UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`RIMFROST AS,
`Petitioner,
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS.,
`Patent Owner
`_____________
`
`Case IPR2018-00295
`Patent 9,320,765 B2
`____________
`
`Record of Oral Hearing
`Held March 12, 2019
`_____________
`
`
`Before TINA E. HULSE, JACQUELINE T. HARLOW, and JOHN E.
`SCHNEIDER, Administrative Patent Judges.
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`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`RIMFROST AS,
`Petitioner,
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS.,
`Patent Owner
`_____________
`
`Case IPR2018-00295
`Patent 9,320,765 B2
`____________
`
`Record of Oral Hearing
`Held March 12, 2019
`_____________
`
`
`Before TINA E. HULSE, JACQUELINE T. HARLOW, and JOHN E.
`SCHNEIDER, Administrative Patent Judges.
`
`
`
`
`
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`
`
`
`
`
`
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`
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`Case IPR2018-00295
`Patent 9,320,765 B2
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`APPEARANCES
`
`ON BEHALF OF PETITIONER:
` JAMES F. HARRINGTON, ESQUIRE
` RONALD J. BARON, ESQUIRE
` JOHN T. GALLAGHER, ESQUIRE
` HOFFMANN & BARON, LLP
` 6 Campus Drive
` Parsippany, New Jersey 07054
`
`ON BEHALF OF THE PATENT OWNER:
` DAVID A. CASIMIR, ESQUIRE
` J. MITCHELL JONES, ESQUIRE
` CASIMIR JONES, S.C.
` 2275 Deming Way, Suite 300
` Middleton, Wisconsin 53562
`
`
`
` The above-entitled matter came on for hearing on March 12, 2019,
`commencing at 2:00 p.m., at the U.S. Patent and Trademark Office, Madison
`Building, 600 Dulany Street, Alexandria, Virginia, 22314.
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`Case IPR2018-00295
`Patent 9,320,765 B2
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`P-R-O-C-E-E-D-I-N-G-S
`(Proceedings begin at 2:01 p.m.)
` JUDGE SCHNEIDER: Good afternoon again. This formal
`hearing is for IPR2018-0295. I'm Judge Schneider. Again, we
`have Judge Harlow appearing from Denver and Judge Hulse coming
`from California.
` As I mentioned before, our court reporter is in Virginia.
`So, again, Counsel, please be sure to speak into the
`microphone either there at your table or at the podium so that
`everybody can hear you in their own sites.
` At the moment, I'd like to get appearances of counsel
`on the record. If we could start with Petitioner, just your
`name and who you represent.
` MR. HARRINGTON: Yes. James Harrington (inaudible).
` JUDGE SCHNEIDER: Okay. And for Patent Owner?
` MR. CASIMIR: David Casimir with backup counsel, John
`Jones, from the Casimir Jones firm on behalf of Patent Owner.
` JUDGE SCHNEIDER: Thank you. All right.
` COURT REPORTER: Excuse me. Excuse me, hi.
` JUDGE SCHNEIDER: We've got 60 minutes allotted for each
`side. I'm sorry for that.
` There's no other question? I guess not.
` All right. We have 60 minutes allotted for each side.
`Petitioner, are you going to reserve the time for rebuttal?
` MR. HARRINGTON: Yes. (inaudible).
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` COURT REPORTER: Excuse me. Excuse me. I cannot hear.
`I can't hear counsel who's speaking.
` JUDGE SCHNEIDER: Yeah. You've got to get close to the
`mic. Are you?
` MR. HARRINGTON: I am now. Yes, 20 minutes, please.
` JUDGE SCHNEIDER: And do you want to let us know or do
`you want to reserve your decision whether or not you're going
`to do a -- serve a reply?
` MR. CASIMIR: We'll reserve 15 minutes at this point.
` JUDGE SCHNEIDER: Thank you.
` All right. One thing I'd like to ask is as you go
`through your presentations today, the judges in the remote
`sites can't see what's on the screen here in the office.
