Speaker 1  0:00  
Take it away, Tim. All right, thank you. And thanks, everyone. It's a pleasure to be presenting today. My name is Tim Van Dyck, and I'm a patent attorney. I've been practicing now for about 27 years. And primarily what I do is patent preparation and prosecution before the United States Patent and Trademark Office. My background is in educational background is in cell biology. And that's what my graduate degree was in. And I've been practicing primarily in the air in the area of life science. So spending my time learning new life science technologies and figuring out best ways to protect those new inventions in that area. And joining me today is Jeff Jackson. And I'm gonna think what we'll do is he's going to be participating a little bit later. And our Jeff, why don't you go ahead and introduce yourself? Yeah.

Speaker 2  1:04  
Hi, everybody. I'm Jeff Jackson. I'm the Director of Innovation transfer at University of California, Santa Cruz. Have I've had about a 15 year career in technology transfer at Translational Genomics Research Institute, Oregon Health and Science University and last seven years at UCSC. Prior to that, I worked about 14 years in the biotechnology industry, did some work focusing on antibodies, and also at OHSU prosecuted a number of patent applications related to antibody. So it was exciting when Tim asked me to join this panel. So they Popa hope we can be fairly informative to some of you today. Thanks. Great.

Speaker 1  1:54  
Thanks. Thanks, Jeff. And I should also point out that, that I work with an IP boutique firm based in Florida, we have offices around Florida and outside of DC. Walter VanDyke Davis, and I'm the managing partner of that firm. So let's get started. We've got a lot to talk about today. And we're going to be discussing the recent Supreme Court decision Amgen V. Sanofi, which resulted in the invalidation of Amazon's patent for lack of enablement. We're gonna walk through the facts of that case and the courts reasoning to attempt to lay down a foundation to discuss how this case changes the paradigm for evaluating enablement and particularly in the context of life science related inventions. We're also going to talk about the interplay between the enablement requirement and written description, which are both threshold standards of whether a patent has sufficient disclosure. And and we'll get into discussing some drafting strategies to optimize patent protection with the goal of reducing risks to succumbing to enablement challenges. And lastly, we'll go over some real life examples where enablement and written description rejections were raised and, and discuss ways to push back against patent examiner's and these situations. So we're going to be looking through this through the lens of a university tech transfer manager. And so and then we'll have some time reserved at the end for q&a. So let's get started. Let me share my screen here

