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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`------------------------------------------- x
`RIMFROST AS
` Petitioner
` -versus-
`AKER BIOMARINE ANTARCTIC AS
` Patent Owner
`IPR2018-01730
`U.S. Patent No. 9,072,752
`------------------------------------------ x
`
` 4 Century Drive
` Parsippany, New Jersey
`
` November 8, 2019
` 9:00 a.m.
`
` DEPOSITION of NILS HOEM, taken pursuant
`to Notice, held at the offices of Hoffmann &
`Baron, LLP, before Fran Insley, a Notary Public
`of the States of New York and New Jersey.
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`RIMFROST EXHIBIT 1153 Page 0001
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`------------------------------------------- x
`RIMFROST AS
` Petitioner
` -versus-
`AKER BIOMARINE ANTARCTIC AS
` Patent Owner
`IPR2018-01730
`U.S. Patent No. 9,072,752
`------------------------------------------ x
`
` 4 Century Drive
` Parsippany, New Jersey
`
` November 8, 2019
` 9:00 a.m.
`
` DEPOSITION of NILS HOEM, taken pursuant
`to Notice, held at the offices of Hoffmann &
`Baron, LLP, before Fran Insley, a Notary Public
`of the States of New York and New Jersey.
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`Page 2
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`A P P E A R A N C E S:
` HOFFMANN & BARON, LLP
` Attorneys for Petitioner
` 4 Century Drive
` Parsippany, N.J. 07054
`
` BY: MICHAEL I. CHAKANSKY, ESQ.
` Phone: (973) 331-1700
` Fax: (973) 331-1717
` mchakansky@hbiplaw.com
`
` CASIMIR JONES S.C.
` Attorneys for Patent Owner
` 2275 Deming Way, Suite 310
` Middleton, Wisconsin 53562
`
` BY: J. MITCHELL JONES, J.D., Ph.D.
` Phone: (608)662-1277
` Fax: (608) 662-1276
` jmjones@casimirjones.com
`
` xxxxx
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`Page 3
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` I N D E X
`WITNESS EXAMINATION BY PAGE
`NILS HOEM MR. CHAKANSKY 4, 94
` MR. JONES 93
`
`EXHIBITS MENTIONED PAGE
`Hoem 2025 4
`Rimfrost 1009 43
`Randolph 1011 76
`Tallon 1006 89
` xxxxx
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` N. Hoem
`N I L S H O E M,
`the Witness herein, having first been duly
`sworn by the Notary Public, was examined and
`testified as follows:
`EXAMINATION BY MR. CHAKANSKY:
` Q. Good morning, Dr. Hoem.
` A. Good morning.
` Q. This is probably your seventh or
`eighth time we've done this in one of a bunch
`of related IPRs; is that correct?
` A. I lost count of them, but it sounds
`right.
` Q. So you're familiar with the process,
`correct?
` A. Yes, I am.
` Q. And is there any reason why your
`testimony would be affected today?
` A. No.
` Q. I would like to start off by handing
`you what was marked as Aker Exhibit 2025 and
`titled the "Reply Declaration of Dr. Nils Hoem
`in Support of Patent Owner's Motion to Amend."
`I ask if you recognize that document?
` A. Yes, I do.
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` N. Hoem
` Q. I would ask you to turn to the last
`page, page 22 and ask you whether that is your
`signature?
` A. That is my signature.
` Q. Dr. Hoem, is it correct that before
`2008, you had no hands-on experience with the
`extraction of krill?
` A. That's correct.
` Q. Thereafter you've had experience
`with the extraction of krill?
` A. That's also correct.
` Q. When did that start?
` A. Slowly from 2008 and onwards we were
`a fairly small team of technical and science --
`technical background and science background. I
`came to Aker as a clinical scientist really and
`pharmacologist, but with a pharmacist
`background at the same time.
` So little by little I have been more
`and more involved in the process, in the
`process development also rather than just the
`clinical side. So it's been a continuous
`process from then on and actually all the way
`until today where I'm involved in science and
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` N. Hoem
`technology and the company on a much broader
`scale than I was in the very beginning.