`So -- but they do have hard copies that you emailed us to --
`by (indiscernible).
` So as you go through the presentation, if there's a
`particular cite you're referring to, you can reference the
`page numbers so the judges can get to it, that's fine.
`Typically, we don't -- if we jump out of order so they know
`exactly what you're talking about.
` Any other questions before we begin?
` MR. HARRINGTON: No.
` MR. SCHNEIDER: All right. Petitioner has the burden of
`showing patentability on the claim. So Petitioner will go
`first, Mr. C.
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` MR. HARRINGTON: Good afternoon. James Harrington here
`on behalf of Petitioner, RIMFROST, AS. We're here to present
`regarding the petition challenging the validity of U.S. Patent
`No. 9,320,765, what we refer to as the '765 Patent throughout
`our presentation.
` And generally, the '765 Patent relates to the extraction
`of krill lipids from krill. And moving onto slide 2, we
`wanted to make the initial point that we're dealing with
`natural components -- living components from krill.
` Slide 2 is from a PowerPoint presentation given by the
`patent owner's expert, Dr. Hoem, who's also their chief
`scientific officer. And we thought this was a helpful slide
`just to generally identify the breakdown of the lipids that
`come from krill.
` There are basically two varieties; neutral and polar.
`And as you can see on the right, under the details, the polar
`lipids make roughly -- make up roughly about 44 percent of --
`the polar lipids are roughly 44 percent. Neutrals, they have
`indicated, at 44.7 percent. And the phospholipids are
`highlighted in blue there. And they give various
`subcomponents of the phospholipids.
` One of the -- the vast majority is phosphatidylcholine at
`38 percent. And there's also listed phosphatidylethanolamine
`at 2.6 percent. And we wanted to highlight those because
`later on we'll be talking about ether-phospholipids and we'll
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`be talking about the ether variety of the
`phosphatidylethanolamine. That's AAPE -- what we'll refer to
`later as AAPE. And the alkylacylphosphatidylcholine will be
`referred to later as AAPC. So those would be the ether
`varieties of those two subcomponents.
` And the chart also identifies the neutral lipids. And we
`just wanted to highlight the triglyceride level, the 34
`percent of the triglycerides. So that makes up roughly -- I
`guess, 75 percent of the neutral lipids are triglycerides.
` Okay. So moving to slide 5. We set forth claim 1, which
`is independent -- one of the independent claims. The moving
`to slide 6, we set forth Claim 25, which is the second
`independent claim, and we just wanted to set forth, just as a
`representative claim.
` And moving to Claim -- sorry -- slide 7, we summarized
`the two independent claims just to highlight the differences
`and the similarities. Claim 1 includes the element of being
`suitable for oral administration. Claim 25 includes the
`element of the capsule, containing a safe and effective
`amount.
` There doesn't seem to be any dispute regarding those
`elements. The presentation will really focus on the elements
`in green. In terms of the various subcomponents of the krill,
`it's ether lipids being greater than about 3 percent.
`Nonether-phospholipids being greater -- being about 27 percent
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`to 50 percent.
` Those added together would give you the total
`phospholipids of about 30 percent to 60 percent, triglycerides
`in a level of about 20 to 50 percent, and the rest is anything
`greater than about 100 milligrams per kilogram. So we're
`talking about fairly broad ranges there.
` And moving to slide 8, we set forth the various pieces of
`prior art that were -- are relied upon in order to disclose
`the various elements. And there doesn't seem to be any
`dispute that these references actually disclose those
`elements.
` JUDGE SCHNEIDER: Counsel, what I understand, one of the
`disputes at least is whether or not one skilled in the art
`would have taken the various extracts that you've listed from
`the different references --
` MR. HARRINGTON: Uh-huh.
` JUDGE SCHNEIDER: -- and would have -- whether they will
`combine them together to make the claimed --
` MR. HARRINGTON: Correct. Correct.
