[MUSIC] Welcome to the first lecture on the use of the old document feature in the European patent register. You should read the examination in the PCT-system, Chapter 3 in the textbook to follow this. And we need to refresh to our memory on the standard timelines. You cannot draw too many timelines, and there are a couple of standard events that we need to fill in our generic timeline. So let's sketch it as we used to with time 0 here, 12 months international filing, 18 months publication of the international filing. Months 30/31, entry into regional and national phase. So what we want to be concerned with now is documents coming out of the examination procedure. And along with the the international complication here at month 18, you will also get a search report. What is a search report? A search report Is the examiner's attempt to do a novelty search. They try to look for prior art in the area that could be damaging to novelty or inventive step of your invention. Now, they don't always make it in time, so maybe it would come out shortly thereafter. And as a separate document and not along with the international publications but the intent is to do it at month 18. Now, all applications have an 18 months black box period where you don't know what goes on. So very often, you will find a supplementary research being performed later on. And then at around this time, month 28, you will get, or you can get an IPRP, an International Preliminary Report on Patentability. And that is something where you really prefer to have a good one because that puts you in a strong position when you enter regional or national phase. These days, you will very often, with the search report, also get a search opinion that is a mini version of the IPRP, you might say. And these are all documents that are very useful for you if you want to follow how an application from a affairs through the system. Now, as you heard, the search report does not always come out exactly when it's meant to. But when it does, the WO publication will carry an A1 suffix, meaning that the publication was with the Search Report appended to the end. An A2 means that the publication was without the Search Report. And in these cases, it will be followed up shortly thereafter by an A3 document, which is the Search Report alone. So the arithmetic is a bit odd but easy to remember, A2 + A3 is equal to A1. You just have the documents in separate files. Now, let us look at a search report. And here, you have a PCT application and publication, and as you can see, this is an A3. So this is a search report alone. The front page is repeated so that you know which document the search report belongs to. And here is the title, Galactosyltransferase From Plants Involved in Galactomannan Biosynthesis. That has something to do with food ingredients. This is stabilizer that you put into ice cream, at least in mention regards. And this is what a such report looks like, or at least it can look like. This is page 1 and page 2. You can see that it is essentially a table. Here, it's continued on the next page of documents. Documents that the examiner has found, and he considers relevant in one way or another to the invention, and in one way or another is filled out in two different columns here. It is filled out which claims in the invention or in the patent application that are affected the things that the examiner have found. And in this column, it's the document type. And then down here, we have a key to understanding these codes, and let us take a look at these keys. Here they are. You have A. That is a document that defines what the person skilled in the art is supposed to already know. So if you want to figure out if something is obvious to a person skilled in the art, then obviousness is something that is judged on the basis of what is common knowledge in the field. And A documents define common knowledge. They are not damaging to neither novelty or inventive step by themselves, and it's the kind of background knowledge that the examiner notes. We will concern ourselves with all the different codes, but the one we see most often. X document is the most important one. That's the document that by itself is damaging to the novelty of your invention. And then, this means essentially that the several things that somebody else has disclosed your invention already. And it can both be damaging to novelty or to inventive step. If it is inventive step, it is related to the A document, what is obvious on the basis of common knowledge in the field. Then there are Y documents. Y documents, you cannot have one Y documents, and they are not distractive to novelty. They only regard inventive step, and you need two of them. So the logic here is that the person skilled in the art can read two different documents and combine them in his head. And by that, infer the invention that you have made. Now, a person skilled the art is very knowledgeable. Knows all literature that is there but is not very creative or imaginative. So Y documents usually have to be very close to one another. It should be easy to take the step from reading these and to inferring the invention that you have made. And then, there are P documents. P documents are A bit tricky. That letter is used in combination with one of the other ones. P documents are documents that are published between the time point 0 and 12 on the standard timeline. So, how can a document placed on the timeline after your initial priority have anything to do with you have mentioned? You were first as you know. But if you look at the way people often make applications, they do it like this. They submit one priority application, then they work more on there invention. And then amongst nine, they publish another one before they wrap the whole thing up amongst 12 and the file PCT application. So if your priority application number one comprises claims related to A and the document number two, A plus variations or new additions to the invention A prime and these are right robin presented in the PCT application. So, assume for the sake of argument that a comparative actually publishes A prime somewhere and now the timeline the before almost 12. The examinees will label this PX and that will then happen to you well. You have priority in A, but A prime can area from your competitor than a different you. So, this means that eventually the examiner will demand that claims related to A prime be removed from your application. Now if the PX document actually is a patent application from a competitor and then whether this actually has anything to do with your A depends on, of course, when was the first priority application from this one. But at the face of it, you will lose a prime place if this occurs. So, you will see and you saw in the previous. So, let's report you saw several PX documents being listed. Could this be an issue without P2? Certainly, yes. Many inventors, they don't go through the trouble of adding a second priority document. They add what ever happened during this period directly to the PCT application in month number 12. So what was then the PX document, the one listed on top. Well, here, you have the document and it's actually a somewhat unusual document. But you should be prepared for those types of documents, as well. This is a database entry. It is from the genome sequencing project. So, this is the sequence of the entire chromosome 5. How on Earth can that be damaging to something related to ice cream food additives? Well, if you look down the long list in the fifth chromosome in our synopsis and get to the open reading frame of a gene which is homogenous to the one used by the inventors in order to control the synthesis of this food ingredient. It's an alpha galactosyltransferase protein. None of those would know at the moment when the application was filed, but the computer that looked through chromosome 5 proposed based on file informatics algorithms that this could be an alpha galactosyltransferase protein. The logic is then that if a computer can actually guess this activity? Then it cannot possibly be inventive whereas the creativity in that algorithm. So, the inventors eventually lost this patent. It's a bit unfair. Because today, many years later, it's still debatable relative cases correctlfully at [INAUDIBLE]. The one that the inventor's used, they provided experimental evidence.. So, be prepared that novelty destroying and information can come from very different sources. Now, I think it's time that we go into the European Patent Register and look at a real file and let us change gears to something a lot more modern and this is about small interfering RNA, this invention and I have a copy from Wikipedia of the definition. Wikipedia is good at providing synonyms, by the way, that can be used for text searches in. And here, you see the small interfering RNAs is a class of double-stranded RNA molecules. 