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`Paper 14
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`RIMFROST AS
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`Petitioner
`v.
`AKER BIOMARINE ANTARCTIC AS
`Patent Owner
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`Case No.: IPR2020-01534
`U.S. Patent 10,010,567
`Issue Date: July 3, 2018
`Title: Bioeffective Krill Oil Compositions
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`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
`PURSUANT TO 37 C.F.R. § 42.24(c)
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`Inter Partes Review Case No.: IPR2020-01534
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`U.S. Patent No. 10,010,567
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`TABLE OF CONTENTS
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`I.
`INTRODUCTION ........................................................................................... 1
`COLLATERAL ESTOPPEL APPLIES .......................................................... 4
`II.
`III. A PREPONDERANCE OF EVIDENCE DEMONSTRATES THAT
`BOTTINO II TEACHES A KRILL EXTRACT HAVING
`LESS THAN 3% FREE FATTY ACIDS ........................................................ 5
`A.
`The Station 11 Euphausia Superba Krill Lipid Extract
`Has less Than 2% Free Fatty Acids ...................................................... 5
`Patent Owner’s Reliance On Freeman & West Is Unavailing ........... 10
`B.
`The Results Reported In Table 2 Are Reliable ................................... 15
`C.
`Patent Owner’s Inherency Argument Is Unpersuasive ....................... 18
`D.
`IV. PATENT OWNER’S ARGUMENTS REGARDING
`GROUNDS 2, 3 AND 4 ARE SIMILARLY MERITLESS .........................20
`CONCLUSION ..............................................................................................21
`V.
`VI. CERTIFICATE OF COMPLIANCE ............................................................22
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`Inter Partes Review Case No.: IPR2020-01534
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`U.S. Patent No. 10,010,567
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`TABLE OF AUTHORITIES
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`CASES
`Aker Biomarine Antarctic AS v. Rimfrost AS
`786 F. App’x 251, 254 (Fed. Cir. 2019) ...................................................... 19
`PAR Pharm, Inc. v. TWI Pharm, Inc.,
`773 F. 3d 1186, 1196 (Fed. Cir. 2014) ........................................................ 19
`Swartz v. USPTO,
`743 F. App’x 426, 428 (Fed. Cir. 2018) ........................................................ 4
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`ii
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`Inter Partes Review Case No.: IPR2020-01532
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`U.S. Patent No. 9,644,169
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`I.
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`INTRODUCTION
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`Each claim of the U.S. Patent No. 10,010,567 (“the ‘567 patent”) requires
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`krill oil having less than 3% free fatty acids. As evidence that this limitation is
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`taught and disclosed in the prior art, Petitioner relies on Dr. Tallon’s testimony that
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`the Station 11 Euphausia superba krill lipid extract reported in Table 2 of Bottino
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`II has less than 2% free fatty acids.
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`The Board has already found five other patents in the same patent family as
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`the ‘567 patent (i.e., continuations of the same nonprovisional application)
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`unpatentable, rejecting Patent Owner’s arguments that those patents were not
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`obvious. In this proceeding, Patent Owner changes tack and, with the exception of
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`Bottino II, does not contest the teachings of the prior art references relied on by
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`Petitioner nor dispute that a POSITA would have been motivated to combine those
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`references. Instead, Patent Owner offers two meritless technical arguments
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`regarding Table 2 of Bottino II: (1) the results reported in Table 2 fail to disclose
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`the free fatty acid content of the Station 11 Euphausia superba krill extract; and (2)
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`the Table 2 results are unreliable. Patent Owner’s expert, Dr. Jaczynski, even goes
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`so far as to proclaim “a POSITA would be discouraged from drawing any
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`conclusions about the actual lipid content” of the extracts described in Bottino II.
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`Patent Owner’s arguments regarding Bottino II and efforts to refute Dr. Tallon’s
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`Inter Partes Review Case No.: IPR2020-01534
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`detailed testimony that Bottino II teaches and discloses a krill extract having at
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`U.S. Patent No. 10,010,567
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`most 2% free fatty acid are not only technically spurious, but are also belied by Dr.
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`Jaczynski’s own publications.