` Q. When did you join Aker?
` A. The first of January 2008.
` Q. What do you mean by you became more
`involved in the process?
` A. Well, when I came to Aker, Aker had
`already done quite, you know, done a lot of
`work on the -- on the harvesting and processing
`of the krill material. So when I came to Aker
`I was, as I said, primarily focused on clinical
`trials, the clinical documentation of effects
`of krill lipids and so forth, but as I said, we
`were a fairly small team and we even reduced
`our team at the time and we were utilizing our
`technical resources differently as we moved
`forward. And as I said, me being a certified
`pharmacist, had experiences in similar fields I
`would say at the beginning and then I was
`asked -- as time passed by, I became more and
`more involved in the processing of our
`material, not just the clinical documentation.
` Q. Can you explain what you mean by the
`processing? I assume of the krill?
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` N. Hoem
` A. It means -- it has meant the
`extraction procedures, how fractionation
`procedures, possible methods, new possible
`methods to do those processes. We, in the
`beginning -- the first years we were working
`together with a third party to do our
`extraction, but we, at the same time, worked on
`experimenting and understanding extraction
`procedures on a broader -- yeah and then I got
`involved in that.
` Q. What was the name of that third
`party?
` A. Natrux, N-A-T-R-U-X.
` MR. JONES: N-A-T-U-R-E-X.
` A. A French company.
` Q. Were there any other companies,
`third-party companies, that you were involved
`with?
` A. I was not involved with any other
`company that I know there were.
` Q. Are you aware of any other companies
`that Aker was involved with in the processing
`of krill?
` A. Yes, I am.
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` Q. Could you name those?
` A. I know we discussed -- we had
`discussions with a company called A-V-O-C-A and
`also I don't even recall the name, but a
`company in New Zealand who did super critical
`extractions.
` Q. Would that be NutraSea?
` A. NutraSea, correct, and finally a
`smaller company in Sweden called Lipid Systems
`where we did that -- yeah.
` Q. The fractionation work that you did,
`what was the purpose of that?
` A. Understanding the material simply.
`Understanding the composition of the tier,
`understanding the properties of the material,
`understanding how we could improve our
`processing of the material.
` Q. How would -- what would be involved
`in improving the processing of the material?
` A. Fractionations, analysis of the
`different fractions, understanding yields,
`understanding such technical parameters that is
`important both from a quality perspective, but
`also from a commercial perspective. That is
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`utilization of the raw material.
` Q. As part of that work with
`fractionation, did you -- were you involved
`with modification of the processes for the
`extraction of krill?
` A. I would say I was more on the
`conceptual side. So I was more early on
`characterizing possible possibilities rather
`than -- you know, I was not in the factory
`and -- so I was more laying the ground for that
`kind of changes rather than taking part in the
`execution of that.
` Q. You say early on you were
`characterizing possible possibilities. What
`type of possibilities were you characterizing
`earlier?
` A. You know, a number of optimization
`problems. We had one product that had set a
`specific specifics and then we wanted other
`products that might differ slightly from that.
` MR. JONES: To the extent that we
` are going to keep from designating this
` confidential, let's try not to get into
` trade secrets.
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` N. Hoem
` MR. CHAKANSKY: Absolutely not.
` MR. JONES: I wanted to bring that
` up.
` MR. CHAKANSKY: I think the
` questions are going to be general enough.
` MR. JONES: That's okay, but I just
` wanted to --
` MR. CHAKANSKY: Absolutely.
` A. Let me also rephrase a little bit.
`I would say that, I think there is a
`distinction where I was working and is that I
`didn't really engage in the engineering part of
`it. That is pumps, tanks, production volumes,
`any of that, that is not my field.
` Q. Insofar as optimizing fractionation,
`were you looking into increasing the
`phospholipid content of the krill oil extract?
` A. Among other things, yes.
` Q. As part of the characterizing
`possibilities, possibilities regarding
`optimizing the phospholipid yield of krill oil
`extracts, did that include increasing the
`co-solvent used in the extraction technique --
`strike that.
