Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`RIMFROST AS
`Petitioner
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS
`Patent Owner
`
`
`CASE IPR: IPR2018-01178 and CASE IPR: IPR2018-01179
`
`U.S. Patent No. 9,375,453 B2
`
`Reply Declaration of Dr. Nils Hoem
`in Support of Patent Owner’s Motion to Amend
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`AKER EXHIBIT 2025 Page 1
`
`

`

`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`TABLE OF CONTENTS
`Introduction .................................................................................................... 3 
`The Contingent Amended Claims are Supported by an
`A. 
`Adequate Written Description ............................................................... 4 
`The Contingent Amended Claims are Not Obvious ............................. 6 
`
`B. 
`
`
`
`
`
`
`
`
`
`2
`
`
`
`
`I. 
`
`
`
`
`
`
`
`AKER EXHIBIT 2025 Page 2
`
`

`

`
`
`I.
`
`Introduction
`I, Dr. Nils Hoem, state as follows:
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`1.
`
`I make this declaration in support of Patent Owner’s Contingent
`
`Motion to Amend the Claims (Papers No. 11) in both IPR2018-01178 and
`
`IPR2018-01179 (“MTA1178” and “MTA1179”) and in Reply to Petitioner’s
`
`Opposition of the Contingent Motion to Amend the Claims.
`
`2.
`
`I have reviewed and considered, in the preparation of this report, the
`
`documents below in addition to the documents identified in my first declaration
`
`(Ex. 2001). In providing this declaration, I have also used the legal standards set
`
`forth in my first declaration.
`
`EXHIBIT NO. EXHIBIT DESCRIPTION
`1086
`Reply and Opposition Declaration of Dr Stephen J. Tallon
`(IPR2018-01178 & IPR2018-01179)
`
`1121
`
`1122
`
`1124
`
`
`
`Declaration by Nils Hoem in Support of Request for Inter Partes
`Reexamination of U.S. Patent No. 8,057,825, Control No.
`95/001,819, executed September 16, 2011.
`Japanese Laid Open Publication S63-23819 (Murata).
`
`Itano Refrigerated Food Co., Ltd., Bio & High Technology
`Announcement and Natural Astaxanthin & Krill Lecithin, pp. 1-
`16, Exhibit 1124 (“Itano”).
`
`
`3
`
`AKER EXHIBIT 2025 Page 3
`
`

`

`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`EXHIBIT DESCRIPTION
`
`Transcript of Deposition of Dr. Stephen Tallon, August 29, 2018
`
`
`
`
`
`
`EXHIBIT
`NO.
`2024
`
`The Contingent Amended Claims are Supported by an Adequate
`A.
`Written Description
`5.
`I have been informed that the written description must convey clearly
`
`to those skilled in the art, that, as of the filing date sought, the applicant was in
`
`possession of the invention claimed. The level of detail required to satisfy the
`
`written description requirement depends on (i) the nature and scope of the claims
`
`and (ii) the complexity and predictability of the relevant technology.
`
`Factors to be taken under consideration include the existing knowledge in the
`
`particular field, the extent and content of the prior art, the maturity of the science or
`
`technology, and the predictability of the aspect at issue.
`
`6.
`
`As stated in my previous declaration (Hoem Decl., Ex. 2001) at ¶89,
`
`the specification provides a written description for producing a krill meal from
`
`freshly caught Euphausia superba by grinding, cooking and drying the Euphausia
`
`superba to provide a dried krill meal. I stand by this statement. The specification
`
`refers repeatedly to use of krill meal as the source material for extraction. One
`
`need look no further than the summary of the invention (Ex. 2012, p. 2-9) and the
`
`
`
`4
`
`AKER EXHIBIT 2025 Page 4
`
`

`

`
`
`Examples confirm that the krill meal is made by steps including cooking, grinding
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`and drying the freshly caught krill. For example, the specification provides the
`
`following:
`
`Ex. 2012, p. 6. The specification further provides working examples, such as the
`
`following excerpt from Example 6:
`
`
`
`
`
`
`
`
`
`5
`
`AKER EXHIBIT 2025 Page 5
`
`

