trials@uspto.gov
`571-272-7822
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`Paper No. 103 and 21
`March 3, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`AKER BIOMARINE, AS,
`Petitioner,
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESOURCES,
`Patent Owner.
`
`______
`
`Case No. IPR2014-00003 & IPR2014-00556
`Patent No. 8,278,351
`__________
`
`Held: October 31, 2014
`____________
`
`
`Before: LORA M. GREEN, JACQUELINE WRIGHT BONILLA,
`and SHERIDAN SNEDDEN, Administrative Patent Judges.
`
`
`
`
`
`The above-entitled matter came on for hearing on Friday, October 31,
`2014, commencing at 10:00 a.m., at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`Paper No. 103 and 21
`March 3, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`AKER BIOMARINE, AS,
`Petitioner,
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESOURCES,
`Patent Owner.
`
`______
`
`Case No. IPR2014-00003 & IPR2014-00556
`Patent No. 8,278,351
`__________
`
`Held: October 31, 2014
`____________
`
`
`Before: LORA M. GREEN, JACQUELINE WRIGHT BONILLA,
`and SHERIDAN SNEDDEN, Administrative Patent Judges.
`
`
`
`
`
`The above-entitled matter came on for hearing on Friday, October 31,
`2014, commencing at 10:00 a.m., at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`
`
`
`
`Case No. IPR2014-00003 & IPR2014-00556
`Patent 8,278,351
`
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`AMANDA HOLLIS, ESQUIRE
`
`
`MICHAEL W. DE VRIES, ESQUIRE
`
`
`ELIZABETH A. CUTRI, ESQUIRE
`
`
`Kirkland & Ellis LLP
`
`
`300 North LaSalle Street
`
`
`Chicago, Illinois 60654
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`ON BEHALF OF ENZYMOTEC:
`
`
`ELIZABETH HOLLAND, ESQUIRE
`
`
`Goodwin Proctor
`
`
`The New York Times Building
`
`
`620 Eighth Avenue
`
`
`New York, New York 10018
`
`ON BEHALF OF PATENT OWNER:
`
`
`JONATHAN G. GRAVES, ESQUIRE
`
`
`LAURA CUNNINGHAM, ESQUIRE
`
`
`DEAN FARMER, ESQUIRE
`
`
`Cooley LLP
`
`
`One Freedom Square
`
`
`Reston Town Center
`
`
`11951 Freedom Drive
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`
`Reston, Virginia 20190-5656
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`Case No. IPR2014-00003 & IPR2014-00556
`Patent 8,278,351
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` P R O C E E D I N G S
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`- - - - -
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`JUDGE GREEN: Good morning. Please be seated.
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`Welcome, everyone. This is the final oral hearing for joined cases
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`IPR2014-00003 and IPR2014-00556. This involves patent number
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`8,278,351. We instituted this Inter Partes review on March 24th,
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`2014, and we joined the proceeding on July 29th, 2014.
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`At this time, we would like counsel to introduce
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`yourselves and your colleagues, beginning with Petitioner.
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`MS. HOLLIS: Your Honor, this is Amanda Hollis from
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`Kirkland and Ellis, I'm here on behalf of the Petitioners Aker and
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`Enzymotec, with me is Mike De Vries and Elizabeth Cutri from my
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`firm, Mitch Jones and Edward Braekke from Aker. We also have
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`Elizabeth Holland. We will let her introduce her team.
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`MS. HOLLAND: Good morning, Your Honor, Elizabeth
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`Holland for Petitioner Enzymotec and with me is Cynthia Hardman
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`and Daniel Margolis.
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`JUDGE GREEN: Good morning, thank you. Patent
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`Owner?
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`MR. GRAVES: Yes, good morning, Your Honor,
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`Jonathan Graves from Cooley, LLP for Neptune Technologies and
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`Bioressources, with me also from Cooley is Lauren Cunningham,
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`behind her also from Cooley, Mr. Dean Farmer, and from Neptune,
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`Benoit Huart, general counsel, and Dr. Fotini Sampalis, the named
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`inventor.