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`First, Table 2 identifies 98% of the lipid components found in the Station 11
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`Euphausia superba krill extract, and a POSITA would have understood that any
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`free fatty acids in that extract would necessarily be located in the remaining 2%
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`fraction labeled “unknown.” Nevertheless, relying a technically flawed
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`comparison of the thin layer chromatography results reported in Bottino II and the
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`chromatograph appearing in Freeman & West, Patent Owner argues that the
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`“unknown” fraction cannot contain any free fatty acids and that Bottino II does not
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`disclose an extract with less than 3% free fatty acids. However, the analytical
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`method used in Bottino II is different from the method described in Freeman &
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`West. Additionally, Bottino II analyzed actual Euphausia superba krill, whereas
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`Freeman & West simply analyzed various “lipids standards.” Thus, any inference
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`Patent Owner seeks to draw from a comparison of the thin layer chromatography
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`results reported in Bottino II to the Freeman & West chromatograph is technically
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`baseless, and is tantamount to comparing “apples to oranges.”
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`Second, the assertions by Patent Owner and its expert that the results
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`reported in Table 2 of Bottino II “cannot be considered reliable,” and that a
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`POSITA “would be discouraged from drawing any conclusions” from those results
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`U.S. Patent No. 10,010,567
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`are based on a mathematically illogical interpretation of those results. As detailed
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`by Dr. Tallon, when the standard deviation of the Table 2 results is properly taken
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`in account, the free fatty acid content of the Station 11 Euphausia superba krill
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`extract reported in Bottino II is between 1.56 - 2.44%. The meritless nature of
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`Patent Owner’s arguments regarding the reliability of the Table 2 results is further
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`highlighted by Patent Owner’s prior omissions and a publication co-authored by its
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`own expert. Specifically, in earlier proceedings before the Board, the results
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`reported in Table 2 were relied on to demonstrate two patents in the same family as
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`the ‘567 patent were unpatentable. Yet in those proceedings, Patent Owner never
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`suggested, much less argued, the Table 2 results were not reliable. Additionally,
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`results from Table 2 of Bottino II were cited and relied on by Dr. Jaczynski in one
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`of his own publications.
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`Patent Owner does not dispute Petitioner’s description of the teachings of
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`any other prior art references or a POSITA’s motivation to combine those
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`references to arrive at the challenged claims. Consequently, the Board’s finding
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`that the Table 2 results for Station 11 disclose an Euphausia superba krill extract
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`having less than 3% free fatty acids, as Dr. Tallon testified, would be dispositive of
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`U.S. Patent No. 10,010,567
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`the unpatentability of claims 1-20 of the ‘567 patent. See Petition, pp. 44-83.1
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`II. COLLATERAL ESTOPPEL APPLIES
`With the exception of Yamaguchi and Hardardottir that teach and disclose
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`the cholesterol limitation recited in dependent claims 13 and 19, Petitioner’s
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`references were analyzed by the Board in the Final Written Decisions finding five
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`other “krill oil” patents in the same family as the ‘567 patent unpatentable.
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`Exhibits 1103-1104, 1129, 1157-1159. Patent Owner, however, wants the Board
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`to ignore its previous analyses of this same prior art. POR, 8-12. Because the
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`inclusion of a limitation in two dependent claims requiring the recited krill oil have
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`“less than about 0.5 g/100 g total cholesterol” does not materially alter the question
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`of the ‘567 patent’s unpatentability, collateral estoppel is applicable. See Swartz v.
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`USPTO, 743 F. App’x 426, 428 (Fed. Cir. 2018).
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`1 Petitioner relies on its Petition (Paper 2), Tallon Decl. (Exhibit 1006) and Tallon
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`Reply (Exhibit 1086).
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`Inter Partes Review Case No.: IPR2020-01534
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`III. A PREPONDERANCE OF EVIDENCE DEMONSTRATES
`THAT BOTTINO II TEACHES A KRILL EXTRACT HAVING
`LESS THAN 3% FREE FATTY ACIDS
`A. The Station 11 Euphausia Superba Krill Lipid Extract
`Has Less Than 2% Free Fatty Acids
`Free fatty acids are a natural lipid component present in live krill and make
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`up a small proportion of the total lipids. Thus, the Euphausia superba krill
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`analyzed in Bottino II naturally possessed free fatty acids. Tallon Reply, ¶¶ 13, 31;
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`see Jaczynski Decl., ¶ 29 (“reasonable to assume that free fatty acids were present
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`in the sample”). Additional free fatty acids are also a by-product of the hydrolysis
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`of fatty acids groups attached to triglycerides and phospholipids caused by lipase
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`activity after harvesting. Tallon Reply, ¶ 14; see Budziński (Exhibit 1008), p.
