UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`FLATWING PHARMACEUTICALS, LLC and MYLAN
`PHARMACEUTICALS, INC.,
`Petitioners,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
` Case IPR2018-00171 (Patent 9,572,823 B2)1
`____________
`
`Record of Oral Hearing
`Held: March 1, 2019
`____________
`
`
`
`
`Before GRACE KARAFFA OBERMANN, TINA E. HULSE, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`
`
`1 Cases IPR2018-01358, -1359, -1360, and -1361 have been joined with
`Cases IPR2018-00168, -169, -170, and -171, respectively.
`
`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`PHILIP D. SEGREST, JR., ESQUIRE
`Husch Blackwell LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, Illinois 60606
`
`STEVEN W. PARMELEE, ESQUIRE
`Wilson Sonsini Goodrich & Rosati
`One Market - Spear Tower, Suite 3300
`San Francisco, California 94105
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`AARON P. MAURER, ESQUIRE
`TONY SHEH, ESQUIRE
`Williams & Connolly LLP
`725 Twelfth Street, NW
`Washington, D.C. 20005
`
`
`
`
`The above-entitled matter came on for hearing on Friday, March 1,
`
`2019, commencing at 1:00 p.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
`
`
`
`2
`
`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`
`P R O C E E D I N G S
`- - - - -
` JUDGE OBERMANN: Please be seated. It's going to take us just a
`few minutes to wake up our computers.
`JUDGE HULSE: Good morning, everyone. I'm Judge Hulse in
`California; and with you in Alexander is Judge Obermann; and in Denver is
`Judge Harlow. We are here for the final hearing in IPR2018-00168, -169, -
`170, and -171, to which IPR2018-01358, -1359, -1360, and -1361 have been
`joined.
`
`Let's begin with appearances, starting with Petitioner FlatWing,
`please.
`
`MR. SEGREST: Yes, Your Honor, Philip Segrest for the Petitioner,
`FlatWing. Also in the gallery is the counsel for the co-Petitioners, Mylan.
`
`MR. PARMELEE: Steve Parmelee, Your Honor.
`
`JUDGE HULSE: Would counsel for Mylan like to introduce himself?
`
`MR. PARMELEE: Steve Parmelee. I'm from Wilson Sonsini for
`Mylan Pharmaceuticals, Inc.
`
`JUDGE HULSE: Thank you; and for Patent Owner?
`
`MR. MAURER: Good afternoon, Your Honors. Aaron Maurer for
`Patent Owner; and in court with me here today is my colleague Tony Sheh.
`
`JUDGE HULSE: Thank you. Welcome everyone. As we stated in
`our hearing order, each party will have 45 minutes of time to present their
`arguments. We'll start with Petitioner and then hear Patent Owner's
`response; and then assuming that both parties reserve time, we'll hear
`Petitioner's rebuttal and Patent Owner's sur-rebuttal. Please remember that
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`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`neither Judge Harlow nor I can see what's on the screen; so if you could
`please be very specific as to where in the slides you are referring -- what
`slide number, etc. We do have them electronically, so we can follow along
`from here.
`
`Judge Obermann will be timing you. She's in the room with you; and
`so she'll let you know how much time you have left. Does anyone have any
`questions?
`
`MR. SEGREST: Does the display here show the time left or is that --
`
`JUDGE OBERMANN: You're going to see the lights. They'll go
`from green -- I think the yellow is going to be a two or three minute
`warning. I can let you know; and then red means you're out of time. I'm
`sorry we don't have the display -- but wait, maybe we will. I see the
`display's up there.
`
`MR. SEGREST: There's one here. I just didn't know if it was
`working.
`
`JUDGE OBERMANN: Yeah. You tell me how much time you want
`to reserve and I'll put it on the clock.
`
`MR. SEGREST: 15 minutes.
`
`JUDGE OBERMANN: Fifteen; so, you're going to have 30 minutes
`to start. Are you seeing that amount of time floating up there?
`
`MR. SEGREST: Yes.
`
`JUDGE OBERMANN: Okay. So, you'll have full warning. Let me
`just get it to 30; and I won't begin the clock until you begin speaking.
`
`JUDGE HULSE: Okay. Are we all set then? Mr. Segrest, you may
`begin.