`

`
`
`Clearly, a POSITA would understand that the specification teaches that the krill
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`meal used for extraction may be produced by cooking, grinding and drying and
`
`that the inventors were in possession of an invention wherein oil is extracted from
`
`the krill meal. As discussed above, relevant factors to be considered in analysis of
`
`written description include the existing knowledge in the particular field, the extent
`
`and content of the prior art, the maturity of the science or technology, and the
`
`predictability of the aspect at issue. These factors all support a finding of adequate
`
`written description. First, there is no dispute that the steps of cooking, grinding
`
`and drying to produce krill meal are taught in the specification. Second,
`
`Petitioner’s expert admits that these steps were known in the art. Tallon Reply
`
`Decl. Ex. 1086, ¶¶253-259. Thus, given the existing knowledge in the field and
`
`the content of the prior art, a POSITA would readily recognize that the inventors
`
`were in position of a method of making krill meal by cooking, grinding and drying
`
`and then using that krill meal for extraction of krill oil as claimed.
`
`B.
`
`The Contingent Amended Claims are Not Obvious
`7.
`I also stand by my previous opinion that the contingent amended
`
`claims are not obvious. Below, I address specific arguments and statements made
`
`by the Petitioner and its expert, Dr. Tallon. Petitioner alleges that the amended
`
`claims are obvious over the following combinations of references:
`
`
`
`6
`
`AKER EXHIBIT 2025 Page 6
`
`

`

`
`
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`
`
`8.
`
`It is my opinion that a POSITA would not combine Yoshitomi with
`
`the other six cited references in a method for producing a phospholipid-rich krill
`
`oil with the claimed properties followed by encapsulation or formulation for oral
`
`consumption and that there is no reasonable expectation of success in arriving at
`
`the claimed invention. Based on the data in Yoshitomi, a POSITA would
`
`
`
`7
`
`AKER EXHIBIT 2025 Page 7
`
`

`

`
`
`recognize that the Yoshitomi krill powder is a poor material for extraction of a krill
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`oil intended for encapsulation or oral formulation because the Yoshitomi krill
`
`powder has acid and peroxide values consistent with hydrolytic and oxidative
`
`degradation and because of the low total lipid content of the powder.
`
`9.
`
`First, I note that Dr. Tallon alleges that I have disregarded prior art
`
`that teaches grinding, cooking and drying krill meal. Ex. 1086, ¶251. What I
`
`testified is that:
`
`First, the proposed claims have been amended to require that the freshly
`caught krill is ground, cooked and dried to provide a dried krill meal which
`is then extracted to provide the krill oil for encapsulation. The prior art,
`including the lead reference Breivik II, specifically teaches away from
`extraction of oils from krill meal made by grinding, cooking and drying as
`required in the claims. As discussed above in ¶40, Yamaguchi et al.
`specifically teaches that krill meal contains polymerized and oxidized
`material that limit extraction from krill meal. See, Yamaguchi et al. (Ex.
`2002) at 2. Breivik II refers directly to Yamaguchi et al., teaching:
`“Yamaguchi et al. reported that oil in krill meal was deteriorated by
`oxidation or polymerisation to such an extent that only limited extraction
`occurred with supercritical CO2.” Ex. 1037 at 0002. As a result, Breivik II
`teaches and exemplifies using whole, fresh krill or whole body parts from
`krill to provide a product with improved quality. Id. . . . Thus, it is clear that
`Breivik II discourages a POSITA from using a dried krill meal made by
`grinding, cooking and drying the krill as a source material for extraction of
`an oil.
`
`
`Ex. 2001, ¶125. Thus, I testified that it is not obvious to perform a process where
`
`an oil as defined in the claims and subsequently encapsulated or formulated for
`
`oral consumption is extracted from krill meal made by cooking, grinding and
`
`drying freshly caught krill and that the prior art as a whole teaches away from the
`8
`
`
`
`AKER EXHIBIT 2025 Page 8
`
`

