Aker BioMarine AS and Enzymotec Ltd. and Enzymotec USA,
`Inc., Petitioners,
`v.
`Neptune Technologies & Bioressources Inc.,
`Patent Owner.
`
`Case No. IPR2014-00003/IPR2014-00556
`Patent 8,278,351
`
`Oral Hearing – October 31, 2014
`
`Patent Owner’s Demonstrative Exhibits
`
`NEPN Ex. 2066
`Aker v. Neptune
`IPR2014-00003
`
`
`Inc., Petitioners,
`v.
`Neptune Technologies & Bioressources Inc.,
`Patent Owner.
`
`Case No. IPR2014-00003/IPR2014-00556
`Patent 8,278,351
`
`Oral Hearing – October 31, 2014
`
`Patent Owner’s Demonstrative Exhibits
`
`NEPN Ex. 2066
`Aker v. Neptune
`IPR2014-00003
`
`
`
`Claim Construction
`
`Claim Construction
`
`
`
`BRI Must Be “In Light of” the Specification
`
`In inter partes review, “a claim in an unexpired patent shall be given its
`broadest reasonable construction in light of the specification of the
`patent in which it appears.”
`
`-- 37 C.F.R. 42.100(b)
`
`“[W]e indulge a ‘heavy presumption’ that a claim term carries its
`ordinary and customary meaning’ … [t]empering the presumption,
`claims ‘must be read in view of the specification, of which they are a
`part’ … [t]he specification ‘is always highly relevant to the claim
`construction analysis. Usually, it is dispositive; it is the single best guide
`to the meaning of a disputed term.”’
`
`-- Chimei Innolux Corp. v. Semiconductor Energy Lab. Co., LTD, IPR2013-00066,
`Paper 10 (Apr. 24, 2013) (citing Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed.
`Circ. 2005) (en banc); CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366
`(Fed. Cir. 2002)).
`
`--PO Response at 9
`
`3
`
`
`
`Neptune’s Constructions Are the BRI
`
`• Neptune’s proposed constructions are firmly rooted in plain
`and ordinary meaning and the specification’s teachings
`• Petitioners distort or cherry pick from the specification to
`advance constructions designed to suit their prior art
`arguments – even to the point of disputing constructions
`that they and their expert, Dr. Brenna, agreed to in prior ITC
`litigation between the parties
`• Petitioners’ proposed constructions lack expert support – in
`fact, Dr. Brenna testified that he applied Neptune’s
`constructions to form his opinions in this case
`
`--PO Response at 9-14
`
`4
`
`
`
`“suitable for human consumption”
`
`Term appears in all challenged claims and all independent
`claims of the ’351 patent:
`• claim 1: “A krill extract comprising…”
`• claim 24: “A capsule, tablet, solution, syrup, or
`suspension comprising a krill extract comprising…”
`• claim 47: “A food, beverage, energy bar, or nutritional
`supplement comprising a krill extract comprising…”
`• claim 70: “A cosmetic preparation comprising a krill
`extract comprising…”
`• claim 94: “An Antarctic krill oil extract comprising…”
`
`--PO Response at 11
`
`5
`
`
`
`“suitable for human consumption”
`
`Refers to krill extracts that are safe and appropriate for
`humans to consume, including by oral ingestion
`• Patentee chose the same term for all claims, whether directed
`to extracts to be ingested orally (e.g., food, nutraceuticals) or
`applied topically (e.g., cosmetic)
`
`• Patentee did not chose to more broadly claim an extract
`suitable for human “application” or “use”
`
`• Therefore, “suitable for human consumption” must mean
`suitable for oral ingestion and topical application
`
`--PO Response at 11
`
`6
`
`
`
`“suitable for human consumption”
`
`• Neptune’s construction comports with the specification, which teaches that
`the claimed extract is preferably consumed (through oral ingestion)
`repeatedly or regularly over an extended period of time
`◦ “When the phospholipid extract of the inventions is used as a
`nutraceutical, it can be in the form of foods, beverages, energy bars,
`sports drinks, supplements or other forms all as are known in the art.”