` JUDGE SCHNEIDER: Is that correct, what I understand?
` MR. HARRINGTON: Yes. Yes. More of a motivation to
`combine argument than whether the references actually
`disclosed the various headlines.
` JUDGE SCHNEIDER: Okay.
` MR. HARRINGTON: Yeah.
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` JUDGE SCHNEIDER: So I understand, Patent Owner's
`(indiscernible) one shows it more clear. But part of their
`arguments is that because they sort of extracted from the
`natural krill using different processes, that there wouldn't
`be a reason to then recombine them to make the claim
`composition. Is that -- is my understanding correct, at least
`as you understand it?
` MR. HARRINGTON: That is roughly my understanding, yes.
`Yes.
` JUDGE SCHNEIDER: So your -- and your position is -- I
`believe, from your expert, is that (indiscernible) would be
`motivated to combine these different elements together to try
`to -- because of the benefits of each of the individual
`elements. They have one element, one compound, and one
`composition that have -- that
`benefits -- that -- of each of those separate -- different
`components?
` MR. HARRINGTON: That's correct. That's correct. And
`we're not actually blending the elements per se. We're
`combining the references in order to just illustrate that
`these subcomponents would be easily attainable using the
`extraction methods that were conventional at the time.
` JUDGE SCHNEIDER: Well, I think Dr. Tallon does talk
`about blending them.
` MR. HARRINGTON: He does talk about blending, you're
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`correct. And that could be an option. That -- the patent
`discusses that as well. So that was also well-known. If you
`wanted to blend, you could, but, you know, it's our position
`as well that the claim ranges are so broad that you would
`almost have to go out of your way to avoid them, frankly, in
`order to -- you know, to not obtain those ranges.
` And so on slide 9, we're not really going to discuss much
`the patent owner's motion to amend. We just wanted to
`acknowledge its existence.
` And moving to slide 10, just highlight the proposed
`amendment where the ether-phospholipid levels are being
`changed to -- in a range of five to eight percent. And the
`astaxanthin levels, we changed to -- from 100 milligrams per
`kilogram to 700 milligrams per kilogram.
` And moving to slide 13, again, we won't get into the
`details, but just wanted to highlight it's -- the various
`references that we've relied upon to disclose the amended
`elements.
` Moving to slide 16, which begins at the prior art
`section. Again, we're not going to go through all the prior
`art. But moving to slide 17, we did want to highlight the
`Catchpole reference, which is our primary reference.
` And moving to slide 18, we wanted to highlight just some
`of what Catchpole discloses in terms of it being an invention
`relating to a process for separating lipid material containing
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`phospholipids.
` They disclose that phospholipids have been implicated in
`confirming a number of health benefits. They also disclosure
`the idea that the super critical fluid and extracting, using
`CO2 is a more natural solvent than some of the organic
`solvents that could also be used.
` And moving to slide 19, we wanted to highlight some of
`what's disclosed in example 18 of Catchpole, where, upfront
`they highlight the concentration of AAPC. Again, that's one
`of the ether-phospholipids. It's a type of phosphocholine.
`And they indicate that they utilize krill powder as a feed
`material. And they calculated that that feed material had
`21.4 percent lipids.
` So what they did is utilizing -- we're starting with a
`super critical CO2 solvent. They did a first extraction that
`included substantially all neutral lipids. And then from the
`remaining residual powder, they contacted that with both co2
`and ethanol at an 11 percent concentration and then obtained
`extract 2 from that residual feed.
` And they obtained what we have highlighted there in
`extract 2. And the -- at the end, they highlight again the
`levels of AAPC and AAPE, both ether-phospholipids.
` And if we move to slide 20, we highlight the fact that if
`you add together that AAPC and AAPE you get an ether-
`phospholipid level of 4.8 percent. And you also obtain in
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`extract 2 53.7 percent of what they refer to as, other
`compounds.
