Inter Partes Review of US 9,072,752
`Ex. 2025, Hoem Declaration
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`RIMFROST AS
`Petitioner
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`v.
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`AKER BIOMARINE ANTARCTIC AS
`Patent Owner
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`CASE: IPR2018-01730
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`U.S. Patent No. 9,072,752
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`Reply Declaration of Dr. Nils Hoem
`in Support of Patent Owner’s Motion to Amend
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`AKER EXHIBIT 2025 PAGE 0001
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`Ex. 2025, Hoem Declaration
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`RIMFROST AS
`Petitioner
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`v.
`
`AKER BIOMARINE ANTARCTIC AS
`Patent Owner
`
`
`CASE: IPR2018-01730
`
`U.S. Patent No. 9,072,752
`
`Reply Declaration of Dr. Nils Hoem
`in Support of Patent Owner’s Motion to Amend
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`AKER EXHIBIT 2025 PAGE 0001
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`Inter Partes Review of US 9,072,752
`Ex. 2025, Hoem Declaration
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`I.
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`Introduction
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`I, Dr. Nils Hoem, state as follows:
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`1.
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`I make this declaration in support of Patent Owner’s Contingent
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`Motion to Amend the Claims in IPR2018-01730 and in Reply to Petitioner’s
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`Opposition of the Contingent Motion to Amend the Claims.
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`2.
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`I have reviewed and considered, in the preparation of this report, the
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`documents below in addition to the documents identified in my first declaration
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`(Ex. 2001). In providing this declaration, I have also used the legal standards set
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`forth in my first declaration.
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`EXHIBIT NO. EXHIBIT DESCRIPTION
`Reply and Opposition Declaration of Dr Stephen J. Tallon
`1086
`(IPR2018-01730)
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`II. The Contingent Amended Claims are Not Obvious
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`3.
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`I stand by my previous opinion that the contingent amended claims
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`are not obvious. I have been informed that Petitioner alleges that the amended
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`claims are obvious over the following combinations of references:
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`AKER EXHIBIT 2025 PAGE 0002
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`Ground 1. Claims 21 and 24-27 are obvious over Catchpole, Sampalis II,
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`Inter Partes Review of US 9,072,752
`Ex. 2025, Hoem Declaration
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`NKO and Randolph;
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`Ground 2. Claims 22-23, 25, and 28-29 are obvious over Catchpole,
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`Enzymotec, Sampalis II, NKO and Randolph; and
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`Ground 3. Claims 21-29 are obvious over Catchpole, Enzymotec,
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`Sampalis II, NKO and Randolph.
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`4.
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`The data in Catchpole demonstrates that the impact of altering
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`extraction conditions such as the co-solvent concentration in SFE extraction
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`procedures is unpredictable. Examples 7 and 8 of Catchpole describes SFE
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`fractionation of “dairy lipid extract B.” I first note that the phospholipid makeup
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`of the dairy lipid extract B is different from the krill feed material used in Example
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`18 and contains, for example, more PE (phosphatidylethanolamine) than PC
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`(phosphatidylcholine), and substantial amounts of PS (phosphatidylserine) and
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`SM (sphingomyelin). The krill feed material contained much higher levels of PC
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`than PE, and had no reported PS or SM. Thus, comparison of the results of
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`Example 7 and 8 to the results of Example 18 is confounded by the differences in
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`the feed materials.
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`5. With that being said, Examples 7 and 8 both use a two-step extraction
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`with neat CO2 in the first step and an CO2 plus an ethanol co-solvent in the second
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`AKER EXHIBIT 2025 PAGE 0003
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`Ex. 2025, Hoem Declaration
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`step. Example 7 used an ethanol co-solvent at a concentration of 10% while
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`Example 8 used an ethanol co-solvent at a concentration of 30%. The extract
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`obtained with the ethanol co-solvent at a 30% concentration contained more PC
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`than the feed material (22.5%) and more PC as compared to extract 2 of Example
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`8, which contained 4.5% PC. However, Example 10 describes fractionation of egg
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`yolk lecithin, also using a two step SFE procedure using neat CO2 in the first step
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`and an ethanol co-solvent in the second step at a concentration of 25%. In
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`Example 10, the feed material is also different from the feed materials in Examples
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`7, 8 and 18 and is reported to contain 56.4% PC. In contrast to Example 8, the
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`extract obtained with the 25% ethanol co-solvent contained a reduced amount of
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`PC (43.5%) as compared to the feed material. This is despite extracting a reported
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`45% of the initial feed material as neutral lipids in the first step. These results
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`demonstrate that it is unpredictable as to whether using ethanol co-solvents in
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`excess of 20% will result in fractionation of a feed material so that the PC content
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`is increased. The Tables from Examples 7 (Table 7), 8 (Table 8) and 10 (Table 9)
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`are reproduced here for reference:
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`AKER EXHIBIT 2025 PAGE 0004
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`Ex. 2025, Hoem Declaration
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`6.