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`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`MR. SEGREST: Thank you. May it please the Board, I'm going to
`
`start pursuant to the guides the Board gave us -- departing a bit from the
`slides -- I want to look first at this question of what's the scope of issues still
`in dispute, especially in light of the previous IPRs. I'd like to refer the board
`to Exhibit 1017. It's the decision in one of the three previous IPRs, page 50;
`and there's a paragraph there which I think explains where we're at in this
`case as well.
`
`It reads that, further, for the same reason set forth above with respect
`to claim 6, we credit Dr. Murthy's testimony that "formulating
`pharmaceutical compositions was well known in the art of cosmetics and
`topical pharmaceuticals. And a number of non-toxic pharmaceutical
`acceptable solvents were known, including water and ethanol." And
`"formulating pharmaceutical compositions involve nothing more than
`routine experimentation based on well-known protocols." And that the '657
`Patent does not "describe any unexpected results attributable to the claimed
`pharmaceutical formulation of claim 9. Of course, we're looking a different
`patent now, but the same principle still applies -- formulating pharmaceutical
`compositions. It's still well known to those in the art. It still involves
`routine experimentation.
`
`At this point, we're down to one claim limitation that we're looking at
`which is the 5 percent white weight of Tavaborole in the claims that are still
`asserted. Most of the claims have dropped out. That 5 percent white weight
`of Tavaborole doesn't have any unexpected results associated with it. There
`needs to be something special about it because the prior art showed ranges
`all around this. There's nothing special about 5 percent. There're no
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`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`unexpected results; there's no undue experimentation that was required. It's
`just an arbitrary amount that's included in the claims and doesn't impart any
`patentability. So, from the same principles that were applied by the Board
`previously, the claims that are still asserted here are invalid.
`
`Up on the display now is slide 1, under which it shows our cover page
`on the demonstratives.
`
`JUDGE HULSE: Mr. Segrest?
`
`MR. SEGREST: Yes.
`
`JUDGE HULSE: Could you respond to the argument that Patent
`Owner made in its sur-reply that with respect to those findings that we made
`previously, those were in the context of a different argument?
`
`MR. SEGREST: Well, it certainly applied those principles to the
`questions of water composition, or ethanol, or glycol. I've got right up now,
`slide 2, which I think will, in part, help me answer your question. This
`shows the claims from the '938 Patent that are still in dispute -- claims 1, 2,
`4, and 6 have dropped out -- a lot of limitations in those claims which, as
`agreed, don't impart any patentable weight. Claims 3 and 5 have many
`limitations other than the 5 percent white weight of Tavaborole; but the
`principle that was applied by the Board previously is that unless that
`percentage weight -- which is within the range as in the prior art -- unless
`that element -- whatever that element is -- has some unexpected result that's
`described in the specification -- just reciting a specific percentage doesn't
`impart patentability. It could be any percentage within this range. Many
`percentages are disclosed in the ranges in the prior art, and this is inside of
`these ranges, it's not outside of them. So, that creates a presumption that it's
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`6
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`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`obvious unless there were some kind of showing that it has a special
`unexpected result; that it required some special undue experimentation to
`produce it; but there is no such evidence. It's just an arbitrary number
`picked out of ranges that were known, that were disclosed in all of the prior
`art.
`Some of our prior art that we had in our initial petition was directed to
`
`particular elements and claims that are no longer involved. The Samour
`reference, for example, that does disclose the 5 percent, but really the reason
`that we needed to include it is because it also disclosed all of the other
`elements of the formulation. But none of those -- Patent Owner agrees --
`none of those impart any patentable weight, but gets down to a 5 percent of
`the active ingredient, but that's shown throughout the prior art.
`
`JUDGE OBERMANN: But doesn't a lot of the prior art pertain to
`chemical classes that are completely unrelated to your drug?
`
`MR. SEGREST: It includes this specific drug, among other things. It
`also includes other drugs; it includes other types of chemicals -- some of
`which are different; and there are very broad ranges that are shown. But 5
`percent active ingredient is within all those ranges. There's nothing
`unexpected or special about it. There would still have to be some showing --
`and there's nothing in the patent that shows that 5 percent was something
`special. There's no invention about the 5 percent. There's nothing non-
`obvious about the 5 percent. It's just the result of routine experimentation
`and a dose range experimentation.