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`0012. Because of this hydrolysis, fatty acids are cleaved or severed to form free
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`fatty acids and residual lipids. When a single fatty acid group is cleaved from a
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`triglyceride, the residual lipid is a diglyceride. Tallon Reply, ¶ 14. Cleavage of a
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`second or third fatty acid group forms a monoglyceride or glycerol, respectively.
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`Id. Additionally, fatty acids can be cleaved from phospholipids containing fatty
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`acyl groups forming free fatty acids and residual lyso-phospholipids. Id. Thus,
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`lipase activity causes increases in free fatty acids, diglycerides and lyso-
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`phospholipids, and decreases in triglycerides and phospholipids. Id. Notably, a
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`POSITA would have been able to readily adjust the free fatty acid content of a krill
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`oil extract to less than 3%. Tallon Reply, ¶¶ 53-54; see Jaczynski Dep. (Exhibit
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`U.S. Patent No. 10,010,567
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`1070), 44:23-45:3.2
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`Thin layer chromatography (“TLC”) is a well-known analytical tool that
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`separates a sample into different compounds present in the sample. Tallon Reply,
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`¶ 15. TLC involves first placing the sample on a plate coated with a silica
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`adsorbent and then exposing the sample to a solvent or solvent system. Different
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`compounds interact differently and travel up the plate at different rates depending
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`on the particular solvent system and absorbent used. Id. Accordingly, the distance
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`an individual compound travels, referred to as the Rf value or retardation factor,
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`will be significantly impacted by those variables. Tallon Reply, ¶¶ 15, 29. The
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`temperature of the solvent and the plate development time are some of the other
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`factors that will also influence Rf values. Tallon Reply, ¶ 15. Once the plate is
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`developed, the individual compounds are recovered to provide a direct
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`2 Patent Owner criticizes Dr. Tallon’s proposed claim construction because he
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`mistakenly mentioned the “broadest reasonable construction” instead of the
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`Phillips standard. POR, 7. However, Dr. Tallon expressly testified that his
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`constructions would be the same under either standard. Tallon Reply, ¶ 6.
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`measurement of the weight percentage of each compound found in the analysed
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`sample. Tallon Reply, ¶¶ 15, 44.
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`Patent Owner does not dispute Bottino II discloses the lipid composition of
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`an extract obtained from fresh krill using a conventional extraction technique and
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`known solvent system. Exhibit 1038, pp. 0001-0002; see Tallon Decl., ¶¶ 171-172.
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`Bottino II then uses TLC to directly measure the weight percentages of the major
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`lipid classes in samples of Euphausia superba krill taken from two locations in the
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`Antarctic Ocean (i.e., Station 8 and Station 11). Exhibit 1038, pp. 0001-0003;
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`Tallon Reply, ¶ 16; see Tallon Decl., ¶¶ 173-176. The weight percentages of the
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`fractions for krill captured at Station 11 are reported in Table 2 and total 100%:
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`36% triglycerides, 4% diglycerides, 58% complex lipids3 (i.e., PC
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`(“phosphatidylcholine”), PE (“phosphatidylethanolamine”), lyso PC (“lyso
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`phosphatidylcholine”) and PG (“phosphatidylylycerol”)) and 2% of a lipid fraction
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`3 In contrast to this Proceeding in which he urges the Table 2 results are
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`“unreliable,” Jaczynski Decl., ¶¶ 29-30, Dr. Jaczynski, in one of his own
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`publications, had no qualms about relying on Table 2’s disclosure of a krill extract
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`having 58% complex lipids. Exhibit 1171, pp. 0004, 0013; see Tallon Reply, ¶¶
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`42, 43.
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`called “unknown.” Exhibit 1038, p. 0003; see Tallon Reply, ¶ 38; Tallon Decl., ¶
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`174.