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`The results obtained in Examples 12 and 18 of Catchpole also
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`demonstrate the unpredictability associated with different feed materials and
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`extraction conditions. Example 12 describes the fractionation of a Hoki head lipid
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`extract by a two-step SFE method using neat CO2 in the first step and an ethanol
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`co-solvent in the second step at a concentration of 31%. Example 18 describes
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`fractionation of krill lipids from a freeze-dried krill powder feed material by a two-
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`step SFE method using neat CO2 in the first step and an ethanol co-solvent in the
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`second step at a concentration of 11%. Table 11 (Example 12, Hoki head) and
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`Table 18 (Example 18, krill lipids) are reproduced below for reference.
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`AKER EXHIBIT 2025 PAGE 0005
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`7.
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`In Example 12 (Table 11), the Hoki head extract obtained with 31%
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`ethanol as a co-solvent contained 14.2% PC and 1.6% AAPC. In Example 18
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`(Table 16), the krill lipid extract obtained with 11% ethanol as a co-solvent
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`contained 39.8% PC and 4.6% AAPC. This example shows that use of an ethanol
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`co-solvent of greater than 20% does not necessarily increase ether phospholipid
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`content to the range of 6 to 10%.
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`8.
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`Furthermore, there appear to be issues with the data reported in
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`Catchpole. Example 11 describes the fractionation of an egg yolk phospholipid
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`extract. The resulted are reported in Table 10, reproduced here:
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`AKER EXHIBIT 2025 PAGE 0006
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`The feed material is reported to contain 21.2% PC. The grams of PC in the feed
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`material may be calculated by multiplying the grams of feed material (40g) by
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`21.2%:
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`(40g) X (.212) = 8.48 g PC
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`The grams of PC in the ethanol co-solvent extract may be calculated by
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`multiplying the starting amount of feed material (40g) by the extract yield (46%)
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`by the reported PC concentration (65.6%):
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`(40g) X (.46) X (.656) = 12.07 g PC
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`The grams of PC in the residue may be calculated by multiplying the starting
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`amount of feed material (40g) by the residue yield (4%) by the reported PC
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`concentration (12.9%):
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`(40g) X (.04) X (.129) = .21 g PC
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`Thus, the amount of PC in the extract and residue equals 12.28 grams which is
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`approximately 50% greater than the amount of PC reported in the feed material
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`(8.48 g PC). There is clearly a problem in either the analysis or reporting of the
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`AKER EXHIBIT 2025 PAGE 0007
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`results as the amount of PC in the extract and residue cannot be greater than the
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`amount reported for the feed material.
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`9.
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`This is not an isolated issue. The Hoki head lipid extract example
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`(Example 12) also contains anomalous results. The amount of PC in the feed
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`material (see Table 11) may again be calculated by multiplying the starting amount
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`of feed material (25 g) by the reported content of PC (9.2%):
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`(25g) X (.092) = 2.3 g PC
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`The grams of PC in the ethanol co-solvent extract may be calculated by
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`multiplying the starting amount of feed material (25g) by the extract yield (72%)
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`by the reported PC concentration (14.2%):
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`(25g) X (.72) X (.142) = 2.56 g PC
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`The grams of PC in the residue may be calculated by multiplying the starting
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`amount of feed material (25g) by the residue yield (27%) by the reported PC
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`concentration (14.3%):
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`(25g) X (.27) X (.143) = .96 g PC
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`Thus, the amount of PC in the extract and residue equals 3.52 grams which is
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`approximately 50% greater than the amount of PC reported in the feed material
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`(2.3 g). Again, there is clearly a problem in either the analysis or reporting of the
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`results as the amount of PC in the extract and residue cannot be greater than the
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`amount reported for the feed material.
