Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth 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: IPR2020-01533
`
`U.S. Patent No. 9,816,046 B2
`
`Declaration of Dr. Snorre Tilseth
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0001
`
`
`Ex. 2001, Tilseth 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: IPR2020-01533
`
`U.S. Patent No. 9,816,046 B2
`
`Declaration of Dr. Snorre Tilseth
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0001
`
`
`
`
`
`
`I, Dr. Snorre Tilseth, do declare as follows:
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`1.
`
`I have personal knowledge of the matters set forth herein, and if I am
`
`called upon to testify, I could testify competently thereto.
`
`
`
`2.
`
`I am one of three joint inventors of the subject matter described in
`
`U.S. Patent Application 15/589,572, filed May 8, 2017 and which issued on Nov.
`
`14, 2017 as U.S. Patent No. 9,816,046 (the “ ‘046 Patent’ ”). The ‘046 Patent is a
`
`continuation of U.S. Pat. No. 9,644,169, which is a continuation of U.S. Pat. No.
`
`9,375,453, which is a continuation of U.S. Pat. No. 9,034,388, all of which the
`
`claim the benefit of the following U.S. Provisional Applications: 60/920,483 filed
`
`March 28, 2007; 60/975,058 filed September 25, 2007; 60/983,446 filed October
`
`29, 2007; and 61/024,072 filed January 28, 2008. The remaining inventors, Inge
`
`Bruheim and Daniele Mancinelli are no longer employed by Aker Biomarine
`
`Antarctic AS or any Aker subsidiary.
`
`
`
`3.
`
`I started working with Aker Seafoods on October 1, 2005. I am
`
`currently employed by Aker BioMarine as a Senior advisor and have worked for
`
`Aker BioMarine since its formation in 2006. I am not being compensated
`
`separately for this Declaration.
`
`
`
`4.
`
`I understand that inter partes review of Claims 1-19 of the
`
`’046 patent has been instituted in IPR2020-01533. I understand that the Grounds
`
`for invalidity which are being considered are as follows:
`2
`
`
`
`AKER EXHIBIT 2001 PAGE 0002
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`Ground 1: Claims 1-10 are alleged to be obvious under 35 U.S.C. 103(a)
`
`over the combination of Breivik II, Yoshitomi, Budzinski, Fricke, Bottino II
`
`and Sampalis I;
`
`
`
`Ground 2: Claims 11 and 12 are alleged to be obvious under 35 U.S.C.
`
`103(a) over the combination of Breivik II, Yoshitomi, Budzinski, Fricke,
`
`Bottino II, and Randolph;
`
`
`
`Ground 3: Claims 13-19 are alleged to be obvious under 35 U.S.C. 103(a)
`
`over the combination of Breivik II, Budzinski, Yoshitomi, Fricke, Bottino II,
`
`Randolph and Sampalis I.
`
`
`
`5.
`
`In early 2006, I was employed by Aker Seafood Antarctic AS. As
`
`
`
`
`
`
`
`part of Aker Seafood Antarctic AS, I started the process to develop a method of
`
`making krill oil from krill meal. This work eventually led to the formation of Aker
`
`BioMarine AS in late 2006 to commercialize krill oil production. The other two
`
`inventors, Inge Bruheim and Daniele Mancinelli were employed by a different
`
`company, Natural ASA, which was acquired by the Aker group for its experience
`
`in nutraceutical products. I began interacting with the other inventors and
`3
`
`
`
`AKER EXHIBIT 2001 PAGE 0003
`
`
`
`
`
`individuals at Natural ASA prior to the acquisition on aspects related to krill oil
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`extraction processes and specifications that are reflected in the claims.
`
`
`
`6.
`
`In 2004, Aker Seafoods obtained a trial license from CCAMLR
`
`(Commission for the Conservation of Antarctic Marine Living Resources) for
`
`harvesting Euphausia superba in Antarctica with the F/T Atlantic Navigator.
