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`IPR2015-01776, Paper No. 69
`IPR2015-01780, Paper No. 69
`IPR2015-01785, Paper No. 69
`December 15, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
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`v.
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`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
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`Case IPR2015-01776 (Patent 7,582,621 B2)
`Case IPR2015-01780 (Patent 7,767,657 B2)
`Case IPR2015-01785 (Patent 7,767,657 B2)
`____________
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`Held: November 3, 2016
`____________
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`
`BEFORE: MICHAEL P. TIERNEY, GRACE KARAFFA
`OBERMANN, and TINA E. HULSE, Administrative Patent
`Judges.
`
`The above-entitled matter came on for hearing on Thursday,
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`November 3, 2016, commencing at 1:00 p.m., at the U.S. Patent
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`IPR2015-01776, Paper No. 69
`IPR2015-01780, Paper No. 69
`IPR2015-01785, Paper No. 69
`December 15, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01776 (Patent 7,582,621 B2)
`Case IPR2015-01780 (Patent 7,767,657 B2)
`Case IPR2015-01785 (Patent 7,767,657 B2)
`____________
`
`Held: November 3, 2016
`____________
`
`
`BEFORE: MICHAEL P. TIERNEY, GRACE KARAFFA
`OBERMANN, and TINA E. HULSE, Administrative Patent
`Judges.
`
`The above-entitled matter came on for hearing on Thursday,
`
`November 3, 2016, commencing at 1:00 p.m., at the U.S. Patent
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`PETER A. GERGELY, ESQUIRE
`JEFFREY BLAKE, ESQUIRE
`RYAN JAMES FLETCHER, Ph.D., ESQUIRE
`KATHLEEN E. OTT, ESQUIRE
`Merchant & Gould
`1801 California Street, Suite 3300
`Denver, Colorado 80202-2654
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`Case IPR2015-01776 (Patent 7,582,621 B2)
`Case IPR2015-01780 (Patent 7,767,657 B2)
`Case IPR2015-01785 (Patent 7,767,657 B2)
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`ON BEHALF OF PATENT OWNER:
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`ANDREA G. REISTER, ESQUIRE
`JESSICA L. PAREZO, ESQUIRE
`EVAN KRYGOWSKI, ESQUIRE
`Covington & Burling, LLP
`One City Center
`850 Tenth Street, N.W.
`Washington, D.C. 20001-4956
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`Case IPR2015-01776 (Patent 7,582,621 B2)
`Case IPR2015-01780 (Patent 7,767,657 B2)
`Case IPR2015-01785 (Patent 7,767,657 B2)
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`P R O C E E D I N G S
`- - - - -
`JUDGE TIERNEY: Welcome everyone. For today's
`hearing is a consolidated hearing for IPR2015-01776, also 01780
`and also 01785. The parties each were given 45 minutes to
`present their case today. We do have that understanding,
`however, that if we do have questions and the parties need
`additional time, we are willing to allow for additional time today.
`Before I begin, I would like to know for petitioner, do
`you wish to reserve time for rebuttal today?
`MR. GERGELY: Yes, Your Honor, I do. I'll probably
`take about 35 minutes in our opening presentation and I would
`like to reserve about ten minutes for rebuttal.
`JUDGE TIERNEY: Also before I begin, do the parties
`have any procedural questions regarding the hearing today?
`MR. GERGELY: No, Your Honor, thank you.
`MS. REISTER: No.
`JUDGE TIERNEY: So petitioner, when you are ready,
`would you please begin. And I'll ask, do you wish to have a
`clock letting you know how time is running down?
`MR. GERGELY: That would be great. I appreciate
`that. Thank you.
`JUDGE TIERNEY: Ready when you are.
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`MR. GERGELY: Thank you. My name is Peter
`Gergely. I'm counsel for the petitioner, Coalition for Affordable
`Drugs X LLC. With me today in the courtroom is lead counsel,
`Jeff Blake, Ryan Fletcher, and Kathy Ott. And we are all of the
`law firm Merchant & Gould. Kathy, Ryan, and I are from the
`Denver office and Jeff is from the Atlanta, Georgia office. And I
`will be handling the argument today.
`First of all, I would like to thank the Board for its time
`and attention to this matter. I think it's an understatement to say
`that this is a voluminous record and we appreciate your time and
`effort in looking at those materials and being with us today to
`listen to our arguments.