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`AKER EXHIBIT 2025 PAGE 0008
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`10. The Hoki head example (Example 10) also contains anomalous results
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`for ether phospholipids. The amount of ether phospholipids (AAPC) in the feed
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`material may be calculated by multiplying the starting amount of feed material (25
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`g) by the reported AAPC content (1.1%):
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`(25g) X (1.1%) = .275 g
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`The amount of ether phospholipids in the ethanol co-solvent extract may be
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`calculated multiplying the starting amount of feed material (25 g) by the extract
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`yield (72%) by the reported AAPC content (1.6%):
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`(25g) X (.72) X (.016) = .288 g
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`Again, the amount of AAPC in the extract cannot exceed the amount of AAPC in
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`the starting feed material. There is clearly a problem in analysis or reporting.
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`11. When viewed as a whole, Catchpole contains data that is clearly
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`incorrect. It cannot be determined from the disclosure of Catchpole whether these
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`issues are due to mistakes in the reporting or problems with the analytical
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`procedures. These results are certainly not indicative of the types of the results that
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`would normally be obtained through the of analytical procedures such as P31-
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`NMR. Given the severity of the issues in the data reporting, a POSITA would not
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`trust the results reported in Catchpole.
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`12.
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`I am informed that Dr. Tallon has stated the following:
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`AKER EXHIBIT 2025 PAGE 0009
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`• Using Catchpole’s disclosed method to increase the extraction of
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`neutral lipids in the first stage, for example using CO2 with 3%
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`ethanol as used in Catchpole Example 9, or other methods for more
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`favourable extraction, the level of neutral lipid remaining to be
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`extracted in ‘extract 2’ would be reduced, reducing the level of ‘other
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`compounds’ present.
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`• By reducing the level of other compounds from 54.9% to, for
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`example, 40%, the content of all the other compounds will increase
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`proportionately. The resulting total phospholipid content in this case
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`would be, by difference, 60%. The ether phospholipid content, which
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`in extract 2 is 10.6% of the total phospholipid content (4.8% ether
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`phospholipids / 45.1% total phospholipids = 10.6%) will increase to
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`6.4 wt% (10.6% percentage of ether phospholipid to total
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`phospholipid * 60% total phospholipid = 6.4 wt% ether phospholipids
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`of extract). If, instead, the level of other compounds was reduced to
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`20%, the level of phospholipids in the extract would increase to 80%,
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`and the ether phospholipid content would increase to 8.5 wt% (10.6%
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`percentage of ether phospholipid to total phospholipid * 80% total
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`phospholipid = 8.5 wt% ether phospholipids of extract).
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`AKER EXHIBIT 2025 PAGE 0010
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`Example 9 of Catchpole indicates that 90% of neutral lipids were extracted using
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`CO2 plus 3% ethanol.
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`13.
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`I am also informed that Dr. Tallon calculated that the total amount of
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`neutral lipids in the freeze dried krill powder feed material in Example 18 of
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`Catchpole to be 739 grams. Example 18 further discloses that 650 grams of neutral
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`lipids were removed in the first step with neat CO2. The percentage neutral lipids
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`extracted in the first step can be calculated by dividing 650g/739g = 88%. Thus,
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`there is only a 2% difference between the amount of neutral lipids extracted using
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`CO2 plus 3% ethanol in Example 9 and using neat CO2 in Example 18. There is no
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`functional difference in the percent of the neutral lipids extracted. Therefore, Dr.
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`Tallon’s calculations showing that the other compounds, especially neutral lipids,
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`could be further reduced to for example 40% as opposed to 54.9% are without
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`basis.
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`14. This conclusion is reinforced by the fact that Dr. Tallon calculated
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`that Extract 2 contains 44 grams of unknown material that is not accounted for by
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`his calculated amount of 89 grams neutral lipids and the measured amount of
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`phospholipids (109 grams). That discussion is provided here:
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`Table 16, copied above, discloses that Extract 2 weighs 242g (4.3% of
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`5620g); that the Extract 2 listed phospholipids weigh 109g (45.1% x 242g).
