`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`PROTIVA BIOTHERAPEUTICS, INC.,
`Patent Owner.
`_____________
`
`Case IPR2018-00680 (Patent 9,404,127)
`Case IPR2018-00739 (Patent 9,364,435)
`____________
`
`Record of Oral Hearing
`Held: June 6, 2019
`_____________
`
`
`
`
`Before SHERIDAN K. SNEDDEN, SUSAN L.C. MITCHELL, and
`RICHARD J. SMITH, Administrative Patent Judges.
`
`
`
`
`
`
`
`IPR2018-00680 (Patent 9,404,127)
`IPR2018-00739 (Patent 9,364,435)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`C. MACLAIN WELLS, ESQUIRE
`MORGAN CHU, ESQUIRE
`MICHAEL R. FLEMING, ESQUIRE
`Irell & Manella LLP
`1800 Avenue of the Stars, Suite 900
`Los Angeles, California 90067
`310-277-1010
`
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`MICHAEL T. ROSATO, ESQUIRE
`SONJA GENRARD, ESQUIRE
`FRANKLIN CHU, ESQUIRE
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`206-883-2500
`
`
`
`
`The above-entitled matter came on for hearing on Thursday, June 6,
`
`2019, commencing at 1:00 p.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, VA 22314.
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`IPR2018-00680 (Patent 9,404,127)
`IPR2018-00739 (Patent 9,364,435)
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`P R O C E E D I N G S
`- - - - -
` (Proceedings begin at 1:00 p.m.)
` JUDGE MITCHELL: Thank you. You may be seated.
`Sorry.
` Good afternoon, everyone. We have a final hearing
`this afternoon in two cases, IPR 2018-00739 and IPR 2018-
`00680. I'm Judge Mitchell and seated to my left is Judge
`Snedden, and with us by video conference is Judge Smith, who
`should be here. Is Judge Smith on?
` JUDGE SNEDDEN: Uh-huh.
` JUDGE SMITH: Uh-huh.
` JUDGE MITCHELL: Oh, great. Sorry.
` JUDGE SMITH: Hello.
` JUDGE MITCHELL: Great, thank you.
` I would like to get appearances for the parties on
`the record, and if we could start with the Petitioner.
` MR. FLEMING: Good afternoon, Your Honor. I'm Mike
`Fleming with Irell & Manella, and with me is Morgan Chu, as
`well as Maclain Wells.
` JUDGE MITCHELL: Great.
` MR. FLEMING: And we all three will be arguing.
` JUDGE MITCHELL: Great. Thank you.
` MR. CHU: Good afternoon.
` JUDGE MITCHELL: Good afternoon. And for Patent
`Owner, please.
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` MR. ROSATO: Good afternoon, Your Honor. Mike
`Rosato on behalf of Patent Owner. I have with me for the
`counsel table Sonja Genrard, as well as Franklin Chu. Thank
`you.
` JUDGE MITCHELL: Thank you.
` Let me get a quick clarification from both of you-
`all, because as I understood from your requests for oral
`hearing, I think Patent Owner requested the two cases be
`separate, which is fine. It's just we could do the 739 first,
`adjourn for a short bit, and come back and do the 680, and
`have one record that gets submitted for both cases, so that
`you can rely on -- you know, if claim construction issues are
`similar, you're going to want to have that discussion in both
`cases. So I want to make sure I understood right or if you
`really do want separate transcripts.
` Petitioner?
` MR. FLEMING: Your Honor, we have prepared for
`having separate hearings.
` JUDGE MITCHELL: Okay.
` MR. FLEMING: Because I will be arguing the 739
`and --
` MR. CHU: All right. The way we're going to proceed
`is Mr. Fleming and I will argue '435.
` JUDGE MITCHELL: Okay.
` MR. CHU: And Mr. Wells will argue the '127 Patent,
`referring to the patent numbers, but having a single unified
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`transcript as constituting the official record --
` JUDGE MITCHELL: For both cases.
` MR. CHU: For both cases makes sense.
` JUDGE MITCHELL: Okay. And -- and Patent Owner?
` MR. ROSATO: We have no objection to this
`suggestion, You Honor. I mean --
` JUDGE MITCHELL: Okay. Okay. So we will go forward
`with the '739. We'll take a short break and then come back on
`but have one complete record for both cases.