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` I'm sorry. I just realized I'm
`assuming something not in evidence.
` In your work with optimizing the
`phospholipid concentration of the extracts, was
`that involving the same two step processes
`described in the '752 patent?
` A. No.
` Q. Did you do any work on optimizing
`the phospholipid content, concentration of
`krill oil extracts using a two step method as
`generally described in the '752 patent?
` A. No.
` Q. Do you have any experience with
`optimizing the phospholipid concentration of
`extract, krill oil extracts using the two step
`process described in the '752 patent?
` A. For that specific process, no.
` Q. Same question where instead of the
`exact process described in the patent, an
`extraction, two step extraction involving C0-2
`first with zero or a minimal amount of
`co-solvent followed by a C02 with a larger
`amount of co-solvent?
` A. No.
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` N. Hoem
` Q. In your -- you said that early on
`you were characterizing possibilities regarding
`the extraction process. Later on -- strike
`that.
` Insofar as characterizing the
`possibilities regarding extraction of krill,
`did that involve analysis of the resulting
`extracts?
` A. Yes, it did.
` Q. Was one of those -- strike that.
` As part of the analysis of the
`resulting krill oil extracts, did you look at
`the concentration of phospholipids?
` A. Yes, I did.
` Q. Did you look at the concentration of
`astaxanthin?
` A. Yes, I did.
` Q. Did the amount of phospholipids that
`you analyzed from these extraction methods
`vary?
` A. Not really.
` Q. Was there a range?
` A. Yes.
` Q. Would you tell us the range without
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` N. Hoem
`giving away a trade secret?
` A. The range is that we have published
`in our documentation as pretty much where --
`yeah.
` Q. The documentation that we have is
`from the patent which was filed?
` A. From the patent, but also from our
`product specifications and they are typically
`about 40 percent and we --
` Q. And your specifications, do they not
`require at least a certain amount?
` A. Sure.
` Q. Do they require a range of
`phospholipids, like a maximum as well?
` A. We published maximums, yes.
` Q. But your product specifications for
`-- you publish, what do you mean by publish
`maximum?
` A. We sell product with a certain
`maximum or we've sold products with a certain
`maximum.
` Q. But, in general, would you provide
`your customers with just a minimum amount of
`phospholipids or with both?
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` N. Hoem
` A. We have provided with a minimum, we
`have also provided with a maximum. Both ways.
` Q. Would the same be true for
`astaxanthin?
` A. For astaxanthin in general we -- in
`our specifications there is a minimum value.
` Q. Can you tell us what that minimum
`value is if that's not violating the trade
`secret?
` A. With regards to our specifications,
`it has changed over the years, different
`products, but the minimum value given in our
`present product would typically be -- well, one
`needs to qualify a little bit here because it's
`given at the end of shelf life because it's a
`parameter that relates to the stability of the
`product and the function of astaxanthin is,
`among other things, to secure that the product
`doesn't oxidize.
` There is a minimum given in the US
`Pharmacopeia which is 100 PPM and has also --
`from the top of my head is 100 PPM and I think
`they stayed with that as the minimum at the end
`of shelf life.
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` N. Hoem
` Q. Let me ask it again because we have
`gone into another document. Insofar as
`specifications that Aker provides regarding the
`quantity of or concentration of astaxanthin in
`its krill oil extracts, is there -- I believe
`you testified there is a -- it's changed
`slightly over the years; is that correct?
` A. When you say changed, it sounds like
`a -- it sounds like a systematic deviation. I
`would say we've -- our specification has been
`in no way a systematic change, but there have
`been changes that has been dictated by a number
`of other factors. For example, as I just
`mentioned, the publication of the USP monograph
`and then there are also other monographs around
`which relates to Codex alimentarius.
` So there has been a number of
`regulatory issues also that relates to the
`amount of astaxanthin and when applicable, Aker
`has set that as minimums at the end of shelf
`life I have to put out.
` Q. Let me ask it again. Do you provide
`specifications to your customers?