Speaker 1  3:57  
All right, very good. So addressing patenting issues post Amgen. So, to get started, let's just lay down the groundwork of what we mean by enablement. So, the purpose of the requirement that a specification describe the invention in such terms that wants to go in there can make and use the claimed invention is to ensure that the invention is communicated to the public in a meaningful way. And classically, the standard for whether or not one meets the test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent, coupled with the information known and the art and with the keywords without undue experimentation. The enablement written description requirements are both under the same section in the patent statute. And they are related, but they have a slightly different focus. So the written description requirement is met when a patent specification describes the claimed invention in sufficient detail, that one skill in the art can reasonably conclude that the inventor had possession of the claimed invention. And, and there are a number of factors that go into determining written description. And as we'll discuss in relation to the empty in case if there's factors that go into the determination of enablement. And it's an it's sometimes hard to hard to really tell, especially when we get rejections from a patent examiner. You know, what's the different rationale between enablement and written description? And I think the rule of thumb on that is that the written the enablement requirement is really more about giving disclosure to others so they can practice the invention. written description is giving it sufficient disclosure that you convey to the public that you are in possession of the full scope of the invention. And the Supreme Court case, which came out last year, the Amgen case deals with enablement. And I'll briefly touch on a related case, Juno V kite that dealt with a written description, requirement, rejection, and invalidation. And I think it'll become clear that the distinction between the two is not so clear. So Amgen V. Sanofi what was this case about so this case involved a patent that covered antigens, cholesterol drug Repatha. And Repatha is an antibody that binds to an enzyme that regulates LDL, low, low density lipoprotein. And the claim that's in question in that case, is I provide here it's an isolated monoclonal antibody that binds to PCs K nine, the enzyme wherein the isolated monoclonal antibody binds an epitope on the enzyme that comprises at least one of residues 237 or 238, of the sequence that encodes that enzyme. And then we have this functional limitation were in the monoclonal antibody blocks the binding to the LDR. So 15 years ago, if I looked at this claim, I would think there's no problem with that claim. It seems to be fine. We all know how to make antibodies, it's well established. And we know what the antigen is that we're trying to target against. And we know how to make antibodies that will target that particular antigen at a certain location. So but Sanofi they did admit that they're competing drug infringed. But they argued that the other patent just simply as invalid, for lack of enablement. And they argued that given the nature of antibodies that this claim could cover millions of possible candidates. And and the claim and issue actually covers any antibody that blocks that receptor that also binds to those sites and and they said that this would just require undue experimentation, the classic standard for determining enablement and Amgen said, No, a, any person skill in the art could follow the roadmap. And this is a word that sort of used a lot in the cases by the parties and the court, but they could follow the roadmap and the specification of using anchor antibodies and well known screening techniques to produce antibodies or make conservative amino acid substitutions in the specific examples that they taught. So they actually did provide some sequence information of the amino acids, I'm sorry, sequence information of the antibodies and that they could just throw routine techniques make variants of the those sequences that should potentially work. And and they emphasize that our roadmap will provide working antibodies every time. And that Sanofi cannot point to an antibody that might be an existence that could not be produced by the techniques that we teach in our application. Well, the Supreme Court as as I've already kind of hinted at, found that they disagreed with Amgen and agreed with Sanofi that the the given the nature of the claims that the patent lacked sufficient enablement for the entire class of antibodies that are, are in their broad claims. And some of the points that they made and, and the decision give some insight as to their thinking. So they dismiss this roadmap idea that was presented by Amgen, as well as the sort of conservative substitution idea of the sequences that they taught and likened that argument and the description involved there to simply being a invitation to conduct trial and error. And that to really fully achieve the full scale, full scope of the claims that it would require, quote, unquote, painstaking experimentation to see what works. And but there was some discussion about the nature of the invention involved in that some of the arguments that were made might might be compelling, in a different type of technology, they didn't really go into a whole lot of detail on that other than going through some older cases that really were not related to antibodies. And but I think the ultimate take home message that the court was making, is that that the broader the claims, the more enablement is needed. And so there really is this sliding scale, and, and determining whether or not a claim has sufficient enablement is going to be very fact specific to the claims in question. So let me Oh, and sorry, they focused on the functionality language and the claims, and said that this essentially amounted to a research project. And one point that I thought that stuck out for me that we're going to revisit later, but they they did, in the dictum of the case, make a point that there was no common structure running through all of the claimed embodiments. And we'll talk later about what that may means and and in relationship to potential strategies to avoid these enablement problems down the road and some of your cases. So I want to switch gears real quick to a different case, which is the Juno therapeutics view, Kate Pharma.