` And Dr. Tallon, the petitioner's expert, has testified
`that according to his calculation, the other compounds would
`include roughly 32 to 37 percent triglycerides. The patent
`owner disputes that, but when we questioned the patent owner's
`expert, Dr. Hoem, on this issue, all he would do is
`acknowledge that the triglycerides could be there, but refused
`to speculate at all about how much triglyceride would be
`there.
` And this is despite the fact that we showed him his own
`slide that indicated that 75 percent of the neutral lipids are
`triglycerides. We -- and we went through the Fricke reference
`that shows roughly 69 percent of the -- in that reference, 69
`percent of the neutrals were triglycerides. And he claimed he
`couldn't venture a guess as to what that other 53.7 percent
`would be.
` JUDGE SCHNEIDER: Counsel, isn't there in the process
`that you just -- you remove the neutral, right? Take them out
`at a separate step? So why wouldn't you say it is -- it's an
`indeterminate amount of -- several reasons that full amount
`that was in there in the (indiscernible).
` MR. HARRINGTON: No, correct. It's not the full amount
`because Catchpole, you're correct, does acknowledge that in
`extract 1, some of the triglycerides will pull out. But it's
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`well-known -- Tenaka 2, this is just one reference that
`discloses the notion that even after some of the triglycerides
`are pulled out in the first step, by continuing the
`extraction, using both the CO2 and the ethanol cosolvent,
`additional triglycerides would be removed. They're very
`soluble in the cosolids.
` And so those neutral lipids continue to come out, along
`with the phospholipids in that second extraction. JUDGE
`SCHNEIDER: But we don't know how much. I mean, we've got a
`very specific range of triglycerides here.
` MR. HARRINGTON: Yeah. We don't know the exact -- we --
`the exact amount. But, again, you know, calculating the
`ratios of triglycerides into the neutral fraction, Dr. Tallon
`testified very clearly that the other compounds would be the
`neutral fraction because extract 2 is all lipids.
` And he's identified the phospholipids in the
`chart -- in the first part of the chart, so the other
`compounds would be neutral lipids. And Dr. Tallon, our
`expert, I should note, was a coinventor of the Catchpole
`reference. So he's very familiar with the process there.
` JUDGE SCHNEIDER: So using that and then the ratio, what
`-- within the neutral lipids, the ratio of how much you would
`expect that to be triglycerides. You said -- does it have a
`calculation that says it's going to be within the range of 20
`to 50 percent? So -- am I --
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` MR. HARRINGTON: Yeah. Roughly, 32 to 37, which then
`would be right in the middle of the 20 to 50 range.
` JUDGE SCHNEIDER: Correct. Okay.
` MR. HARRINGTON: Okay. Moving to slide 21, it's a little
`busy, but we just wanted to flag this because the patent owner
`has estimated the amount of neutral lipids in the feed as
`being 650 grams by applying the Fricke ratios directly to the
`feed.
` And so by doing that, they roughly calculate 750 neutrals
`in the feed. And then they say that because Catchpole removed
`650 grams of neutrals in the first extract, there would be no
`neutrals yet for extract 2.
` But we think that that's incorrect for a number of
`reasons. Again, it leaves no explanation as to what the other
`53.7 percent would be since extract 2 is a lipid extraction.
`And it also ignores the data that's specifically set forth in
`the Catchpole example. Again, if we go back to slide 19,
`Catchpole discloses that 21.4 percent of the feed was lipid.
` And in Table 16, they provide the amount of phospholipids
`in the feed. So by doing a simple calculation of a -- of
`subtracting the number of grams of lipid in the feed from the
`number of grams of phospholipid in the feed, we can get the
`number of grams of neutral lipids in the feed. Which is not
`650. It's more like 765. Which would leave 150 grams left
`over for the neutral lipids, which would be more than enough
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`to account for the 30 -- 32 to 37 percent that Dr. Tallon
`estimates would be in that other fraction.
