that i'd like to discuss and i was hoping to use my time equally between the two the st is regarding the nineteen patent and it's whether limiting claims to a preferred embodiment where the specification shows the invention is broader is appropriate and the nd is relating to the nine dollars to six dollars patent that's whether in the mission by the defendants to the f d a regarding the safety of their product in order to seek approval to sell this product to the public should have been permitted to go to what's the status of that proceed there's been appeal filed in that appeal is still pending so that an appeal to your people before the appeal before i'm not handling that case that but it's an appeal to so there is a possibility i mean are we believe that there's a good chance it will be overturned that there are some good issues otherwise it wouldn't be proceeding here and wasting the court's time in that regard but do you hear there's no it just before this court you know there's none it's just the issue there's the issue bout the inequitable a stop all that we raised and then the other issue that i wanted to mainly focus on which is whether in summary judgment the judge was appropriate in not allowing the issue of the f d a admission to go in front of a jury and we believe that that should been something that went in front of the jury and not decided on summary judgment so so defendants responded to the question by the f d a asking well let me back up just a moment the limitation in the patent of the nine to six the nd issue that i wanted to talk about requires no thermal damage further than five micro the sole source of evidence you have is this f d a submission and then the other side came forward with an expert justifying that well whatever the contents of the f d a submission you can't understand what's going on here and being a true zero micron term the damage because that's a physical impossibility and then explain that through an expert declaration and so that submission and there isn't any expert testimony on the other side well the problem i have with the expert testimony is st of all you have an admission under oath as the safety of the product you know to the a ok versus a highly paid expert who admitted who there's no evidence they conducted any testing whatsoever on this so these are just their radical ideas that they're putting forth and i think a reasonable jury with the request and the request was temperature elevation data from tissue adjacent to cuts to confirm that the higher rate is not producing thermal damage so it's the same thing we're talking about here in the patent not seen at any laser repetition rate tested so their response in their statement of their thermal side effects was a complete it was in response to the f d a requests of whether there's thermal damage and then they continue to sta there for there's insufficient time for thermal energy to diffuse into the surrounding tissue the absence of thermal side effects is one of the advantages of plasma mediated photo disruption for cut tissue cutting so i understand that their statement says their most side effects but it was in direct response to the f d a request of whether there's a general damage i mean in f d a i understood it to be that with respect to get even less damages unless there are most side effects and then we show the wave light there is evidence that they are spent a nd is it three hundred and fifty five dollars to a nd so you're going to get their own scientists said the shorter wave for i surgery ok these lasers are marketed in the f d a it's represented that they cause no damage i mean no one wants a laser to cut into your eye and cause damage to the surrounding tissue and that's what these  to do and when you have an f d a statement as to the safety of it that there's no damage i mean it you know whatever an expert says i mean that's the admission that's there that should be sufficient so turning to the preparation of the target region limitation ok the one hundred and ninety nine patent teaches changing the scattering and the absorption characteristics of target material to affect how a laser interacts with the material so scattered and you make changes to the material to change how that light to the lasers who are doing the modification of the tissue are going to be affecting the tissue and so the court country made a construction that applies that reference a preparation or an agent and nothing in the claims talks about the preparation or asian they say that they need interpreted later in summary judgment to mean that you have to add a substance or and the requested construction was actually a construction that was decided and approved by previous court as well in the district and district of delaware so our position is that it claims not you know just discar and if you look at the plain meaning of preparing a target region by spatially or temporally varying at least one absorption characteristic of the material or scattering characteristic material this is easily understood nothing in the pla ht wouldn't it be appropriate under that instance for the court to understand the preparation of a target region limitation to be all about being in the region but i do understand that case i think there's g p s and it was one of those cited in the language it was used in the cases when a pattern repeatedly and consistently characterize the claim term in a particular way here they are not dealing with a claim term that's being characterize a certain way the claim terms themselves are the preparing the target region by varying absorption characteristics or scout encrypt its characteristics and material and then what the other side is using doing is taking the word agent which isn't even part of the claim term and then trying to import it into the claimed term using this law but it's not even part of the claimed term it doesn't fall in this law and nd you don't have a repeated inconsistent characterization of a claim term the work prepared prepared in any form appears in the entire ninety page patent only three times so you know how could you possibly have a consistent and repeated characterization in that regard and when you have i mean you have other areas like for example in appendix and i'm getting into my rebuttal time but in appendix one hundred and seventy one and you have a distinct th example or a method that doesn't refer to path to agents at all you also have technical field preparing the target region of the target material by spatially or temporally bearing and it gave that term the only meaning that supported by the intrinsic record under this court's basically in construction rules when there is no single ordinary plain meaning to a term when the patent repeatedly and uniformly describes a term one way and does so with language like key to the present invention the panty cannot be that context in the specification striking the expert testimony or are yes well that was an unfortunate of the local pattern rules it's under abuse of discretion standard your honor never mind the standard what is your view on what discussion at all of anything like i dropped that could satisfy the preparing limitation and given that fact the district court was well within its discretion to strike the expert  submission in that case i think that you know under this court's precedent the only way that it would overturn the enforcement of local rules would be if it's unreasonable arbitrary or fanciful and i think when we're talking about could not rely upon that expert testimony i think that if we take a step back step back and look at what is arguing here and that's very clear in his reply brief at pages one thousand to twenty it's basically say he's basically saying that all he needs to do is say that our accused device practices this element and then once he said that he can come back at the end of a case later in the case before trial and say these are all the ways now in which i think that your device practices that element but the rules here require a much greater specificity they require where and how each