`◦ “The phospholipid extract of the present invention may be used in the
`treatment or prevention of a variety of disease states including…”
`◦ “This example illustrates the use of the present krill extract in
`improving dyslexia and abnormal motor function in a 7 year old girl. 2
`g per day of the krill extract were given to a 7 year old girl suffering
`from dyslexia and abnormal motor function. After 1.5 months, she
`showed…”
`
`–AKBM Ex. 1001, ’351 Patent, col. 20:34-37, 42-44; 26:3-8;
`PO Response at 9-11
`
`7
`
`
`
`“suitable for human consumption”
`
`• Petitioners’ expert relies on a flawed approach—the abstract principle that
`anything could be suitable for human consumption if ingested in small
`enough doses
`• Claim construction must be based “not only in the context of the particular
`claim…but in the context of the entire patent, including the specification.”
`Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005).
`
`Q. So you’re relying on the principle that
`something with an unknown
`concentration of solvent could be suitable
`for human consumption if ingested in
`small enough doses; right?
`A. Yes.
`
`–NEPN Ex. 2037, Brenna Tr. 33:20–34:2
`
`--PO Response at 35
`
`8
`
`
`
`“suitable for human consumption”
`
`• Petitioners argue that “‘suitable for human consumption’ reads on
`any form of consumption by a human (e.g., oral or topical
`administration) and places no limit on the amount that is
`consumed.” Aker Pet. at 9.
`• Under Petitioners’ proposed construction, an extract is suitable for
`human consumption if it can be applied topically, e.g., on the skin
`or nails, even if the extract is not safe to ingest (no matter how
`small the dose)
`• This interpretation is untenable in light of the claims and
`specification teachings
`
`--PO Response at 9-11, 35
`
`9
`
`
`
`“capsule, tablet, solution, syrup, or suspension”
`
`• Term appears in claim 24 and its
`dependents
`• Specification establishes that “capsule,
`tablet, solution, syrup, or suspension” refers
`to an oral preparation of the claimed
`extraction
`
`“Thus, the extract may be formulated for
`oral administration… pharmaceutical or
`nutraceutical compositions may take the
`form of, for example, tablets or
`capsules…. Liquid preparations for oral
`administration may take the form of, for
`example, solutions, syrups or
`suspensions….”
`
`–AKBM Ex. 1001, ’351 Patent, col. 20:10–22;
`PO Response at 14
`
`10
`
`
`
`“capsule, tablet, solution, syrup, or suspension”
`
`Petitioners’ expert admitted that in the context of the ’351
`patent, this term refers to an oral preparation
`
`Q. So as you look at the terms “solution,
`syrup, or suspension” in Claim 24,
`you understand those to be examples
`of liquid preparation for oral
`administration; right?
`A. I…I—I—yes, I suppose so.
`
`– NEPN Ex. 2037, Brenna Tr. 245:20–246:2
`
`--PO Response at 14
`
`11
`
`
`
`“about 40%” and “about 45%”
`
`Claim Language
`
`Neptune’s Proposed Construction
`(undisputed in ITC litigation)
`
`Claims 2/25
`
`“the extract has a total phospholipid
`concentration in an amount of about
`40% w/w, wherein about represents ±
`10%”
`
`Claims 3/26
`
`“the extract has a total phospholipid
`concentration in an amount of about
`45% w/w, wherein about represents ±
`20%”
`
`40% ± 10% of 40% = 36-44%
`
`45% ± 20% of 45% = 36-54%
`
`--PO Response at 13-14
`
`12
`
`
`
`“about 40%” and “about 45%”
`
`Both sides’ experts used Neptune’s construction to form their opinions
`
`Dr. Brenna
`
`Dr. Jaczynski
`
`Q. [F]or purposes of the opinions that
`you have given in this case that
`Beaudoin I inherently anticipates
`Claim 2, how did you interpret Claim
`2 with respect to the range of
`phospholipid concentration that
`is permitted?
`A. I don't remember if there's a claim
`construction section in here. I'm not
`finding it. 36 to 44 was the—was the
`thinking when this
`was drafted.
`–NEPN Ex. 2037, Brenna Tr. 136:6–16
`
`“…the term “about 40% w/w, wherein
`about represents ± 10%” as it
`appears in claims 2 and 25…the
`meaning of the term is 36% w/w to
`44% w/w. A person of ordinary skill
`in the art would understand that
`because 10% of 40% is 4%, 40%
`w/w ± 10% would yield 36% w/w to
`44% w/w.”