Speaker 1  13:53  
And this is an interesting case, in the sense that some of the tech or the technology involved has a lot of analogies to antibodies. So this case, involved car T cells. And and so I put in a little bit of just tidbits of interest here that this this patent was originally owned by Sloan Kettering, and licensed to Juno. And was, it sort of self proclaimed as like, the birth of Carty technology, which I thought was kind of interesting. So that's just some side commentary. But the claim involved in the genome case here is a nuclear nucleic acid polymer encoding A chimeric T cell receptor, where the receptor comprises a zeta chain, a co stimulatory signaling region, and a binding element that specifically interacts with the selected target They also add in here, the sequence of the costimulatory six signaling region. And just to kind of get our bearings here, of what this claim is covering is that this is the this area right here is the binding element that is in that claim. And this is the stimulatory region. And so the binding domain is really a chimera of the light and heavy chains of an antibody. And that and that's the part that gives each antibody its very specific binding affinity to a target. So in essence, this is akin to an antibody and related to the subject matter that was in the Amgen case. And so, the the doesn't, there really was not a dispute about infringement. The kite therapy was the Scarda, which was also a car T cell type of technology. And and and their drug had or their, their biologic here had the same components that are in the Jeanneau claim. Now, the court found that, given the nature of the invention care that the genome patent failed to disclose enough representative species that would allow a full possession in evidence that they fully possessed, possessed any binding element that they are claiming, similar to Amgen, any antibody that binds to this end the PCs K nine M enzyme. But they the the court in Juneau, found that the patent was invalid under written description, not enablement. But the rationale behind the decision is, is very similar to what the Supreme Court and Amgen said. And and part of Geno's problem was that they really did not just provide any working example of the binding elements that they were claiming that would target the CD 19. And, and so they did have a, an exam, a couple of examples where they referred to binding elements, but they didn't provide any sequence information. So it looks like that they did actually have working operable embodiments but they didn't show or provide any other information about what those were. And so the court found that, that the Juno patent failed to show possession of the full scope of claims. So this is again, possession, not necessarily sufficient disclosure to make or use. And, but as with the Amgen case, the Court pointed to the functionality of the binding element. And in so merely claiming something by its function without without really talking about its structure. And that, therefore, the claim covers just about any single binding element for any target. And so a lot of the same discussion in Juneau, was made by the court that was made by the court in Amgen. And so a couple quotes from the Geno court that I think are helpful. They, it's they said that the 190 patent claims that you know, claims that just claim a problem to be solved, while claiming all solutions to it and covering any compound that later actually invented and determined to fall within the claims functional boundaries. Sounds a little bit Amgen court. And the written description requirement ensures that when a patent claims a genius by its function or resort a result? The specification recites sufficient materials to accomplish that function. And then even accepting that the SC FV is the binding element were known and that they were known to bind. This specification provides no means of distinguishing which binding elements bind to which targets. So these are the problems found in by the court in both of the prospective cases. And so where does that leave us in terms of I mean, what can we learn from these two cases? And what strategies might there be that help us address these these potential problems at the outset when you're having patents prepared. And so I'm gonna go over a number of practice strategies that I think might be helpful. My colleague, Jeff is kind of pointed out that a lot of these are, some are a lot of times pie in the sky, and in real life situations, especially in a university setting. So we'll have to take these with a grain of salt. But I think later on, we'll go into some some real life examples where some of this these type of strategies play out. And hopefully that will be informative of how you might be able to learn from those examples. So. So I think one thing that seems to be very important in both of the decisions is the the composition, function, issue. And, and so what do I mean by that? So when there's a appears to be hints and decisions that when you're claiming a composition, those are looked at different than, say, methods? And if you're claiming a composition strictly by function, with the appearance of potential structure, but but if the, if the reality of the claim is that it's much broader than any specific structure, that's going to be a problem. And as I'm sure many of you know, I mean, that there's other areas in life science, where the technology is so mature, that we're able to take certain shortcuts and assumptions when we are describing an invention. Where if we're describing an expression construct, for example, that has certain sequences that are responsible for certain functionality, and we we call those out, but then we may leave a very generic gene of interest type of language in the claim, which seems to have caused no problems with at least with the patent office, and I have not seen any case that's been decided, or that's looked at that issue. So I just wanted to kind of make a passing comment that I think that the maturity of the technology can be relevant. And that seemed to be a relevant point, especially in the Juno case, it was such an early filing, and in a nascent technology that