`

`
`
`claimed process as a whole. The analysis presented by Dr. Tallon focuses on the
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`krill meal production steps in isolation and does not consider the claims and the
`
`prior art as a whole.
`
`10. When the amended claims are considered as a whole, it is apparent
`
`that they are directed to a process whereby a phospholipid-rich krill oil with a
`
`defined ether phospholipid, total phospholipid, triglyceride and astaxanthin ester
`
`content is extracted from a krill meal made by grinding, cooking and drying fresh
`
`krill and then either formulated for oral consumption or encapsulated. I note that
`
`in the Grounds for obviousness for the amended claims Dr. Tallon has changed the
`
`lead reference from Breivik II to Yoshitomi. Substitution of Yoshitomi for Breivik
`
`II does not change my opinion that the contingent amended claims are not obvious
`
`for the following reasons.
`
`11. As stated in my previous Declaration (Ex. 2001 at ¶¶40 and 125),
`
`Yamaguchi teaches that supercritical fluid extraction with carbon dioxide should
`
`be used to extract neutral krill oil from krill meal to exclude “phospholipids that
`
`interfere with the utilization of krill oils.” Ex. 2002, abstract. Yamaguchi further
`
`reported that extraction from krill meal yielded one-third less neutral krill oil than
`
`extraction from a freeze-dried krill powder. Id. at p. 905, col. 2. As stated by
`
`Yamaguchi: “The lower yields from meal oil are probably attributable to the fact
`
`that that the oil of the krill meal was in part deteriorated by oxidation or
`9
`
`
`
`AKER EXHIBIT 2025 Page 9
`
`

`

`
`
`polymerization to such an extent that only limited extraction occurred with SC-
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`CO2.” Id.
`
`12.
`
`In arguing that Yamaguchi does not teach away from the invention of
`
`the amended claims, Dr. Tallon alleges that I intentionally omitted the sentence
`
`following the above quoted sentence, which reads “Judging from this result we
`
`think that SC-CO2 extraction is suitable method to obtain undenatured oils from
`
`meals of marine origin.” Ex. 1086 (Tallon Reply Decl.), ¶263. However, this
`
`sentence from Yamaguchi, which was not intentionally omitted, actually supports
`
`and is consistent with my analysis. Extraction with neat SC-CO2 removes only
`
`neutral lipids. The amended claims are directed to extraction of krill oils with a
`
`defined phospholipid content. Yamaguchi specifically teaches that extraction with
`
`neat SC-CO2 is used to selectively extract neutral lipids (described as undenatured
`
`oils) from krill meal so that extraction of phospholipids as well as oxidized and
`
`polymerized lipids (denatured lipids) derived from phospholipids is avoided.
`
`Breivik II echoed that concern, stating: “Yamaguchi et al. reported that oil in krill
`
`meal was deteriorated by oxidation or polymerisation to such an extent that only
`
`limited extraction occurred with supercritical CO2.” Ex. 1037 at 0002. As a result,
`
`Breivik II teaches and exemplifies using whole, fresh krill or whole-body parts
`
`from krill to provide a product with improved quality. Id. The prior art, including
`
`Yamaguchi and Breivik II, does teach away from the use of krill meal made by
`10
`
`
`
`AKER EXHIBIT 2025 Page 10
`
`