` Okay. Moving on to slide 23, we wanted to highlight some
`of the other sections of Catchpole that also refer to the
`level of ether-phospholipids that can be generated, beyond
`just what's in example 18. Here in the original claims that
`were published, they claim a process for separating feed
`material into various components that includes -- they made a
`mistake -- a typographical error. It says
`alkylacylphospholipids.
` Then claim 40, which depends upon claim 1, further
`specifies the feed materials being from marine animals. And
`claim 95, which refers back to 77, which refers back to 40, it
`specifies that the product can include greater than 5 percent
`alkylacylphospholipids.
` And in terms of the marine animals -- the examples
`provided, three examples of marine animals being utilized;
`krill is just one of them. They have another example that
`relates to muscles and another two to fish. So krill is just
`one of the marine animals that's disclosed in Catchpole, where
`they can obtain greater than five percent ether-phospholipids.
` And moving to slide 24, Catchpole, not only discloses the
`general notion of getting greater than five percent, here they
`actually disclose how they would do it. They specifically
`indicate that if you increase the cosolvent of the ethanol
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`concentration above 10 percent -- which, remember, I think, it
`was 10 or 11 percent was used -- 11 percent was used in
`example 18.
` Here they say if you increase that solvent above 10, more
`like 20 or 30, you would get a higher ether-phospholipid
`level. And it turns out, that's exactly what is disclosed in
`example 7 of the '765 Patent. There they use a CO2 and
`ethanol cosolvent at 23 percent in order to achieve their
`highest level of ether-phospholipids is -- would be 7.8.
` So this teaches exactly what's happening in the '765
`Patent. And they also highlight here, achieving levels of
`extraction that include ALP. And ALP, earlier in the
`Catchpole reference is specifically defined as
`alkylacylphospholipids, ether-phospholipids.
` JUDGE SCHNEIDER: Is it correct also that in the
`Catchpole -- it's page -- I believe it's page 9 -- those are
`teaching there, again, specifically that the products that are
`produced by Catchpole comprises greater than five percent of
`the alkylacylphospholipids. And those it goes on to also
`teach greater than ten percent?
` MR. HARRINGTON: Correct. Yes. Yeah. That's in the
`subject, you're right.
` And moving on to slide 27, again, sort of getting back to
`what we were talking about, the neutral lipid level here. Our
`expert, Dr. Tallon, just generally, you know, highlights the
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`idea that the ether-phospholipid levels and phospholipid
`levels in general can be increased if the neutral lipid level
`is decreased. And so that's something that was well within
`the ability of those skilled in the art.
` Moving on to slide 28, we introduce the Sampalis (ph)
`reference. I'm not sure how much time I have left.
` JUDGE SCHNEIDER: I think you have about 20 minutes.
` MR. HARRINGTON: Twenty minutes.
` And on slide 29, we note that the Sampalis reference is
`studying the Neptune krill oil and Neptune krill oil, NKO, is
`what's the -- disclosed as admitted prior art in the '765
`Patent and -- including Table 22.
` And here, Sampalis did a clinical study using krill oil
`extracted from Euphausia superba. And they indicate that it's
`rich in phospholipids and triglycerides, carrying long-chain
`omega-3 polyunsaturated fatty acids. They also disclose the
`fact that each of the patients was administered two one-gram
`soft gels of NKO once daily. So the soft gels would be a
`well-known way of administering this krill oil.
` And Sampalis on slide 30 also indicates that the Neptune
`krill oil can significantly reduce symptoms related to PMS,
`which includes inflammation. And they highlight the unique
`biomolecular profile of the phospholipids in krill oil and the
`omega-3 fatty acids. And the fact that the association
`between the phospholipids and the long-chain omega-3 fatty
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`acids increases their bioavailability.
` So in others, such as fish oil, the omega-3 fatty acids
`are associated with triglycerides. In krill oil, they're
`associated with the phospholipids. And so it was known at
`least as early as 2003 that this association between the
`omega-3s and the phospholipids increased their
`bioavailability.