`
`Operation of the Atlantic Navigator in Antarctica for the 2004 and 2005 is
`
`described in Ex. 2002 which is a report by scientific observers that were on board
`
`the Atlantic Navigator for part of the fishing season. The krill meal used for the
`
`extractions described below was produced on May 6, 2005, shortly after the time
`
`periods on which the observers were on the ship. The predominant krill species
`
`caught in these area is Euphausia superba, which is consistent with the size of the
`
`krill described in Ex. 2002.
`
`7.
`
`In 2005, I initially presented the idea of ethanol extraction of krill oil
`
`from krill meal to Kjell Inge Rokke, the owner of Aker Seafood. As part of this
`
`project, analysis of materials such as krill meal and krill oil were contracted to
`
`Fiskeriforskning (the Norwegian Institute of Fisheries and Aquaculture Research).
`
`The krill meal used for extraction of krill oil is described in Ex. 2003, “F/T
`
`Atlantic Navigator 2004-2005” which is a report prepared by Fiskeriforskning and
`
`which bears the date of December 23, 2005. Ex. 2004 is a screenshot of the
`
`internal metadata for the report provided as Ex. 2003. This metadata indicates that
`4
`
`
`
`AKER EXHIBIT 2001 PAGE 0004
`
`
`
`
`
`the report provided as Ex. 2003 was created and last modified on January 27, 2006.
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`The author of Ex. 2003 is Eyolf Langmyhr of Fiskeriforskning. I stored a copy of
`
`this file as a corporate record on the hard drive of my computer and the copy
`
`provided is true and correct copy of the report. The dates of the report are
`
`consistent with my memory of the events.
`
`8.
`
`Sections 6.1 and 6.2 of Ex. 2003 (p. 0022-23) describe production and
`
`sampling of the krill meal during different production steps. The Atlantic
`
`Navigator was equipped with a standard compact fish meal factory. The krill meal
`
`was produced by a standard meal process where fresh krill is brought on board the
`
`ship, cooked, pressed and decanted, and then dried to provide the krill meal. The
`
`krill meal had a reduced particle size as compared to the fresh krill and was a
`
`powder as discussed below. Heating of the krill material sufficient to denature
`
`lipases and phospholipases occurs at the cooking stage prior to decanting/pressing.
`
`This meal is the same meal described in Example 1 of the ‘046 Patent (Ex. 1001 at
`
`pp. 0034-35) and Example 1 of the priority document U.S. Prov. Appl. 60/920,483
`
`filed March 28, 2007 (Ex. 1005 at pp. 0023-26).
`
`9.
`
`In the spring of 2006, I contacted the company Fresenius Kabi to
`
`discuss extracting krill containing phospholipids. I chose Fresenius Kabi as a
`
`potential partner due to their expertise in extracting phospholipids from egg yolk.
`
`During the project and my interaction with Fresenius Kabi, I produced and saved
`5
`
`
`
`AKER EXHIBIT 2001 PAGE 0005
`
`
`
`
`
`notes as Microsoft Word documents. Ex. 2005 is a copy of a Microsoft Word
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`document containing my notes from a meeting with Fresenius Kabi on May 5,
`
`2006. Ex. 2006 is the certified Norwegian to English translation of Ex. 2005. Ex.
`
`2007 is a screenshot of the internal metadata for Ex. 2005 showing that Ex. 2005
`
`was created by me on May 5, 2006 and last modified on May 8, 2006. I stored this
`
`document as a corporate record on the hard drive of my computer and the copy
`
`provided is true and correct copy of the document. The dates of the document are
`
`consistent with my memory of the events. These notes reference an initial
`
`extraction of krill meal and plans to run a pilot scale extraction on several hundred
`
`kilograms of krill meal which we provided to Fresenius Kabi for extraction.