Speaker 1  23:51  
if that same patent were filed today, it may or may not meet the same challenge, but at least from a written description standpoint, but I think it's possible that the Amgen case may still have some bearing on on what challenges it would face. But talking about some specific techniques and things to consider in the drafting part. So I often think about having different independent claims that have different levels of breadth and and and so you constantly want to be mindful of making sure that you build into the application and the claim layout that there are certain fallback positions. And, and I think, in many of the types of technologies that are relevant to this, whether it be antibodies or car T cell answer that the sorts of things that we certainly want to provide as much as many working examples as possible, which I understand is not always easy to do for university researchers. One of the things that I like to think about too, is, you know, cross referencing, I mean, to other patents and, and literature references that might build up the number of examples that can work within the confines of the embodiments being claimed. And so, in some ways, the Amgen case serves as an invitation to, to, to almost create an encyclopedia of things which which is not not very practical. So I do, but I do like to try to include as many cross references to working examples or, or at least portions, or components of embodiments that we can build and support through a simple cross reference. And I think this slide represents what I view as a key feature and a key aspect of the Amgen and Juno line of cases. And that is being ever mindful of the structure function relationship, and making sure that the claims and the application specify some structure that would limit how just limit the breadth in the in the Amgen case, both parties admitted that the claims could cover millions of antibodies, and they only provided 26 examples. So I think that was a big factor in the courts thinking that there was nothing that could confine the open end of how broad this could actually be. And in the example of antibodies, one, one strategy that is is used is providing some structure elements around those aspects of the antibody that are responsible for its binding to a unique target. And primarily, what I'm referring to is the CDR, the complementary domain region. So and that's the part of the antibody that that is going to be specific to the target. So the problem there is that given the how variable the antibodies can be, it could unduly narrow the claim and provide less protection or significantly reduced protection for an antibody that has been determined to have a very important therapeutic benefit. And so it's not always a a, an optimal solution. But I believe it is a solution that will ensure our give a much higher likelihood that the claims won't be found invalid for lack of enablement. And, and the second point about dependent claims is really a variation on that theme. And that would be to have incremental, dependent dependent claims that have incremental limitations surrounding structure involved in the compositions being claimed. And the court in Amgen, I alluded to this before, had the statement about the fact that Amgen did not provide any structure that would run through running through all of the different embodiments that would meet the functional limitation of binding to the enzyme and preventing the enzyme from binding to its receptor. And so I think that would be a nice Q whenever looking at new disclosures, and figuring out if how broad claims that you might feel pursue is, is determining a and perhaps a list eliciting from an inventors? What components might there be that are common to the entire class, or maybe there might be groups that share a common structure, and you can claim those separately. And I said, this slide is just the representation of antibody. And I was going to use this to show you illustrate where the CDRs so this whole blue region is the variable Region of the antibody. And these ends here are the CDRs. And so being able to claim a sequence related to these regions, and build in some variability, such as adding at least 95% identity type of language, to the sequence of these CDRs, it is a possible claiming strategy, at least, to prevent this open ended pneus of the claim. And I also think that methods and compositions are viewed will be viewed differently going forward. And that methods of use claims could save the day. I so I think any patent that's wanting to claim a composition should include methods of using it for some therapeutic purpose. And in at least the technologies that I deal with most that's mostly how these discoveries arise is looking for certain targets related to a disease. And once you identify a certain type of molecule that binds that target, you would have a fairly good basis to claim that you could use that molecule to treat the the certain disease or condition that the assay is built around to find the molecule in the first place. And so I think that it would have been a very interesting inquiry to see, if the Amgen case if they would have had methods of using an antibody that binds to the specific regions that they said of the enzyme for treating a certain condition that those would be viewed differently. And I and I, and I can tell you, just from personal experience, at least with the examiners, that they tend to be much more lenient, and allowing a very broad class of compounds, if you are using that broad class for a specific purpose. So I think that's something that should always be considered in these situations. And and another thing that the court hinted at was that Amgen didn't include claims of, to their roadmap or their methodology of determining what antibodies might bind to the PCs K nine enzyme. And I think that and there's been a fair amount of discussion about this. And in the legal forums, that you it would could have been possible to claim a very broad method, where you're using a, a portion of the enzyme, at least in the case of the engine case, to generate antibodies. And the argument could be that what is novel here is knowing what portion to use to generate the antibody so so you could have a very broad method of producing or method of making claim that would be I think, hard for competitors to design around. And, and one of the problems that I think maybe we all know about these types of claims is they're harder to enforce. Because it's hard to know what people are doing behind closed doors, obviously. But I think in the case of trying to get through FDA approvals, there's likely going to need to be some disclosure of how these were made. And so I think that this type of information could be discoverable and that these claims might be very, could end up being very powerful claims after the end Amgen decision. So in the interest of time, I'm going to end my portion of the talk right there. And I'm going to bring into the fold here, my colleague, Jeff Jackson. So Jeff, go ahead and get started on your portion. Yeah,