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`Case No. IPR2014-00003 & IPR2014-00556
`Patent 8,278,351
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`JUDGE GREEN: Thank you very much. Welcome to
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`the Board. Consistent with our previous order, each side has one hour
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`to present our argument. Petitioner will proceed first, as to its case as
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`to the challenged claims, and you may reserve rebuttal time if you
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`would like. Thereafter, Patent Owner responds to Petitioner's case.
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`Counsel for Petitioner, do you have demonstratives?
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`MS. HOLLIS: Yes, Your Honor, may I approach with
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`copies?
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`JUDGE GREEN: Yes, please. And do you have them
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`for the court reporter and the opposite side?
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`MS. HOLLIS: Yes, Your Honor.
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`JUDGE GREEN: And would you like to reserve any
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`rebuttal time?
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`MS. HOLLIS: Yes, Your Honor, I would like to reserve
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`20 minutes for rebuttal, please.
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`JUDGE GREEN: Thank you very much. You may
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`begin when you're ready.
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`MS. HOLLIS: Thank you, Your Honor. I would like to
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`begin with the patent slide 1, please. What did Neptune say its
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`invention was in this patent? It said its invention was a novel
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`phospholipid, a new molecule, one that has EPA and DHA
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`simultaneously attached. What do we now know? We know that this
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`molecule absolutely was not novel. This molecule exists in nature, in
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`krill, in nature, and it's extracted with nearly any polar extraction
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`process, anything that takes out lipids.
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`Case No. IPR2014-00003 & IPR2014-00556
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`Neptune didn't create this molecule. People have been
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`extracting this molecule for years and years before its patent. We
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`have shown this to you in so many ways. We have shown this to you
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`with our tests. We looked at the extraction methods in Beaudoin, we
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`used superba, we used pacifica, we used heat, we used no heat. We
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`showed this to you with Dr. Haugsjerd's testing, with Dr. Budge's
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`testing. We showed this to you with the tests of Fujita, the hexane
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`method, the hexane methanol method, the hexane once through
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`method. We showed you this with the Bergelson experiments. This
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`molecule is extracted even with water.
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`This molecule is not novel. This was the basis for their
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`patent. We should be done. Neptune's expert admits this. He says,
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`these molecules exist in krill, in nature, and he doesn't know of any
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`polar solvent that won't extract them.
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`So, now what do they say their invention is? They now
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`say that they have invented a new process. They say that they
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`deviated from the prior art processes because they didn't use heat, but,
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`Your Honors, they don't cite the patent when they tell you this, and
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`there's reason why. They don't talk about any new method of
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`extraction, instead they say essentially the opposite.
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`Slide 9, please. They tell you that what they used to get
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`their molecule was a method similar to the commonly owned prior art
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`Beaudoin patent method, and they incorporate that entire patent by
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`reference. They don't tell you that they deviated, they don't tell you
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`Case No. IPR2014-00003 & IPR2014-00556
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`it's different, and they don't tell you that they incorporated it except
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`for the heating step.
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`Now, they say "similar," and Neptune is going to say that
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`that somehow means different, but we showed you, with an analysis
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`of the fraction I process, which is indisputably a product of the
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`Beaudoin process, that the steps are identical for that fraction
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`preparation.
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`Slide 10, please. In this chart, which they have not
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`rebutted, we walk you through step by consecutive step of each of the
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`processes for producing fraction I, in the prior art Beaudoin process,
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`and in the '351 process, and they are identical. For example, they start
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`with material consisting of freshly harvested and preferably final
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`divided marine and aquatic animal material that's subjected to acetone
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`extraction for about two hours and preferably overnight. That's what
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`Beaudoin says the first step is.
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`The '351 patent, it's the identical step. Preferably, freshly
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`harvested and final divided marine and aquatic animal material that's
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`subjected to acetone extraction for at least about two hours and
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`preferably overnight. They used slightly different words, but the step
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`is identical. And the same type of identity is found step after step.
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`We didn't cherry-pick pieces of this process, we didn't string them
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`together from different parts of the art, these are exactly as cited, as
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`recited in consecutive order in Beaudoin.