`

`
`
`grinding, cooking and drying as a starting point for extracting oil that contains
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`phospholipids. Presumably this is the reason why Dr. Tallon has switched from
`
`Breivik II to Yoshitomi as the lead reference for the contingent amended claims.
`
`However, as discussed below, a POSITA would not utilize the Yoshitomi krill
`
`powder for extraction because it suffers from the same problems of hydrolytic and
`
`oxidative degradation of lipids as conventional krill meal and also because it has an
`
`abnormally low lipid content.
`
`13. Yoshitomi does not teach or suggest extraction of a phospholipid-rich
`
`krill oil from its krill powder for formulation for oral consumption or for
`
`encapsulation. Yoshitomi is directed to inactivation of proteolytic enzymes that
`
`would degrade the protein components of krill. This is because, as specifically
`
`stated in Yoshitomi, the krill powder itself is intended as a food product where
`
`protein quality is important:
`
`[0036] The krill product of the present invention can be
`used as a main material of feed for cultured fish in place of
`fish powder, and in food applications it can be mixed as a
`shrimp taste seasoning in fish-paste products, etc.
`
`
`Ex. 1033, p. 0003. There is no teaching or suggestion that the powder can or
`
`should be used as a starting material for extraction of a phospholipid-lipid rich krill
`
`oil. As discussed in detail below, a POSITA would not combine Yoshitomi with
`
`Catchpole, Sampalis I, Bottino II, Randolph, Sampalis II and NKO to arrive at the
`
`
`
`11
`
`AKER EXHIBIT 2025 Page 11
`
`

`

`
`
`process of the present invention. This is because the data in Yoshitomi
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`demonstrates that lipids in the krill powder are subject to the same degradation and
`
`oxidation problems noted in Yamaguchi and also because the total lipid content is
`
`much lower than sources such as the freeze-dried krill powder of Catchpole (or
`
`Yamaguchi)
`
`14.
`
`In my capacity as Chief Scientist of Aker Biomarine, I have been
`
`involved in the design and operations of krill fishing boats and have also
`
`participated in research trips in Antarctica. The process described in Yoshitomi is
`
`a slight variation of standard krill meal processing and the lipids in the resulting
`
`krill powder would be expected to have properties similar to the krill meal used,
`
`for example, in Yamaguchi. In the Yoshitomi process, the krill is captured in a
`
`trawl and then brought on board and placed in a holding tank as described in
`
`Figure 2 of Yamaguchi. When the krill is captured in the trawl it is crushed and
`
`begins to die. Thus, much of the krill in the holding tank is dead and has already
`
`started to be acted on by enzymes contained in the krill such as lipases and
`
`phospholipases. The only difference with standard krill meal procedures is that
`
`drying and cooking steps are preformed at the same time. Ex. 1033 at p. 0007,
`
`[0051]. As described in Yoshitomi, since there is no water added for boiling “the
`
`components originally contained in the krill are all kept in the product without
`
`being discarded externally.” Id. This slight change in the boiling and drying
`12
`
`
`
`AKER EXHIBIT 2025 Page 12
`
`

`

`
`
`process would not be expected by a POSITA to avoid the lipid degradation,
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`oxidation and polymerization problems noted by Yamaguchi.
`
`15. Data in Yoshitomi confirms the fact the lipids in the krill powder
`
`disclosed in Yoshitomi suffer from the same described for krill meal in Yamaguchi
`
`and Breivik II. As described in Table 3 of Yoshitomi, reproduced below, the acid
`
`value of the Yoshitomi powder immediately after manufacture was 18.1 with no
`
`anti-oxidant added and 19.2 with anti-oxidant added.
`
`
`
`Acid value is a general indicator of hydrolytic rancidity of lipids which in krill can
`
`be caused by both enzymatic and non-enzymatic processes. These acid values are
`
`consistent with hydrolytic degradation of the lipids in the Yoshitomi powder and in
`
`
`
`13
`
`AKER EXHIBIT 2025 Page 13
`
`