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`Although the TLC chromatograph was not reproduced in Bottino II, Table 2
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`reports the Rf value of the “unknown” lipid fraction is between the Rf values for
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`triglycerides and diglycerides. Exhibit 1038, p. 0003; see Tallon Decl., ¶ 174.
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`Using Bottino II’s disclosure of the Rf values of these fractions, Dr. Tallon
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`confirmed that the “unknown” fraction includes any free fatty acids in the krill
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`sample analyzed and, as a result, the Station 11 krill extract included no more than
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`2% free fatty acids. In particular, a POSITA would have understood, when
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`analyzed by TLC, free fatty acids will typically have an Rf value between the Rf
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`values of triglycerides and diglycerides as described in the footnote to Table 2 of
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`Bottino II. Tallon Reply, ¶¶ 9, 24-28, 31-37. Additionally, Table 2 identifies 98%
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`of the lipid components found in the Station 11 Euphausia superba krill extract, and
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`a POSITA would have understood that any free fatty acids in that extract would be
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`located in the remaining 2% fraction labeled “unknown.” Tallon Reply, ¶¶ 9, 16,
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`39, 48-52.
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`Dr. Tallon’s determination that the “unknown” fraction included all free fatty
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`acids in the extract analysed is consistent with other data reported in Table 2. For
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`example, in contrast to the krill extract from Station 11, the Station 8 extract had
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`reduced triglycerides (8%), reduced complex lipids (54%), increased diglycerides
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`(17%), and increased “unknowns” (21%). Exhibit 1038, p. 0003. These results
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`(i.e., reduced triglycerides caused by the cleavage of fatty acid groups, the
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`corresponding formation diglycerides and free fatty acids, and the significant
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`increase in diglycerides from 4% to 17%) indicate that the Station 8 extract
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`experienced increased lipase activity compared to the Station 11 extract. Tallon
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`Reply, ¶¶ 38, 43, 51; see Fricke (Exhibit 1010), pp. 0002-0003; Tallon Reply, ¶ 33.
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`As Dr. Tallon testified, the only reasonable interpretation of the Table 2 data is that
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`the “unknown” fraction includes any free fatty acids present in the respective
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`extracts. See, e.g., Tallon Reply, ¶ 9, 16, 39, 48-52; see Tallon Decl., ¶¶ 174, 459.
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`Based on Table 2’s results, a POSITA would have understood the Euphausia
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`superba krill extract from Station 11 necessarily had less than 3% free fatty acids.
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`Tallon Reply, ¶¶ 9, 16, 49-50; see Tallon Decl., ¶¶ 174, 459.
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`The TLC method used by Bottino II provides direct measurement of the free
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`fatty acids found in the Station 11 extract. Tallon Reply, ¶¶ 15, 44. Bottino II’s
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`disclosure of a krill extract having less than 3% free fatty acids is also confirmed
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`by the prior art. Tallon Reply, ¶¶ 32, 44-46. For example, Fricke states that the
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`level of free fatty acids present in krill “rang[es] from 1% to 3% of total lipids.”
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`Exhibit 1010, p. 0003; see, e.g., Exhibit 1173 (Phleger), p. 0004 (free fatty acids
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`equal 1.1 - 1.8%); Tallon Reply, ¶¶ 44, 54. While Fricke was relied on in the
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`Petition, neither Patent Owner nor its expert mention, much less dispute, that
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`Fricke confirms the validity of Dr. Tallon’s analysis of Bottino II and Table 2’s
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`disclosure of a krill extract having less than 3% free fatty acids. See Petition, 22,
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`27, 47; Tallon Decl., ¶ 259.
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`B.
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`Patent Owner’s Reliance On
`Freeman & West Is Unavailing
`Patent Owner tries to dismiss Dr. Tallon’s testimony in its entirety, asserting
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`that free fatty acids “cannot be within the ‘unknown’ fraction,” and that the
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`“unknown” fraction “could not include free fatty acids as concluded by Dr.
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`Tallon.” POR, 6, 15. These assertions are based on inferences Patent Owner
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`wishes to draw from a comparison of the TLC results reported in Table 2 of
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`Bottino II and the chromatograph appearing in Freeman & West (Exhibit 2002).