`
`10. Ex. 2008 is a draft of an agreement I participated in preparing which
`
`describes the relationship with Fresenius Kabi and which I maintained as a Word
`
`Document in my electronic files. Ex. 2009 is a screenshot of the internal metadata
`
`for Ex. 2008 showing that Ex. 2008 was created by me on June 19, 2006 and last
`
`modified on December 8, 2006. I stored this document as a corporate record on the
`
`hard drive of my computer and the copy provided is true and correct copy of the
`
`document. The dates of the document are consistent with my memory of the
`
`events. This document further demonstrates that we recognized that ethanol could
`
`be used to extract a phospholipid-containing krill oil from krill meal and the
`
`
`
`6
`
`AKER EXHIBIT 2001 PAGE 0006
`
`
`
`
`
`resulting oil used for a variety of purposes. All oil produced was intended to be the
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`property of Aker Seafoods.
`
`11. The pilot scale extraction referenced in Exs. 2005 and 2006 was
`
`conducted on June 6, 2006 at my direction on krill meal provided by Aker
`
`Seafoods. Ex. 2010 is a copy of a Microsoft Word document containing my notes
`
`from a meeting with Fresenius Kabi on June 6, 2006. Ex. 2011 is the certified
`
`Norwegian to English translation of Ex. 2010. Ex. 2012 is a screenshot of the
`
`internal metadata for Ex. 2010 showing that Ex. 2010 was created on June 27,
`
`2006 and last modified on June 27, 2006, which is when I made the Microsoft
`
`Word Document containing the notes of the earlier meeting. I stored this document
`
`as a corporate record on the hard drive of my computer and the copy provided is
`
`true and correct copy of the document. The dates of the document are consistent
`
`with my memory of the events.
`
`12.
`
`In this pilot scale production run, approximately 3150 kg of krill meal
`
`(a denatured krill product) produced on board the Atlantic Navigator in May 2005
`
`was extracted with ethanol. I should point out that there is a typographic error in
`
`the notes which indicates that the krill meal was produced on 06.05.06. This date
`
`is actually 06.05.05 or 6th of May, 2005, as correctly stated in Ex. 2013 discussed
`
`below and as referenced in Ex. 2003 Table 19. As indicated in my notes, we
`
`produced several hundred kilograms of a polar krill oil suitable for encapsulation
`7
`
`
`
`AKER EXHIBIT 2001 PAGE 0007
`
`
`
`
`
`and further concentration. Samples of this oil were provided to Fiskeriforskning
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`for analysis.
`
`13. Ex. 2013 is the Fiskeriforskning analysis of the ethanol extracted krill
`
`meal oil from the pilot scale extraction at Fresenius Kabi which was conducted at
`
`my direction. This report bears the date of September 14, 2006. I maintained a
`
`copy of this report in my electronic files as a Microsoft Word Document. Ex. 2014
`
`is a screenshot of the internal metadata for the report provided as Ex. 2013. This
`
`metadata indicates that the report provided as Ex. 2013 was created on August 23,
`
`2006 and last modified on September 14, 2006. The author of Ex. 2013 is Eyolf
`
`Langmyhr of Fiskeriforskning and I am identified as the employer. I stored a copy
`
`of the document as a corporate record on the hard drive of my computer and the
`
`copy provided is true and correct copy of the document. The dates of the
`
`document are consistent with my memory of the events.
`
`14. As stated in the report in the report at page 0005, “Krill meal, 3210 kg
`
`(107 bags á 30 kg) produced on board F/V Atlantic Navigator 06.05.05, was
`
`extracted with ethanol at Fresenius Kabi, Kungsängen, Sweden.” This report
`
`correctly identifies the date of production of the krill meal from which the oil was
`
`extracted as the 6th of May, 2005. Since the extraction of the meal occurred in
`
`June 2006 and the meal was produced in May 2005 the meal had been stored after
`
`heat treatment for 13 months. Photographs of the krill meal before and after
`8
`
`
`
`AKER EXHIBIT 2001 PAGE 0008
`
`
`
`
`
`extraction are provided at page 0005 as well as an analysis of the composition of
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`the krill oil in Table 3, p. 0007. As analyzed by Fiskeriforskning the krill oil
`
`contained 25.3% w/w phosphatidylcholine, 6.2% w/w lysophosphatidylcholine,
`
`and 36.9% w/w total polar lipids. This data is provided in Table 8 of the ‘046
`
`Patent (Ex. 1001, p. 0036) and at page 0028 of Ex. 1005.