`

`
`
`my experience are similar to or higher than conventional krill meals such as those
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`described in Yamaguchi. Furthermore, the starting peroxide value reported in
`
`Table 3, which is an early indicator of oxidative degradation, is 1.8 with the
`
`antioxidant and 4.1 without the antioxidant. These values are high for a product
`
`that has just been manufactured and indicate that the lipids in the krill powder are
`
`subject oxidative degradation. Based on this data, a POSITA would recognize that
`
`the Yoshitomi process does not improve lipid quality as compared to conventional
`
`krill meals such as those disclosed in Yamaguchi. By comparison, the NKO GRAS
`
`submission (Ex. 1075) which has been relied on Petitioner in these proceedings,
`
`indicates that the peroxide value of Neptune Krill Oil is less than 0.1. Ex. 1075 at
`
`0010, Table 2. This is over 18 times lower than the value reported in Table 3 of
`
`Yoshitomi. Table 4 of Yoshitomi does indicate that initial peroxide values were 0
`
`for some samples but does not provide acid values. No reason is provided for this
`
`inconsistency. However, a POSITA would consider the data in Tables 3 and 4
`
`together and would conclude that the Yoshitomi krill powder suffers from
`
`hydrolytic degradation as well as oxidative degradation. Additionally, I recognize
`
`that Yoshitomi states that boiling will “perfectly disable” proteolytic enzymes.
`
`That may be true, but the data in Yoshitomi indicate that the process is not
`
`sufficient for preventing degradation of lipids during the processing. Furthermore,
`
`I note that while a stated goal of the Yoshitomi process is to provide a krill powder
`14
`
`
`
`AKER EXHIBIT 2025 Page 14
`
`

`

`
`
`with the components of fresh krill, the data indicates that the lipids are subject to
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`both hydrolytic and oxidative degradation. The cooking and drying process
`
`described would also be expected to produce polymerization as indicated by
`
`Yamaguchi.
`
`16. Based on the data in Yoshitomi, a POSITA would recognize that the
`
`lipids in the Yoshitomi krill powder have been subject to both hydrolytic and
`
`oxidative degradation, similar to conventional krill meals. This is exactly the
`
`reason why Yamaguchi and Breivik II teach that krill meal made by processes
`
`including grinding, cooking and drying is not suitable for production of
`
`phospholipid-rich krill oils such as krill oil with the lipid profile defined in the
`
`contingent amended claims. I am informed that Petitioner has argued the
`
`following : “Breivik teaches that cooking denatures krill lipases, thus permitting
`
`grinding without hydrolysis concerns. See Exhibit 1037, p. 0004, lines 2-6; Tallon
`
`Decl. (Exhibit 1006), ¶ 189.” The cited text from Breivik II, reproduced below,
`
`does not support this statement and actually teaches away from “conventional
`
`processing” which would be understood by a POSITA to include grinding, cooking
`
`and drying to make a krill meal such as taught in Yamaguchi or Yoshitomi.
`
`
`
`15
`
`AKER EXHIBIT 2025 Page 15
`
`

`

`
`
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`
`
`17. The Yoshitomi krill powder also has a low crude fat content. Crude
`
`fat refers to the total lipid content of the krill powder. As provided in Table 5, the
`
`Yoshitomi krill powder has a crude fat content of 7%. In contrast, the freeze-dried
`
`krill powder of Catchpole has a lipid content (i.e., crude fat content) of 21.4%. Ex.
`
`1009, p. 0024. In my experience, the 21.4% lipid content of the freeze-dried krill
`
`powder of Catchpole is consistent with the average lipid content of both freeze-
`
`dried krill powder and krill meals. The abnormally low lipid content of the
`
`Yoshitomi krill powder is consistent with lipid degradation. This amount of total
`
`lipids is less than half of the 16.2 percent total lipids that were reported for the
`
`Yamaguchi krill meal, which was characterized by Dr. Tallon as being a “much
`
`lower starting lipid content” as compared to the freeze dried krill powder
`
`described in Yamaguchi. See Ex. 1086 ¶ 263, footnote 24. A POSITA would
`
`certainly not choose to design an extraction using the Yoshitomi krill powder
`
`when, for example, the freeze-dried krill powder described in Catchpole has a lipid
`
`content of more than three times higher. Moreover, Yamaguchi teaches that
`
`
`
`16
`
`AKER EXHIBIT 2025 Page 16
`
`

