versus austin scientific appeal fifteen fifteen from two thousand and eight molecules there's been enormous amount of debate on what minimally poor as to not macromolecules means but it is quite clear that the specification defines exactly what that means and it defines it as meaning horse or openings not chemical bonds not chemical linkages not iraq traction or anything else and it does sell in column fourteen and i'll just read it to its one sentence figure two ticks displays a critical the third line of that paragraph says regardless of poor size they are what are you saying that this is an embodiment that's not going yes that's exactly what i'm saying your honor because i wonder why you can see that i mean  defined minimal core size it's to find it in terms of pores i read you two statements in the specification where it defines in turn supports in the statement right above the paragraph you're looking at i eight it says that the perp for the purposes of this invention the poor should be small enough to restrain molecules greater than around five hundred dogs is telling you that the key is pores and it goes says regardless of poor size what that means is that the definitions i read you before talk about the porous this embodied mint is not related to the poor as it's related to an  the specification talks about chemical balances heavy reliance by dr saffron on chemical bonds the the specification does not tar i chemical bonds to restraining macromolecules the specification discusses chemical bonds in terms of reaction rates in terms of release rate and in terms of specificity neither of which has to do with macromolecules and i it sounds like your argument so far has been one of claim construction that express claim terms should be given the meaning as clarified in the specification but i thought that was a heavy focus of our great so let me go into it our position is that there was a clear disclaimer in this case of a structure that has large holes large pores such as the stance involved in boston scientific so taxes stent and the specification continually criticize criticizes prior art structures having large pullers that either you don't need to reach the uk that's exactly right and there's there is still a third one which i'll get to in a second dealing with material released me now dr saffron tries to minimize the disclaimer by saying well all they talked about were metal stents they didn't talk about stents that are coated drug eluting stent says in this case i submit that that is a distinction without a difference if you've got a layer that tracks the stent with large openings and large holes it presents the exact same problem that you have with metal sense whereas the disclaimer burden weir's the disclaimer the disclaimer is criticizing in the prosecution history or  spec on this issue in the middle in the middle and the material released means it's in both in this case it's in the spec in this case the there are continually continuing statements retain the macromolecules provided by the healing tissue in the sight of the healing tissue and not let them escape away from the human tissue so they can accentuate further him through the use of minimally porous openings that's exactly right mr going is there is the dispute here between the sides it seems to me the other side is pointing to a diagram on page is a critical aspect of the debate between us and their argument that all you do is look at a struct is taking the claim language and instead of saying a regular of minimally force material they're saying a portion of the layer and their theory doesn't work because cramer nine there's a metal strut under that minimal portion if you just look at one strut and pre guess at the entire layer not only do you ignore all of the discussion is  about the method of claim eight which is one of the independent crimes were by the leather permits the through passage of small molecules such that the devices nontoxic to the damaged tissue the reason it's minimally porous is that it's not it promotes some molecules to come through small molecules which are beneficial and if all you do is look at strut and say you need to just see whether that strut is minimally porous you've got a metal piece  there is a disclosed in body which doesn't fall of this category how can the specifications be a clear and unmistakable disclaimer but that's a that's a real problem here on our it shouldn't be a problem and let me explain why if the specification said here's an embodiment of minimal i'm going to do a hypothetical which i ask you to accept the use of course through the use of openings and then you had another paragraph which said another body mint is one that wasn't minimally porous but you could also restrain that way you can use ionic charges or you can use hydrophobic interactions now i would suggest that in that situation with with that kind of statement i wouldn't think you should have any problem because the spec is telling you the embodiment that is claimed minimally  defined here and this is what i mean by minimally porous and when i get when i talk about ionic charges i'm not talking about minimally porous now my hypothetical is really not a hypothetical this that's exactly what this specification says the to the size of the pores now i think that's a clear and unmistakable difference between the two and i'm suggesting that there are cases and i mentioned before i argued unsuccessfully i lost one to  now when you lose eleven to one that it does no but saying that you don't know but saying if you don't claim under sloes i don't recall seeing any cases in which we lied on the that i know i don't know your honor i cannot cite any case since then but i can remember that case is indelibly ingrained in my head so i argued it unsuccessfully and the point is there can be disclosure which is on claimed and i suggest but there's a presumption against it at least there's a maybe and if i had a situation where i had to embodiments and one of them and i'm saying there is a disclaimer and one of them was covered by the language i'm talking about the other one was not i'd be making a different argument than i make now i don't think that's our case i think our case is one where they expressly say this is not minutely porus which they define in another part of the  are smart enough to pass through the openings in the stent there's no dispute about that so if i'm right that minimally porous has been defined as having winnings which in effect are smaller than these molecules and if i'm correct in saying there's disclaimer where you got these openings and i submit that there's no substantial evidence to support the jury verdict i'd like to go into the third part and that is a separate independent and i submit that there is nothing in the specification and