`
`JUDGE OBERMANN: And you're saying that's not disputed by your
`colleagues?
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`7
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`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`MR. SEGREST: They've put forth no evidence of it. Their dispute
`
`consists of --
`
`JUDGE OBERMANN: They don't bear the burden of doing that.
`You bear the burden of showing that each and every limitation in
`combination would have been obvious.
`
`MR. SEGREST: Yes; and we met that burden in the opening petition
`by showing overlapping ranges that the 5 percent falls within, including
`ranges on Tavaborole itself.
`
`JUDGE OBERMANN: Which particular references actually include
`ranges on that drug?
`
`MR. SEGREST: Well, often is what shows Tavaborole.
`
`JUDGE OBERMANN: Is that the only one?
`
`MR. SEGREST: That's the one that shows Tavaborole; and then
`Samour is showing causeabrenin; and Brehove was showing a different kind
`of drug.
`
`JUDGE OBERMANN: And what evidence do you have that your
`Tavaborole would have behaved the same way as any of these other drugs?
`
`MR. SEGREST: Well, in Samour, for example, it discloses a large
`number of compounds; and it describes them all as working basically the
`same in these topical formulations.
`
`JUDGE OBERMANN: And you argued that in your petition?
`
`MR. SEGREST: Yes.
`
`JUDGE HULSE: Okay. Before we get too far into the weeds, I just
`want to ask sort of a high-level question. It seems like the post-decision on
`institution briefings were virtually identical in all four cases. So, do you
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`8
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`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`contend that all of the claims should rise and fall together in all of the
`proceedings?
`
`MR. SEGREST: We certainly contend that, Your Honor. The only
`limitation that was a focus after the opening petition was this 5 percent white
`weight of Tavaborole; and our briefing -- and, I believe, Patent Owner's
`briefing as well -- were substantially identical. There were some differences
`in the citations just because each of the expert declarations included
`quotations of the claims that were disputed, which changed the paragraph
`numbering, for example; but, substantially, the testimony, the evidence for
`all of the claims that are at issue was identical after the opening petition.
`And I'm going to be referring to the exhibits from the 168 petition to the
`extent that we get into specific paragraph numbers. The paragraph numbers
`may be slightly different in some of the other petitions, but the substance of
`that evidence is still the same in them.
`
`Moving through the other patents -- the '938 -- there's only the two
`claims that are still asserted not to be invalid; and it's based purely on that 5
`percent white weight of Tavaborole. The '289 Patent -- Patent Owners no
`longer contend that claims 1 through 9, and 11 are valid; they admit that
`those are invalid. The only ones that they are defending are claims 10, and
`12 through 15, based solely on the 5 percent white weight of Tavaborole
`limitation.
`
`Moving to slide 3 -- this is the '290 Patent -- the same thing. Claims
`1, 3, 4, 7, 8, 9, and 10, Patent Owner concedes are invalid. Again, the only
`claims asserted to be valid are the claims 2, 5, and 6; 11 and 12 -- which is
`based solely on that 5 percent white weight of Tavaborole.
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`9
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`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`Slide 4 shows the claims from the '823 Patent. Again, it's only claim
`
`2 in this patent. That's the only claim that includes that 5 percent limitation.
`It's the only one that Patent Owners are still contending might not be invalid.
`
`Departing from my demonstratives for a minute -- in our reply brief,
`pages 1 through 6, we went through a list of findings from the previous case.
`All of which have applicability here, which are not in dispute; and Patent
`Owners in their sur-reply didn't contend to any of these findings were in
`dispute. Some of the important aspects of that are that the prior art
`reasonably suggested administering the Biobar product to treat nail fungus.
`That there's a reasonable expectation of success in penetrating the nail --
`that's key. This is already known. There is a reasonable expectation of
`success that Tavaborole will penetrate the nail. There's not just a reasonable
`expectation -- the Board's previously found that there is a high expectation
`of success -- that Tavaborole would effectively treat nail fungus. This is all
`in Exhibit 1018 -- another of the Board's previous decision at page 48.