` We set forth our procedure for how we're going to
`handle this oral hearing in our order, but I want to go over a
`couple of things as a reminder.
` Each party will first present argument in the '739
`case, and each party will have an hour for that case, and then
`we will have a second hearing for the '680 case, and that
`case, there's a 40, 45 minutes per side of total time.
` And to assist Judge Smith in following along with
`your argument and for the clarity of the record, it is very
`important that you refer to an exhibit. When you refer to an
`exhibit, that you state the exhibit number and the page number
`to which you are referring, and when you're referring to a
`demonstrative, that you state the slide number.
` Petitioner has the burden of showing the
`unpatentability of the challenge claims in both cases, so the
`Petitioner will go first. The Patent Owner will then have an
`opportunity to present its response and may reserve a small
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`amount of time for some rebuttal.
` We have reviewed Patent Owner's notice of objections
`to Petitioner's demonstrative exhibits. We're not going to
`exclude any of the demonstratives at this time for the
`hearing. The Patent Owner may certainly address any
`objectionable demonstrative in your argument time, if you
`choose.
` We also want to furthermore note for the record that
`demonstratives are evident -- or not evidence and will not be
`considered as such. They're used for the benefit of those in
`this room and for the benefit of the transcript that will
`become part of the public record.
` The Panel will distinguish evidence in the record
`from argument appearing in demonstrative exhibits and all
`arguments must be supported by evidence; already of record and
`relied upon in the briefing. The Panel will not consider
`arguments or evidence appearing only in the demonstrative
`exhibits.
` So with that, let me ask Petitioner if you'd like to
`reserve time for rebuttal.
` MR. FLEMING: Yes, Your Honor. So our
`understanding, that is when we go first, we'll be addressing
`both the principal case as well as the motion to amend.
` JUDGE MITCHELL: Yes, I'm sorry. Yes, of course.
` MR. FLEMING: And --
` JUDGE MITCHELL: Well -- yes.
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` MR. FLEMING: Or --
` JUDGE MITCHELL: I'm sorry, yes.
` MR. FLEMING: Would it --
` JUDGE MITCHELL: That's correct.
` MR. FLEMING: Would it be better that we do the
`principal case and then later, the motion to amend?
` JUDGE MITCHELL: I mean, however you've decided to
`do it, we'll -- we'll take the argument whatever you're
`comfortable doing. So that's fine, however you do.
` MR. FLEMING: Okay. We'll -- we plan to reserve.
`If we're going to go forward with the principal case and the
`motion to amend first, we will reserve 30 for rebuttal.
` JUDGE MITCHELL: Okay. Whenever you're ready.
` MR. FLEMING: Your Honor, may I --
` JUDGE MITCHELL: Oh, sure.
` MR. FLEMING: Approach the Bench and present hard
`copies?
` JUDGE MITCHELL: Please.
` MR. FLEMING: We might need the -- evidently the --
` JUDGE MITCHELL: Oh, is it not working?
` MR. FLEMING: Well, it was working just a minute
`ago.
` JUDGE MITCHELL: Oh, no.
` MR. FLEMING: This is (indiscernible).
` JUDGE MITCHELL: Would you like some help?
` MR. FLEMING: Yeah, Your Honor. Could we get
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`technical assistance?
` JUDGE MITCHELL: Can we have like a (indiscernible).
` FEMALE TECHNICAL STAFF: This equipment that they
`have it hooked up to, I can't mess with the equipment if they
`have it hooked up to --
` JUDGE MITCHELL: Oh, okay.
` FEMALE TECHNICAL STAFF 1: Because surely if
`somebody -- because it was up and then you shook it. It came
`up and it (indiscernible).
` JUDGE MITCHELL: Whenever you're ready.
` MR. FLEMING: Thank you, Your Honor. Appreciate the
`patience. We should have it up here.
` Okay. I'm ready, Your Honor.
` JUDGE MITCHELL: Go ahead.
` MR. FLEMING: Okay. Good afternoon. May I have
`Slide 4, please?
` The Petition challenges just Claims 1 through 20 of
`the '435 patent.
` And if I can have Slide 6, please? Here is the
`independent claim before you. It's important to note that
`what we have is a nucleic acid lipid particle comprising a
`nucleic acid, a cationic lipid with this particular range and
`non-cationic lipid with the 13 to 49.5 range and a conjugated
`lipid from 05 mole to 2 mole range.