`
`–NEPN Ex. 2059, Jaczynski Decl.¶ 38;
`accord ¶ 39 (as to claims 3/26)
`
`--PO Response at 13-14
`
`13
`
`
`
`“about 40%” and “about 45%” Should Be
`Interpreted Consistently with “about 5%”
`
`•
`
`•
`
`•
`
`•
`
`“free fatty acids of about 5% w/w” term of claim 5 requires free fatty acids of 5% ± 50%
`
`“where the term ‘about’ is used with a numerical value, the numerical value may vary
`by at least ± 50%.” AKBM Ex. 1001, ‘351 Patent, col. 21:62-64.
`
`POSITA would not understand 5% ± 50%, as used in claim 5, to mean 5% plus or minus
`an absolute value of 50%
`
`Otherwise, claim 5 would allow -45% to 55% free fatty acids, a nonsensical result
`
`•
`
`•
`
`An extract cannot have a negative amount of free fatty acids
`
`Specification emphasizes recovery of intact PL; consistent with low free fatty acids
`
`•
`
`POSITA would interpret “about 5%” in claim 5 to mean 5% ± 50% of 5%
`
`•
`
`•
`
`50% of 5% is 2.5%
`
`5% ± 50% of 5% = 2.5-7.5%
`
`-- NEPN Ex. 2059, Jaczynski Decl., ¶ 37.
`
`--PO Response at 11-14
`
`14
`
`
`
`The Claims Are Novel Over
`Beaudoin I
`
`
`
`Beaudoin I
`
`• WO/0023546, entitled “Method of
`Extracting Lipids from Marine and
`Aquatic Animal Tissues”
`
`• Describes a “general extraction
`method used to prepare extracts
`from marine and aquatic animal
`material”
`
`--IPR2014-00556 Institution Decision at 9;
`PO IPR2014-00556 Response at 9
`
`16
`
`
`
`Beaudoin I
`
`• Focus on extracting omega-3 fatty acids, in any form, from a wide
`variety of marine and aquatic sources
`◦
`
`“Considering the beneficial effects of omega-3 fatty acids, oils from krill,
`Calanus and fish could be used as dietary supplements to human diet.”
`
`◦ No disclosed benefit of krill over more widely utilized resources like fish
`
`◦ No disclosed benefit of omega-3 fatty acids in phospholipid form
`Incorporated by reference and extensively considered during
`prosecution of the ’351 patent
`
`•
`
`– Beaudoin I, AKBM Ex. 1002, p. 1; ‘351 Patent, AKBM Ex.
`1001, col. 18:34-36; PO Response at 3-4, 56-57; PO 2014-
`00556 Response at 9; PO Preliminary Response at 4
`
`17
`
`
`
`Beaudoin Requires Heating to Remove Solvent
`
`Table 13 shows that
`fraction I is comprised of
`10.0% volatile matter and
`humidity after evaporation
`of the solvent. For the
`same test, fraction II gives
`a value of 6.8%. To get rid
`of traces of solvent, it is
`important to briefly heat (to
`about 125ºC, for about 15
`min) the oil under nitrogen.
`
`–Beaudoin I, AKBM Ex. 1002, p. 10
`
`-- PO Response at 17.
`
`18
`
`
`
`Petitioners’ Theory That Heating Is Not Required
`Crumbled With Their Experts’ Admissions
`
`Q. In order to obtain the Fraction I that is disclosed in
`the Beaudoin patents, would one understand that the
`heating step needs to be performed?
`
`A. To produce the final product described in the
`Beaudoin patent, yes, I believe that that
`postextraction heating step is required.
`
`Q. Why do you say that the postextraction heating step
`is required to produce the final product?
`
`A. Because Beaudoin mentions heating it, heating the
`oil.
`
`* * * * *
`
`A. Yeah. Beaudoin has suggested—or I guess teaches
`us—to perform these heat treatments to remove
`traces of organic solvent.
`
`– NEPN Ex. 2039, Budge Tr. 90:1-19;
`91:13–15; PO Response at 18-19
`
`19
`19
`
`
`
`Dr. Brenna Abandoned the Theory that Beaudoin
`Uses Heat Merely to Prepare Extracts for Analysis
`
`Q. Would a person of skill understand that
`there's any purpose for those heating steps
`other than preparing an extract for analysis?