`
`Most of the evidence from the Patent Owner is essentially a collateral
`attack on these findings. There's testimony from Dr. Reider to the affect that
`Tavaborole would not be expected to penetrate the nail because of the
`keratin content of the nail; or because of the water content of the nail, it
`would break down. The problem with that testimony -- the reason it can't
`overcome the prima facie showing of obviousness is that it's, essentially, a
`collateral attack on the Board's previous finding that Tavaborole would
`penetrate the nail. None of that is tied to this 5 percent limitation. All of it
`is about how the substance Tavaborole operates on the nail; and that's
`already been decided. That's not in dispute.
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`10
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`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`JUDGE HULSE: What about teaching away? Is it your contention
`
`that we have already decided that issue as well in the prior cases?
`
`MR. SEGREST: No, Your Honors, our contention is that there is no
`teaching away. Let me skip to that slide and we can talk about the teaching
`away issue.
`
`The first thing to look at -- this is on slide 16 -- see if I can get to that
`one. Samour is the reference that's contended to include a teaching away.
`So, the first thing to look at in Samour -- let's look at slide 12 first -- slide 12
`shows the ranges that are disclosed in Samour. This is important. In the
`specification, Samour teaches that certain ranges are typical of an active
`antifungal agent, and it can range from 0.5 to 20 percent, or from 1 to 10
`percent; 5 percent is right in the middle of that range.
`
`JUDGE OBERMANN: Counsel, just to clarify -- Samour isn't
`specifically dealing with the compound at issue in the challenged claims,
`right?
`
`MR. SEGREST: No. Samour was primarily about the form of the
`lacquer, the formulation; and the teaching in Samour is that, that formulation
`can be used with any type of compound that's effective for treating nail
`fungus. So, it lists a whole bunch of active ingredients that can be used with
`it; and it's showing the percentage of active ingredient that you would use,
`it's in this range 1 to 10 percent. So, Tavaborole --
`
`JUDGE OBERMANN: And that's regardless of the chemical
`characteristics of the actual antifungal compound?
`
`MR. SEGREST: Regardless of the chemical characteristics it's going
`to be somewhere within the broad ranges that are disclosed -- and Samour
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`11
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`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`discloses some fairly broad ranges and some narrower ranges. But routine
`experimentation through a dose-ranging study will show you whatever dose
`is appropriate for a particular active ingredient. It's just that's routine
`science; that's not an invention. That's the previous finding that formulation
`of pharmaceuticals is routine experimentation.
`
`Now, that doesn't mean it's never patentable. There could be
`something patentable if there's an unexpected result; if there's some type of
`special showing; but that's what's not here. There's no type of special
`showing; there's no type of unexpected result.
`
`Now, my point though before about the ranges that are disclosed in
`Samour, if it's disclosing -- if it's saying a range from 0.5 to 20 percent -- and
`preferably from 1 to 10 percent -- then there can't be a teaching away from 5
`percent. These are the ranges that it says. If you look at the claims later on
`in Samour, the claims cover these ranges as well. It can't be teaching away
`if it's claiming those ranges.
`
`The particular example that is said to be a teaching away is example 9.
`We've got it on slide 16. The first table in example 9 shows more
`penetration with a 10 percent or a 20 percent weight, and less penetration
`with a 5 percent weight. But it's not zero. It is showing penetration at 5
`percent. That's in table 13. Example 9 doesn't even end with table 13,
`which shows -- you know, table 13 is showing a 5 percent, 5 percent, 10
`percent, and 20 percent; but it goes on from there. The very next sentence
`after saying that the results suggest no significant benefit was achieved by
`increasing the dose from 10 to 20 percent. It says in order to test the
`effective antifungal agent below 5 percent, the following antifungal nail, of
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`12
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`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`course, were prepared -- and these formulations were tested and that's shown
`in 14. It's not teaching away from 5 percent if the first thing it does after that
`table is go below 5 percent; and it goes below 5 percent; and then in the
`specification where it's describing ranges, it shows broader ranges that go
`below 5 percent and include 5 percent.
`
`JUDGE HARLOW: Counsel --
`
`MR. SEGREST: Yes?
`
`JUDGE HULSE: Go ahead, Judge.
`
`JUDGE HARLOW: My question was simply does example 9 involve
`any active agents that are similar or related to the claimed active antifungal?
`
`MR. SEGREST: It's not the Tavaborole -- it's not Tavaborole in
`example 9, as such.