` The key here, as far as patentability goes, it's the
`cationic lipid comprising the range of 50 mole percent to 85
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`mole percent.
` I want to point out that the claim is not directed
`to a particular use or how effective the particle is, and it
`doesn't require that the particle is to be non-toxic or that it is in vivo or in
`vitro.
` If I have Slide 5, please.
` JUDGE SMITH: Counsel, could you speak up or perhaps
`be moved closer to microphone?
` MR. FLEMING: Yes, Your Honor. Can you hear me now?
` JUDGE SMITH: Yes. Thank you.
` MR. FLEMING: Just to test, can you hear me now?
` JUDGE SMITH: Yes.
` MR. FLEMING: Okay, great. I'll speak up.
` If I can have Slide 5. There's no dispute that the
`nucleic acid, the cationic lipid, the non-cationic lipid, and
`the conjugate lipid are all known in the art.
` If I can I have Slide 9, please? So turning to
`claim construction. The term in the preamble is at issue, and
`that's the nucleic acid lipid particle.
` And the board's construction is correct. The
`nucleic acid lipid particle is a particle that comprises a
`nucleic acid and lipid, where the nucleic acid may be
`encapsulated.
` Now Slide 11, please. The intrinsic evidence
`supports this construction in Column 11, Lines 14 through 22.
`The '435 Patent defines lipid particle has a lipid formulation
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`that can be used to drive nucleic acid for the nucleic acid
`making it encapsulated in the lipid.
` A person of ordinary skill in the art would derive
`that the nucleic acid lipid particle comprises a nucleic acid
`and a lipid. And I want to point to Dr. Janoff's testimony in
`his reply declaration on Page 13 that affirms this.
` May I have Slide 15, please? The '435 Patent in
`Column 11, Lines 23 through 46 also define a stable nucleic
`acid lipid particle, SNALP, as a particle made from a lipid,
`wherein the nucleic acid is fully encapsulated.
` So the term nucleic acid lipid particle encompasses
`SNALP, but does it -- but is not so limited.
` JUDGE MITCHELL: What happens to your case, if we
`agree with Patent Owner and we think that Claim 1 is limited
`to a SNALP?
` MR. FLEMING: Your Honor, as we point out in our
`petition, that the 554 Publication actually teaches
`encapsulation of the nucleic acid in the particle. So as
`you're correctly pointing out, even if they do get this
`narrower term, which I don't believe is the broadest
`reasonable, it still won't matter as far as what the prior art
`teaches.
` May I have Slide 19, please? Which really takes me
`to Ground 3. And Claims 1 through 20 are anticipated by or
`obvious in view of the 554 Publication.
` If I can have Slide 21, please? There is a formula
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`that was tested, and that is L054 that reads on the claim.
`The first thing is that it teaches that the nucleic acid lipid
`particle in Table 4 and in Example 17 encapsulates siNA.
` May I have -- can you pull up the Example 17?
` MALE TECHNICAL STAFF: I can't get back into that.
` MR. FLEMING: Oh, okay. Well, not a problem.
` Example 17 is -- explains the preparation of the
`nanoparticle that encapsulates siNA formulation that's shown
`in this Table 5 -- 4.
` May I have Slide 22, please? So you can see in the
`Table 4, it teaches a cationic lipid that it's 50 percent --
`50 mole percent, which is within the range.
` If I can have Slide 23, please? It also teaches a
`non-cationic lipid. That's 48 percent. That's within the
`range.
` And if I could have Slide 24, please? It also
`teaches a conjugated lipid. That's two percent. That's also
`in the range.
` JUDGE MITCHELL: So are these all referring to a
`starting formulation and not necessarily a particle?
` MR. FLEMING: No, Your Honor. This is referring to
`a particle. And in the art -- and we have testimony for both
`the experts that that's how they refer to the particle, but,
`indeed, it was formulated as a particle.
` So if we can go to Slide 30, please? We also have
`overlapping ranges, and we can establish a prima facie case of
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`obviousness.
` So if I can go to Slide 32, please? The 554
`Publication teaches, in Paragraph 0313, the nucleic acid
`particle formulation that in -- formulation that encapsulates
`siNA and if we have the overlapping ranges.
` And if I could have Slide 31. This summarizes and
`shows side-by-side the overlapping ranges.