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`POR 14-15; Jaczynski Decl., ¶¶ 26-28. Specifically, Patent Owner posits that the
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`“unknown” fraction in Table 2 could not possibly include free fatty acids, as Dr.
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`Tallon testified, because Bottino II’s TLC results show the Rf value of this fraction
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`was located between triglycerides and diglycerides, not below both triglycerides
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`and diglycerides as seen in Freeman & West’s chromatograph. POR, 14-15;
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`Jaczynski Decl. ¶¶ 27-28. Patent Owner’s comparison of Bottino II’s TLC
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`analysis of the Station 11 Euphausia superba krill extract to Freeman & West’s
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`chromatograph and its associated Rf values showing free fatty acids did not travel
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`as far as triglycerides and diglycerides is technically baseless.
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`First, it is undisputed that the TLC methodologies, as well as the samples
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`analyzed in Bottino II and Freeman & West were different making any comparison
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`of the resulting Rf values inapt. Tallon Reply, ¶¶ 19-29. In particular, Bottino II
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`expressly states that its TLC method differed from the method used in Freeman
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`and West in at least three (3) ways, including differences in the solvent system and
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`adsorbent used. Exhibit 1038, p. 0002. Based on Dr. Jaczynski’s tepid and
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`unsupported speculation that the solvent system “would not be expected to change”
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`the results, Patent Owner sheepishly characterizes Bottino II as a mere “variation”
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`of the TLC method described in Freeman & West. POR 13; Jaczynski Decl., ¶ 28.
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`However, the particular solvent system used significantly influences the distance
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`individual compounds travel on a TLC plate, making direct comparisons of Rf
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`values obtained using different solvent systems inappropriate. See, e.g., Tallon
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`Reply, ¶¶ 19-29.
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`Instructive is Table 11 of the Handbook of Food Analysis (Exhibit 1177)
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`which illustrates the effect different solvent systems have on the Rf values of, inter
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`alia, free fatty acids, triglycerides and diglycerides. Id., p. 0020. Tellingly, in all
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`but two of the various solvent systems analyzed, the TLC spots and corresponding
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`Rf values demonstrate that free fatty acids are located between triglycerides and
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`diglycerides, consistent with the Rf values described in Bottino II. Tallon Reply, ¶¶
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`24-26. Because the solvent system and absorbent significantly influence Rf values
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`and the distance individual components travel on a TLC plate, Patent Owner’s
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`comparison of the results reported in Table 2 of Bottino II and Freeman & West’s
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`chromatograph is unavailing. See Tallon Reply, ¶ 29.
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`Second, not only does Bottino II and Freeman & West use different
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`methodologies, each method focuses on different lipid components. In particular,
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`Bottino II reports the separation of the main lipid class present in krill, including
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`phosphatidylcholine, (“PC”), phosphatidylethanolamine (“PE”), lyso
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`phosphatidylcholine (“lyso-PC”) and phosphatidylylycerol (“PG”). Exhibit 1038,
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`p. 0003. In contrast, the Freeman and West chromatograph shows that
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`phospholipids remain at the bottom of the plate demonstrating that the different
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`solvents and absorbent used in Freeman &West failed to separate the sample into
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`individual phospholipid classes. Tallon Reply, ¶ 22; see Exhibit 2002, p. 0002.
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`This further confirms that the results reported in Table 2 of Bottino II cannot be
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`compared to the chromatograph found in Freeman & West. Tallon Reply, ¶¶ 21-
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`23, 29.
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`Third, Patent Owner and Dr. Jaczynski both argue “Bottino II’s ‘unknowns’
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`which migrated between the triglycerides and diglycerides, could not include free
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`fatty acids as concluded by Dr. Tallon.” POR, 15; Jaczynski Decl., ¶ 28. This
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`technically frivolous argument is refuted by numerous publications showing the Rf
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`value of free fatty acids between triglycerides and diglycerides. See Tallon Reply,
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`¶¶ 26, 30-39. For example, Yamaguchi provides the TLC analysis of krill samples.