`There are two patents at issue in this case -- in these
`cases. One is what we refer to as the '621 patent and the other is
`the '657 patent. The '621 patent is the subject of the 1776 case
`and the '657 patent is the subject of the 1780 and 85 cases. We
`don't think there's any real dispute that all of the elements of the
`claims in the '621 and '657 are shown in the prior art. We believe
`that the real dispute here between the parties is whether the
`petitioner has articulated a reason to combine or reasons to
`combine the references under KSR as well as have they have
`identified an analysis of a reasonable expectation of success also
`under the KSR decision.
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`And we think we have. Petitioner articulated those
`reasons in detail in its petition for each and every claim. And the
`reasons and analysis were supported by their experts, Dr. Kahl
`and Dr. Murthy. For example, with respect to the '621 patent
`which has much overlap in the subject matter with '657, petitioner
`identified three reasons to combine the Austin and Brehove
`reference. One, both references taught the use of boron-based
`compounds as fungicides. Two, both references also disclosed
`the use of boron-based compounds to specifically inhibit Candida
`albicans, which is a known cause of onychomycosis. There's no
`dispute there. Three, Austin discloses boron-based compounds
`that have lower molecular weight than the successful compounds
`of Brehove and are therefore more likely to penetrate the nail
`barrier. That was cited in the petition as supported by the Murdan
`reference.
`But the analysis didn't stop there. Petitioner then
`identified five reasons why a person of ordinary skill in the art
`would have had a reasonable expectation of success in combining
`the references to arrive at the claimed inventions. One,
`boron-based compounds were well-known biocides. That's
`shown by both references, Austin and Brehove. Two, tavaborole
`shares common structural features with the boron compounds of
`Brehove, namely all are boron heterocycles. They are not exactly
`the same compound. That's obvious. But they are both boron
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`heterocycles. Three, tavaborole was disclosed as a preferred
`fungicide in the abstract and it shared common activity with the
`boron compounds of Brehove. Specifically tavaborole, as shown
`in Austin and the compounds, the boron-based compounds in
`Brehove both inhibited Candida albicans. So even though they
`were different compounds, they behaved in the same manner in
`that respect. Based on the fact that they are both boron
`heterocycles and they both share common activity, a person of
`ordinary skill in the area would have expected that tavaborole
`would have other common activities as well, such as the
`inhibition of other fungi that cause onychomycosis.
`The fourth reason was tavaborole has a lower molecular
`weight than the boron compounds of Brehove, and therefore,
`would have been expected to penetrate the nail given Brehove's
`success. Compounds in Brehove were higher molecular weight.
`And in the art it was known that lower molecular compounds
`would penetrate better per the Murdan article.
`Five, Brehove demonstrated the successful application
`of a boron-based industrial fungicide to a human to effectively
`treat onychomycosis. That's shown in Brehove.
`The analysis continued. Petitioner also specifically
`identified why a person of ordinary skill in the art would have a
`reasonable expectation of success determining a therapeutically
`effective amount of tavaborole to treat or inhibit onychomycosis.
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`That's because the level of skill in the art is so high, it's a matter
`of routine experimentation to determine that therapeutically
`effective amount. And Dr. Murthy opined to that and he actually,
`I believe, cited one of the protocols, the standard protocols in the
`patent for doing that.
`None of that analysis has changed. I believe you'll hear
`from Anacor, they will say, well, petitioner has changed its
`theories midstream. That's not the case. If you look at our reply
`brief, we cited the reasons for a reasonable expectation of success
`in our reply brief at pages 21 and 22, for example, in the '621
`reply brief. We cited to the declarations of Dr. Kahl and
`Dr. Murthy for those propositions.
`However, because there was a reply brief, we also
`responded to some of the specific arguments made by petitioner.
`And in particular, Anacor argued that a person of ordinary skill in
`the art would never have selected tavaborole from the allegedly
`millions of compounds disclosed by Austin. But that statement is
`theoretical and it ignores the fact that tavaborole is specifically
`identified as a preferred compound on the first page of the
`document in the abstract which the Board pointed out in its order
`granting institution and found that fact persuasive.
`Additionally, as the petitioner pointed out in its reply,
`tavaborole would be the first compound to be selected by a
`person of ordinary skill in the art for use in onychomycosis due to
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`its low minimum inhibitory concentration, also known as the
`MIC value and its low molecular weight.