` If you could go to Slide 61, please? I want to
`point out that the Patent Owner has not been able to establish
`unexpected results, and the key here is that looking at
`Example 3, which they relied on heavily, there's really only
`three points that are within the range -- within the scope of
`the claim. And those three points don't show that it's
`commensurate in scope with the entire range of the claim.
` But even if you look closer at what the table is
`teaching you, if we can go to Slide 62, please? Here, what we
`have is the Figure 2 that shows all the groups in the
`comparison. And so Groups 2 through 10 and 12 have cationic
`lipids less than 50 percent mole. So if you look at Figure 2,
`it shows the test results of each of these groups. And so
`what is going on here is you have -- for each group, four mice
`were administered 1:57 SNALP.
` And the upside-down T, if I can show second slide of
`62? Can I have the next slide? When you have the upside-down
`T, it represents experimental error between these experiments.
`So when you consider the experimental error, Groups 2 through
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`5 have similar results compared to 14.
` So if we can have the next slide, please. So the
`other aspect of this figure that is important to understand is
`the vertical axis; lower is better.
` Can I have the next slide, please, and the next
`slide. You don't? Is that all I have?
` MALE TECHNICAL STAFF: Yeah, it's all for 62.
` MR. FLEMING: So if you look on the Y-axis, the
`vertical axis, lower is better because what that is showing is
`that it's showing how effective the formulation is in
`silencing the target gene, so you want a lower value there to
`show that it's more effective.
` Okay. So if you look at -- if I can go to the next
`slide? So the prior art is 2:40, and that's the 40 percent
`cationic lipid and 2 percent conjugate. And that's what you
`need to compare to determine whether you have unexpected
`results because that is the closest prior art.
` And there, you see, that for Group 7, it's really --
`can I have the next slide? See if it does -- so if you look
`at Group 14, it's worse than the prior art, and if you look at
`-- if you go to the next slide, please? If you have Group 13,
`it's no better or worse than the prior art.
` If I have next slide, please? And if you look at
`Group 12 versus Group 11, it's pretty close. So, at best, all
`you have is one point, but it's certainly not surprising
`unexpected results. It's very close to what was the prior
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`art.
` May I have the next slide, please? The Patent Owner
`is relying on surprising results for the placebo. But the
`problem there is it's not proper to compare to the procedural
`or placebo. You need to compare to the prior art.
` So if we could go to Slide 67? What is not
`addressed by the Patent Owner is the fact of how broad this
`claim is. So to be considered -- to be commensurate in scope
`with this claim, it's not only showing how effective the
`particle is, but what you also have to show -- well, what
`about all the payloads? It could be -- because you have a
`very broad term, nucleic acid, which can be a bunch of
`different payloads.
` So they certainly haven't shown surprising and
`unexpected results for all the payloads. And, again, there's
`only a few lipids that were tested and only a few
`formulations. So there's a problem here. It's just not --
`they're showing us -- this is not commensurate in scope for the
`claim. I'm going to --
` JUDGE MITCHELL: Is it your position that -- you
`know, I'm trying to figure out how much testing would they
`actually have to show to basically show that they have the
`full range of their claim? I mean, what is -- what is your
`suggestion? I mean, they can't possibly formulate every lipid
`particle that would be within the claim. I mean, we don't
`hold them to that kind of a standard to say that they already
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`achieve or at least support the scope of a particular range in
`a claim.
` MR. FLEMING: Yes, Your Honor. What would be
`required would be enough testing to show that -- to one of
`ordinary skill in the art that these surprising and unexpected
`results would result -- you know, that you'd have enough test
`to show that you would have a same -- unsurprising unexpected
`results for the entire range, for one. But the other issue
`though is, again, you also need to show that you have testing
`across the nucleic acid as well. So here we only have siNA
`payloads.
` So, again, this claim is very, very broad, Your
`Honor, and so there lies the problem.
` If there's not any further questions, I'd like to
`turn it over to Morgan Chu to argue the motion to amend.
` MR. CHU: Good afternoon again, Your Honors.
` I want to start with what the Patent Owner argues
`are two new limitations and then later, I'll go to the
`modified ranges.
` The first alleged limitation is adding to new
`independent Claim 21, the phrase, serum-stable. And as Your
`Honors will know, looking at that new proposed Claim 21,
`serum-stable appears in the preamble.
