PATENT OWNER ORAL PRESENTATION
`PATENT OWNER ORAL PRESENTATION
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RIMFROSTAS,
`Petitioner,
`
`V.
`
`AKER BIOMARINE ANTARCTIC AS,
`Patent Owner.
`
`IPR2020-01534
`Patent 10,010,567 B2
`
`
`AKER EXHIBIT 2021 PAGE 0001
`
`AKER EXHIBIT 2021 PAGE 0001
`
`
`PATENT OWNER ORAL PRESENTATION
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RIMFROSTAS,
`Petitioner,
`
`V.
`
`AKER BIOMARINE ANTARCTIC AS,
`Patent Owner.
`
`IPR2020-01534
`Patent 10,010,567 B2
`
`
`AKER EXHIBIT 2021 PAGE 0001
`
`AKER EXHIBIT 2021 PAGE 0001
`
`
`
`INSTITUTED GROUNDS
`INSTITUTED GROUNDS
`
`Claims Challenged|35 U.S.C. §
`Sampalis I, BottinoII.
`Randolph?
`Sampalis I, Bottino II.
`Randolph, Breivik IT°
`
`7-11, 15-17
`
`6, 14, 20
`
`03(a)°
`
`103(a)
`
`103(a) Sampalis, I, Bottino IT,
`
` Claims Challenged
`
`
`
`12,18
`
`35 U.S.C. §
`
`13, 19
`
`103(a)
`
`Randolph, Bottino I’
`
`References
`Sampalis I, BottinoII,
`Randolph,Fricke,® Yamaguchi,’
`Hardardottir!®
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`AKER EXHIBIT 2021 PAGE 0002
`
`AKER EXHIBIT 2021 PAGE 0002
`
`
`
`INDEPENDENT CLAIMS
`
`1. Encapsulated krill oil comprising a capsule containing Euphausia superba krill oil
`suitable for oral administration, said krill oil comprising greater than 30%
`phosphatidylcholine w/w of said krill oil, less than 3% free fatty acids w/w of said krill
`oil and astaxanthin esters.
`
`15. Encapsulated krill oil comprising a soft gel capsule containing Euphausia superba
`krill oil suitable for oral administration, said krill oil comprising greater than 30%
`phosphatidylcholine w/w of said krill oil, less than 3% free fatty acids w/w of said krill
`oil, less than about 3% lysophosphatidylcholine w/w of said krill oil and at least 100
`mg/kg astaxanthin esters.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`AKER EXHIBIT 2021 PAGE 0003
`
`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`
`• Ground 1, applied against independent claims 1 and 15, relies on Bottino II (Ex. 1038) for the claim
`limitation of less than 3% free fatty acids.
`• Petitioner asserts that the “unknown” fraction in Table 2 of Bottino would have contained free fatty
`acids and that since the value reported for the Station 11 is 2 +/- 22% the free fatty acid content is less
`than 2%.
`
`Petition at 74:
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`AKER EXHIBIT 2021 PAGE 0004
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`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`THAN 3% FREE FATTY ACID LIMITATION
`
`Table 2. The lipids of Antarctic krill
`
`E. superba
`
`£. crystallorophias
`
`Station 8(1)*
`
`Station 11(2)
`
`Station 13(4)
`
`Station 16 (2)
`
`Ex. 1038, BottinoII
`Ex. 1038, Bottino II
`
`Waxes
`Steroid esters
`
`Triglycerides
`Complex lipids
`
`Diglycerides
`
`—
`—
`
`8
`54
`
`17
`
`PEt
`Lyso PC
`PG
`Unknown§
`
`21
`
`—
`
`36+££6
`s8ai4
`
`48
`8
`1
`1
`2422
`
`weight %
`44+ 10}
`2+3
`
`—
`53+8
`
`—
`
`46
`6
`I
`
`20+1
`27+9
`
`—
`424+8
`
`4+1
`
`—
`1+2
`
`7T+1
`
`* Number of determinations in
`
`t PC, Phosphatidyicholine; PE,Dhosphatidylethanolamine; PG, phosphatidylglycerol.