everything the specification against it nothing supporting that the chemical bonds and linkages are taught to relate to road to specificity neither one of which has to do with directing with try getting or directing the molecules and in fact the specification is replete with statements that two additional structures are necessary for the directionality provision and one of those structures is the minimally porous layer at the other one is coming that minimally courseware on one side and there are sites are through it on blue twenty and twenty one there is a list of sites supporting that everybody meant every embodiment in this back that deals with with directional release has coding on one side and if there are any doubt the statements in the prosecution history are really compelling and i will just route them to you it is on page nine seventy four and ninety seven for line and it personally sad as strong about this gut and it says the critical concept missing from my designs is directional drug delivery the future direction delivery which lead to squares in my patent for karate and that's a set chemical bonds and linkages don't try to get anything they just release once they're released there's nothing in this patent that says they will go toward the that's a well so your argument and the other version of the other side that's exactly right your honor it is completely counted on four sides and one of them side as access to the bloodstream and the other one is closest to the vessel  restrain and there's evidence to support this it's restrained not by the poor size but as the pack attack so is small enough to go through the openings it is restrained by some other mechanism and this patent does not target chemical room can staple suture otherwise and we didn't want to get involved in a debate which is what happened below that because you have an enumeration here only one of which sheet and the other ones which are spray in tube therefore somehow  we have multiple embodiments and this is just one embodiment on the other hand the spray creates a film which once it's applied seems to look and work like a layer and the tube likewise suggests a continuous surface which seems to be the opposite of a mesh cylinder normal stand your honor i agree completely with you and i would be i would be happy to  the device that says the device comprising a layer but then it goes on finally in the last passage just talk about the device in capel then substantially restricting the passage and so a device is coincidental coextensive with the entire structure stat then clearly the q s product doesn't meet this limitation of iran or you must have been a fly on the wall of our pre hearing conference we discussed that you're exactly right that argument can be made the right to c one is the minimal importance cause and the other one is the device which doesn't talk about away or it doesn't talk about anything smaller than that being capable of substantially restricting that through passage of at least one type of ma molecule there through that argument is a viable argument one that you just pointed out and again i think that bolsters our point there are only so many arguments one can make in a grave and we made what we felt were the strongest arguments but that point is a reinforcing point that we can rely on because that to the disclaimer applies both to that cause and applies to the minimally porous clause so that your or the point you minutes and you will have the same that chemical bonding thing is reflected in figure three is that correct your honor this is what you point out in the column a is one of several places in the patent were talked about regardless of study is one example of chemical bonding that shown it one of several different invited to what problem is that if you look at figure three year it shows item one and if you look at the definition of item one of the reference layer in their reply brief a page twenty five that that layer is not a sheet but the problem with trying to call it a sheet is this is a sprayed on layer you could take a look at any of the struts of the step and referred not a step what the claim one and claim eight and eleven when into the record and not limited to those who one of the embodiment as a stand but the words that in the reference to a stent does not appear until claim eighteen the broad claims in this patent are directed to a layer and in fact what's unscientific i was surprised to hear the comment that they think it it is that the claims are directed to a stat or to a wire messed up because in their briefs they indicate that no they agree that the invention is a layer and not a step and that is exactly what we have here it's as they've indicated in their brief it page nine what's being accused of infringement is the would not be a sheep that's wrapped around the metal rod this would be similar to the struck can i just clarify it's your theory of infringement depends then on are construing each struck separately right actually it doesn't but we believe that that is what involved here when i look at the r defies a lair on the entire stent then there are clearly holes they're still clearly opening so the only way i think you can come up with a viable theory on infringement is just suggest that we you know we look at school supply every strut individually and not to the stepped entirely which is a combination of structure i believe what your honor is talking about it's gone back to be  s argument minimally ports requires small core sizes for the pendulum or sizes and if i'm correct in that then our position is that the layer and the control of the release of the drug sufficient if i applied to first i apologize for not talking about whether or not the strut restrains the treating material it is the layer that chemical bonds and linkages causes the restraint for example if you look in the patent prosecution the judge approached is correct that the restraint provided by the struck can't be the the layer that's referred to here the mechanical restraint is not the mechanical the strike if i indicate it differently out say so and so the question is can we read the specification to refer to chemical restraint as opposed to restraint by mechanical sheep right absolutely it can  and that is the way we submit it should be right but but it's packed with taxes on chemistry and not the chemistry of the defiance that keeps the drug in the tissue right how is the device capable of restricting the through passage if it has holes when you're dealing with shoot with some chemistry when the drug is released and if you look at claim one what it says is the layer of having material released means throughout the pan it talks about the release being controlled by the chemical bonds and link s that only when those bonds are broken is the drug