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`JUDGE SNEDDEN: Does this process require heat, the
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`Beaudoin process?
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`MS. HOLLIS: There is an evaporation step at the end,
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`but the heating step that Neptune points to, it's not required, it is
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`disclosed.
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`heating?
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`And that's my next point, Your Honor. What they are --
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`JUDGE BONILLA: Does evaporation require heating?
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`MS. HOLLIS: I'm sorry, Your Honor?
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`JUDGE BONILLA: Does the evaporation step require
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`MS. HOLLIS: It requires heating, that's the only known
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`way to evaporate. And it's in both processes, you evaporate.
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`What they have told you is the difference between the
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`Beaudoin process and theirs is a heating step. Slide 22, please.
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`And this is where that step is, according to Neptune.
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`After you go through the extraction process of Beaudoin, they tell you
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`Beaudoin has this extra heating step, 125 degrees for 15 minutes
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`under nitrogen. But, Your Honor, even if you agree with them, but
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`this is a required step, it doesn't matter for the anticipation analysis,
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`and here's why.
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`Number one, they don't explain why the product of the
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`process of Beaudoin up through this step wouldn't be identical to what
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`they say is their invention. If the steps are identical, so must be the
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`products, and there's no question that an intermediate piece or extract
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`can anticipate just as well as the final product.
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`Reason number two, we have shown you with and
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`without heat this molecule still is there, and this is the only reason --
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`JUDGE BONILLA: Can I ask you a question? There's
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`some confusion with us about the extraction of the different
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`phospholipids and the analysis of the phospholipids after they do the
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`extraction. We're trying to figure out whether that heating step relates
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`to the extraction process, or fine tuning of the extraction versus what
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`they do when they just analyze what the sample actually has. It
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`appears here that you're conceding that the heating step is actually part
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`of the extraction process itself. Is that what I'm hearing?
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`MS. HOLLIS: It's part of the disclosed process for
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`making an extract, yes, Your Honor. What Beaudoin does talk about
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`is that they evaporate the solvent using this step for analysis, and the
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`bottom line is that it's not a required step, and even if it was a required
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`step, for analysis, for extraction, either way, it doesn't matter, and the
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`reason is because the only thing they have said as to why this process
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`step makes a difference is because it somehow will destroy all of the
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`claimed phospholipid molecules. That's their argument. And we have
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`shown you with test after test that that doesn't happen, that the
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`claimed phospholipid is still there, even with this heating step.
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`JUDGE SNEDDEN: Why do you believe that the
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`heating step, the evaporation step is optional?
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`MS. HOLLIS: It's -- so, it's a well-known principle of
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`anticipation that any process disclosed by the prior art reference, so
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`long as there's one process in there that anticipates, that's sufficient.
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`You don't have to show that every different process disclosed by the
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`prior art would result in the claimed invention.
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`Patent 8,278,351
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`JUDGE SNEDDEN: So, the process that does not use
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`heating, where is that located in the Beaudoin reference?
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`MS. HOLLIS: It's in the table 19, the disclosure of the
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`best mode of the process.
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`JUDGE SNEDDEN: Okay.
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`JUDGE GREEN: But if we're talking about the
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`intermediate, that would make a big difference between independent
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`claims 1 and 24, because why would one take the intermediate and
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`then make it into a tablet or something else, if this is a required part of
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`the process?
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`MS. HOLLIS: Yes, Your Honor, claim 24 doesn't
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`require a tablet or a capsule, it also extends to a solution, which would
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`absolutely encompass the intermediate. A solution, as Neptune's
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`expert admitted, is just a composition that's composed of multiple
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`fractions, and that's exactly what this would be.
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`So, Your Honor, and this is their argument, this is what
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`they say is the process, is this extraction plus the heating step. That's
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`the only reason they actually got this patent is because they convinced
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`the examiner that this makes a difference with respect to the claimed
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`phospholipid, but it doesn't. We've shown you with the tests, and they
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`have no other tests. And we've shown you with the experts'
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`admission.