`} Weight per cent plus or minus the standard deviati
`R;
`triglycerides and diglycerides. The recovered amountof this fraction was too
`small for further characterization.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`AKER EXHIBIT 2021 PAGE 0005
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`AKER EXHIBIT 2021 PAGE 0005
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`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`
`Bottino II discloses that it used the Thin Layer Chromatography (TLC) of Freeman and West (Ex. 2002) to
`quantitate lipid fractions:
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`AKER EXHIBIT 2021 PAGE 0006
`
`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`
`In the legend of Table 2, Bottino II specifically
`discloses that the “unknown fraction” had an
`Rf or retardation factor between diglycerides
`and triglycerides.
`
`• The experts agree on what the retardation factor is.
`“The rate of movement can be expressed as an Rf value or retardation factor representing how far along the
`•
`plate they travel compared to the solvent front. See also the description by PO’s expert. Jaczynski Dec.,
`EX2001 at ¶¶ 27-29.” Ex. 1086, Tallon Reply Decl. at ¶15.
`“Different analytes such as triglycerides, diglycerides, phospholipids and free fatty acids will have different Rf
`values, indicating that they travel different distances on the TLC plate.” Ex. 2002, Jaczynski Decl. at ¶27.
`
`•
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`AKER EXHIBIT 2021 PAGE 0007
`
`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`
`The data in Figure 1 of Freeman and West (Ex.
`2002) shows that in the solvent system utilized
`free fatty acids do not have an Rf between
`diglycerides and triglycerides. This means that
`the “unknown” fraction of Bottino could not
`contain free fatty acids as asserted by Petitioner.
`PO Response at 13-16; Ex. 2001 (Jaczynski Decl.)
`at ¶¶25-29; PO Sur-Reply at 5-17.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`AKER EXHIBIT 2021 PAGE 0008
`
`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`
`• Dr. Tallon admits “[t]he Rf values observed in one analysis cannot be directly compared to Rf values used with
`different solvent systems, different adsorbent, different equipment, and different operating conditions. That
`is why reference standards are used to calibrate the analysis.” Ex. 1086 (Tallon Decl.) ¶21.
`
`• However, Petitioner argues: “a POSITA would have understood, when analyzed by TLC, free fatty acids will
`typically have an Rf value between the Rf values of triglycerides and diglycerides as described in the footnote
`to Table 2 of Bottino II. Tallon Reply, ¶¶ 9, 24-28, 31-37.” Pet. Reply at 8.
`
`• Petitioner and its expert ignore the closest system to that utilized by Bottino II (i.e., Freeman and West) and
`instead make the argument that free fatty acids have an Rf between triglycerides and diglycerides in other
`systems that use other solvents. PO Sur-Reply at 10-11.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`AKER EXHIBIT 2021 PAGE 0009
`
`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`
`• Even Exhibit 1177 (Zamora and Hildago) cited by Petitioner and its expert demonstrates that
`free fatty acids do not have an Rf between diglycerides and triglycerides in some solvent
`systems. PO Sur-Reply at 11-12; Ex. 1086 (Tallon Decl.) at ¶27.
`• The Rf of free fatty acids did not fall between those of diglycerides and triglycerides in the TLC
`methods summarized in columns 3 and 7.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`AKER EXHIBIT 2021 PAGE 0010
`
`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`
`• Petitioner did not provide any evidence that the modifications made by Bottino II to the TLC method
`of Freeman and West would change the Rf of the free fatty acids, triglycerides and diglycerides in any
`meaningful way. PO Sur-Reply at 13-14.
`• The changes were substitution of Adsorbosil-5 for silica gel-G and deletion of 0.2% acetic acid from
`solvent mixture 1. Id.
`• Dr. Tallon admitted when deposed that he could not quantify what differences in Rf values could be
`expected by these changes. Ex. 2020 (Tallon Depo.) p. 0035, l. 22 – 0036, l. 14 and p. 0038, l. 10-20).
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`AKER EXHIBIT 2021 PAGE 0011
`
`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`
`• Petitioner poses the question: “If the “unknown” fraction does not include free fatty acids, in which lipid class of the
`Station 11 extract are the free fatty acids found?” Pet. Reply at 14.
`
`• It is not Patent Owner’s burden of proof to show what percentage of free acids the Station II extract contained or identify
`where the free fatty acids are – they are definitely not in the unknown fraction as discussed above. PO Sur-Reply at 14.