`
`A. Well, yes.
`
`Q. What would that alternate purpose or
`purposes be?
`
`A. Well, I'll give you an example: Simply to
`remove the water, for instance, if that were
`a desirable -- desirable thing.
`
`Q. How about to remove solvent? Would that
`be another purpose?
`
`A Could be. Would be.
`
`–NEPN Ex. 2037, Brenna Tr. 69:20–70:9;
`PO Response at 19
`
`20
`20
`
`
`
`Mr. Haugsgjerd Likewise Abandoned the
`“Analytical Testing” Interpretation
`
`Q. Well, if the solvent doesn't interfere, then
`why is Beaudoin saying that it's important
`to heat to remove solvent if that heating
`step is to prepare the sample for laboratory
`analysis?
`A. I don't know exactly why he wrote what he
`did. And there could be other reasons than
`I can think of right now. I am sure he had
`his reasons. But the description here was
`very brief, and it doesn't give these
`reasons. So -- so I -- I cannot tell you
`anything about his intentions or . . . ideas.
`
`–NEPN Ex. 2035, Haugsgjerd Tr. 176:12–177:1;
`PO Response at 20
`
`21
`21
`
`
`
`Dr. Brenna Admitted Solvent Removal Is a
`“Plausible” Purpose of the Heating Step
`
`Q. And my question is, might that [heating]
`step also be intended to make the extract
`more suitable for inclusion in a commercial
`product, such as a nutraceutical, like
`Beaudoin just describes?
`
`A. That may be a consequence of that step.
`
`Q. But not the purpose?
`
`A. It—it can—the statement that “it may be a
`consequence” is—it’s plausible that that
`could be a purpose. That’s not my reading
`but that’s—it’s plausible.
`
`–NEPN Ex. 2037, Brenna Tr. 83:4–13;
`PO Response at 20
`
`22
`22
`
`
`
`Heat and Free Fatty Acids Influence the
`Occurrence of Hydrolysis
`
`“As shown in Figure 2-4 above, the smoke point of soybean oil decreases as
`the free fatty acid concentration increases. Smoke point is the threshold
`temperature at which wisps of smoke will be observed, which is an indication
`that the lipids are being hydrolyzed. As shown above, the smoke point of
`soybean oil with 10% free fatty acids is about 125°C.”
`
`–NEPN Ex. 2059, Jaczynski Decl. ¶ 18; PO Response at 5, 23
`
`23
`
`
`
`Hydrolysis Causes Rupture of Ester Bonds
`
`NEPN Ex. 2004,
`Solomons and Fryhle
`
`NEPN Ex. 2059,
`Jaczynski Decl. ¶ 14
`
`–PO Response at 5, 23-24
`
`24
`
`
`
`Petitioners Cannot Meet the High Bar of Inherent
`Anticipation
`
`Anticipation by inherent rather than express disclosure requires clear
`and convincing proof that the missing descriptive material is
`“necessarily present, not merely probably or possibly present, in the
`prior art.”
`
`Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1295
`(Fed. Cir. 2002) (internal quotations omitted).
`
`“The mere fact that a certain thing may result from a given set of
`circumstances is not sufficient” to prove inherent anticipation.
`Bettcher Indus. v. Bunzl USA, Inc., 661 F.3d 629, 639
`(Fed. Cir. 2011).
`
`–PO Response at 7-8
`
`25
`
`
`
`The “Recreation” Testing Results Rebut Inherency
`
`The Budge recreation samples had highly variant phospholipid
`concentrations, ranging from <0.5% to 44.4%
`
`–AKBM Ex. 1044, Moore Decl., Table 16;
`PO 2014-00556 Response at 9
`
`26
`
`
`
`The “Recreation” Testing Results Rebut Inherency
`
`One-third of the recreation samples do not anticipate claims 2 or 3
`under any construction – this alone is sufficient to disprove inherency
`
`“Novopharm's experts performed the process disclosed in Example 32 of the '658 patent
`thirteen times and each time they made Form 2 crystals . . . [b]ut the district court found
`that the practice of Example 32 could yield crystals of either polymorph. It specifically
`found that Glaxo's David Collin originally made Form 1 by practicing Example 32, and
`that Glaxo's expert, Nicholas Crouch, did too . . . [t]he district court correctly rejected the
`anticipation defense.