Speaker 2  35:28  
thanks so much, Tim, this is a very, very informative and very engaging talk. And really, I think it reveals a lot, going through this process and working with you on it is just these last few days, we've really, I've changed my thinking a bit, I'll just, I'll just suggest that, you know, my experience with with claiming antibodies, has basically just been the idea of, we're going to claim an antibody with these six complementarity determining regions, and then the dependent claims just flow from there with regard to whether they're going to be human, or chimeric, or fully human or mouse or what have you. And, you know, I would suggest that these, these are pretty interesting from the licensing manager perspective, because they're very easy prosecutions, six complementarity determining regions, that's going to be unique, and it's going to be non obvious. And you're going to, you're going to get a patent composition claimed and, and that's great. The problem is, it's a lottery ticket, you know, that that molecule needs to be the one that goes to the clinic. So, you know, I've had to do that, largely because of art, the idea that the one we prosecuted, which has been licensed, licensed out to, to accompany and I think, is moving through the clinic. It there were other antibodies for this target. So the idea of a, of a generic version just wasn't available. So we got that done. And it's, it's a first step, it's often the first action allowance. So you know, and we don't know, we would only talk about, we talked about methods of treatment with it as well. So, you know, I would suggest, though, you know, part of this thing is a single chain of, you know, a single chain of V or an antibody basically complement any determining region, you know, they're the most unpredictable things we can possibly have in the biotechnol, biotechnology space, you know, and, you know, thinking as, as you're giving your presentation, you know, one thought I had was just, you know, these things, it's, you know, an ambience roadmap, and the like, was basically just go fishing, that's how these are made is like, you're gonna take, and I think you're correct, that you probably have a good method of, you probably have a good method of making these antibodies with a particular with a particular antigen. But you can, you know, ultimately, you're gonna have to just, you know, inject it into a mouse or, you know, come up with some type of screening method, and there's no design there, and data. And usually, there is no common thread running through these at all they are, they're nearly impossible to determine. So, you know, one thought I had was, you know, is, is this, you know, how does this then relate to other potential antibodies that come out? Or antibodies? How does this relate to other potential technologies that we might be taking claims on? You know, the idea is, if you have, if you're, if you're given a small molecule, for example, and you've made about 20 versions, and you know, somebody has done a structural activities relationship, and so, you have a, you know, you do have a common structure that you can claim, you know, are we you know, you're providing at least some guidance, you're providing something for somebody to start working on, in case you know, these cases are used to handle in case he these, this class of cases is used to limit those down. Or alternatively, you know, you have, if you have an mRNA sequence, you know, you have, you have every si RNA available, and there are pretty common techniques, and they're usually defined fairly clearly in the specification to, you know, to determine which si RNAs are good or uh you know, and then the question you mentioned sequence homology, I'm starting to get concerned about being able to, examiner's really don't like, you know 90% 70% homology sequence homology and it seems to be examiner by examiner. What do you think the chances are of this? This these cases creeping in believing antibodies? I mean scfvs Are antibodies to and, and then creeping into some of these other technologies.

Speaker 1  40:37  
Yeah, that's a great question, because that scares me. Well, I was just getting ready to say that that scares me too. Yeah. And it certainly, examiner's are opportunistic. And if they feel like they have a new basis of rejecting the claim, they're gonna take it. And certainly the same would be for any defendant in that court case. But I, in going through the process of studying the Amgen case, and that related Juno case, I started out pretty cynical about it. And but I think the more I thought about it, I do see where just justice Gorsuch it's coming from. And I do think that it relates to the point that you made about antibodies being one of the most unpredictable and complex type of subject matter that we claim in life science area. And, and I think the boundary lines, what is required to enable the, say, a sequence or an SI RNA, or IDs, or RNA or something like that. I mean, one, I think that the policy considerations, there would be pretty significant. In that it would, it would invalidate the hundreds of important patents. But I do think, though, that the tech, there's a difference in the technology and talking about something that has homology or identity. It I believe is a little more contained than having four different CDRs with that the permutations just start becoming exponential. And, and so I think I'm hoping I haven't had a something come up where I've had to argue that at least with respect to enablement, but I'm hoping that some of the well established types of approaches to claim and things outside of antibodies are not disruptive. And and I'm thinking that given some of the ways that we're already dealing with having to capture the structure, or are the defining that the the limits of what the claim could cover will essentially prevent a lot of spillover of the Amgen case, but that's yet to be determined. Really?

