that you would then use in that context, in the patent litigation context. It's got a— it has to review the patent and the file history. It needs to have a claim construction, and it needs to apply that claim construction to the product, okay, to make these determinations. That's basically it. They can be complex. So the freedom to operate survey, I'd say, is really more of a business tool The opinion of counsel is, all right, I'm expecting litigation and I'm going to get this opinion of counsel done. We've had them prepared after filing a complaint, knowing that it's going to be in litigation. That doesn't mean your FTO survey can't serve the same purpose, but the opinion of counsel type is, is going to stand up a little stronger if you get to that place. Okay. And those can be prepared at a later time.

And what are the costs for that FTO lite and then the opinion of counsel, which is— Yeah, the—

I would say it varies and it's going to depend on how many patents Andrea finds, you know, more or less. Okay, so if I'm doing an FTO survey and I've got to go through 30 patents, that's going to be more expensive than, say, 5. But what I've— I usually provide a quote that, that I, I would get from, from Andrea or our other search firm, and then my service fees. And, you know, I think this FTO survey, it— you're in the— you're probably in the $5,000 to $7,000 to $8,000 range by the time you get the search done and you evaluate these patents and you, you can write this basic, you know, sort of FTO survey. An opinion of counsel is, is probably going to be double that and sometimes higher depending on if you add invalidity to it. So, you know, $5,000 to $7,000 to start, you know, $15,000 I would say to, to do what needs to be done in an opinion of counsel. Sometimes it could be higher depending on, you know, years ago, um, you've probably seen these. There might be 150 claims in a patent, okay? And, and your opinion of counsel needs to go through at least all the independent claims. And if you got 10 there, that's going to be— that's going to be a bigger deal. There's not as much of that that happens now because of how much claims cost, claim fees at the Patent Office. So, got it. In that range, I think, is where you start.

So, Dave, Dave has a novel knee brace, and that's, that's, there's, I'm sure there's decades of patents and bracing. So what, wouldn't it make sense to do the cheaper FTO first just to sort of unearth all of the likely patents and then decide later to do the opinion?

Yeah, usually what'll happen is we'll do, we'll do this, you know, the cheaper version you know, first. And maybe we find 10— Andre finds 10 patents. We can whittle that down pretty easily to 5, and 5 are going to be in the letter. Okay, um, maybe one of those is, is a close call, all right, where it— there's— you, you can't read the claim in, in, in 15 or 30 seconds or a minute and just find something that's different. You've got to go to the patent and say, what is this? What do they mean by a bioabsorbable bone anchor? You know, what does that mean in terms of the patent? You know, how does that apply to, uh, you know, the product in question? And then once you have— in my mind, once you have to dig into the patent more and dig into the file history more, then you're getting into the category of this opinion of counsel where I, I really need to be careful about the claim construction that I'm, that I'm developing. You know, sometimes there's usually, you know, something will come out of the search where it's kind of close, you know, in an unexpected way. But usually it's, you start, you start with a survey and, and, you know, that's the plan. And then if you can't dismiss, you know, a, a patent quickly and easily, then it's— it gets more into this opinion of counsel range where we've got to dig into it a little bit more and really understand the patent scope.

And you just want to make sure, right, that your search is proper because you can always, you know, go look for 5 minutes or maybe your patent attorney is really good in that art and knows of a patent or there's a particular competitor and you look only at their patent. And then they can write FTO opinions on those patents that show up that way. But you don't know what else is out there, right? So that is still not like a full FTO. You want to have a proper, proper search done, find everything that is potentially threatening, and then whittle that down.

Right. She brings up a good point. I mentioned willful infringement earlier, and there are cases where they find willful blindness is, is a factor showing willful infringement, meaning I know this patent is there, I'm just not gonna look at it. Ignorance is not a defense, right? You know, um, you can't know about a patent, not address it, and decide you're going to infringe it anyway and not ex— you know, and, and expect to, to have the court land on your side. Yeah, yeah. Or jury that matter.

Another thing I think you could do is you could, like what Andrew said, you could— I mean, Dave knows his competitors. He could probably list the top 5 bracing companies, and that would cover 99% of the waterfront.

And you know, you can do an FTO on in phases, right? So you, if you know your competitors, you can start with those, clear those patents, and then still still look at the rest because you never know. There's so many, you know, surgeon entrepreneurs or smaller players, people who have filed maybe, but, but haven't— they don't have a product out in the market. So you might not know of them, but they might have IP. So it's always good to do the full search at some point, but you don't have to do everything from the beginning.

I agree. Did I answer your question, Dave?

Yeah, it did. Sorry, I'm driving here. And yeah, and it's actually, you know, so it's this tensioning mechanism that is peripher— well, not peripheral, it's integrated within our knee braces and actually all of our joint braces. It's used to generate tension across the joint. And it's really useful for a lot of other applications, actually. Yeah. And so So we have a patent awarded and, uh, we, we just want to know how far that could go. And so we're trying to figure out if we, um, and actually we're coming up on our Series A raise, and so we want to get a sense of where our boundary is, if at all. And, um, and then also to show that, you know, we do have license to hunt here and that this product should be added to our revenue stream, you know, forward, and we're, we're less likely to have a lawsuit type of thing, right?

Offense and defense. Yeah, that's right.