` Now, this is not a lonely patent prosecutor who's
`overworked writing claims for many different patents. This is
`a team of lawyers in a hotly contested IPR proceeding where if
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`they wanted serum-stable to be a limitation, it would have
`been easy to put it in the body of the claim.
` Now, let's suppose for the moment they did that,
`which they didn't do. If you have your copy of the '435
`Patent handy, I want to show that serum-stable does not add a
`limitation that the claim must be in vivo or involves systemic
`delivery.
` And the second argument that the Patent Owner is
`making about the term serum-stable is that it requires
`encapsulation. Those two arguments.
` So if you have your patent handy and can go to
`Column 13, Line 32, or I can pull it up on the screen. We'll
`do both. Okay. Column 13, Line 32, and then let's highlight
`that language, third -- Line 32 through 37. Column 13, 32
`through 37. And we'll highlight the word -- okay.
` You see, serum-stable is defined by the Patent Owner
`in a particular manner. It is a defined term in the '435
`Patent. And if you look at that language, there is nothing in
`that language that requires in vivo use or systemic delivery
`whatsoever. Indeed, if you go to the following lines in
`Column 13, starting at Line 38 through 41, it's the beginning
`of the definition of another defined term, quote, systemic
`delivery. And if you look at that language, systemic delivery
`is intended to be in vivo.
` So if the Patent Owner, in proposing amended claims,
`wanted to have the claims limited to in vivo or systemic use,
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`instead of using serum-stable, which doesn't include an in
`vivo limitation, he could use the next definition, systemic
`delivery. They chose not to do so.
` JUDGE SNEDDEN: In the definition for serum-stable,
`you have a reference to assays that can be used to test
`whether or not the particle is serum-stable.
` MR. CHU: Yes. And we will see actual testimony by
`Dr. Thompson after I leave the language of the claims where he
`is saying that the claim includes in vitro, so we will get to
`that. It can include it. But remember where we are. We're
`looking at some words added to the preamble, so although there
`can be an argument that they are -- could be read, as being a
`limitation, the general law is, no, you start out, it's just
`the preamble, and unless it's necessary to give life, and
`meaning, and vitality to the claim, it's just a preamble.
`It's not a limitation. If the Patent Owner wants it clearly to
`say it is limited to in vivo, they could have used the
`definition, systemic delivery.
` Second point, on encapsulation. The serum-stable
`definition we were looking at in Column 13, line -- beginning
`at Line 32 did not say encapsulate. If the Patent Owner
`wanted the new proposed Claim 21 to require encapsulation as a
`limitation, there's a handy word to do that, and that is to
`add the word encapsulate. But in addition --
` JUDGE SNEDDEN: That --
` MR. CHU: Yes?
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` JUDGE SNEDDEN: That would suggest that you can have
`a serum-stable particle without it being encapsulated.
` MR. CHU: Yes, I agree.
` JUDGE SNEDDEN: Okay.
` MR. CHU: Okay.
` JUDGE SNEDDEN: And then --
` MR. CHU: But --
` JUDGE SNEDDEN: Then the next question will be, how
`would something pass these assays and also be serum-stable if
`it was not encapsulated?
` MR. CHU: Okay. So let me get to that. But I
`just --
` JUDGE SNEDDEN: Okay.
` MR. CHU: I'm told there's some problem if I try to
`switch to --
` JUDGE SNEDDEN: Sure.
` MR. CHU: Some pre-prepared slides from the language
`of the patent. Let me just show you what else the Patent
`Owner could have done --
` JUDGE SNEDDEN: Okay.
` MR. CHU: If it wanted to say encapsulate. There's
`a limitation.
` So there's the possibility of using the word
`encapsulated. There's another possibility. And it includes
`the possibility of defining the new Claim 21 as a SNALP
`because if you go to Column 11 starting at Line 23, the term
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`SNALP is also a defined term, which includes being fully
`encapsulated.
` So quick points, one, serum-stable was just in the
`preamble. It's no limitation. If we pretend for the moment
`it was a limitation, which it is not, the choice of the defined
`-- particular defined terms and not others and not using clear
`words would not limit the claims to either in vivo or
`encapsulation.
` So let me go to some of the slides. And maybe we'll
`just go to 78 for a second, and you can see serum-stable there
`in the preamble.
` And then let's go to the next slide. I'm going to
`do my own work. It's a different definition of full-service
`lawyer. Someone who's going to advance the slides himself.