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`Slide 23, please. This is Neptune's expert. I asked him:
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`"Dr. Jaczyniski, following the procedure of the Beaudoin I patent, is it
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`Case No. IPR2014-00003 & IPR2014-00556
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`your position that the claimed phospholipids would be in the extract
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`prior to the 125 degree Celsius heating step?
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`"Answer: Yes. "
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`"Question: And after the 125 degree Celsius heating
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`step, for 15 minutes, is it your opinion that every last molecule of the
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`claimed phospholipids would be destroyed? "
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`"Answer: No, it is not."
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`How many would be there? He doesn't know.
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`Before I go on to the other elements, I would like to
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`address a few points on claim construction. Slide 5, please. One of
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`the disputed terms here is "suitable for human consumption." We
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`argue that you should apply the plain and ordinary meaning of this
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`term, and that would include multiple types of human consumption,
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`including oral, including topical, and this is well supported by the
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`intrinsic evidence. The claims talk about more than just oral dosage
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`forms, the specification talks about more than just oral dosage forms,
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`and there's no basis to exclude those embodiments.
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`Neptune argues that you must construe this term, even
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`though you're applying the broadest reasonable interpretation standard
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`to require repeated oral ingestion, and safety for repeated oral
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`ingestion over an extended period of time. This is merely an attempt
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`to backfill in the exact same suitable-for-FDA standards type of
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`limitation that Your Honors correctly rejected. They have pointed
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`you to no basis for limiting the plain and ordinary meaning of human
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`consumption to require such a limited form.
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`The best that they have been able to point you to are
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`statements in the specification that say the extract can be used for
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`some oral forms, but even under the Phillips analysis, which results in
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`narrower contructions more often, that would not suffice to limit that
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`term.
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`On solution, Your Honors, that's slide 6, this is a disputed
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`term in the preamble of claim 24. We have a general argument that
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`applies to the whole preamble. Neptune again, the issues are similar,
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`they want you to find that that preamble, although it says nothing
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`about oral dosage forms, must require safety for oral dosage, and there
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`is an "or" there, it can be a capsule, a tablet, a solution "or" a
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`suspension, and just taking solution on its own shows you clearly this
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`is not going to require an oral dosage form as they've asked you to
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`construe it to.
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`Neptune's expert agrees that the general meaning of
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`solution is just a solution -- is "a composition composed of different
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`fractions." That's the ordinary meaning, and again, there's no reason
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`for you to limit it as Neptune has proposed.
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`Free fatty acid concentration, slide 4, please.
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`JUDGE BONILLA: Before you get there, can we talk a
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`little bit about the term "about" in the claims?
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`MS. HOLLIS: Yes, Your Honor.
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`JUDGE BONILLA: Patent Owner has argued that the
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`term in the specification that talks about "about meaning plus or
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`minus 50 percent," and suggests that "about" refers to plus or minus
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`50 percent of the number that's there and that's recited.
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`So, for example, about 5 percent would be plus -- would
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`be 2.5 to 7.5 percent, and they suggest that 50 percent -- plus or minus
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`50 percent of 5 percent would get you into negative percentages,
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`which is nonsensical. That seems pretty persuasive. Do you have a
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`response to that?
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`MS. HOLLIS: Yes, Your Honor, it's not the broadest
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`reasonable interpretation. They specifically defined this term as you
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`correctly found. They have an explicit definition of what "about"
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`means in this claim.
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`JUDGE BONILLA: Well, the specification is
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`inconsistent with what they are suggesting, and you could say that it's
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`not reasonable to assume that we're talking about negative 45 percent.
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`MS. HOLLIS: It actually is inconsistent with what
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`they're saying, Your Honor, though, because it says, "at least." So, it
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`says, "about means that the numerical value may vary by at least plus
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`or minus 50 percent." So, to put bounds on numerical bounds and to
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`say it can't go beyond that does conflict with their own strategic,
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`deliberate definition of this term in the specification.
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`JUDGE BONILLA: So, your position is the fact that it
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`says "at least," by definition means that it must go to as low as
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`negative 45 percent?