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`Therefore, the Extract 2 neutral lipids weigh 89g; leaving only 44g (242g –
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`(109g+89g)) of Extract 2 as unknown, in contrast to PO’s assertion of 130g
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`(242g x 0.537) of Extract 2 as being unknown. The neutral lipids of Extract
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`2 will comprise triglycerides, as well as free fatty acids, di- and mono-
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`glycerides, etc. See Fricke, Table 1, p. 822, Exhibit 1010, p. 0002.
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`Thus, Dr. Tallon calculations cannot account for 44 grams of extract 2. This
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`amount (44 g) substantially exceeds any contribution that would be made
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`extracting 2% more neutral lipids in the first step of the extraction. Thus, it is far
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`from certain that the ether phospholipid content of Extract 2 could be increased as
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`proposed by Dr. Tallon.
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`15.
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`I am informed that Dr. Tallon also stated that, as an alternative to
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`extracting more neutral lipids in step 1 of the Example 18 extraction as just
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`discussed, the ether phospholipid content of Extract 2 could be increased as
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`follows:
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`Alternatively, the extraction conditions used for the second stage
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`extraction in Example 18 can be made more favourable (for example the
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`higher cosolvent concentration of Example 12, in which total extraction of
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`AAPC was achieved) and more ether lipid can be extracted. This will have
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`the same effect of reducing the level of ‘other compounds’ present in extract
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`AKER EXHIBIT 2025 PAGE 0012
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`2 by diluting them with additional phospholipid rich extract, which will
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`therefore raise the level of ether phospholipids.
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`However, as discussed above in detail, the results reported in Example 12 are
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`flawed as the amount of PC and AAPC reported in the extract and residue exceeds
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`the amount present in the starting material. A POSITA would therefore not rely on
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`the results reported in Example 12. I also note that Example 12 reported a lower
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`content of ether phospholipids in the extract as compared to Example 18. As also
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`discussed above, other examples in Catchpole show that when the ethanol content
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`is increased to above 20%, the amount of phospholipids in the extract actually
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`decreases as compared to the feed material. Thus, when the data in Catchpole is
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`viewed as a whole, a POSITA could not predict that changing the conditions as
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`suggested by Dr. Tallon could increase the ether phospholipid content of an extract
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`from a krill feed material.
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`16.
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`I also stand by my testimony that prior art does not teach or suggest
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`the claimed range of 100 to 700 mg/kg astaxanthin esters. First, as I previously
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`testified at ¶¶135-136 of my initial declaration (Ex. 2001), Dr. Tallon’s testimony
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`established that a POSITA would understand Neptune Krill Oil contained at least
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`1500 mg/kg astaxanthin esters. This is evidenced by the values listed in Ex. 1070
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`and Ex. 1071. This is consistent with Neptune’s GRAS statement, which discloses
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`AKER EXHIBIT 2025 PAGE 0013
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`that Neptune Krill oil contained at least 1500 mg/kg astaxanthin esters as shown in
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`the following excerpt from Table 2 of the GRAS notification:
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`Ex. 1075, p. 0010. I am aware that Petitioner has argued that the ‘752 patent states
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`in Table 16 that NKO contained 472 mg/kg astaxanthin esters. However, a
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`POSITA did not have access to this information as it was not previously published
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`and would have understood NKO to contain astaxanthin levels consistent with its
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`published content and especially with the content published in its GRAS
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`notification (Ex. 1075).
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`17. Dr. Tallon’s references to alleged astaxanthin levels in Randolph and
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`Sampalis II also do not change my opinion. In fact, Dr. Tallon has misrepresented
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`the teachings of Randolph with respect to astaxanthin content of krill oil.