20 to 25 base pairs in length and they play a role in gene regulation, and then that quiet both in plants and in humans. And here, cancer is the interesting thing that we will use this for in this application that we are going to investigate on this. So now, we are going to look at small interfering on RNAs. We have an implication here. You can see, it has a priority in 2010 and international filing precisely a year later. And now, we better take a look at what is the core of this invention. And fortunately, most patent applications have a paragraph called summary of the invention and this is no exception. It is the present invention rates of oligonucleotides for modulating the activity of a target RNA. You can either do that by harnessing the RNA interference systems or by not. And in a preferred embodiment, this invention regards preventing the micro RNA from regulating the target RNA and that is what we will be concerned with in the following. So now, we are in European Register and we click Legal status first to see why an application from 2010 is not already out of the PCT system. Here, you can see the designated stage. You can see request for examination filed and various fees being paid, but no entry into regional or national phase. So, let us move on to all documents. And the first thing we want to do is to take a look at the search report. So, we take it off down here. And you can tick off as many as you want and then you click download selected items up here. [COUGH] And when we scroll down to the section with the With the documents. They're null. It's empty. Wow. Nothing to interfere with novelty or to question events of step. More or less, this is not the situation. Here, it says claims 1 to 9 because they relate to part of the international application that do not comply with the prescribed requirement to such an extent that no meaningful international search can be carried out specifically. And then see an extra sheet, which we will not. So something is not good enough for the examiner to know what actually to conduct a novelty search for. So we will not find an international preliminary report and patentability, but we do find a European search opinion, so let´s take a look at that and figure out what goes on. And you can see that a search started, so even though it did not start to begin with, we can expect to find documents cited in there. And here you see it, and you can see five different documents regarding a particular microRNA called 33 listed. Then the examiner moves on to discuss the various documents always with a reservation for the problem that gave rise to the InterSearch report in the first place. And that problem is seen here. And that's a matter of clarity. On one hand, that claim 1 is not clearly defined. It does not define the blocking microRNAs by their certain features, but by a negative feature that's no recipe for, except making the entire invention. And it's said in the next paragraph that there are no experimental evidence to provide any examples of microRNAs that belong in this class. Now we better compare the original claim number 1 with the amended version where the inventors have tried to do something about this, because this is actually both a tricky problem and a problem that is quite easy to run into. So here we have the amended claim sets with annotations, so we can see what they're doing about it. Let's download that, and let us go back to the original finding and find claim number 1 from there, and then compare these. >> Okay, so what you saw while we were in the database, was that the inventors had got into trouble with their claim number 1. And the claim number 1 reads, a steric block oligonucleotide incapable of recruiting the RNase H and the RNA interference machinery, and so on and so forth. And what the examiners were very unhappy about was the word incapable. I hope. Here you can see, repeated, what they actually say, that it does not define the compound by its structural features, but by a negative feature. And they don't provide a recipe, really, for knowing this, except if you do the entire invention with it. And they repeat it with reference to another rule in the patent law. Says that it is an undue burden to leave it to the competitors or to the reader of the patent to figure out which small RNase fit and perform like the invention wants them to, and which do not. That's not enough. They need to specify it further. Does this drawing ring a bell? It's from the textbook. I hope it does. This is a patent about lubricating a wheelbarrow, and I hope that you see the parallel. This invention also was a circular argument. It was a claim that stated or wished that such a thing as lubricants existed. Just like the claim that we've just seen expresses the wish that there would be smaller RNase that would bind to the target, yet not launch an interference machinery. And that is not allowed. Circular arguments and patent claims expressed as wishes are considered not sufficiently disclosed. So what did the inventors do about it? Well, they added a technical feature. And they simply write the same thing wherein the oligonucleotide comprises, and then, you can see this is a locked nuclei-acid strategy. So they think they can create a smaller RNA that will bind to the target, but it's an artificial one, and it does not set off the RNA interference machinery. So this is very clever, if it works. This is a way of preventing the endogenous RNA regulation of this gene in question. And if that's one that is important for a disease, this could be very useful. However, why didn't the inventors put this into the claim in the beginning? Well, what if this doesn't work? Does that make it a bad idea? Certainly not. And the inventors are very aware of that. So they want the claim number one to be as broad as possible so that's just horrible that any particular strategies that they have would not work. And you very often run into that problem. When you want to generalize from your particular examples to the general principle, you end phrasing your claim number one as a wish that there would be such a class of solutions to taking the problem. But you don't provide sufficient technical features, so that the examiner's happy, and says, this is probably disclosed. A competitor will know whether his solution to the problem is within or without or outside the scope of what you have done. And the inventors here, they have a particular extra problem because they're running a risk with, they're taking full feature. It's not something they've done in the lab. It's a thought experiment carried out in the armchair. You will recognize this also from the textbook. I think you should read up these two sections about the lubrication, invention, and armchair examples. It's perfectly okay to do experiments in your armchair, but you better guess right. If you guess incorrectly, you have not substantiated your invention. [MUSIC]