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`MS. HOLLIS: Your Honor, it -- that's their nonsensical
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`argument, they're telling you that your construction, in their own
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`words, are nonsensical. Absolutely people can make sense of this, it
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`doesn't -- the claim term doesn't require negative values.
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`Your Honors, when you put that claim term in the claim,
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`you still -- it still says it has a concentration of free fatty acids. Free
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`fatty acids obviously must still be present and anyone would
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`understand this, reading the claim.
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`Their own definition and Your Honors' own construction
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`of it in the initial decision doesn't encompass negative values any
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`more so than the simple term "less than." So, if a claim term, as some
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`of Neptune's claim terms say "less than 0.3 milligrams of selenium,"
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`for example, technically that may encompass negative values under
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`their theory, but everyone understands, that doesn't mean negative.
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`JUDGE BONILLA: If we interpret "about" the way that
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`Patent Owner is suggesting, however, does that mean that your
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`positions fail on some of the claims that require specific percentages
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`using the term "about?"
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`MS. HOLLIS: No, Your Honor. Both Beaudoin and the
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`Fricke reference disclose free fatty acid levels in the claimed amounts,
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`and the 40 percent and 45 percent, the total phospholipid limitations
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`also would be meant even under their proposed constructions.
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`A couple of more points on free fatty acids.
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`JUDGE BONILLA: Can we go through those? For
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`example, I'm looking at claim 5 and it says that the extract has a
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`concentration of free fatty acids in about 5 percent weight of the
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`lipids. In your petition, on page 46, you say that that would be 8.5 --
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`that your samples as you tested would have 8.5 to 16.1 percent, if I'm
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`reading that correctly. And if we interpret "about" the way that Patent
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`Owner is suggesting, that would be outside. Is that correct?
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`MS. HOLLIS: Your Honor, we also, after Neptune
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`proposed its narrow construction, we filed our reply, and we pointed
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`you to an additional disclosure in Fricke that is --
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`JUDGE BONILLA: So, this is in relation to the
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`obviousness, not the anticipation?
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`MS. HOLLIS: Obviousness.
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`JUDGE BONILLA: So, are you conceding that there's
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`no anticipation of that claim by the -- I don't want to say it wrong,
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`Beaudoin?
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`MS. HOLLIS: Beaudoin, I'm sorry, I thought we were
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`talking about Fricke. For Beaudoin, no, we're not conceding. Like I
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`said, that claim term also would be met, and here's why.
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`Slide 28, please. This is one reason. Neptune's expert,
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`and Neptune's argument to you is that there is a correspondence
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`between phospholipid levels, total phospholipid levels, and free fatty
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`acid levels, in these extracts. There's a numerical correspondence.
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`And when you see 40 to 45 percent total phospholipids, which we
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`have demonstrated through our testing exists in the Beaudoin extracts,
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`you will get the claimed amount of free fatty acid levels, 2.5 to 7.5
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`percent.
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`So, even under their construction, Beaudoin would
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`anticipate under their own expert's testimony and their own argument.
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`In addition, we have this elephant in the room that they
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`have used the Beaudoin process. Their process, what they have told
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`you, you can use to make their invention, the exact same steps are in
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`Beaudoin. There is that heating step, but that's not required, and that
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`would be an error of law to say that you must --
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`JUDGE BONILLA: Let me ask you again, I'm sorry.
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`MS. HOLLIS: Yes?
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`JUDGE BONILLA: So, I'm looking at the petition on
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`page 42 and it's relating to claim 5, among others, and it looks at the
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`Brenna declaration, and it says, "Extracts contained" -- presumably
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`are extracts that were obtained using the Beaudoin reference -- it says,
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`"extracts contained from 8.5 percent to 16.1 percent free fatty acids,
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`which is about 5 percent as defined." That's what you state in your
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`petition. You're saying that in your reply you're suggesting that it's
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`actually something else?
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`MS. HOLLIS: This is from their table, this is the express
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`disclosure in Beaudoin, but we have repeated Beaudoin and shown
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`you that the phospholipid levels are between 40 and 45 percent and
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`they are telling you that it would be 2.5 to 7.5 percent if you have
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`those phospholipid levels. So, the repeats, the experimental repeats
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`show you the claimed free fatty acid levels.