`And the importance of a low MIC of tavaborole is not a
`new issue. In fact, in its order granting the institution of the '657
`petition, the Board stated, quote, Of the three preferred
`compounds tested, tavaborole demonstrated the lowest minimum
`inhibitory concentration, MIC values, against several pathogens,
`including Candida albicans, and cited the declaration of Dr. Kahl
`for that point.
`Dr. Murthy also stated in his declaration in support of
`the petition that tavaborole, quote, has significant antifungal
`activity against Candida albicans at a concentration as low as five
`parts per million, ppm, which was the lowest concentration tested
`by Austin. And that was his declaration in the 1776 case,
`Exhibit 1008 at page 29, paragraph 91.
`JUDGE HULSE: Counsel, what is your response to
`patent owner's argument that Table 8 shows a whole slew of
`different compounds that have a MIC of 5 PPM?
`MR. GERGELY: Yeah, that is true that Table 8 shows
`that. The point, though, however, is all of those compounds are
`much higher molecular weight. So they wouldn't be as desirable
`for use in treating onychomycosis. The prior art shows that lower
`molecular weight compounds are much more effective at crossing
`the nail barrier than a higher molecular weight compound. And I
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`believe those compounds you are referring to in Table 8 are all
`much higher. I believe those are the o-esters that counsel refers
`to from time to time. And those are higher molecular weight
`compounds. They would not be as desirable.
`In fact, I believe that of the compounds that have five
`PPM MIC in Austin, I believe that tavaborole is the lowest
`molecular weight compound of those that have that MIC value.
`So given that it has the lowest MIC and the lowest molecular
`weight, it would be the most desirable. In fact, Dr. Murthy said it
`would be his first choice.
`Again, this is not a new issue. In its order granting
`institution, the Board specifically cited low molecular weight as a
`reason to combine the references. And that's at page 9 of the
`order granting institution in the '621 case. And Dr. Murthy
`specifically relied on low molecular weight of tavaborole as part
`of his analysis of reasonable expectation of success, which is his
`declaration in the 1776 case, Exhibit 1008, pages 33 to 34 at
`paragraph 102. So the importance of low molecular weight and
`MIC values were emphasized in the reply brief for those reasons.
`Additionally, in their response, Anacor argued that there
`were number of other factors that needed to be tested before a
`determination of reasonable expectation of success as it relates to
`the nail penetration could be made. And they identified a number
`of factors, including log P and keratin binding and so forth. The
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`reply brief pointed out that low molecular weight was the primary
`factor determining whether or not a compound would penetrate
`the nail. And that's cited at pages 17 through 21 of the reply brief
`in the '621 case. By the way, I keep referring to the '621 case as
`shorthand. The same arguments were also made in the '657 cases.
`And in its reply declaration, Dr. Murthy cited all the
`references which made this point. And he did that in detail in his
`declaration, Exhibit 1044 in the 1776 case at pages 38 through 43,
`paragraph 63 through 71. And this is shown in our slide
`presentation at slides 54 through 70.
`So I mean, here is the Murdan article which has been
`cited by both sides, and I believe it's actually part of the file
`history in the '621 patent, at least. And this explains --
`JUDGE HULSE: Counsel, I apologize, but I cannot see
`what you are projecting on the screen. So if you could point me
`to an exhibit or a slide number, that would be really helpful.
`MR. GERGELY: Sure. It's the article by Murdan. And
`her first name, I believe, is pronounced Sudaxshina, although I
`think she goes by Sudax. It is Exhibit 1028 in the 1776 case and
`the page number is page 9, right-hand column under
`paragraph 4.1.1.
`JUDGE HULSE: Thank you.
`MR. GERGELY: And this states the general principle,
`as expected molecular size has an inverse relationship with
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`penetration into the nail plate. The larger the molecular size, the
`harder it is for molecules to diffuse through the keratin network
`and lower the drug permeation. And she cites the Mertin and
`Lippold article for that point. We'll come back to that article.
`So Judge Hulse, now we are on, I believe page 10 of the
`Murdan article. And she actually reproduces a graph from the
`Mertin and Lippold article which shows this relationship, which
`shows a linear relationship between molecular weight and the log
`P, which in this case means permeation.