`

`
`
`extraction yields from meals that have been cooked and dried is about one third
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`that of freeze-dried krill powders. Given the already abnormally low lipid content
`
`of the Yoshitomi powder and recognized inefficiency of extraction from meals that
`
`have been cooked and dried as disclosed in Yamaguchi, a POSITA would not
`
`choose the Yoshitomi krill powder as a starting point for extraction of a
`
`phospholipid-rich krill oil as claimed due to expected very low yields.
`
`18. Thus, due both to the presence of lipids that have been subjected to
`
`hydrolytic and oxidative degradation and the abnormally low lipid content of the
`
`Yoshitomi krill powder, a POSITA would not choose to combine Yoshitomi with
`
`the six other cited references for production of a krill oil with the lipid profile
`
`defined in the claims and which is formulated for human consumption or
`
`encapsulated as required by the claims. In fact, a comparison of the starting
`
`materials for krill oil extraction in the references in the proposed Grounds indicates
`
`that all of the extractions used to provide the ranges for the lipid components in
`
`step (b) of the independent claims were from freeze-dried, fresh or frozen krill as
`
`opposed to a krill powder made by grinding, cooking and drying. The following
`
`chart summarizes the materials used for extraction and extraction methods utilized
`
`in the references cited against the claims.
`
`
`
`
`
`17
`
`AKER EXHIBIT 2025 Page 17
`
`

`

`Reference Krill material
`Yoshitomi Krill powder made by
`grinding and then
`boiling/drying (Ex.
`1033, p. 0007)
`Freeze-dried krill
`powder. Ex. 1009, p.
`0024.
`
`Catchpole
`
`Sampalis I Neptune Krill Oil
`(NKO). Ex, 1012, p.
`0001. NKO is extracted
`from deep frozen
`Antarctic krill as
`disclosed in the Neptune
`Gras statement. Ex.
`1075, p. 0006.
`Fresh, non-frozen krill.
`Ex. 1038, p. 0001
`
`Bottino II
`
`Randolph
`
`The only identified krill
`oil is NKO. Ex. 1011, p.
`0006, ¶[0039]. NKO is
`extracted from deep
`frozen Antarctic krill as
`disclosed in the Neptune
`Gras statement. Ex.
`1075, p. 0006.
`
`
`
`
`
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`Extraction method
`No extraction described
`
`Step 1 – extraction of neutral lipids
`from freeze dried krill powder by
`SFE with neat CO2 to provide a
`residual powder.
`
`Step 2 - Extraction of residual
`powder by SFE with CO2 plus 11%
`ethanol to yield Extract 2 (krill
`phospholipid extract).
`
`Ex. 1009, p. 0024.
`Acetone extraction. Ex. 1075, p.
`0006.
`
`Single step extraction of total lipids
`in a single step process by the
`method of Folch et al. Lipids were
`extracted by homogenizing tissue
`with 2:1 chloroform-methanol (v/v).
`Ex. 1038, pp. 0001-2.
`Acetone extraction. Ex. 1075, p.
`0006.
`
`18
`
`AKER EXHIBIT 2025 Page 18
`
`

`

`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`Acetone extraction. Ex. 1013, pp.
`0033-34.
`
`Acetone extraction. Ex. 1075, p.
`0006.
`
`
`
`
`Sampalis II Fresh or frozen krill. Ex.
`1013, pp. 0033-34. Also
`states that the “present
`invention” is Neptune
`Krill Oil.
`NKO is extracted from
`deep frozen Antarctic
`krill as disclosed in the
`Neptune Gras statement.
`Ex. 1075, p. 0006.
`
`NKO
`
`
`
`19. Thus, Yoshitomi describes a krill powder made by grinding and then
`
`cooking/drying the krill. The remainder of the combined references use either
`
`freeze-dried krill powder, frozen krill or fresh krill that has not been exposed to a
`
`cooking and drying process. In this regard I note that freeze-dried krill powder is
`
`understood by a POSITA to be a powder made by grinding freeze-dried krill.
`
`There is no cooking and drying process as described in Yoshitomi involved in the
`
`production of freeze-dried krill powder. Thus, each of the references utilized to
`
`provide the ranges for the lipid components of the krill oil described in step (b) of
`
`the independent claims (i.e., total phospholipids, ether phospholipids, triglycerides
`
`and astaxanthin esters) uses freeze-dried, fresh or frozen krill, which are different
`
`starting materials than the krill powder described in Yoshitomi. These refences
`
`demonstrate that when choosing a starting material for krill oil extraction, a
`
`
`
`19
`
`AKER EXHIBIT 2025 Page 19
`
`