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`The plates labelled I and II of Figure 2 show free fatty acids (spot 4) located
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`between triglycerides (spot 3) and diglycerides (spot 5). Exhibit 2002, p. 3; Tallon
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`Reply, ¶ 36. Similarly, Tsuyuki’s chromatograph shows free fatty acids located
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`between triglycerides and diglycerides. Exhibit 1172, p. 0004; Tallon Reply, ¶ 37;
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`see Handbook of Food Analysis (Exhibit 1177), p. 0020. These chromatographs
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`correspond to the Rf value of the “unknown” fraction between triglycerides and
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`diglycerides as reported in Table 2 of Bottino II. See Tallon Reply, ¶ 39.
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`Additionally, Dr. Jaczynski’s opinions relying on the migration of
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`triglycerides, diglycerides and free fatty acids in Freeman & West’s chromatograph
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`are contradicted by his own work. Specifically, a TLC chromatograph of krill oil
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`appearing in a publication co-authored by Dr. Jaczynski shows the free fatty acid
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`fraction located between the triglyceride and diglyceride fractions. Exhibit 1174,
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`p. 0004; see Tallon Reply, ¶ 40. This publication directly refutes the opinions
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`offered by Dr. Jaczynski regarding the Freeman & West chromatograph, and calls
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`into question his credibility and the weight the Board should give his opinions. See
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`Jaczynski Decl. ¶¶ 26-28. Like Yamaguchi and Tsuyuki, the chromatograph in Dr.
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`Jaczynski’s publication confirms that Freeman & West’s chromatograph cannot be
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`used to draw conclusions about the results of other TLC analyses, including those
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`reported in Bottino II, and confirms the validity of Dr. Tallon’s testimony that the
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`“unknown” fraction of Table 2 includes all the free fatty acids of the Station 11
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`Euphausia superba krill extract. Tallon Reply, ¶¶ 9, 16, 48-52; Tallon Decl., ¶¶
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`174, 459.
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`Finally, the sum of the weight percentages of the Station 11 krill extract
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`reported in Table 2 equals 100%: triglycerides (36%), diglycerides (4%), complex
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`lipids (58%), and “unknown” fraction (2%). Exhibit 1038, p. 0003. Additionally,
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`Patent Owner’s expert, Dr. Jaczynski, concedes “it would be reasonable to assume
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`that free fatty acids were present” in the Table 2 extracts. Jaczynski Decl. ¶ 29.
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`Although the linchpin of Patent Owner’s argument is Bottino II’s “unknown”
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`fraction could not possibly include free fatty acids, Patent Owner and its expert
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`tellingly neglect to answer one simple question. If the “unknown” fraction does
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`not include free fatty acids, in which lipid class of the Station 11 extract are the
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`free fatty acids found? See Tallon Reply, ¶¶ 34, 52. The preponderance of
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`evidence and Dr. Tallon’s testimony provides the answer: the “unknown” fraction
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`includes all free fatty acids found in the Station 11 krill extract. Tallon Reply, ¶¶
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`9, 16, 48-52; see Tallon Decl., ¶¶ 174, 459.
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`Patent Owner’s attempt to compare the results reported Table 2 to the
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`Freeman & West chromatograph is technically baseless and fails to rebut Dr.
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`Tallon’s detailed testimony that the “unknown” fraction represented the free fatty
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`acid fraction of the krill extract analysed in Bottino II.
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`C. The Results Reported In Table 2 Are Reliable
`Patent Owner asserts Bottino II’s results are “poor quality” and “cannot be
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`considered to be reliable, even anecdotally.” POR, 16; Jaczynski Decl., ¶ 30.
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`Patent Owner’s argument is based on a mathematically impossible interpretation of
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`the standard deviation associated with the data reported in Table 2.
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`The footnote associated with Table 2 states that the reported values are
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`“weight per cent plus or minus the standard deviation.” Exhibit 1038, p. 0003.
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`Since the “unknown” fraction for Station 11 is reported as “2±22,” Patent Owner
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`proposes that the standard deviation should be interpreted as units of weight
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`percent, and then erroneously concludes that the standard deviation of the
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`“unknown” fraction is “about 1000% greater than the actual value it represents.”