Speaker 2  43:37  
Yeah. I mean, I, the main thing with my concern is usually if it's good, I could say you're claiming a mutant enzyme, that that works, that works in a particular way does a particular thing. You can claim that for something you know, 70% 90% homology, it depends on it almost depends on which examiner you get, what they'll accept. But then you also you also add in the, and it's still gotta have this function, you know, obviously, because, you know, if it doesn't work, okay, if it doesn't work, we're not going to claim it examiner's don't really like that, either. So, you know, I, I'm hopeful, but it's unclear and I don't know, and, hopefully, you know, genius claims a small molecules will still work so long as people keep them a bit reasonable. So, yeah, so yeah, I

Speaker 1  44:36  
think you're right. I mean, one way to view this case is that this is now established or will at least force people to be thinking about how to contain the scope of an antibody claim. And, and you know, we alluded to having to put in like the CDR type of language in there. But you know, each each sort of subject matter kind of has its own little way of, of claiming strategies that help address these written description enablement problems. And maybe this is, this is just going to be the antibody case, which, again, I think we both are hopeful of that. Yeah.

Speaker 2  45:23  
One thing I'll add for, from a technical perspective, sequencing CDRs, and sequencing antibodies is no joke, even monoclonal antibodies. There's a group, there's a group at UC Santa Cruz, who did come up with a new technique, that seems to be pretty helpful, where we're trying to work through getting it getting a loud, but if not, it's still a pretty decent way to do it. So I would, you know, for everybody who's a licensing manager, you know, I, I would really try to pound in your investigators that we can't do much unless we have a sequence to an antibody, oftentimes, you know, research, researchers will make a monoclonal find that it works, and not really get around to, to actually sequencing it. And yet, while we can, you know, while you can claim it as a cell line, for example, you know, it's, it's so much easier to have a sequence place, I'm going to kind of skip through our section on the ones factors, because I think that's, that's us eking out pretty heavily. But I do want to give some examples that I've seen coming out of the 1600 art unit, and this is one where it's bleeding over into methods claims. So I got, you know, we this is a recent office action we've received and ultimately, there's a theme amongst showing two examples, I, I have about three or four more. But what we're seeing what I'm seeing as a trend is there are his patent examiner's are basically going to limit your claims. And they're going to base it on written description. And they're going to limit you to whatever working examples you have only they're not letting us go beyond our working examples. So for this one, we had an investigator who discovered and this is disclosed for the first time in this patent application is a notch for inhibits milk production in mammals and protein called notch four. She also discovered a protein called Robo one inhibits not four and a protein called Robo two inhibits Robo one. So the end result is that Robo one agonist and notch four and Robo to antagonists will increase milk production in mammals. And so we this is blue sky, there was there was really, there's no argument decided against us in this in this case. So the examiner, you know, basically got it into his head, that is going to be too broad. And so, you know, all we're claiming here is methods of increasing milk production, we're not claiming compounds in this until we're getting to dependent claims. You know, we're basically inhibiting by doing one of these. By doing one, we're increasing milk production by doing one of these three things is our clamp. But the examiner is trying to limit our methods to specific compounds. In the patent application, a lot of work was done with a robot one agonist examiners trying to limit us just to those Robo one agonists that we use, we describe a few si RNAs and the exact you know, but we give the RNA sequence of of nots foreign and Robo to and the examiner is saying, Well, you got to show us exact si RNAs that that. So, you know, we've submitted this for pre appeal conference. We shall see how that goes. But, and then in another one, you know, we is even further afield. It's not even a method of treatment. Its method of screening compound libraries, or inhibition of a complex that when it forms, it's involved in circadian rhythm regulation. We describe these screens in excruciating detail back in the first office action the examiner either didn't bother reading the example section or or was looking at it other application, he said, we provided one pathetic example. And we went it out, you know, nine different example sections that were credible detail. But ultimately he dug in and suggested that, you know, we'll, you know, it's a good suggested that we never ran this with a test compound, despite the fact that one of the, you know, so we claimed an element is contacting the complex with the test compound, we described a compound at work that worked in an independent claim, we also suggested that you can run this with the positive control. And the dependent on that is, it's a, it's this positive control, because that's what we did. So the examiner is basically rejecting all claims on the basis that we never read it with the test compound, and we're on appeal. And I can't believe we're having to do this, but we're explaining that the positive control was a test compound, before we knew it was going to work. We did actually formally describe what a test compound is, and it's pretty much any compound, we don't know whether it's going to work or not. So, you know, we are, you know, we are seeing this and, you know, I guess, you know, the, you know, we're we're working out what we're doing, to push back. And so, you know, my main, my main view on this, and, and, Tim, you can suggest this as well. You know, it's response, we all know that with something like this a response after final was pretty worthless. I used to do a lot of a series of RCS in this case. But, you know, we if you come into exam or that's dug into something, I think it's it's, I'm rapidly getting to the point that it's, we have to get the case in front of other examiner's and I'm suggesting three ways to do this here, you know, the 19 year old pilot program of the pre appeal brief review request conference. Full we've done full appeal on on certain cases, we have done the Fast Track appeal yet, largely because largely, because if you win an appeal, you get all the time spent an appeal tacked onto the end of your patent term. And that, to me is more valuable usually than getting claims in a big hurry. Obviously, you shoot for the faster I could feel when you have a licensee and maybe there's somebody infringing. So but that's generally out of our hands. So I don't know, Tim, what's your experience been? With these?