`

`
`
`POSITA would and did choose to use fresh, frozen or freeze-dried krill as opposed
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`to a krill powder made by grinding, cooking and drying fresh krill.
`
`20.
`
`In summary, a POSITA would not combine Yoshitomi with
`
`references that utilize fresh, frozen, or freeze-dried krill (i.e., Catchpole, Bottino II,
`
`Sampalis I, Randolph, Sampalis II, and NKO) to arrive at the invention claimed in
`
`the contingent amended claims. First, the data in Yoshitomi indicate that the lipids
`
`in the krill powder subject to hydrolytic and oxidation degradation consistent with
`
`conventional krill meals. As of the priority date of the claims, a POSITA looking
`
`to extract krill lipids for formulation for human consumption or encapsulation
`
`would not use a krill powder with the acid values or peroxide values reported in
`
`Yoshitomi. From the data disclosed in Yoshitomi, a POSITA would have
`
`concluded that the lipids in the powder were subject to both hydrolysis and
`
`oxidation. Instead, as evidenced by the remainder of the cited references, the
`
`POSITA would have chosen to utilize fresh, frozen or freeze-dried krill and not a
`
`krill meal made by grinding, cooking and drying krill as claimed. Furthermore, the
`
`data in Yoshitomi demonstrates that the Yoshitomi krill powder had an abnormally
`
`low lipid content as compared, to example, the freeze-dried krill powder used in
`
`Catchpole.
`
`21. Second, the claims require extraction of a krill oil with a defined lipid
`
`profile. Yamaguchi specifically teaches a method of extraction of neutral lipids
`20
`
`
`
`AKER EXHIBIT 2025 Page 20
`
`

`

`
`
`from krill meal by supercritical fluid extraction (SFE) with neat CO2 to
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`specifically avoid extraction of phospholipids and oxidized and polymerized lipids.
`
`Ex. 2002, pp. 1-2. As taught in Yamaguchi, the yield from krill meal was much
`
`lower than that obtained from freeze-dried krill due to the presence of oxidized and
`
`polymerized material in the meal:
`
`Further, yields of krill meal oil were one-third of those of freeze-dried krill
`oil. The lower yields from meal oil are probably attributable to the fact that
`the oil of the krill meal was in part deteriorated by oxidation or
`polymerization to such an extent that only limited extraction occurred with
`SC-C02. Judging from this result, we think that SC-C02 extraction
`is suitable method to obtain undenatured oils from meals of marine origin.
`
`
`Ex. 2012, p. 2. These concerns were echoed in Breivik II. Ex. 1037, p. 0002-4. A
`
`POSITA as of the priority date of the claims would have understood that the prior
`
`art taught away from use of krill meals made by grinding, cooking and drying for
`
`the extraction of phospholipid-rich krill oils that are subsequently formulated for
`
`oral consumption or encapsulation as claimed.
`
`22. Third, a POSITA would also conclude that the combined references
`
`do not provide a reasonable expectation of success. Specifically, a POSITA would
`
`not have a reasonable expectation of success in extracting a krill oil with the
`
`defined lipid profile from the krill powder described in Yoshitomi. The claims
`
`require extraction of an oil from meal with a specific lipid profile of from 4-8% or
`
`5-8% ether phospholipids, 30 to 60% total phospholipids, from 20 to 50%
`
`
`
`21
`
`AKER EXHIBIT 2025 Page 21
`
`