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`JUDGE BONILLA: And I'm sorry, can you remind me
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`where that is in your reply?
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`MS. HOLLIS: Page 12, Your Honor.
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`JUDGE BONILLA: So you're relying on Neptune's
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`expert's statement rather than whatever you were relying on in your
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`petition?
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`MS. HOLLIS: One second. I'm sorry, Your Honor, I
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`believe these numbers, 8.5 to 16 percent are coming from the Fricke
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`table, as opposed to Beaudoin. I think I said Beaudoin, but they are
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`from Fricke.
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`JUDGE BONILLA: Got it.
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`MS. HOLLIS: Your Honor, they cannot get around this
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`fact that the free fatty acid concentrations must be the same if the
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`process is the same.
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`JUDGE SNEDDEN: When we look at the recreation
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`samples, though, did we -- and that's of the Beaudoin extracts, then
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`specifically with respect to I just want to make sure we're talking
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`about the same thing, but I'm looking at claims 2 and 3, and there
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`we're talking about total phospholipid concentrations, right? As
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`opposed to I think other claims that are specific to free fatty acids. If I
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`have that wrong, please let me know, but when we look specifically at
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`phospholipid concentrations, and we then go to the Beaudoin
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`recreation samples, you know, I'm not sure all samples fall in that
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`narrow range of what would be 36 to 44 percent, or they would under
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`the broader construction fall under the 30 to 50 percent. This portion,
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`this argument about how to construe "about" I think does affect the
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`outcome.
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`MS. HOLLIS: Your Honor, the -- let's go to the total
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`phospholipid claims. Slide 27, please. The proper construction here
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`is the one that you reasonably decided it was, it was -- you used that
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`plus or minus 10 percent as an absolute, not -- you don't multiply it by
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`the stated number, which is what --
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`JUDGE BONILLA: Let's just assume for the sake of
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`argument that we are going to interpret it the way the Patent Owner
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`says.
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`MS. HOLLIS: Right, and Beaudoin would still
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`anticipate. The pacifica repeats give you 44.4 percent, the MPEP
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`section in the Allen case, within that section, we cite that MPEP
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`section in our briefs, tells you that it is not novel, it's not new, it's not a
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`patentable invention to get you to claim a range that's very close to
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`what's already in the prior art, unless you've shown that there's some
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`difference associated with that range. Critical. Criticality with that
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`range.
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`And if you agree with them, that somehow this shows
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`Beaudoin doesn't anticipate, what that means is you're saying they
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`should get a patent because they had 0.4 less phospholipids than the
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`prior art. They had a crummier phospholipid concentration than the
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`prior art.
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`JUDGE BONILLA: We're talking about anticipation,
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`right, of the Beaudoin reference?
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`MS. HOLLIS: Yes, we are, Your Honor.
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`JUDGE BONILLA: And I'm sorry, I apologize, earlier I
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`was getting confused between the Fricke ground and the Beaudoin
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`ground, so now I'm looking at the petition on page 20, and you're
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`citing to the Beaudoin table 14, and it says that the free fatty acids are
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`above 20 percent.
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`MS. HOLLIS: Right.
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`JUDGE BONILLA: Which is what you state.
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`MS. HOLLIS: Right.
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`JUDGE BONILLA: If we interpret "about" the way the
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`Patent Owner is suggesting, that would fall outside. Is that correct?
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`MS. HOLLIS: The express disclosure, that number is not
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`7.5 or less, but again, Your Honor, they haven't shown you any
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`criticality associated with their number. They haven't shown you that
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`somehow the difference between 7.5 and 20 free fatty acids is going
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`to have any effect whatsoever on this extract.
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`JUDGE GREEN: But that's more an obviousness
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`argument than anticipation argument, because with anticipation, you
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`have to have a 1:1 correspondence, and so I understand what you're
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`saying, and I don't disagree, but when we're talking about anticipation,
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`every element has to be found that's in the claim, and you're making
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`more of an obviousness argument.