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`Paragraphs [0043]-[0044] of Randolph provide the following:
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`AKER EXHIBIT 2025 PAGE 0014
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`These paragraphs indicate that a composition can contain any amount of
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`astaxanthin, not that krill oil can contain any amount of astaxanthin. The
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`compositions of Randolph can contain more than 25 ingredients, only one of which
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`is krill oil, and that astaxanthin can come other sources. As disclosed in paragraph
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`[0021]:
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`AKER EXHIBIT 2025 PAGE 0015
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`A POSITA would not understand Randolph to teach that krill oil can contain any
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`amount of astaxanthin. In fact, Randolph discloses that the source of the krill oil
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`used in the compositions can be NKO which as discussed above was known to a
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`POSITA to contain at least 1500 mg/kg astaxanthin esters. See Ex. 1011 at [0039]
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`(“Conventional oil producing techniques can be used to obtain the krill oil. In
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`addition, krill oil can be obtained commercially from Neptune Technologies and
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`Bioresources of Quebec, Canada.”).
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`18. Furthermore, a POSITA would not calculate an astaxanthin ester
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`content for krill oil from Randolph as proposed by Dr. Tallon. See Ex. 1086,
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`¶¶250-256. Paragraph [0040] of Randolph states: “Typically, a composition
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`contains between about 300 mg and about 3000 mg of a krill oil ingredient.” Dr.
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`Tallon attempts to combine this with the following statement from paragraph
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`[0044]: “Typically, a composition contains between about 0.5 mg and about 50 mg
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`of an astaxanthin ingredient.” The statement in paragraph [0044] refers to a
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`composition of the invention, which can contain more the 25 ingredients, and not
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`to the astaxanthin content of krill oil. A POSITA would therefore not understand
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`the 300 mg to 3000 mg krill oil described in paragraph [0040] to contain from 0.5
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`mg to 50 mg astaxanthin.
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`19. Furthermore, in order to arrive at an astaxanthin content falling within
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`the claimed range of 100 to 700 mg/kg astaxanthin ester from the disclosure in
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`Randolph, Dr. Tallon has chosen to use low end of the range (i.e., 0.5 mg) from
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`paragraph [0044] and the high end of the range (i.e., 3000 mg) from paragraph
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`[0040]. See Ex. 1086, ¶256. Even if these ranges could be combined to describe
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`the astaxanthin content of krill oil, there is no reason for a POSITA to choose the
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`high end of one range and the low end of the other range. Dr. Tallon’s calculations
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`are clearly based on hindsight in an attempt to reach the claimed range.
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`20. Dr. Tallon further argues that Sampalis II provides the claimed
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`astaxanthin ester range. Ex. 1086, ¶¶257-261. However, a POSITA would not
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`understand Sampalis II to provide the claimed astaxanthin ester range either. First,
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`the disclosure relied on by Dr. Tallon for the teaching of 200 mg/kg astaxanthin
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`does not specifically refer to astaxanthin and instead refers to generally to
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`antioxidants. As disclosed in Sampalis II:
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`Antioxidants present in the extract may include vitamin A (for example, all-
`trans retinol), vitamin E (for example, alpha-tocopherol), beta-carotene,
`astaxanthin (mainly esterified but non-esterified may be present),
`canthaxanthin and/or flavonoids. Antioxidants are preferably present in the
`extract in an amount of at least 20 and preferably at least 200 mg/100 ml.
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`Ex. 1013, p. 0032. This excerpt does not state that astaxanthin is present at the
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`level of 20 mg/100 ml, it states that antioxidants collectively are present at “at
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`least” those levels.
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`21. Dr. Tallon also refers to Table 5 of Sampalis II, reproduced here:
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`A POSITA would not credit the astaxanthin values in this Table. First, a POSITA
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`would discredit the data because it lists both canthaxanthin and flavonoid as being
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`present in the krill oil. As disclosed in Grynbaum, which has been cited by
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`Petitioner in these proceedings, the only carotenoid present in krill is astaxanthin.
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`Ex. 1039 at 0008. There is no canthaxanthin. Similarly, flavonoids are compounds
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`synthesized by plants, not animals, and in my experience have never been
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`identified in krill oil. Thus, the listing of the materials as being present in krill oil
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`would indicate to a POSITA that however the krill oil was analyzed, the analysis
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`was wrong. In other words, if the assays used in Sampalis II identified
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`canthaxanthin and flavonoids, then any value reported for astaxanthin could not be
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`trusted. Second, the values listed are minimum values with no upper limit. Thus, a
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`POSITA presented with Table 5 would not be able to rely on the ≥ 10 mg/100 ml
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`value listed for astaxanthin because the values listed are obviously wrong when
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`canthaxanthin and flavonoids are listed as being present and are not tied to actual
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`analytical data.