`JUDGE TIERNEY: I think it's best, Judge Hulse, what
`he's on is page 56 of their demonstrative.
`MR. GERGELY: Correct. That's a lot easier.
`JUDGE HULSE: Thank you.
`MR. GERGELY: By the way, we have extra copies in
`hard copy that are colored and they look nice if you want a copy.
`Would that be of value?
`JUDGE TIERNEY: I'll take one.
`MR. GERGELY: So again, at slide 56, Dr. Murdan is
`showing this graph from the Mertin and Lippold article which
`shows the linear relationship between molecular weight and
`permeability. This is a book, slide 57, written by -- well, edited
`by Dr. Murthy, who is our expert, and then Dr. Maibach, who is
`one of Anacor's experts. This postdates the priority date, but this
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`is relevant to the understanding of persons of ordinary skill in the
`art.
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`And in their book, it's stated at slide 58 molecular size
`of a permeant is the most important parameter determining the
`nail permeability of the permeant. Transungual transport is
`significantly decreased from the molecular weight when the
`permeant increases, again, citing Mertin and Lippold.
`Slide 59, another article, and I don't recall the date,
`whether this is pre or post priority, but again, it's written by
`Dr. Maibach, who is one of Anacor's expert's. And Dr. Maibach
`says in this article on slide 60, using this model, the molecular
`weight has the largest contribution in predicting ungual
`absorption, ungual meaning the nail, in both equations as
`compared to the other predictor variables in the model. This
`finding is in accord with previous studies where molecular weight
`was determined to be a main parameter in predicting permeability
`coefficients, citing Kobayashi from 2004 and Mertin and Lippold.
`So they are basically confirming what was shown in the prior art.
`This is a post-priority date article, I believe, from one of
`the inventors as well as Anacor's expert, Dr. Maibach. One of the
`inventors is Steven Baker. You've seen his name on the patents.
`They refer to a recent study from Mertin and Lippold, and they
`say they found that permeation -- Judge Hulse, we are on 62, if
`you are tracking with us. They found that permeation through the
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`nail was mostly influenced by molecular weight and little, if any,
`by lipophilicity, which is in agreement with earlier studies. I'm
`sorry, they are citing a recent study and they are saying it's in
`agreement with Mertin and Lippold which were the earlier ones.
`And Baker and Maibach go on to state the space
`between the strands must have a finite size causing the nail plate
`to act like a molecular sieve or size exclusion medium. Small
`molecules can weave through these spaces while larger molecules
`are unable to pass. And then it states the molecular weight of
`most antifungal agents is greater than 300 Daltons. Accordingly,
`these drugs will have difficulty penetrating the nail plate, a likely
`reason for the low clinical efficacy observed. Again, in this case,
`tavaborole is half that. It's about 151 Daltons.
`JUDGE HULSE: Counsel, as far as I can understand, I
`don't think patent owner is really contesting that molecular weight
`is a factor in determining nail penetration. But I could imagine
`that there might be other factors like, you know, if for instance
`tavaborole were highly toxic, then even if it were small, a person
`of ordinary skill in the art would know not to use it. So can you
`discuss the toxicity issue a little bit more? In particular, if you
`have any evidence that shows that the benzoxaboroles were safe
`when administered topically or even countering what it is that
`patent owner is arguing.
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`MR. GERGELY: I can answer that question. And the
`short answer to your question is are there toxicity studies that
`predate the patent or that are in that patent? No. No one did that
`work with respect to tavaborole. It's not shown in Austin. And
`it's not shown by the patent owner. And this is an issue that was
`created by the patent owner saying that boron compounds as a
`class are considered highly toxic or there's fears of toxicity so
`people would be afraid of boron, which is not the case. I mean,
`we have cited numerous papers, both in our opening petition as
`well as in the reply brief, showing that fears of boron toxicity
`were misplaced.
`And really the way it all started was there was a
`researcher named Grassberger who made a statement, I think, in
`the mid-'80s, and he put a statement in his papers that there was
`some concern about boron toxicity. And that statement wasn't
`supported by any data. And Anacor relies on that paper, among
`others, which all trace back to Grassberger for that proposition.