Speaker 1  52:49  
Yeah, so I, I would say that I'm much more that your first line, though. Fine RCD post following. Yeah,

Unknown Speaker  53:00  
I wasn't till now.

Speaker 1  53:05  
And, you know, and maybe they're not exclusive of one another, either. I mean, if you've got some good compelling evidence, it's probably good to, and, and good expert, you know, input from scientists, whether they inventors or maybe some of their colleagues in the in that field. You know, I think it'd be good to bolster the record for appeal. But I am, and I think this is an intriguing approach, I have tended to shy away from appeal. And my thinking was that it was going to be more expensive. But I, you know, what, if you think it through, you might want to just, you could, you could maybe save expensive multiple RCTs and responses that go into each state stage of that process by if you're at a point and establishing a record that you feel confident and, and it really might be worth pulling the trigger filing an appeal and getting at least some resolution quicker than later. And, and there is also that possibility that having fresh eyes on this, and those that are a lot more attuned to the legal standards, and the case law might have a different perspective than an examiner who's who maybe has put his ego and behind his position, or position.

Speaker 2  54:46  
I think we're at the point for q&a. i We could I've got more stuff but if I want everybody to, and we did decide we can stick around for a little bit past the time by the hour. And I'll stop my sharing for

Unknown Speaker  55:03  
not sure that I know how to do the q&a

Unknown Speaker  55:12  
I have an open. Hello, yeah, I

Unknown Speaker  55:14  
can help too if they're okay.

Unknown Speaker  55:18  
I'll give people the chance when

Speaker 1  55:19  
I saw the q&a. I toggled that. And then it says, oh, has the, the tab with open? And then so that's where the questions would be. Right. If there's any.

Speaker 3  55:30  
Right, there are any questions, no questions?