`
`JUDGE HARLOW: So, Patent Owner's teaching away argument is
`not dissimilarl from Petitioner's argument likewise premised on an active
`compound that doesn't necessarily share chemical similarities to Tavaborole
`other than that it's an antifungal, is that fair?
`
`MR. SEGREST: That's true. All of the antifungals -- and this is part
`of the teaching of Samour and it's discussed in our briefing -- all of the
`antifungals behave somewhat similarly in this regard, and that's why Samour
`teaches you can use any of them with this lacquer preparation it's developed
`and the penetrations and answers that are involved there. But, yes, to the
`extent that Patent Owner is saying that example 9 teaches away from 5
`percent for Tavaborole, they're agreeing that example 9 is illustrative of
`what would apply to Tavaborole. The problem is example 9 doesn't really
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`13
`
`

`

`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`teach away; example 9 goes above 5; it goes below 5. And the case law
`that's cited as well shows that it's simply not a teaching away.
`
`Our slide 17 is the E.I. duPont de Nemours case which explains that
`all of the case law is that after a reason to conclude otherwise, the factfinders
`justified in concluding that a disclosed range does just that -- discloses the
`entire range. So, presumptively, because we're within the ranges in Samour
`-- we're within the reasons that are discussed in Brehove; we're in the ranges
`that are discussed in Freeman; we're within the ranges that are discussed in
`Austin. Because we're within all of those ranges, presumptively, anything
`you pick out of those ranges is obvious unless there's some showing that it's
`not obvious, that it's special -- that there's something unexpected about it.
`
`And that's what's absent here. It's not that it was Patent Owner's
`burden of proof to begin with, but they've done nothing to overcome the
`presumption showing obviousness.
`
`JUDGE HULSE: Could you please respond to Patent Owner's
`argument challenging the credibility of your argument, and that you ignored
`example 9 in your papers?
`
`MR. SEGREST: I don't think we did ignore example 9, and I've just,
`you know, discussed example 9. But the main point is that example 9 was
`showing preferred ranges, and that's what de Nemours -- the case that I just
`cited -- is explaining; is that showing any preferred range -- even if 10 to 20
`percent were a preferred range -- which, by the way, is not what the
`specification says -- but even if that were a preferred range, that's not a
`teaching away. It's legally insufficient to be a teaching away in addition to
`being factually just not a teaching away. That's not what example 9 says;
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`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`and that's not what this patent says; and that's not how a person of ordinary
`skill in the art would read it.
`
`A case that the Patent Owner cited in their sur-reply is the Alcon case.
`We've got an excerpt from this on slide 18 in our demonstratives. This is
`687 F.3d at 1370. Now, the Alcon case is interesting. Patent Owner cites it
`to say that there can be something non-obvious within the scope of all
`therapeutically affected amounts; but Alcon actually said much more than
`that. Alcon was dealing with a range up to 0.1 percent. That's what was
`disclosed in the prior art. And there were claims in Alcon -- 1 through 3, and
`5 through 7 -- that were held obvious because those claims overlap with the
`ranges disclosed in their prior art. There were also two claims in Alcon that
`did not overlap the ranges disclosed in the prior art. They were an order of
`magnitude higher -- it was 1 percent instead of up to 0.1 percent.
`
`Those were the claims that the court held were not proven to be
`obvious because they were outside of the range that the prior art disclosed.
`Alcon is actually a good example of why our situation is that it's within the
`ranges in the prior art, and that's what creates the prima facie case of
`obviousness; and that's what they've not overcome with any of the testimony
`from their experts.
`
`JUDGE HULSE: Counsel, on page 19 of your reply, you say that
`Patent Owner agrees that the concentration is a result effective variable; and
`you're citing pages 33 and 41, and 42. Can you point me to exactly where
`on those pages you think that they made that admission?
`
`MR. SEGREST: So, Patent Owner's response -- 33, 41, and 42. So,
`this is their discussion of example 9; and in their discussion of example 9 to
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`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`argue that it's teaching away, they argued that the percentage matters -- the
`percentage has an effect; the percentage is a result-effective variable. That's
`what this argument means.
`
`JUDGE HULSE: But is it really though? I mean if you look at table
`13 of Samour and the statement right after that table saying that these results
`suggest that no significant benefit is achieved by increasing the dose of
`antifungal agent from 10 to 20 percent; and you look at Table 13 and the
`total amount absorbed of econazole for 20 percent concentration is actually
`less than 10 percent. So, wouldn't that suggest that it's not a result effective
`variable?