`What's curious in this case is that when Anacor filed
`their preliminary response, Dr. Kahl looked at the papers they
`were citing and he pulled all of them and he read them and he
`traced it all back to Grassberger and determined that Grassberger
`wasn't supported by any data. Ironically or maybe coincidentally,
`Anacor did the same thing. Dr. Baker published a paper post
`priority date, I think, from 2009, where he came to the exact same
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`conclusion. He looked at the prior art that was available and said
`that it wasn't supported by any data. So those fears of boron
`toxicity were unfounded. So basically he did what a person of
`ordinary skill in the art could have done back in 2005, pull all the
`relevant papers and read them and determine for themselves
`whether there was any issue of boron toxicity.
`The fact of the matter is there was plenty of other
`evidence in the record showing that boron compounds as a class
`were not considered toxic. I believe Dr. Maibach in 1998 -- here
`it is, slide 44. He published a paper, I believe, this was sponsored
`by U.S. Borax, but don't quote me on that. I believe that to be the
`case. Dr. Maibach actually did some human studies where he
`concluded at the end of this paper that based on his analysis of
`boric acid, which by the way, is one of the compounds that
`Anacor says created this fear of toxicity, he said you could
`actually immerse a human being in boric acid for 24 hours with
`no safety issues.
`Here it is. So on slide 47, he talks about in vivo
`absorption of boron applied for 24 hours to human skin, and he
`says this is equivalent to .7 milligrams of absorbed boron for a
`person entirely immersed in a saturated boric acid solution for 24
`hours. For comparison .7 milligrams boron is significantly less
`than the average daily dietary intake.
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`JUDGE HULSE: Can you apply these findings, though,
`to all classes of boron-containing compounds?
`MR. GERGELY: I think the point that Anacor was
`trying to make is that boron, as a class of compounds, was
`considered toxic. And there are references that predate the
`priority date of the patent which show that they are not.
`JUDGE HULSE: As a class, though, right? But there
`were specific boron-containing compounds that were quite toxic,
`right?
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`MR. GERGELY: Right. I mean, some of the work that
`Dr. Kahl did on boron neutron capture therapy involves
`anticancer drugs which are considered toxic because they are
`injected intravenously at such high levels, they are intended to be
`toxic. They are intended to kill cancer cells. So that would be
`one class. But I think -- I believe he stated in his declarations, at
`least in his reply declaration, that boron neutron capture therapy
`is not relevant to the issues at hand because here you are not
`injecting high doses of boron into the body. You would be
`applying a boron compound in a formulation to the nail. And it's
`not intravenous. It's not oral. And there's no fear of systemic
`toxicity. In fact, I think Dr. Murdan, in her paper, which is
`Exhibit 1028 in the 1776 case, says that topical application are
`desirable for that reason, is they avoid systemic toxicity.
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`And again, most of this concern about boron toxicity in
`the prior art is all traceable back to Grassberger. And both
`Dr. Kahl and Dr. Baker, who is one of the inventors, they pulled
`all the papers that repeat Grassberger's statement and they traced
`it back to Grassberger, and they say there's no data to support
`that.
`
`JUDGE OBERMANN: I'm just looking at their brief
`and they do have a section on unexpected results where they talk
`about selective toxicity, and they have the statement that seems to
`be supported by the declaration that it was over one-thousandfold
`for tavaborole. I'm looking at your reply brief and I don't see any
`real evidence countering that.
`MR. GERGELY: There was an analysis of selective
`toxicity as a secondary consideration. My understanding of
`secondary considerations is that they have to be appreciated at the
`time of the invention. I don't believe that this was. But you are
`right, they did point that out. But I also note that in their own
`patent they don't do any selective toxicity studies. They don't do
`any toxicity studies whatsoever. And the Board pointed that out
`in the order granting institution. I believe in the '657 case,
`pointed out that, look, there are potentially millions of
`compounds that can be claimed in the '657 patent. And there was
`a criticism from Anacor that, well, there would be no reasonable
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`expectation of success because you haven't determined that boron
`is not toxic.
`JUDGE OBERMANN: This goes beyond that because
`now we have them arguing secondary considerations, and they do
`have a fact that may come forward with evidence that tavaborole
`had selective toxicity. In other words, it was able to kill fungus
`but not toxic, and it cites this number over one-thousandfold.
`And then we have the expert and I just read his declaration saying
`that this would have been unexpected and it was remarkable for
`any antifungal. And I look at your reply brief and you talk about
`their argument, but I don't see anything -- we are left with a
`factual assertion here that seems to be supported.