Well, it sounds like you're, you know, you're, you're doing, you're doing the right— you're taking the right steps if, if they're preparing— your counsel, counsel's preparing, you know, Freedom to Operate letters. You know, when, when I go through due diligence, I think knowing that there's a process and, and that you followed it and that it's reasonable is, is about the best you could do. Okay, you know, some companies are going to be way risk-averse, and that's just who they are. Um, but you're, you're not going to have perfect knowledge of everything, and, and anybody that's really kicking under the hood on your patents and IP are going to understand that, at least at some level. They may not explicitly say, uh, You know, but it's, it's more about the process and being reasonable and, and understanding what, what your boundaries are. You know, you, you can only do so much, right? And, and the law doesn't require— the law doesn't require us to do a search. You don't have to do any of this. It's just good business practice to do it because you want to have your eyes wide open as you're, as you're moving forward.

Yeah, yeah. And hey, you know, one other follow-up is, and maybe you said it, and actually it's my, my phone cut out when you were saying pricing, but, you know, maybe Tiger, maybe, you know, I don't want to bore everybody with that again unless you can just put that into a nutshell real quick. But, you know, the other thing is, can, you know, does it have to be a third party? Is there any restriction for your own patent examiner or, I mean, attorney to do the FTO?

I have clients that do both. There's one of my clients now where they did a big search on their own. He, he was just knowledgeable and knew how to do searches. I would go over the search terms and his search strategy with them. And he has a team where they will review I would kind of give them guidance on here's the things you kind of want to look at. You know, you can look at the drawings and figures all you want, but if you're going to do an FTO, spend some time on some of the independent claims. And if they're, if they're causing you some concern, then they bring it to me and then we, we dig into that a little bit more. There's a lot that you can do on your own, I think. Um, certainly talking with someone like, like Andrea, if you're going to do the search on your own she could provide some excellent sort of guidance. And there's no reason you couldn't. Reasons people don't is more time. You know, if you're at a stage in your product lifecycle and your business lifecycle where you have the ability to devote our resources, internal people resources to devote to spend some time on doing the search and doing this initial culling,. And then once you, you get to a point where you find a patent where 2 or 3 people reasonably disagree on what it means, that's, that's an indicator to just, you know, talk to counsel and let them focus on what's the most important patent to review and, and have them, you know, evaluate it, you know. But they're, they're documents in, in English language, and there's no reason You know, if you can't read through a claim and say, you know, I don't, I don't have an implant, you know, I'm not going to make an implant, I'm never going to touch an implant, you know, there's, there's no reason for you to look at and get a patent attorney to say, you know, you don't have an implant when you have a knee brace. I mean, there, that's an extreme example, but there's no reason you can't do some of this on your own. Um, what I would do is once you get down to this, this handful of patents, I would, I would talk, talk it over with, with counsel and see how they, you know, they can work. I typically will— we may do analysis and I will give an oral opinion when we're in this design development phase because I know, and, and they know probably, that there's going to be some changes. And then we'll confirm our analysis once we have a final product, um, that is consistent with what we've, we've been evaluating, you know, over time. You know, there's— I, I don't think you need to get a letter each time you change a color or change a fastener. You know, if you're changing fundamental things is where I will get an updated letter, is my view.

Is that helpful? Yeah, that's helpful.

Thank you guys. Hey, here's the— hey Dave, real quick, the numbers that were thrown out were $6,000, $7,000, $8,000 for freedom to operate, uh, exercise, or landscape, and then sort of double that, like $15,000 to $20,000 for an attorney letter with a thorough opinion.

Okay, that's a lot cheaper than what I've heard in the past. I've heard it's, uh, can be up to $100,000.

3K. Um, no, no, no, no, you shouldn't.

That's crazy.

Yeah, I think in, in, in situations where you're, you're in— well, there's some debate on, on that. If you're sued and you want to get an opinion of counsel, you're essentially drafting a summary judgment motion in an opinion letter, and that could be expensive, you know. But there's no reason that, you know, one or two patents should cost you more than, than what I've, you know, described. We can go through a patent file history that's relatively simple and, and, and review that, you know, for the numbers that I gave Tiger and everybody here today.

Yeah, I think it depends on the technology too. I mean, if you're looking at expandable interbody implants, I mean, those claims are incredibly long and complicated and the search will cost more and then you find 50 to 100 patents and then an attorney has to go through those claims, it can be very expensive. So it just depends if it's just a patent or two.

Yeah, then it's not a big deal. Yeah. Okay, great. Yeah. Yeah, we've, we've actually, I mean, we pretty much write all of our patents and then kind of just go through like an editing exercise with our examiner. We've gotten pretty, pretty good at it. So I bet we could do a good, a good amount of it to get it started.

I love Icarus. You guys are homegrown and lean. Thanks.

Yeah, we got to update you on some of our latest developments. Yeah. So yeah, it's pretty exciting. All right. We'll be at AAOS if anybody wants to come by.

Oh, cool. First booth?

No, no, no. We've been doing booths for a few years now. But, but we'll have 2 or 3 additional products beyond just the knee stuff. So. Wow. So that's exciting. Yeah.

Cool. Well, I don't want to take anybody's time anymore. We've gone way over, but it's been, been very interesting. Thanks for all the questions. I've learned a lot. And so thanks, Greg. We'll call that a wrap and we'll see everybody next week. Okay, bye everybody. See you, Bone Chatter.

Have a great day. Thanks. Bye. Thanks, Frank.