`
`Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047-48 (Fed. Cir. 1995);
`PO 2014-00556 Response at 7
`
`27
`
`
`
`The “Recreation” Testing Results Rebut Inherency
`
`• Enzymotec attempts to show inherency by cherry-picking E. pacifica sample
`results while ignoring E. superba sample results
`
`• This approach fails because neither Beaudoin nor the ‘351 claims are limited
`to a particular species of krill
`
`• Enzymotec has no expert support for this theory which, tellingly, even Aker
`did not assert in its Petition
`
`• Dr. Brenna opined that only one of the two E. superba samples
`anticipates claim 2
`
`Q. Is it your opinion that only the superba extracts heated to 125C
`inherently anticipate Claim 2?
`
`A. Based on the 36 to 44 percent claim construction, that would be
`what this says.
`
`--NEPN Ex. 2037, Brenna Tr., 143:17-21; PO 2014-00556 Response at 9, 12-13
`
`28
`
`
`
`Beaudoin Is Not Limited to One Species of Krill
`
`• Beaudoin provides a “general extraction method used to prepare
`extracts from marine and aquatic animal material.”
`
`• Beaudoin discloses extracts from multiple species of krill, e.g., E.
`pacifica and M. norvegica, and gives no reason to chose E. pacifica
`over other species
`
`•
`
`“This invention relates to the extraction of lipid fractions from
`marine and aquatic animals such as krill, Calanus, fish and sea
`mammals.”
`
`--AKBM Ex. 1002, Beaudoin, p. 1, Tables 3, 4; IPR2014-00556 Institution
`Decision at 12; PO 2014-00556 Response at 9
`
`29
`
`
`
`Mere Disclosure of E. Pacifica Is No Basis to Exclude the
`Majority of Recreation Samples
`
`For a reference to inherently anticipate, it must “clearly and
`unequivocally disclose the claimed [invention] … without any need for
`picking, choosing, and combining various disclosures not directly
`related to each other by the teachings of the cited reference.”
`
`Sanofi-Syntheslabo v. Apotex, Inc., 550 F.3d 1075, 1083 (Fed. Cir. 2009)
`(quoting In re Arkley, 59 C.C.P.A. 804, 455 F.2d 586, 587 (1972)).
`
`“[I]f the teachings of the prior art can be practiced in a way that yields a
`product lacking the allegedly inherency property, the prior art in
`question does not inherently anticipate.”
`
`Armodafinil Patent Lit Inc., 939 F. Supp. 2d 456, 465 (D. Del. 2013)
`(citing Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047 (Fed. Cir.
`1995)).
`
`-- PO 2014-00556 Response at 9, 13
`
`30
`
`
`
`Dr. Brenna’s Admissions Rebut Inherency
`
`Q. Other than the choice of superba as the starting material
`and heating to 125 C, what other parameters must be
`chosen from Beaudoin I to get an extract that satisfies
`Claim 2?
`
`A. Well, I . . . I can't -- I can't answer that other than with the
`experimental evidence that's in -- in front of me, so I -- I
`know of one set of conditions that will produce it.
`* * * * *
`Q. So if Dr. Budge were to repeat this exact same experiment
`over again, you wouldn't necessarily expect that all of the
`pacifica extracts would be any closer to the claim ranges
`of Claim 2 than the superba extract; right?
`
`A. I don't know what she would get. I know what she got. What
`I would expect . . . I expect that -- that there may be some
`starting material differences, but doing the same thing with
`the same material should give the same answer.
`
`–NEPN Ex. 2037, Brenna Tr. 145:5-12; 274:12-22;
`PO 2014-00556 Response at 13-14
`
`31
`
`
`
`Budge Recreation Samples Not Proven Suitable for
`Human Consumption
`
`Q. Okay. Just in general, do
`you think it’s safe to consume
`a krill oil extract containing an
`unknown amount of residual
`solvent?
`
`A. No, I don’t think it’s safe
`containing [sic] an unknown
`amount of residual solvent.