released back to treating macromolecule ok when you go down to the last part klein forty six is says it divi the device there is the layer of flexible material with the material release means an approach of second surface be capable of substantially restricting the through passage of at least one macromolecule only from the side facing and that's a medley adjacent to the damaged tissue then it is kept in that area it's directly deliberate and it what it's back through that layer won't pass around the side it's kept in that area it's not talking about anything else it's not talking about the openings in a meth stem and in fact what we need to focus on what we see i submit you need to focus on here is that claim one is only talking about the treating material it's only talking about one at least one type of macromolecules that's the treating material there's a lot of references in there disclaimer argument and the disclaimer argument is dependent upon saying that the which shows an embodiment where and dodginess micra molecules would be released how do you deal with the prosecution history ninety seven forty to forty which seems to say referring to a sheet as your it's not referring to a sheet and in fact if you go to ninety seven thirty eight of the appendix and that this is and this just a couple pages before in the same op in the same response it says this device is capable of releasing medicines by chemical bonds where as the mountable fracture stabilisation device with minimal pores which was the two six two pattern that's referred to requires micro cores to release medicine this patent is depending on chemical bonds for the released only it is relying on the chemical that the letter for only chemical bonds well what it's relying really chemical the drug is held to the layer sheet that provides a mechanical restraint of the macromolecules is not within these claims no because what you need is you need something to hold that that treating material inside using the if it is a sheet to hold of to the sheet and only when that's released when those bonds are broken is the drug released this is the problem with the argument that in the excludes you know drugs on both sides both the side or the both surfaces both the surface facing the damaged tissue as well as the opposite surface the issue is not where the drug is present the issue is where is the drug released and only if the chemical bonds are broken wood and it's only broken it's adjacent to the damaged tissue only where it's broken is a release of the drug it's not released on the other side and that's what this thing which is over scott the fact that it's not released on the other side whether or not it's present doesn't matter and scott it released in well direction got washed away but dr sandford wanted to do and did disclose and his is that you only release that on one side the surface that is adjacent to the damaged tissue and it's only when those bonds are broken is that there's a release occur and that layer has to be made of a material that is that's not talking about the size of the corporal's that's talking about a function and that the material the trading material once it's released will not as back through that layer and that it will not be able to be washed away the healing molecules and skipping from the injury site on the part of the war i have several responses dr sandford has several responses your honor first if you look at the pending claim ten on a one seventy two it says the method of claim eight were in molecules produced by the damaged tissue are substantially restricted adjacent to the damaged tissue so that the issue that they're talking about of controlling the  tissue and very little of it next to none of it coming off toward the healthy tissue the whole purpose of this the primary purpose and it's replete throughout the patent is the treating material the healing released they would not will be restrained they want why should we accept the idea that claim one is only dealing with the medication and not the end dots and those not promoted because claim one talks about number one a treating material really look at claim one is says on my question the question is whether the first appearance of the word macromolecules shouldn't be read as including both types of the indicted innes and the medication if we can look at claim one th what is actually being blocked in plain want and it says the flexible material that is minimally porous the material is decoding that's the material and the function and that's functional language adjective that describes the material and it's saying that material the function of it has to be that it substantially contains the macromolecules on one side  function as a as opposed to a description of the material it has particular pore sizes as well i'm not referring to prosody what i'm referring to is minimally porous a minimally port's is what's the function of that material itself it talks about it but for you to say common meaning and then not cite anything that's were that's a little problematic we don't think it is chris we think it's a term that doesn't need any special definition one side of the device so then your argument ends on our accepting the idea that minimally orus is the fewer really functional definition not the definition of structure  only is it purely a functional definition but that it's not referring to a mechanical function it's referring to a chemical function right no we're saying that we're saying that it's not achieved by a mechanical function it's not  functional structural and if it's only functional then see the me you have a big problem it's our position that the material itself has to be minim only a small amount of minimal now passes through it and that's all it's talk about it's not talking about the structure of the bites not throwing the portside it's openings it's not punk but a mechanical structure it's what is the material made of what is the function of the material and that function is that the material is minimally poorest that has its odd position that has nothing to do with foresight and throughout the patent such as you pointed out in the beginning literally no clue are you suggesting then that minimally poorest means it has some pores of unknown size that it has very few of them we submit that minimally porous only means that the material that the treating material is not substantially passed through that also if you go down into the bottom of column fourteen it talks about controlling the release by chemical reactions and set of course eyes if you look at column twenty two line six and goes through the line fourteen and it begins the method of medicine released by chemical bonds then when you go further down in that section rather than relying on random effects of molecules from various