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`22.
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`In the absence of such data, a POSITA as of the priority date of the
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`present invention would turn to other disclosure in Sampalis II to determine the
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`astaxanthin ester content of krill oil. As disclosed in Sampalis II, the present
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`invention is “Neptune Krill OilTM”. Ex. 1013, p. 0036. As discussed above, the
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`published values for NKO, including those listed in Neptune’s GRAS notification
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`(Ex. 1075), are greater than 1500 mg/kg.
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`23. Dr. Tallon alleges that there is motivation to reduce the amount of
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`astaxanthin from krill oil so as to be able to extract and sell it separately. Ex. 1086,
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`¶262. Even if that were done, there is no motivation to reduce to the claimed range
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`to 100 to 700 mg/kg or to reduce astaxanthin in a krill oil that is going to be
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`formulated for oral consumption or encapsulation as claimed. In fact, if extraction
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`of astaxanthin was the goal, it would likely be reduced to far lower than 100
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`mg/kg. Furthermore, this testimony is inconsistent with Dr. Tallon’s previous
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`statements in this case as outlined in my previous Declaration (Ex. 2001) at ¶136:
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`
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`20
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`AKER EXHIBIT 2025 PAGE 0020
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`
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`
`
`
`Inter Partes Review of US 9,072,752
`Ex. 2025, Hoem Declaration
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`• “In 2006, the product specification for Krill Bill krill oil disclosed
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`that the krill oil contained greater than 40% phospholipids and
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`greater than 1500 mg/kg astaxanthin esters. See Exhibit 1070 (see
`
`Exhibit 1076 from Internet Archive regarding contents of Exhibit
`
`1070 and Exhibit 1071).” Ex. 1006, ¶18. Krill Bill Krill Oil is
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`Neptune Krill Oil.
`
`• “Before the effective filing date of the ‘752 Patent, a POSITA was
`
`aware that astaxanthin (both free and esterified), the called “super
`
`Vitamin E”, possesses an unusual antioxidant activity which had
`
`caused a surge in the nutraceutical market for the encapsulated
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`astaxanthin product.” Ex. 1006, ¶89.
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`• “Randolph’s 1 percent astaxanthin content is equivalent to 10,000
`
`mg/kg.” Ex. 1006, ¶284.
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`• “Thus, Sampalis II discloses a krill oil extract with, in my
`
`opinion, a minimum trans-astaxanthin esters content of 1,444
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`mg/kg (2000 mg/kg x .95 x .76).” Ex. 1006, ¶304.
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`24. Finally, I am aware that Petitioner has made allegations with respect
`
`to a Declaration (Ex. 1121) I prepared for the re-examination of U.S. Pat. No.
`
`8,057,825. The statements in that Declaration relate to the claims at issue in the
`
`
`
`21
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`AKER EXHIBIT 2025 PAGE 0021
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`
`
`
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`‘825 patent which did not have limitations to specific ranges of ether
`
`Inter Partes Review of US 9,072,752
`Ex. 2025, Hoem Declaration
`
`phospholipids, total phospholipids, triglycerides or astaxanthin esters. The claims
`
`in the ‘825 patent were directed to a method of using krill oil to reduce cholesterol
`
`and did not list specific ranges for the components of the krill oil. The statements I
`
`made in that Declaration are not relevant to the current claims which are to krill
`
`oils with defined levels of ether phospholipids and other components.
`
`25.
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`I further declare that all statement made herein of my own knowledge
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`are true and that all statements made on information and belief are believed to be
`
`true; and further that these statements were made with the knowledge that willful
`
`false statements and the like so made are punishable by fine or imprisonment, or
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`both, under section 1001 of title 18 of the United States Code, and that such willful
`
`false statements may jeopardize the validity of the application or any patent issued
`
`thereon.
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`Respectfully submitted,
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`
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`
`
`
`
`
`
`
`
`
`Dr. Nils Hoem
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`
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`
`
`October 17, 2019
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`
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`22
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`AKER EXHIBIT 2025 PAGE 0022
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`
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