`
`–NEPN Ex. 2029, Brenna ITC Tr. 112:9–113:1
`
`32
`
`–NEPN Ex. 2055
`• No testing of residual
`solvent content
`• No testing of water content
`--PO Response at 10, 30-31
`
`
`
`The Claims Are Non-Obvious
`
`
`
`Petitioners’ Strained 5-Way Combination Does Not
`Disclose All Elements of Any Claim
`
`-- PO Response at 38-58
`
`34
`
`
`
`Krill Noted as a “Non-Conventional” Species
`
`“Improved technology would be needed to catch
`and process unconventional resources (e.g.
`mesopelagic fish species and krill) to turn them
`into acceptable edible products.”
`
`–Garcia & Granger, “Gloom and doom?
`The future of marine capture fisheries” (2005), NEPN Ex. 2016
`
`“Other products that can be derived from
`Antarctic krill, e.g., chitosans from the shell,
`astaxanthins proteolytic and lipolytic enzymes,
`together with exploitation of its high fluorine
`content, represent novel areas for research.”
`
`–WHO Bulletin (1995), AKBM Ex. 1018
`
`-- PO Response at 55
`
`35
`
`
`
`The Claimed Extracts Were Unknown at the Time
`of the Invention
`
`Q. So someone of skill reading th[e
`WHO Bulletin] in 2001 or 2002 in
`North America would not know of
`the existence of any krill oil extract
`that could be consumed by humans;
`right?
`
`A. Since it didn’t exist, then I presume
`they wouldn’t—wouldn’t know of it.
`
`–NEPN Ex. 2037, Brenna Tr. 239:16–21
`
`-- PO Response at 39
`
`36
`
`
`
`No Evidence of Motivation to Combine
`
`No evidence that POSITA would have even heard of a krill extract suitable for
`human consumption at the time of filing, let alone have been motivated to combine
`and modify five disparate prior art references in attempt to produce it
`
`Q. When is the first time that you heard of a krill oil
`extract that was intended for human consumption?
`
`A. Me, personally?
`
`Q. Yes.
`
`A. You know, I’ve never really thought about that very
`much. In order to narrow it down, it would be—it
`would require a bit of thought. I—I had heard of krill
`oil extracts that were used in scientific studies. I
`can’t really date them, though. I…so I—I really am
`not sure if—I don’t know that I’ve heard of them in
`2001 or not, if that would be the next question.
`–NEPN Ex. 2037, Brenna Tr. 240:3–17;
`PO Response at 38-39
`
`37
`
`
`
`No 103 Reference Teaches or Suggests the
`Claimed Phospholipid
`
`Petitioners’ argument that Fricke Table 6 suggests the claimed phospholipid is
`belied by Dr. Brenna’s admissions
`
`Q. So as a person of ordinary skill in the art, not taking
`into account the patents at issue here, would you
`look at this table and understand it to be disclosing
`a phospholipid with E[P]A and/or DHA at both sn1
`and sn2 positions?
`A. Outside the context of this case, I would not.
`Q. Okay. And from this Table 6, is it possible to tell
`whether there's a phospholipid with one of EPA and
`one of DHA attached simultaneously?
`A. No, it's not possible to tell outside the context of the
`case.
`
`–NEPN Ex. 2029, Brenna ITC Tr., 217:18–218:8;
`PO Response at 39-40
`
`38
`
`
`
`No 103 Reference Teaches or Suggests Claimed
`Phospholipid
`
`•
`
`•
`
`Petitioners also argue claimed phospholipid must be present in the extract of Fricke
`based on a 2009 article, Le Grandois, but this is obviously impermissible hindsight
`Dr. Brenna adopted this view in his declaration but later admitted Le Grandois does
`not disclose a Folch krill oil extract and therefore is entirely irrelevant to Fricke
`
`Q. There wasn't a Folch extraction on the
`krill oil that was used by Le Grandois,
`was there?
`A. Rereading it, I'm not sure there was,
`but…hold on just a second, please. I
`think not.
`
`–NEPN Ex. 2037, Brenna Tr., 160:14-18; PO
`Response at 40-41
`
`39
`
`
`
`No 103 Reference Teaches or Suggests a Krill
`Extract Suitable for Human Consumption
`
`•
`•
`
`103 references teach extraction only with chloroform and methanol solvents
`These solvents are notoriously toxic and were condemned in the prior art
`
`Beaudoin inventors:
`“Folch in the article published in the year 1957 in J. biol. Chem. 226: 497-509 “A simple
`method for the isolation and purification of total lipids from animal tissues”…[t]his method is
`not commercially feasible because of the toxicity of the solvents involved.”