`MR. GERGELY: I believe in our reply brief we said
`that their arguments concerning secondary considerations lack
`nexus, that they weren't tied to any particular claim. And I think
`that's where that's lacking. I don't see an analysis of that point.
`They may be making that point about selective toxicity, but it's
`not tied to any particular claim language. The issue of toxicity is
`just not within the scope of these claims. There's no -- for
`example, there's no property claim. You know, such and such a
`compound having an LD-50 of X amount or less than X amount
`or greater than X amount is just not there in any form or fashion.
`So there's nothing about toxicity in the claims. Nor is there
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`selective toxicity. I would argue that that secondary
`consideration would fail for that reason.
`JUDGE TIERNEY: I'm curious here. Did the inventors
`actually discover this toxicity, this one-thousandfold?
`MR. GERGELY: I don't know if they did or they
`didn't. Quite frankly, you are stumping me at this point.
`JUDGE TIERNEY: The reason I ask is because the
`expert, Dr. Ghannoum, paragraph 165 of the declaration says that
`it's Ali, et al., which is Exhibit 2113, is reporting results.
`MR. GERGELY: Thank you, Your Honor, for
`reminding me. I believe those papers were from years later. And
`not -- I want to say maybe it was post priority date, these third
`party papers.
`JUDGE TIERNEY: Ali, et al., I believe Exhibit 2113,
`was 2007?
`MR. GERGELY: Right. So priority date is February of
`'05. Two years later someone publishes this analysis. So is that
`an unexpected result? I think it has to be appreciated at the time
`of the invention. Plus it also lacks nexus.
`JUDGE TIERNEY: Could you please address the
`argument about the compounds of Austin and Brehove and also
`Austin and Freeman being structurally dissimilar.
`MR. GERGELY: Yes. The point the experts were
`making was that the these compounds had similar structural
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`features to Brehove and Freeman. In the case of Brehove, they
`were boron heterocycles. In the case of Freeman, they were
`boron cyclic compounds. Because of that fact and the fact they
`did share common activity against Candida albicans in the case of
`Brehove or Candida species in the case of Freeman, specifically
`Candida parapsilosis, one of ordinary skill in the art would
`reasonably expect, based on that common activity and the fact
`that these compounds are from the same class, that they would
`also be effective against dermatophytes, which is relevant to a
`couple of claims. A lot of these claims just refer to
`onychomycosis generally. Some claims actually call out tinea
`unguium. So it's relevant to those claims.
`Now, in their slides, Anacor has selectively cited some
`of the deposition of Dr. Kahl on these issues. I would invite the
`Board to read the several pages that follow those cites. And you
`can see exactly what Dr. Kahl was talking about, which is, yes,
`these are different compounds. There's no question they are
`different compounds. But one of ordinary skill in the art would
`recognize their similarities, and one of ordinary skill in the art
`would recognize that both of these compounds would have
`antifungal effect. So that's what he said in total. Not the snippet
`of testimony that's going to be presented in the slides.
`So unless the Board has further questions, I'll stand
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`down.
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`JUDGE HULSE: I do have one question. Patent
`owner, I guess, challenges the credibility of your expert because
`they are not mycologists. Can you address that?
`MR. GERGELY: Yeah. The mycologist wasn't part of
`their proposed definition or our definition of a person of ordinary
`skill in the art. I think it was an afterthought. They also said that
`now a person of ordinary skill in the art must have clinical
`dermatology expertise. Again, that wasn't part of the parties'
`definitions.
`You know, with respect to Dr. Murthy not being a
`mycologist, it's not required. There's actually deposition
`testimony of record from Dr. Ghannoum where I asked him, does
`one need to be a medical mycologist to be a person of ordinary
`skill in the art, and he answered no. So actually I asked him can a
`person be a person of ordinary skill in the art without having
`training in medical mycology. And he says, could be. That
`person could be a person of ordinary skill in the art. And we
`cited that. I don't have the pinpoint cite, but I could get it in
`rebuttal if it's necessary. But he did say that.
`JUDGE HULSE: So I think Dr. Murthy testified about
`the person of ordinary skill in the art expecting that the
`benzoxaborole would share functional activity with the
`compounds of Brehove. In other words, if they -- this is what we
`are talking about, that the compounds that would be active against
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