`

`
`
`triglycerides and 100 to 700 mg/kg astaxanthin esters. As discussed above, the data
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`in Yoshitomi indicate that the lipids in the krill powder were subject to hydrolytic
`
`and oxidation degradation. A POSITA would recognize that this is consistent with
`
`the disclosure in Yamaguchi that krill meals made by cooking and drying
`
`processes contain oxidized and polymerized lipids.
`
`23. Moreover, Yamaguchi provided a direct comparison between neat
`
`SFE CO2 extraction from a freeze-dried krill powder and krill meal and found the
`
`extraction yield of lipids from the krill meal was one third of that obtained from the
`
`freeze-dried krill powder and concluded that the difference was to oxidized and
`
`polymerized lipids in the krill meal. This data shows that meals made by grinding,
`
`cooking and drying as disclosed in Yoshitomi and Yamaguchi provide a different
`
`matrix for extraction as compared to a freeze-dried krill powder. Based on this
`
`data, a POSITA would recognize that there is no reasonable expectation of success
`
`in making a krill extract with the defined lipid profile by extraction from the
`
`Yoshitomi krill powder by any of the methods described in the other cited
`
`references such as Catchpole, Bottino II, or the NKO references. The krill lipid
`
`extracts described in those references were obtained by extraction from fresh,
`
`frozen or freeze-dried krill and there is no basis to conclude that similar extracts
`
`could be obtained from krill meal made by grinding, cooking and drying.
`
`
`
`22
`
`AKER EXHIBIT 2025 Page 22
`
`

`

`
`
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`24. Finally, Dr. Tallon’s testimony confirms the fact that freeze dried krill
`
`extracted in Breivik II is in fact different from a krill meal made by grinding,
`
`cooking and drying. As stated by Dr. Tallon:
`
`267. Breivik II (Exhibit 1037) describes methods known for producing a
`high quality unoxidized krill meal. “In another embodiment, the process
`according to the invention is used to extract krill meal, wherein provided the
`krill meal has been produced in a sufficiently mild way to avoid
`deterioration of the krill lipids.” Breivik II, 11:16-18, Exhibit 1037, p. 0011
`(emphasis supplied). Such a process is exemplified in Breivik II’s Example
`1 “Processing of freeze dried krill” (Exhibit 1037, pp. 0006-0007), in which
`freeze dried krill meal is used as the starting material, and successful
`extraction of the key components of a krill oil are disclosed including omega
`3 fatty acids, astaxanthin, and phospholipids using a CO2 followed by
`CO2+ethanol extraction process.
`
`
`Ex. 1086, ¶267. Thus, according to Dr. Tallon, freeze dried krill is an example of a
`
`material that is not oxidized and which has been produced in a “sufficiently mild
`
`way.” As I discussed above and as clearly indicated in Breivik II, the material
`
`extracted was freeze-dried krill and did not involve cooking or heating steps.
`
`Breivik II directly teaches a POSITA that materials such as freeze-dried krill and
`
`frozen krill should be utilized for extraction, not krill materials that have been
`
`cooked and dried as claimed.
`
`25. A POSITA would also not be motivated to combine the references to
`
`arrive at a process for extraction from krill meal preparing by cooking, grinding
`
`and drying to provide a krill oil with from 4 to 8% or from 5 to 8% ether
`
`phospholipids. Dr. Tallon has provided a number of arguments in his Reply
`23
`
`
`
`AKER EXHIBIT 2025 Page 23
`
`

`

`
`
`Declaration to attempt to show that Extract 2 of Catchpole would have contained
`
`Inter Partes Review of US 9,375,453
`Ex. 2025, Hoem Declaration
`
`from 20 to 50% triglycerides. I stand by my previous testimony that a POSITA
`
`reading Catchpole would understand Catchpole to teach that the first extraction
`
`step with neat CO2 removes the neutral lipids so that none are available for extract
`
`2. Therefore, a POSITA would understand that one would need to add at least
`
`20% triglycerides to Extract 2 to arrive at the claims which would reduce the ether
`
`phospholipid content of Extract 2 to no more than 4.8% - (4.8 X .20) = 3.84%.
`
`26. Dr. Tallon provides a number of rationales for his calculations. ¶¶31-
`
`101, 273-301. For example, Dr. Tallon argues that the neutral lipid content
`
`remaining after the extraction step with neat CO2 can be calculated by subtraction
`
`of the phospholipids listed in Table 16 of Catchpole. Dr. Tal