limitation in the sort of claim is found in the device and he didn't do that and so given that fact it is within the district court's power to enforce its local rules and strike report again and just one more point on this doctrine if you're never he never asked to amend his infringement conten we're looking at a situation where he just unilaterally change this infringement contentions and this is a case that was involved at the time when this case began many multiple parties a number of patents it was very complex there were a lot could have filed a motion to amend his infringement contentions and then the district court could have decided what to do how that was going to affect the proceedings and what steps should be taken but here in this situation he didn't do that he respond to i don't see how this point had no opportunities to respond to these arguments from the very beginning was the one that gets to say this is the way in which the accused of vices practice the limitations he set forth his reasons why he thought that our devices practiced these limitations and then after a fact discovery closes he changes his theory the district court in that situation to require such an opportunity i think that the need would have had me have had the opportunity here in this case to set forth infringement contentions that would address this limitation he did it's a matter of a fair trial for the defendant to know the way in which that limitation was practiced so it could conduct just took discovery on the issues so it could look at it  validity contentions based upon those infringement contentions it's too late after discover his clothes after invalidity contentions have already been submitted for him now to say i have a new theory of infringement but even saying th site is a matter of fair process if the case had changed in a way that he then wanted to introduce new infringement contentions the appropriate mechanism for her to him to do that would have been to ask the district court to amend the patent briefly on the claim construction issue just to say that this is the type of case in which it repeatedly and uniformly discusses adding an agent in this technical term this case is like the g p and he case in fact it it's a step further from that where there might have been a plain order meaning of the term node which then was held to be a pager but here you're talking about a claim which has at appendix one  section of title principles of operation use of doping agents and selective marking of targeted reaches within the material and the patent uses language like key to the practice of the present invention and then just discusses the use of an agent so you have in here a situation where you don't have a term in which there is a plain ordinary meaning that a person would have understand a foreigner skilled or would understand outside the context of the patent and the only way that you can discern what that meaning is is by looking to the specification and when you look at the specification the patent exclusively and consistently and uniformly describes using an agent in this claim and so have here is an f d a document in which al can already has an indication and it wants to get an additional indication and so what it's doing is it's doubling the pulse repetition rate and the f d a wants to know if this is going to affect approved indication and so in order for a need to have an argument here based upon this f d a document you would have to have some evidence that explained that when the f d a is talking about thermal damage and al about thermal side effects in the process of trying to get an additional indication that means the same thing with respect to the ninety six dollars patent of the very precise microscopic limitation of no more than five will the disruptions and there is no evidence and here there is an absolute and complete failure of proof and so one could not imagine if this case did proceed to trial that all me would have would be this f d a document and he would show that to the jury that's not enough for a reasonable fact finder to determine that this very specific limitation in the ninety six patent of no more than five microns is satisfied i think that if you but what we have here is no idea what thermal damage means in the context of f d a submission and i think that's important you look at what our engineer explained in his deposition he said that  engineer discussed in this is an appendix for eighty that when you're talking about the precise thermal damage of the ninety six pan it's different he said it's a matter of measurement measurement it's not the thermal damage as we discussed perceive you know observed by necessarily clinicians but there is thermal damage and i don't know if five microns is a good threshold it's slightly deeper than five front and so he's talking about is that if you're talking about clinicians people who are using the laser people that the f d a would be talking about to see if there are safety issues you're talking about these microscopic amounts and so there's no thermal damage but if you're talking about in this very technical field the no more than five microns there's no evidence of that and they don't know and this again is neves burden to prove infringement to offer evidence from which a reasonable jury could find infringement and he did not do that here in this case talks about utilizing preferential time dependent and or space dependent marking of the target region and this refers to temporally or spatially not a find the target material characteristics without any reference their scattering and or absorption such selective location may occurred naturally or may be inserted earned used artificially by the operator additionally we have other references for example appendix one  it may be naturally done or inserted or induced artificially so it's contemplating inducing changes in the target tissue below the surface in the only way i mean if not actually i mean the only way you could substance would be like through a needle or something i mean if you if you continue on to other references it talks about doping agents are added to the material being a plating before it is optionally obstinately doping agents are added to the material and often small residual modifications to the surface follow the interaction with the laser source act as a subsequent absorbing agent and perpetrate the process at any desired results repetition so here we have a d acts as an absorbing agent and there is nothing added no substance and that as required by the courts construction so i think oh i still have a bit more time i thought it was a no no no  honor judge newman was asking about only substance that adding the drops my perspective when you add drops you change the density and the same thing happens when you add compression the patent is about changing the density of the material and that the timing didn't allow an opportunity to amend counsel on the other side had tried to do that with the related case and wasn't allowed on the depositions however disclosed everything and so did the reports there was plenty of opportunity to take a look at this to ask about it and to discuss it and so that the timetable was pretty compress and we'd even asked at one point st day because of the patent reexamined that was going on in the ninety six and that was denied as well is once as you have the philips once you begin to include elements not mentioned in the claim in order to limit such claim we never know where to stop and here there's no mention in claim one and there's no basis in them porting that claim t limitation of applying a preparation was completely created just not in the language of claim one and a limitation the district court then interpreted as summary judgment required the application of a substance so at least two points steps that were taken that required accepting my perspective the original construction if you didn't view agent as a substance would have been fun but when the court reviewed interpreted that to mean a substance that had to be applied then that's where the real