`
`MR. SEGREST: To the extent -- Your Honor, I think that's probably
`a fair reading of at least those two particular formulations; and Samour
`specifically says that it doesn't look like there's any benefit from going from
`10 to 20. It did show some different affects for lower percentages -- 5
`percent, 2 percent, and 1 percent. But the argument that there's a difference
`based on the percentage, that's the entire basis for their teaching away
`argument. It may not be that they agree that it's a result of effective variable;
`but in effect they do in order to make that argument. Without that argument,
`we're still back to it just being prima facie obvious. There's nothing that
`distinguishes 5 percent from anything else if it's not a result effective
`variable. At that point it's purely arbitrary. It's even less meaningful; and
`there's certainly no unexpected result associated with it if it's not result
`effective.
`
`Examples -- let me back up again. If there are other questions on this,
`let's certainly address them, but Dr. Reider argues, for example, that the
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`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`promiscuous nature of boron would cause a person of ordinary skill in the art
`to expect it not to work, or that there would be no routine experimentation
`that could be done for a boron-containing compound. The problem is that
`we've already talked about Tavaborole as a boron-containing compound.
`The previous Board decisions and the federal circuit decision were all
`dealing with a boron-containing compound. So, when the Board previously
`spoke about routine experimentation, it was talking about routine
`experimentation for a boron-containing compound; and thus ranging study is
`just another form of routine experimentation. There's nothing about boron
`that would prevent one from doing a dose-ranging study as was done with
`Tavaborole.
`
`Similarly, for Dr. Reider's testimony about the keratin content of the
`nail -- yes, the nail has keratin in it, and that may result in some binding with
`Tavaborole, but the Board has already found that a person of ordinary skill
`in the art would have a reasonable expectation of success on Tavaborole
`penetrating the nail and on Tavaborole being effective to treat nail fungus.
`That really precludes an argument that keratin in the nail is going to prevent
`Tavaborole from working or being effective.
`
`There's also some discussion about the Biobar Service Bulletin talking
`about incompatibility with water, and water and jet fuel; and it's true that the
`Biobar product was produced in jet fuel; and, in general, you don't want to
`have water in jet fuel. Just having water in the jet fuel would be a much
`bigger concern than the affect it would have on the antifungal product that
`was in there. This is shown by the percentages that are in there -- the
`ASTM, 30 parts per million that is cited by the patent owner in that product,
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`Case IPR2018-00168 (Patent 9,549,938 B2)
`Case IPR2018-00169 (Patent 9,566,289 B2)
`Case IPR2018-00170 (Patent 9,566,290 B2)
`Case IPR2018-00171 (Patent 9,572,823 B2)
`
`is order of magnitudes lower than you would even start to worry about any
`possibility of hydrolysis.
`
`And the other problem with the testimony about hydrolysis, Dr.
`Reider admitted in his cross examination that he had not looked at the
`kinetics of the reaction. So, there may, eventually, be some breakdown of
`Tavaborole, but it's not going to happen during the treatment period or even
`during the shelf-life period of the products that are being used to treat nail
`fungus. That was Dr. Kahl's rebuttal testimony that, yes, when you look at
`the kinetics of the reaction, it's going to take years for this type of
`breakdown to occur. That, yes, the reaction can occur, but it's not something
`that's going to affect the expectations of a person of ordinary skill in the art.
`
`Dr. Lane's testimony, in many places, also amounts to simply a
`collateral attack on the Board's previous determinations. For example, she
`quotes a statement from a Nair 2009 article about problems with delivery of
`antifungal medications across the nail. Now, a number of issues with that --
`some of which were raised in our motion to exclude -- it's a 2009 article --
`the priority date here is 2005. Something that's said in a 2009 article is not
`prior art. She's just quoting what an author said about it being difficult to
`penetrate the nail and reciting that as that author's opinion, which is basically
`treating that author as another testifying expert; and for that reason all of that
`type of stuff should be excluded. But, even if it's admitted, all that article --
`and the other similar articles -- say is that it's difficult to treat nail fungus
`with a topical product; it was difficult before 2005. After Tavaborole was
`developed, it was still difficult. Ta