` So these are the changes that I will be discussing,
`and I will try to answer Your Honor's questions along the way
`here. And just to look for a moment at the Whereas clause,
`there's an argument being made about the Whereas clause
`possibly adding a limitation other than what the plain language
`states. And, here, it's pretty clear that this can be done in
`a Petri dish. So contrary to the lawyer's argument, this is
`not suggesting anything about in vivo for degradation. And
`this was Slide 86. Okay.
` Let me go to 87, and this is just showing of the
`three principal references, the 554 Publication, Exhibit 1004,
`the 196 PCT, which is Exhibit 1002, and the 198 publication,
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`which is Exhibit 1003 on the Slide 87, that the nuclease
`degradation resistance was disclosed in the prior art, so the
`wherein clause is not adding anything new.
` Let me go to the new narrow ranges. You see them in
`blue highlighting in Slide 88. You can tell from the
`brackets, it shows the original range. So for the cationic
`lipid, the original range was from 50 to 75 percent of -- the
`original was from 50 to 85 percent, and the new range is from
`50 to 75 percent. And as Mr. Fleming already addressed in the
`554 Publication, this is Slide 89, we see the range covered as
`well as the second range in Slide 90.
` And the next Slide 92 shows that the prior art still
`overlaps for the proposed cationic lipid range from 50 to 75.
` And in Slide 93, we show the actual overlap and note
`that the relative amount of overlap is greater than it was in
`the original claim, which was from 50 to 85. By narrowing the
`original claim, there's relatively more overlap as shown in
`93.
` And then the point about the lack of surprising and
`unexpected results can be shown in Slide 96. You've seen this
`before, Figure 2. You see Group 7, and Group 12 is the prior
`art, 14 is worse than the two pieces of prior art, 13 is worse
`than Group 12 and about the same as Group 7, so neither worse
`or no better. And if you compare Group 11 to Group 12, it's
`hard to tell whether there is any meaningful statistical
`difference between the two because of the error bars. And, in
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`fact, Dr. Janoff discusses the fact that in his opinion,
`looking at the figure, it's hard to read of course. In this
`tight comparison, he said in effect, it's likely not
`statistically significant. It's very close.
` But let's for the moment, for the purposes of
`argument, say that the Patent Owner has one data point for
`this very broad range of 50 to 75 cationic percent.
` In answer to Judge Mitchell's question earlier, it
`cannot be the case for that broad range. A single data point
`is commensurate with the scope of the range. Indeed, that 50
`to 75 percent includes 70 to 75 percent no data point that the
`Patent Owner points to is in the 70 to 75 percent. And the
`record is replete with the fact that slightly different
`combinations can lead to grossly different results.
` So even if the Patent Owner has one data point that
`shows or maybe shows somewhat better results, it is not
`commensurate with showing surprising and unexpected results
`for the entire range.
` So you've seen the -- we call the PBS, the inert of
`placebo standard.
` And before I go to the next point, I think Judge
`Snedden, you asked a question, and chemically modified siRNA,
`for example, can avoid the degradation. I believe that's in
`the record, and maybe someone's going to find the exact
`paragraph for that.
` If you go to --
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`IPR2018-00739 (Patent 9,364,435)
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` JUDGE SNEDDEN: Before we read the spec, is there
`anything that spec about a chemically modified nucleic acid or
`a particle?
` MR. CHU: We will look that up, and if I don't get
`to it in the little bit of time, I have here --
` JUDGE SNEDDEN: To me, the amended claim essentially
`refers -- but -- it recites serum-stable, you go to the
`definition of specification, it -- it gives you a brief
`definition of that, and what -- in that is that it must
`survive exposure to nuclease.
` MR. CHU: So --
` JUDGE SNEDDEN: And you have referenced here DNA's,
`RNA's acid. And if you read that in the context of the
`specifications, it seems the only way that they're attempting
`to achieve that with this invention is through encapsulation;
`is that correct or --
` MR. CHU: Because I've run over the time, let me
`just on a somewhat different --
` First of all, we will answer your question. My
`colleagues are --
` JUDGE SNEDDEN: Okay.
` MR. CHU: Looking through the spec and other
`references now, and when I get up -- stand up to give rebuttal
`testimony, hopefully, I'll have a cogent answer to that.
` Let me just finish by saying there are other slides
`as well as in our briefs.
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