Speaker 2  55:34  
I can, I could just, I could just suggest one more, you know, I guess more discussion on what we do on the, you know, that's the back end, we filed a number of cases, and now we're under this new, we seem to be under new rules, which, you know, that's part of the game we play. That's, that's what's fun about working with, with patents is, is rules change constantly. And then completely during the game,

Unknown Speaker  56:01  
job security,

Speaker 2  56:02  
it is, you know, and it's it's like, you know, it's good, good, sometimes good to be less experienced, too, because you can notice that in your ways, or he can't be, you know, like, like, we discuss more on the front end. You know, I guess, you know, we alluded to this is there's there's not much that we in the university setting can really do to control what our patent applications look like, you know, people, students want to graduate, our, our, you know, our, our faculty need bead grants, that beats publication, they need to give talks, and they, you know, it's, it's important for everybody to get out there and talk about things. And so we have to, you know, we're driven by filing in front of publication. And oftentimes, there's just, you know, if we're sticking with working examples, we're, we're stuck with that. We're stuck with what we have. And so I guess, you know, one thought, is just to embrace this. It's like, yeah, we have what we have. And if we, you know, if we want something else you know, if we, if we want another, another Pinay, another embodiment, we're probably going to have to file another patent application on it. If it comes later. I guess the, you know, the one obvious question for that is, okay, then are we going to, you know, are we going to trip over ourselves with art. And as it's, it's, though it's the case, I'd really love to see in front of the Supreme Court, you know, the, the person of having ordinary skill in the art for enablement, is nowhere near as competent as the person having ordinary skill in the art for obviousness. And so, you know, do we do we think that, you know, because if you're gonna say, none of this isn't made, an examiner is gonna say, Yeah, nothing, but this right here is enabled, then, technically, it's not prior art or anything else either. Again, I have yet to be able to make that argument. I'm looking forward to it, I guess.

Speaker 1  58:32  
For jobs, so using the Amgen case, as a defense of prior art rejection, I think that's kind of also a your is that is, you know, if the if the running, well established principle is that prior art must sufficiently teach in order to render something novel or a hobby or not, not anticipated or obvious. Then, you know, the reason the rationale here in Amgen case might be helpful to rebut those types of rejections. That's a lot more nuanced. And I'm not sure examiner's are, well, they aren't gonna like it at all, they're not gonna be like that or be willing to entertain those arguments. But, again, kind of looting about that referring back to your point about pursuing appeals sooner than later. That that is the type of argument that might might be convincing to an appellate panel. Yeah.

Speaker 2  59:34  
And ultimately, I think, you know, the, if this is the direction we go, then in biotechnology type cases, I think we just need to embrace, you know, in terms of being in terms of costs being in terms of, you know, basically just just effort and, and, and, and well being in terms of cost cost or effort or whatever you have is, I think the idea of of, you know, smaller, smaller claim sets or narrower claim sets, but too powerful things like, like composite, you know, basically new ish composition claims. Something we're going to have to try to do now, you know, we're not, we have to license everything out. And yeah, there are workarounds, but you know, here, here's the thing that works, you know, play with it at your own risk. Why don't you just license it? I think that's, that's the mindset we have to have is more apps less breath, and maybe less, less hassle, if we're aiming for something that's ultimately ultimately fairly clear and easy to easy to defend. I, I I'm always kind of a I was trained by I was my mentor in law school was a contingency fee plaintiffs patent litigator and he suggested, he said, you know, what, what's the best claim you could get? Like, well, it's broadest claim you can get through the patent. Yes, it's the it's the narrowest claim that somebody needs to infringe. That's your that's your best claim. And so maybe we need to, maybe some of us need to embrace that a little more. In any questions, I think people are

Speaker 3  1:01:34  
heading out. Yep. No, no questions. Okay.

Unknown Speaker  1:01:38  
Okay. Oh, great.

Speaker 3  1:01:41  
All right. So thank you very much, Jeff. And, Tim, for this informative presentation. Any for any final remarks from either of you?

Unknown Speaker  1:01:54  
I think I just did mine.

Speaker 1  1:01:56  
I guess mine would would be, you know, I hope that it was informative. And I'm certainly willing to entertain any questions offline if anybody wants to reach out to me via email.

Speaker 2  1:02:11  
Yes, me as well. And come, come see. Come find me to autumn. The national meeting. I'll be there. So

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