sizes puir providing a surprising consistency to drug delivery not before seen in the prior art so it's talking about relying on chemical bonds versus poor sizes for controlling the release of mr morris or mr turner me to sharp distinction as i recall between controlling the release of the men of the medication and retaining it in the area of the injured you that is preventing it from escaping to some other location you seem to only be focusing on the release of the medication because the cloud city saying that there is a disclaimer is that the means for or i'm sorry give the exact language mature release means he's trying to read into that one of the it dition all aspects in addition to chemical bonds and link it just has to be that there be no openings in the layer and that that's an additional feature that must be present in order to obtain material release means and we submit that it's not an additional feature when you get down to a subsequent portion and that is what judge prototype refer in lines forty six substantial restricting the through passage of at least one type of macromolecule there throw that indicating that the drug once released is not passing back through that layer  material and that's because the material is made of that the material is minimally porous what we're saying that that doesn't have to do with or size when i think it can't be poor side but we're saying that does or similar to what they ab as what they happen as their layer that's coated on to each of the truck that the fence on the terrace coated want to the rot and that's exactly what they're doing in their product which one figure five know what what's the difference between what you wrap the own supporting rod with the layer of a flexible material versus you create the layer on the rod bison when the spring operation is over you've got exactly the same thing you got a continuous seaplane who are layer like enclosure around the entire rot and we're focusing on what that we submit the claims are focused on focusing on is that layer that's there and that would be the same as when they coat the strut their stent that layer that on that's coated on to it struck would be identical to what's in five of five shows the layer all the way around facing the bone as it does show it all the way around facing the bone however in their situation their layer that's coded on to their structure is all the way around and in a little bit in wait a moment in five d there's item one in there right in the in the specifications specifically defines item one is a sheep so this big year has a sheet  cement that when you look at the letter ok when you what they're trying to say is that the sheet has to be a continuous heat the covers up all the openings in the so that our position is when you look at the layer with the you not this plane doesn't say that there can't be openings or that in the end pattern layer or the entire device the concept of blocking the  macromolecules which is what they're talking about has to be read in the here would be inconsistent with other embodiments such as in figure four  actually your honor i don't think that has to be decided because if the claim construction from the court below is not overturned then boston scientific does not challenge that there is infringement the issue here is whether or not the plane construction should be overturned and whether or not there is a disclaimer the issue of the disclaimer was specifically rates below and rejected by the district court the issue of if the claim construction was correct and if there is no disclaimer then there is no challenge as to the issue of infringement well i don't think they answers my question but my question was whether to accept your argument we have to treat the stru as being the device mentioned in claim one no i don't believe you do because it's the layer that's the device and it's the layer with the treating material and the means material release means for releasing the trading item one here defines this as a sheet and every one of these embody moments shows a sheep that's your problem the issue is if you want to if it is called a sheet it's still co cheap does not mean that there can't be openings and that she the material that makes up the layer or the sheath is has to be minimally course and it has to hope reading material to it and control the release of that treating return through chemical bonds and linkages and the wheat trading material once release can't ask back through that material however when it gets down to the claims it's the material that makes up the layer that has to be an up and you know siri problem of inadequate notice to competitors if we deduce or if to assess and whether the product i me infringes or not would be screaming difficult to know we submit that there's not a problem with and out of with notice because each of the itself is what's talked about as being minimally porous and whether you want let's take the stand but even that being accused here what's right what's coded on each of the struts as a layer or you want to call it or call it a shape it is still that layer that we're talking about it's that material that we're talking about and it's the properties of that material and it's the fact that there's material release means by chemical bonds and link some other columns a talk about release rate talk about specificity it nowhere relates chemical bonds and linkages to restraining what the patent talks about is coolers restraining and if as mr hoffman says you just look at this letter this embody from the entire structure you end up with a ridiculous situation and you end up with a layer which looks exactly if i had was a negative of it you'd see what looks like a promotes to go through to tell the public that what you concerned about are these openings these hurdles and i think for the life of me i don't understand the focus on our letter this embodied from the rest of the  public is not reading this as a disembodied disclosure it's looking at it as a complete disclosure as broad as the minimally porous limitation is concerned that clearly a structure if you had swiss cheese and you described it as having put words you would describe that a structure if you describe it as poor as you describe it a structure is described as minimally porous it's still structure it may be minimal in terms of how much a little but the patent tells you what it is the point is it is undeniable that all of these materials are sheet the coil surface the spray you end up with a sheet however you define it now there's a reference to what material is restrain means to restrain the macromolecules elaborated body owing to issue as well as the ability to the strain to restrain any number of medicines in the space adjacent to the injury flaw and it is also income twenty