` A. Yes.
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` Q. Are those specifications printed?
` A. Yes.
` Q. Do they have values for astaxanthin?
` A. Yes.
` Q. With respect to the specifications
`offered to your customers in writing, has the
`number that is given for astaxanthin changed,
`that number?
` A. We have given a number, different
`numbers for different products and for
`different -- yeah, even for different
`utilities.
` Q. The product I'm talking about is
`generally described as a krill oil extract or
`krill oil. It may come in various forms, but
`I'm focusing in on the product being krill oil
`or krill oils and asking you whether the
`astaxanthin number for the krill oils has ever
`changed in the specifications given to your
`customers and if so, what is the range?
` A. I think I have already answered your
`first -- the first part of your question quite
`clearly. I have said it has changed. I said
`that it has been an incremental, not systematic
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` N. Hoem
`change, and it is actually different for
`different varieties of what you call krill oils
`and I told you also already that the range is
`a -- the ranges we have given is a minimum
`because that's what is important at the end of
`shelf life.
` From the top of my head I can
`remember 100 PPM at the end of shelf life given
`and maybe even 80 PPM in one instance. And
`then largely, we try as -- as public
`monographies have come about to stay with those
`and actually the numbers I gave you reflect
`that.
` Q. By PPM you mean that would be the
`equivalent of milligrams per kilogram?
` A. Correct.
` Q. So you just testified that the
`specification provided to clients had minimums
`of less than a hundred milligrams per kilogram
`and less than 80-milligrams per kilogram; is
`that correct?
` A. Above.
` Q. I'm sorry. I'll restate that. Then
`your testimony, if I'm correct, at this time
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`that your specifications to your customers have
`had the amount of astaxanthin given as greater
`than a hundred milligrams per kilogram and
`greater than 80 milligrams per kilogram?
` A. And we have had higher numbers also
`as a minimum previously.
` Q. Can you tell us what those numbers
`were?
` A. In fact, from the top of my head, I
`cannot go through all of those.
` Q. Did you have 200 as a minimum?
` A. Frankly I can't recall the exact
`numbers.
` Q. Have you had higher than 700 as a
`minimum?
` A. As a specification I can't really
`recall.
` Q. Other than a specification?
` A. If I have seen krill oils with more
`than 1,500?
` Q. Aker krill oils.
` A. I have seen Aker krill oils with
`more than 800 PPM, yes.
` Q. Once again, PPM is milligrams per
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`kilogram?
` A. Yes.
` Q. You said that you were
`characterizing processes and working on
`optimizing krill oil extracts in the past and
`that you analyzed the results. With respect to
`astaxanthin, do you recall what the results
`were from your work?
` A. Part of my work was actually to
`characterize how much astaxanthin do we have in
`krill, how much astaxanthin do we have in krill
`meal, how much astaxanthin would we have in the
`krill oil when the extraction was efficient.
`That is what would be the natural ranges on an
`efficient extraction of krill oil for
`astaxanthin and we analyze -- I analyze a
`number of such situations and came to
`conclusions that was different than in the
`regular marketplace with regards to the amount
`of astaxanthin that you should find in
`efficiently extracted krill oil.
` Q. Let me ask it again based upon the
`work that you did and optimizing the extraction
`and then looking at the results of the
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`astaxanthin portion of your analysis of the
`product, the krill oil product, what range,
`what were the ranges of astaxanthin
`concentration in those optimized extractions?
` A. Typically, you will find any krill
`oil that contains more than, and this is an
`approximate number, 400ish PPM of astaxanthin
`is suboptimal with regards to total lipid
`extraction.
` Q. Regarding the actual testing
`analysis of the products that you extracted,
`what range did you get in astaxanthin
`concentration?
` MR. JONES: I'm going to object.
` Relevance.
` A. I can answer. Since we optimized
`yields we came to realize -- I gave you a
`ballpark number, 400, but in the range of two
`to 800 definitely is where you want to be if
`you have an efficient extraction of krill oil.
` Q. Can you tell me your recollection as
`to the results of the analysis?