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`MS. HOLLIS: Your Honor, if you look at the Allen case
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`that's in the MPEP section that we cited, I believe it's 214405, it
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`doesn't say this only applies in the obviousness context, and it's -- if
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`you think about it, it's the right result. You shouldn't be able to, you
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`know, look at a prior art reference as they did, and see that they have
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`one number and just write a different number in your patent and say
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`that's new and you get a patent on it. Especially, Your Honor, when
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`it's a crummier number.
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`JUDGE SNEDDEN: On the actual construction of
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`"about," Patent Owner's expert has testified that a person of ordinary
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`skill in the art would not find our interpretation reasonable, in fact,
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`you know, a person of ordinary skill in the art would look at the
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`narrower range of plus or 10 percent means 10 percent of the number,
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`not the, you know, 10 percent as 10 percent.
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`MS. HOLLIS: Right. And, Your Honor, that's wrong.
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`Let's take a look at their own slide, Neptune's slide.
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`Twelve, please. This is what they need to do to convince
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`you that your construction is unreasonable. They need to rewrite the
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`claim. This says, "40 percent weight/weight represents plus or minus
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`10 percent full step."
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`In order to get you to agree that it has to be the narrower
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`range, they need to rewrite that to say 10 percent of 40 percent. That's
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`one reason this argument fails.
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`The other reason is they haven't given you anything on
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`which to conclude that your construction was nonsensical or
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`unreasonable. Their only nonsensical argument is this negative values
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`argument, and that doesn't apply here. This was absolutely a
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`reasonable construction, and again, they haven't shown you anything
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`in the patent or anything else that would explain why 36 percent to 44
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`percent is somehow the invention.
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`What's the difference between that and 30 to 50? They
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`haven't shown you anything. In fact, they're telling you the more
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`phospholipids the better. So, 50 -- you know, the higher is more
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`appropriately the construction.
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`And I want to make a couple of other points on total
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`phospholipids in free fatty acids. They're telling you free fatty acids
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`must be low, must be consistent with what they're telling you because
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`of this hydrolysis theory. Hydrolysis is nowhere mentioned in their
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`patent, and in fact, instead of saying low free fatty acids are good,
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`they tell you on slide 4, please, that greater than 5 percent free fatty
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`acids is the way to go. They want -- in their patent, they say free fatty
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`acids should be greater than or equal to 5 percent, no upper bound,
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`and they tell you again here, it's better to have higher free fatty acids.
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`Preferably 4 percent, at least 4 percent, preferably at least 5 percent.
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`The more the better is what they're telling you.
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`This is absolutely the reason why one of ordinary skill in
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`the art would reasonably understand that free fatty acids limitation to
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`mean what exactly the Patent Owner has said it means.
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`On total phospholipids, please let's go back to that chart
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`showing the Beaudoin samples. Slide 27, please. Under their
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`construction, also this falls exactly within their claimed range. Under
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`the narrower construction, which is improper, the superba repeat falls
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`within the claimed range. That is clearly anticipatory. Both sides
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`agree you may practice the Beaudoin method with superba. That's
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`anticipatory.
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`JUDGE BONILLA: I'm sorry, just remind me, where are
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`these numbers, the total phospholipid numbers? Are those coming
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`from your own experts doing the samples or is that coming from the
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`Beaudoin reference?
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`MS. HOLLIS: This is from our own repeats, yes, Your
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`Honor. And, Your Honor, why have I circled these here? Dr. Budge
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`did multiple experiments. She repeated pacifica, she repeated
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`superba, she used with heat, she used without heat. She covered the
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`map in terms of what Neptune was going to argue was the proper way.
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`And what I've circled here are the Beaudoin I repeats. What they're
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`telling you that there was variation in the samples, they are relying on
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`prior art that's not even part of the grounds that were instituted here.
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`They rely on --
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`JUDGE BONILLA: I'm sorry, just so I understand. So,
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`was that including the heating step or without it?
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`MS. HOLLIS: This is including the heating step which
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`they say is required.
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`JUDGE BONILLA: And not just the evaporation, the
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`subsequent --
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`MS. HOLLIS: Correct, the 125 degree heating step,
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