` So that would be one of the motivations to have a high
`phospholipid level krill oil that includes the omega-3 fatty
`acids.
` Okay. Moving on to slide 32, the Randolph reference
`is utilized to disclose the idea of mixing krill oil with
`other phytonutrients that they disclose here. And Randolph
`also, on slide 34, indicates that these compositions can
`include various levels of astaxanthin as an ingredient.
` Astaxanthin is sort of a natural carotenoid present in
`krill oil. Here they disclose the idea that any levels of
`astaxanthin can be added. It was a well-known commercial
`product.
` JUDGE SCHNEIDER: Yeah. I see that Dr. Tallon uses a
`calculation that's reflected at the bottom of the
`slide --
` MR. HARRINGTON: Uh-huh.
` JUDGE SCHNEIDER: -- where he picks the 50 milligrams
`astaxanthin and the 300 milligrams of krill oil. They'd walk
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`away with 167 milligrams per kilogram astaxanthin. And makes
`an assumption that 95 percent of that would be the esters --
` MR. HARRINGTON: Right.
` JUDGE SCHNEIDER: -- coming down to 158 milligrams per
`kilogram. But, you know, if you look at the text of Randolph,
`you know, the composition can be 300 milligrams, it could be
`3000 milligrams --
` MR. HARRINGTON: Right.
` JUDGE SCHNEIDER: -- and it could be .5 or .50.
` MR. HARRINGTON: Right.
` JUDGE SCHNEIDER: Why did he pick those particular
`values? You know, pick one at the low end of your total
`composition and the other at the high end of the astaxanthin.
`If you use other numbers, you would fall outside the range of
`the claims, wouldn't you?
` MR. HARRINGTON: That's correct. Yeah. I think he was
`just noting the fact that, you know, by analyzing the various
`concentrations that are disclosed on Randolph, you would come
`within the range that's claimed.
` JUDGE SCHNEIDER: Well -- and also --
` MR. HARRINGTON: Within -- I'm sorry. That you could
`come within the range that's claimed.
` JUDGE SCHNEIDER: If you go back to that slide again. If
`you go to the one percent, doesn't that calculate out to be --
`it says, at least one percent of it can be astaxanthin,
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`correct? That would be calculated in -- on a kilogram basis.
`How many milligrams would that be? That'd be 1000.
` MR. HARRINGTON: That would be high, yeah.
` JUDGE SCHNEIDER: I know.
` MR. HARRINGTON: That would be a high number.
` JUDGE SCHNEIDER: All right. Thank you.
` MR. HARRINGTON: Okay. And moving onto slide 36, again,
`we just wanted to highlight Fricke that discloses a lipid
`extraction. And on Page 37, we highlight claim 1 that, again,
`discloses the triglycerides forming in the vast majority of
`the neutral lipids. And then they also have the phospholipids
`present.
` And so I'm not going to go through, in the interest of
`time, the other references, but I did want to touch on the
`motivation to combine. Beginning on slide 48 is where we
`start this section.
` And if we move to slide 49, we highlight here, Bunea
`, which is another study -- the Bunea Reference, another
`study that utilized the Neptune krill oil. And here, again,
`they show -- or they describe some of the unique molecular
`aspects of krill oil that was known at the time, with its
`abundance of phospholipids and antioxidants, which would
`include astaxanthin.
` On slide 50, they highlight the unique biomolecular
`profile and, again, the increased bioavailability of the
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`omega-3 fatty acids in krill oil by being associated with the
`phospholipids, as opposed to the triglycerides.
` And so moving to slide 51, it's our -- it's Petitioner's
`position that the motivation to combine is demonstrated by
`what's disclosed in the prior art. It's well-known -- or it
`was well-known at the time of the earliest effective filing
`date that krill was a good source of phospholipids, that krill
`contained high levels of phospholipids, and the
`phosphatidylcholine, and the omega-3 fatty acids within the
`phospholipids conferred various health benefits.