`“Prior to the present invention, the only solvents that appeared to produce good results to
`extract total lipids from krill was a combination of chloroform and methanol. Notably,
`however, these solvents are unacceptable for the food industry, because after their
`evaporation, some toxic residues could remain in the lipids.”
`Maruyama reference:
`“The method using chloroform ethanol described above also entails the fear that
`harmful substances might remain, no matter how the soy beans are refined and
`fractionated, making it difficult to use this in food products, which is a problem.”
`
`-- AKBM Ex. 1002, Beaudoin I, p. 5;
`NEPN Ex. 2044, Beaudoin ‘299 FH, p. 44;
`AKBM Ex. 1004, Maruyama, p. 2;
`PO Response at 42-44
`
`40
`
`
`
`Dr. Brenna Admits the Toxicity and Legal
`Restrictions on the Use of Chloroform
`
`Q. Are you aware of what legal restrictions
`there were in the United States around
`2000 for the use of chloroform in consumer
`products?
`
`A. I’m…in consumer products now so…I…
`am not a hundred percent on top of it, but
`it was in the 1970s that the Federal
`government declared that chloroform
`should be as low as possible and avoided
`when other solvents could be used and that
`sort of thing. So it was a while—it was a
`while ago in the United States. So I can’t
`speak for the UK or Canada or anywhere
`else.
`
`–NEPN Ex. 2037, Brenna Tr. 226:6-16;
`PO Response at 45
`
`41
`
`
`
`Not Shown Obvious or Even Possible to Extract
`Lipids for Human Consumption Using Chloroform
`
`Q. Have you ever attempted to remove chloroform from an
`oil extract that was intended for human use or
`consumption?
`A. Not to my recollection.
`* * * * *
`Q. Are you aware of any example in which chloroform was
`used to extract an oil that was to be used or consumed
`by humans?
`A. Off the top of my head, I don't have an example for you.
`* * * * *
`Q. But you're not aware of anyone actually attempting to
`remove enough chloroform by any means from an oil
`extract in order to render it suitable for human
`consumption; right?
`I'm not aware, sitting here right now, of a specific
`instance.
`
`A.
`
`–NEPN Ex. 2037, Brenna Tr., 211:17–19,
`212:13–16, 216:16–21; PO Response at 45
`
`42
`
`
`
`CERTIFICATION OF SERVICE UNDER 37 C.F.R. §§ 42.6(e), 42.205(b)
`I, J. Dean Farmer, Ph.D., hereby certify that the foregoing PATENT OWNER’S
`
`DEMONSTRATIVE EXHIBITS was served electronically (as consented to by Petitioners) on
`October 27, 2014, the same day as the filing of the above-identified document in the United
`States Patent and Trademark Office (USPTO), upon:
`Elizabeth J. Holland
`Amanda Hollis
`eholland@goodwinprocter.com
`amanda.hollis@kirkland.com
`Goodwin Procter LLP
`KIRKLAND & ELLIS
`The New York Times Building
`300 North LaSalle
`620 Eighth Avenue
`Chicago, IL 60654
`New York, NY 10018
`Telephone: 312-862-2011
`Telephone: (212) 813-8800
`Facsimile: 312-862-2200
`Facsimile: (212) 355-3333
`Reg. No. 55,629
`Reg. No. 47,657
`
`Cynthia Lambert Hardman
`chardman@goodwinprocter.com
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Telephone: (212) 813-8800
`Facsimile: (212) 355-3333
`Reg. No. 53,179
`
`
`Respectfully submitted,
`
`COOLEY LLP
`
`J. Mitchell Jones
`jmjones@casimirjones.com
`docketing@casimirjones.com
`CASIMIR JONES SC
`2275 Deming Way, St. 310
`Middleton, WI 53562
`Telephone: (608) 662-1277
`Facsimile: (608) 662-1276
`Reg. No. 44,174
`
`
`Dated: October 27, 2014
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, N.W.
`Suite 700
`Washington, DC 20004-2400
`Tel: (617) 937-2370
`Fax: (202) 842-7899
`
`
`/J. Dean Farmer/
`J. Dean Farmer, Ph.D.
`Reg. No. 57,917
`
`
`
`By:
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