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`POR, 16; Jaczynski Decl., ¶ 30. Applying Patent Owner’s implausible
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`interpretation, the “2±22” value of the “unknown” fraction of the Station 11 extract
`15
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`Inter Partes Review Case No.: IPR2020-01534
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`would encompass weight percentages ranging from minus 20% (2 - 22) to positive
`
`U.S. Patent No. 10,010,567
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`24% (2 + 22). However, a weight percentage of minus 20% is impossible. Tallon
`
`Reply, ¶ 48. Additionally, a weight percentage of positive 24% would mean that
`
`the total weight percentage of the components of the Station 11 extract would total
`
`more than 100%, another mathematical impossibility.
`
`Contrary to Patent Owner’s interpretation, the standard deviation associated
`
`with the weight percentages reported in Table 2 would have been understood by a
`
`POSITA as the percentage variation. Tallon Reply, ¶ 47. Thus, the “unknown”
`
`fraction with a value of 2 wt. % has a standard deviation that is 22% of the
`
`reported value, i.e., a standard deviation of ± 0.44 wt. % (22% x 2). Tallon Reply,
`
`¶ 49. Because, the standard deviation is a statistical representation of a confidence
`
`interval within which the results likely fall, a POSITA would have understood that
`
`Station 11’s “unknown” fraction, including any free fatty acids, was 1.56 - 2.44%.
`
`Tallon Reply, ¶¶ 49-50. Thus, the free fatty acid content of the Station 11 extract
`
`could be no more than 1.56 - 2.44%, and therefore necessarily less than 3% as
`
`recited in the claims of the ‘567 patent. Tallon Reply, ¶¶ 9, 16, 49-50.
`
`Notably, in earlier Proceedings before the Board involving two patents in the
`
`same family as the ‘567 patent, Petitioner relied on results reported in Bottino II.
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`Tallon Reply, ¶ 53. Yet, Patent Owner never questioned the reliability or validity
`
`16
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`Inter Partes Review Case No.: IPR2020-01534
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`of those results in either proceeding. Specifically in IPR 2020-01533, one of the
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`U.S. Patent No. 10,010,567
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`limitations recited in the challenged claims was krill oil having “less than 3% free
`
`fatty acids,” the same limitation Patent Owner now argues is not taught or
`
`disclosed by Bottino II. As in this Proceeding, Petitioner relied on the results
`
`reported in Table 2 for the Station 11 krill extract as evidence that this limitation
`
`was taught and disclosed in the prior art. See, e.g., Exhibit 1178 (Petition), Paper
`
`2, 22, 46-47, 53, 74, 81. However, in IPR 2020-01533, neither Patent Owner nor
`
`Dr. Jaczynski disputed the reliability of the Table 2 results. See generally Exhibit
`
`1175, IPR2020-01533 (Patent Owner’s Response), Paper 9. In fact, addressing the
`
`“less than 3% free fatty acid” limitation, Patent Owner simply confirmed, “natural
`
`components of krill oil can be extracted in desired amounts by known methods.”
`
`Id., 28; Tallon Reply, ¶¶ 53-54. Likewise, in IPR 2018-01178 and IPR 2018-
`
`01179, Petitioner relied on the results in Table 2. Again, Patent Owner never
`
`argued any of those results were unreliable. Importantly, the Board validated
`
`Petitioner’s reliance on the Table 2 results, finding all claims of U.S. Patent No.
`
`9,375,453 unpatentable. Exhibit 1157, pp. 20, 27-29; Exhibit 1158; pp. 20, 27-29.
`
`Finally, Patent Owner’s expert criticizes the results reported in Bottino II,
`
`stating a POSITA “would be discouraged from drawing any conclusions about the
`
`actual lipid contents” of its extracts, and that Table 2 “cannot be considered as
`
`17
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`Inter Partes Review Case No.: IPR2020-01534
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`reliable, even anecdotally.” Jaczynski Decl., ¶ 30. However, Dr. Jaczynski’s
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`U.S. Patent No. 10,010,567
`
`assertion that Bottino II’s results are not reliable is belied by his citation and
`
`reliance on results reported in Table 2 in a publication he co-authored. Exhibit
`
`1171, pp. 0004, 0013; supra, 7, n.3. This is the second publication by Dr.
`
`Jaczynski contradicting the opinions he has proffered on behalf of Patent Owner in
`
`this Proceeding, again calling into question his credibility and the weight the Board
`
`should give those opinions. Supra, 13-14.
