[MUSIC] Welcome to the second video in the series on the All documents feature in Patent Register, where follow prosecution through the PCT system. In this case, I think it will be fun to look into the diagnostics field. We will not deal or try to predict what the consequences are of the recent decisions in courts in both the US and Australia. That rules out, in principle, the use of any national nucleotide sequencing the sequence for diagnostic purposes, but we will rather look at the fate of one of the relevant inventions in the European systems and see how that went. This is a document that we are going to take a closer look at it. You can see that it is a A2 document meaning that this document does not have the search report appended to it. You can see that we have priority in 2010 and international filing precisely a year later. And the assignee is Myriad Genetics. If we scroll down to the title and abstract, you can see the title again from before. You can see that it regards detecting a particular signature called LOH. And most importantly, I think is the last sentence that uses this diagnostic method to classify patient according to what type of treatment they are likely to respond to. So here is the record and we begin by taking a look at the patent family. You can see here that a couple of US patent applications up here on top but no patents. This looks like a divisional application, and that is indeed what it is, as you see down here at the bottom. And let's go into All Documents and the first thing we are going to take a look at is the international search report that we did not have at the end of the pdf of the PCT publication. If we scroll down in the search report document listing, you see here that all the documents are labeled with A. I hope you remember that this means that it's general background knowledge the field, kind of things that a person skilled here is expected to know already. But here something else happens. Some of the claims, 6.30 to 17.30 and 34, were not used in the novelty search by the seminar. The reason is that these claims regard treatment claims and that is not allowed in most PCT countries. In fact, the PCT countries as well as the US, or including the US agree that direct treatment of the human body is not something that you can patent methods for. You can patent a scalpel, but not the way to wield it. You can sell patented Titanium screws for setting bones, right? But the manual procedure of setting bones right is not acceptable for patenting. But the way of drawing this distinction is done very differently in the US and in the European system, for example. So the inventors they will have to do something about the phrasing of some of these claims in order to make them allowable outside of the US. If we scroll down you can see there's nothing else of particular interest in the search report. So let us move back to the patent register. And for this application, we can find a international preliminary report on patent ability. Let's take a look at what it contains. And you can see here. Notice the absence of opinion with regard to some of the subject matter in the application is noted here as well. And here the claims, the same claims that are not allowed and the reason for not allowing them is stated. And here is something Interesting. You can see for all the other claims, the inventors get, yes, both for novelty inventive safer and endorsable ability. But now actually, a document as a result of the search is listed, D1. Let's see what the examiner has to say about that. And that is actually quite good news for the inventors. None of the prior documents, including D1, discloses or suggests technical feature of the present invention. So they're in very good shape. Now we better look into what they actually do about the medical treatment claim. And in order to do that, we better look at claim number six, the key claim for this. And as you can see, a method for treating cancer comprising, this is a clear-cut medical treatment claim not allowed in the PCT system. And it ends with the criterion for using the diagnostic method to decide whether the patient is likely to be responsive to the treatment or not. It is not immediately obvious where to go look for what the inventors intended to do about that. It turned out to be in amendments received before examinations. And what we find there is this letter from the patent attorneys. And here they say something interesting. Support for this amendment, here they speak about what they do about the claims and they know that they have to lift out the text from the patent description, they cannot invent new text at this point in time. And then they say something else which is relevant, and that's the Swiss-type medical use format, something that was in use up to January 2011, and you remember we had a 2010 priority date. So let's take a look at the new claim, and the new claim that corresponds to this one is actually claim number four in the amended claim set, and we can find that here. Use of one or more drugs chosen from the group consisting of DNA damaging agents, then the list of agents, for the manufacturing of a medicament for treating a cancer in a patient. This is a very typical, classical Swiss-type medical use claim. We will return to discussing those and what you do today because, as I said, by January 2011, these actually went out of fashion. So where does this analysis leave us? I think it's reasonable to assume that they will actually end up with a claim set that is accepted by the examiners. And you can see here the latest amend is in September 2015. If you are knowledgeable in this area or excel in this area, you would also be able to adjust the claim set and see whether it dominates what do you want to do. As long as you remember its a divisional, so there many more documents that need to be evaluated for you to be sure. So we ran into the complicated claim phrasing problem of treatment of first, second and further medical use claims and the difference between the US and the European system. And a claim in the form, use of a substance or composition X for the manufacture of a medicament for therapeutic application Z, that was allowable either for first or subsequent application and this is a Swiss-type claim. This is how that is defined. And remember, this is a way of overcoming that medical treatment claims are not allowable in most PCT countries. And why is that a solution? That is because the invention now doesn't regard a treatment, but the making of a medicament. However remember, that by January 2011, this was regarded not good practice anymore. You cannot phrase it that way and so we need a replacement for it. And here's the replacement. And it actually, on the face of it, is pretty close to actually allowing medical treatments, the way that I read it. But it's very subtle differences that you should be aware of in how you phrase them. Use of a substance of composition X for the treatment of disease Y is still not okay. But, substance X for use as a medicament is fine. It doesn't pertain treatment. It is, in a sense, a simpler and more easily-read version of the Swiss-type claim that you see here. Now if you do that for substance X, this means that you are the first one to discover the medical uses of this substance. And medical uses could, in this case, also be used as a diagnostic tool that's also a medical use. Now the curious thing is that if the use was anything outside the medical field and the substance X was known already, then you will get a use claim. You will not be able to get a product claim because the substance is not novel. It is the use that is novel. However, society apparently wants to give certain precedence to solving disease problems. So if you are the first one to discover a medical use of a chemical compound, then you are granted what you could view as a product claim within the domain of pharmaceuticals. This also means that if somebody else discovers a medical use of the same substance, X, but for a completely different indication that you have not thought of, they can also get a claim on this. But they will be dominated by you because you were the first to discover medical uses of this compound. So if I'm the one who discovered a completely unrelated medical use of this substance X then I can write substance X for use in the treatment of disease Y. So now you can see this, this has the flavor or a use claim and you might wonder why is this not a treatment claim. Well this is a second indication, use claim of a known substance X whereas somebody else, you, had discovered that there were medical uses of it. It's not trivial and you might argue that Myriad may have had a quicker and less-expensive way through the PCC system, if they had they been really sharp on Swiss-type claims and the like. So that they did not submit the US phrasing of that claim directly to the PCT system only to be delayed in the process. So I would encourage you to reread the chapter 2.8 on national differences and you are now also ready to read chapter 6 now that you have seen some claim phrasings, some nasty ones to be quite honest. [MUSIC]