` A. That's what I'm giving you.
` Q. So 200 to -- 400 to 800?
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` A. No, 200 on a lower level, typically,
`maybe a little more and up to -- all the way up
`to seven, 800 and we use this as -- we used
`astaxanthin concentration as one way of
`optimizing our extraction procedures.
` Q. In your specifications to clients
`where you give the amount of astaxanthin, you
`testified that -- well, this number is at the
`end of shelf life, correct?
` A. Correct.
` Q. On your specifications does it say
`at the end of shelf life?
` A. Of course.
` Q. So if one were to look at one of
`your specifications that had an astaxanthin, it
`would say on it this number is at the end of
`shelf life?
` A. That is given for any product that
`is sold in the open market, in the marketplace.
`That is, for example, if I sell the bulk oil
`then it is -- have to be at the end of shelf
`life. The same goes for if anybody buys krill
`oil from us, encapsulates it, they have to
`specify it at the end of their shelf life.
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`That is the rules.
` Q. The question was and I think -- I
`believe you just testified that on your
`specifications that go to your customers, there
`is written expressly that these numbers or at
`least the astaxanthin number is at the end of
`shelf life; is that correct?
` A. It is by the law. You have to
`specify at the end of shelf life. I can't
`recall if it says but everyone who deals with
`this knows that is the rules.
` Q. You have seen many specifications?
` A. I have seen many specifications.
` Q. You can't recall whether there is
`any notation regarding whether there is the end
`of shelf life on it; is that correct?
` A. You know, it is inherently by the
`rules and by the law that is how you specify.
` Q. So I take it that you can't recall
`at this time?
` A. I can't recall if it says at the end
`of shelf life, but if you, in any oral
`communications with customers, you know, we
`would tell them that our specifications is, of
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`course, at the end of shelf life because that
`is by law. You're not allowed to sell a
`product into the marketplace without specifying
`it at the end of shelf life.
` Q. What is the shelf life of active
`krill oil?
` A. It depends on -- typically two
`years, 18 months. It depends on -- but
`typically two years in bulk, but then under
`certain storage conditions, you know, it might
`be -- there might be conditions for keeping it
`cool. There might be conditions for what the
`shelf life at 20-degrees Celsius. There are
`different climate regions that we have to take
`into account, but all such specifications is at
`the end of shelf life, otherwise we would sell
`a product that was out of spec.
` Q. That's what I'm asking about and the
`spec is specification and the question was
`you've seen many, but you can't recall at this
`time whether there is an express reference to
`these numbers are at the end of shelf life; is
`that correct?
` A. What I'm trying to tell you is that
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`it is inherently -- you are not allowed to sell
`into the marketplace under existing regulations
`anything that doesn't stand with that number at
`the end of shelf life.
` If I sell something that is below
`that number at the end of shelf life, then that
`is actually illegal. That is in breach of
`regulations. So it's given that this is at the
`end of shelf life.
` I cannot recall if it says at the
`end of shelf life. You know, it might even
`make us look silly to put in that because it's
`given that that is the way it is supposed to
`be.
` Q. With respect to your analysis of
`krill oil, Aker krill oil, and in particular
`the astaxanthin content, we have talked about
`certain minimums, correct?
` A. Yes.
` Q. How about the actual values of the
`astaxanthin in these krill oil extracts; do
`they vary?
` A. Yes, they do.
` Q. And can you give us a range of
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`which -- over which they vary?
` A. Well, you have the minimum.
` MR. JONES: Objection. Relevance.
` A. You have the minimum and they could
`be variations within, typically within the
`ranges that you see that is published in our
`patent.
` Q. The question is from your actual
`observation of the results of analysis on it,
`can you give us the range of which -- the range
`of the astaxanthin concentration in the krill
`oil?
` A. That was the answer I gave.
` Q. Range would be a number beginning to
`an end. Can you give any specific numbers for
`that use?
` A. I told you the minimum at the end of
`shelf life. I also told you typical numbers
`would be in the range that is given in our
`patent. That is 200 to 800 PPM.