`
`D.
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`Patent Owner’s Inherency Argument Is Unpersuasive
`
`In suggesting Petitioner is relying on “an obviousness by inherency
`
`rationale,” Patent Owner misconstrues Petitioner’s argument and ignores the
`
`testimony of Dr. Tallon. See POR 16. Specifically, Patent Owner’s puzzling
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`“inherency” argument is directly refuted by Dr. Tallon’s testimony that any free
`
`fatty acids in the Station 11 krill extract reported in Bottino II are found in the
`
`“unknown” fraction. Thus, the Station 11 Euphausia superba krill extract contains
`
`at most 1.56 - 2.44% free fatty acids, and therefore necessarily less than 3% as
`
`recited in the challenged claims. Tallon Reply, ¶¶ 9, 16, 48-52; Tallon Decl., ¶¶
`
`174, 459.
`
`Patent Owner’s assertion that “inherency” must be resorted to demonstrate
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`the existence of a krill extract with less than 3% free fatty acids is further refuted
`
`18
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`Inter Partes Review Case No.: IPR2020-01534
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`by the previous decisions of the Federal Circuit, the PTAB, as well as admissions
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`U.S. Patent No. 10,010,567
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`by Patent Owner’s expert.4
`
`In affirming the Board’s Final Written Decisions finding Patent Owner’s
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`U.S. Patent Nos. 9,028,877 and 9,076,905 unpatentable, the Federal Circuit agreed
`
`with the Board that:
`
`the lipid components of krill oil can be extracted
`using any number of suitable solvents, that the
`proportions of the components could be varied in
`predictable ways, and that the resulting extracts
`could be blended to produce a final krill oil
`product.
`Aker Biomarine Antarctic AS v. Rimfrost AS, 786 F. App’x 251, 254 (Fed. Cir.
`
`2019).
`
`Similarly, in its Final Written Decision finding Patent Owner’s related U.S.
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`Patent No. 9,375,435 unpatentable, the Board gave “persuasive weight” to Dr.
`
`Tallon’s testimony that:
`
`
`4 Patent Owner’s citation to PAR is unavailing. POR, 16. In PAR, because the
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`district court failed to provide any findings of fact, the Federal Circuit could not
`
`find that the patent challenger “failed to present evidence sufficient to demonstrate
`
`that the . . . limitations are necessarily present.” PAR Pharm, Inc. v. TWI Pharm,
`
`Inc., 773 F. 3d 1186, 1196 (Fed. Cir. 2014).
`
`19
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`Inter Partes Review Case No.: IPR2020-01534
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`U.S. Patent No. 10,010,567
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`a POSITA would have known that the relative
`proportions of natural krill and hence the natural
`krill oil constituents could be varied in predictable
`ways by applying a single solvent or combination
`of solvents including super critical fluid extraction
`to selectively extract specific groups of lipid
`components based on their different solubility, and
`by blending these selective extracts in known and
`predictable ways to produce a desired krill oil
`composition.
`Exhibit 1157 (IPR 2018-01178), 36; see Exhibit 1129 (IPR 2018-00295), 37-39.
`
`Additionally, in IPR 2020-01532 and IPR 2020-01533 challenging Patent
`
`Owner’s related U.S. Patent Nos. 9,644,169 and 9,816,046, Dr. Jaczynski
`
`confirmed that a POSITA would have known that “natural components of krill oil
`
`can be extracted in desired amounts by known methods” to obtain to krill oil
`
`having less than 3% free fatty acids. Exhibit 1070, 44:23-45:3; see Tallon Reply,
`
`¶¶ 53-54.
`
`IV. PATENT OWNER’S ARGUMENTS REGARDING
`GROUNDS 2, 3 AND 4 ARE SIMILARLY MERITLESS
`In arguing that claims 6, 14 and 20 (Ground 2), 12 and 18 (Ground 3) and 13
`
`and 19 (Ground 4) would not have been obvious, Patent Owner simply relies on
`
`the same meritless arguments regarding Bottino II. POR, 17. For the reasons
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`discussed previously, the results reported in Table 2 of Bottino II disclose a krill
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`extract having less than 3% free fatty acids. Supra, 5-18.
`
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`20
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`Inter Partes Rev
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