`
`• The most likely explanation is that the free fatty acid content was simply not reported in Table 2, for example, due to
`poor resolution. Id., See Ex. 2001 (Jaczynski Decl.) ¶29.
`
`• When deposed, Dr. Tallon admitted that the TLC methods of references such as Tsuyuki and Yamaguchi identified
`components of krill lipids including cholesterol, cholesterol esters, pigments and monoglycerides. Ex. 2020 (Tallon Depo.)
`0023, l. 13 – 0025, l. 7).
`
`• Tsuyuki quantified these components by TLC and found that krill lipids contained 2.2% monoglycerides, 4.7% sterols,
`0.8% sterol esters, and 4.1% pigments. See Ex. 1172 at 0005 (Table 1) and Ex. 2020 (Tallon Depo.) 0064, l. 23 – 0065, l. 19.
`
`• Bottino II fails to report any of these lipid classes, which do not migrate between diglycerides and triglycerides in the
`method of Tsuyuki. PO Sur-Reply at 15.
`
`• No conclusions can be drawn from the absence of any reference to free fatty acids in Table 2 of Bottino II – Bottino II may
`simply have chosen not to report free fatty acids levels.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`AKER EXHIBIT 2021 PAGE 0012
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`
`
`COMBINED REFERENCES DO NOT TEACH LESS
`THAN 3% FREE FATTY ACID LIMITATION
`• Petitioner is using an inherency rationale for the free fatty acid limitation. PO
`Response at 16; PO Sur-Reply at 16-17.
`• When deposed Dr. Tallon admitted that there is no direct reference to free fatty
`acids in Table 2 of Bottino or anywhere else. Ex. 2020 (Tallon Depo.) p. 0074, l. 6-
`23 ).
`• The TLC method used by Bottino II does not provide “direct measurement of the
`free fatty acids found in the Station II extract” as argued by Petitioner. See Pet.
`Reply at 9.
`• At best, Petitioner and Dr. Tallon are arguing that the “unknown” fraction, which
`by its own description is unknown, would have necessarily contained free fatty
`acids.
`• This is the very definition of an inherency argument - here it fails because
`Petitioner has failed in its burden to prove that the “unknown” fraction
`necessarily contained free fatty acids.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`AKER EXHIBIT 2021 PAGE 0013
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`
`
`ALL GROUNDS SHOULD BE DENIED
`
`• Ground 1 relies on Bottino II for the “less than 3% free fatty acids”
`claim limitation.
`• Ground 1 should be denied because the combined references do not
`teach this element.
`• Ground 1 addresses both independent claims (Claims 1 and 15).
`• Grounds 2, 3 and 4 should be denied as well because those grounds
`address claims dependent on claims 1 and 15.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`AKER EXHIBIT 2021 PAGE 0014
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`
`
`COLLATERAL ESTOPPEL DOES NOT APPLY
`
`• None of the claims in the previously decided IPR’s contained the “less
`than 3% free fatty acid” limitation.
`• As established by the argument above, this new claim element raises
`new questions of fact with regard to disclosures of the prior art and
`their failure to teach to limitation.
`• Petitioner has provided no analysis under the factors established by
`the Federal Circuit in, for example, Stephen Slesinger, Inc. v. Disney
`Enterprises, Inc., 702 F.3d 640, 644 (Fed. Cir. 2012). See PO Reply at 8-
`12.
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
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`AKER EXHIBIT 2021 PAGE 0015
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`
`
`FRICKE CANNOT RESCUE PETITIONER
`
`• Petitioner argues “For example, Fricke states that the level of free fatty acids
`present in krill “rang[es] from 1% to 3% of total lipids.”
`
`• The instituted grounds do not utilize Fricke for the free fatty acid limitation.
`• As held by the Supreme Court, the petitioner is the “master of its complaint,” SAS
`Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018). As such, “[i]t is of the utmost
`importance that petitioners . . . adhere to the requirement that the initial petition
`identify ‘with particularity’ the ‘evidence that supports the grounds for the
`challenge to each claim.’” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359, 1369 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3)).
`
`DEMONSTRATIVE EXHIBIT - NOT EVIDENCE
`
`AKER EXHIBIT 2021 PAGE 0016
`
`
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