` Q. Would it be fair to say that at this
`point you cannot recall any particular
`astaxanthin concentrations in the analysis that
`you observed of the krill oil extracts at Aker?
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` MR. JONES: Objection. Relevance.
` A. Absolute not. I completely disagree
`with that statement.
` Q. Can you give us some numbers then?
` A. I gave you numbers.
` Q. No numbers. You gave us ranges.
`Let me ask it this way again. There is a
`certain minimum.
` Have you ever seen an analysis that
`came below a hundred milligrams per kilogram
`astaxanthin in a krill oil product?
` A. Are you talking about research
`products or are you talking about finished
`product after we sell?
` Q. Both.
` A. What relevance does that have?
` Q. I'm asking you the question, sir.
` A. Of course I would have seen other
`numbers when you work with different fractions.
`That is pretty obvious because you work on
`mapping out the properties of this product. In
`the finished product, no, because we have to
`stay within the limits given and we have to
`fulfill the criteria at the end of shelf life.
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` So that is a clear no in the
`finished product. As I said, I have seen a
`number of different numbers. We are talking
`about ten years worth of data here. In the
`range of 200 to 800 typically.
` Q. So you've never -- is it fair to say
`then you've never seen an analysis that showed
`less than 200 milligrams per kilogram?
` A. I have seen less than 200 for
`specific fraction for whatever, yes, I have.
`There are a number of products that doesn't
`fulfill the criteria to be released for
`example. So you do see the whole spectrum, but
`I can't give you -- there is nothing --
`typically it is within those ranges.
` I also clearly indicated that if you
`optimize your process, you typically would like
`to stay below 400.
` Q. Why is that?
` A. Because the amount of astaxanthin in
`krill itself, if you transfer all astaxanthin
`in krill into the lipid fraction of krill, that
`is where you end up. So if you have a hundred
`percent extraction of krill, then you wouldn't
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`have super high concentrations.
` So you actually want your
`astaxanthin to be within certain regions when
`your extractions are efficient. If you want to
`waste a lot of lipids together super high
`concentration of astaxanthin, then that be it,
`but we didn't go in that direction. We
`actually wanted to stay within the limits we
`gave.
` Q. Do your -- I don't know how to
`describe this. Does your commercial product,
`your krill oil -- no, I'm sorry, strike that.
` Is there currently -- I don't want
`to know how you do it -- is there currently a
`process that produces your superba krill oil?
` A. Yes.
` Q. And have you ever analyzed the
`results of that process?
` A. Yes.
` Q. Does the astaxanthin concentration
`of all the krill oil extracts made by that
`process fall within a certain range?
` A. What do you mean by certain range?
` Q. For example, 100 milligrams per
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`kilogram to 400 milligrams per kilogram?
` A. I couldn't say absolutely at that.
`We are talking about an extract of raw material
`that is of natural origin and that also shows
`natural variations. So there is a range.
` The range given for our -- or the
`numbers given for our released products is what
`it is and we have not put up a maximum on that
`one. We've put on a minimum and I have given
`you reasonable ranges of that variability
`already.
` Q. Just to recapitulate, what are those
`ranges of natural variability?
` A. I have given you the minimums.
` Q. Just repeat it to make it easier.
` A. I said in one of our products I
`think the minimum is at the end of shelf life
`at above 80 and in another one I think it's a
`hundred and that is related to the USP volume
`or the USP monography and then there is another
`one in relation to Codex alimentarius and then
`I've said that I have seen numbers, 200, 300,
`400. I have seen all of those. It is also
`dependent on the method of analysis.
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` Q. Are there any cases where after
`extraction by the process that Aker uses, that
`the astaxanthin level is too low to be sold as
`spec.
` A. If that has happened in ten years
`probably. I can't recall really, but probably.
`That must have happened.
` Q. What would happen in a case like
`that with getting that product to market?
` A. Well, if you don't fulfill the
`criteria to getting it to market, then you have
`no product to send to the market. It will be
`discarded.
` Q. If you discard it, if it was out of
`spec?
` A.
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