` It was known that the omega-3s, again, being associated
`with the phospholipids, conferred a higher level of
`bioavailability. And the various extraction techniques in
`order to, you know, achieve these krill lipids was well-known.
`It was also well-known to utilize the soft gel capsules as a
`convenient form of administration.
` So taking all of this together, a person's ordinary skill
`in the art would be motivated to obtain the krill oil with a
`high phospholipid content and its other attendant
`subcomponents, such as the ether-phospholipids, along with the
`astaxanthin and the triglycerides that just come along with
`those extractions.
` JUDGE SCHNEIDER: Would they create by blending the
`individual extracts or by using a technique that yields you a
`final product that has that?
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` MR. HARRINGTON: Well, it could be both. But we, you
`know, rely mainly on the notion that by carrying out the
`extraction using well-known techniques, such as that disclosed
`in Catchpole, that you would obtain a level -- the claimed
`levels of ether-phospholipids, triglycerides, and the
`astaxanthin as well.
` JUDGE SCHNEIDER: At the different levels, what I'm
`understanding at least of Patent Owner's argument is that the
`different levels that you get of these individual ingredients
`that talk about the different references were acquired using
`different extraction techniques, so -- and with the exclusion
`of another.
` So why would you expect a product using one extraction
`technique and still leave you with all the high levels of the
`individual components taken using a separate or different
`extraction?
` MR. HARRINGTON: Well, the -- I think the references show
`that the different techniques really don't make that much of a
`different. You know, even if we look at Catchpole again, we
`have an extraction there, where ten percent -- a cosolvent and
`ten percent achieves 4.8 ether-phospholipid level.
` We still have what Tallon calculates as roughly 32 to 37
`percent triglycerides. It was known that the astaxanthin is
`mainly found in the neutral fractions. So the astaxanthin
`would be there.
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` So we're really -- we're pointing to the other
`references, not in order to combine the different techniques
`so much as to show that by doing the well-known techniques as
`exemplified by Catchpole, you would almost necessarily obtain
`the subcomponents that are claimed in the claimed ranges.
` JUDGE SCHNEIDER: But you don't preclude blending, taking
`the individual fractions that you might obtain, by one
`technique and another fraction from another third technique
`and blending together to come up with what's been claimed,
`right?
` MR. HARRINGTON: No. No, we don't. We --
` JUDGE SCHNEIDER: The claims don't preclude that?
` MR. HARRINGTON: Right. The claims don't preclude that.
`And that -- and the references don't preclude that either.
`For example, if you were, let's say, to have an extraction
`that resulted in a lower level, let's say, of astaxanthin that
`was disclosed in the admitted -- in the '765 Patent for the
`NKO, roughly 472 or -3 milligrams per kilograms of
`astaxanthin.
` You could easily, if you wanted to boost that level of
`antioxidant, just simply add astaxanthin to that composition,
`and you could have a higher level of astaxanthin. So that
`would be very easy and well-known.
` JUDGE HULSE: Counsel, can I ask a high-level question?
`We have quite a few of these, we call them, krill oil cases.
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` MR. HARRINGTON: Yes.
` JUDGE HULSE: I think we have about eight or so. Four
`which have already been through final written decision. Have
`we -- do you contend that we have heard any of these arguments
`before, that we have made findings already as to any of the
`arguments that are made in this case?
` MR. HARRINGTON: There is some overlap, yes. And one of
`the items, actually, I have up on slide 55 here is the PAF
`argument. That has been presented previously. The patent
`owners, I think, are taking a slightly different take now that
`the first round was unsuccessful in terms of how these oils
`may be oxidized.
` But that has been addressed. And I think the notion that
`the triglycerides would be in the Catchpole oil, I believe,
`was settled in the earlier case. Although, where it's being
`argued again now arguably, I think that -- I don't know,
`settled may be overstating it, but it was addressed.
` So, yeah. There is some overlap, you're correct.
` JUDGE HULSE: Thank you.
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