`
`15. Together, these documents establish that by at least as early as
`
`September 14, 2006, we had developed a method of extracting krill oil with a polar
`
`solvent (specifically ethanol) from freshly harvested krill treated to destroy the
`
`activity of lipases and phospholipases in the krill (specifically krill meal produced
`
`by cooking and drying the krill) on a ship and then stored for 13 months prior to
`
`the extraction. As indicated in my notes (Ex. 2011), the extracted oil was suitable
`
`for both encapsulation and for further processing to concentrate the phospholipids.
`
`16.
`
`I have been informed that the earliest possible priority date for Breivik
`
`II (Ex. 1037) is November 16, 2006, which is approximately two months after
`
`September 14, 2006. Breivik II discloses processes where fresh krill is heated and
`
`then extracted with a polar solvent to provide krill oil containing phospholipids.
`
`17. The evidence and documents discussed above demonstrate that we
`
`conceived and reduced the entire invention to practice before the November 16,
`
`2006 priority date of Breivik II and in any event conceived and reduced to practice
`
`at least as much of the claimed invention as is disclosed in Breivik II. The
`9
`
`
`
`AKER EXHIBIT 2001 PAGE 0009
`
`
`
`
`
`following claim chart which I have been provided and adopt matches the evidence
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`in the Exhibits discussed above with the claim features and provides a comparison
`
`to Breivik II. I have been informed that we are only required to show as much as
`
`what is taught of the claimed invention by Breivik II in order to remove it as a
`
`prior art reference. This chart shows that before November 16, 2006, we had
`
`completed at least as much of the invention as is disclosed in Breivik II and
`
`specifically identifies the relevant evidence in relation to the disclosure of Breivik
`
`II. While I have been informed that we are only required to show as much as what
`
`is taught in Breivik II in order to remove it as a prior art reference, I further have
`
`been informed that Rimfrost’s expert, Dr. Tallon, has admitted in his Declaration
`
`for this proceeding and in previous proceedings that a person of ordinary skill in
`
`the art could easily manipulate extraction conditions to alter the composition of
`
`krill oil and that the krill oil components listed in the claims are the natural
`
`components of krill oil. For example, I have been informed that in Ex. 1006, Dr.
`
`Tallon states:
`
`
`73. From my experience and knowledge, and as is apparent from the
`literature cited here, the krill oil lipid components described and claimed in
`the ‘046 Patent are known to the POSITA as natural lipid components in the
`krill oil that can be extracted using conventional solvents and established
`methods that were also known to a POSITA. For example, Tanaka (Exhibit
`1015, see ¶¶ 352-358, below) discloses a process for extracting and
`separating out, if desired, factions which are (i) predominately neutral lipids,
`
`
`
`10
`
`AKER EXHIBIT 2001 PAGE 0010
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`(ii) mixtures of neutral and polar lipids, and (iii) predominately polar lipids.
`Tanaka, pp. 422-423, Exhibit 1015, pp. 0006-0007 and Figure 7.
`
`
`
`
`
`
`Applying this logic, a person of ordinary skill in the art would have known that
`
`once our process of extracting krill oil from stored denatured krill material had
`
`been described, the oil could be expected to contain the components identified in
`
`the claims or the process could be further modified to provide the components
`
`identified in the claims.
`
`‘046 Claims
`
`1. A method of
`production of krill oil
`comprising:
`
`obtaining a krill meal
`produced by a process
`comprising treating krill
`to destroy the activity of
`lipases and
`
`
`
`Evidence of Conception
`and Reduction to
`Practice
`Ex. 2011 – notes describe
`extraction of krill oil
`from krill meal. See p.
`0002.
`Ex. 2013 – analysis of
`krill oil obtained from
`extraction of krill meal.
`See p. 0005-8.
`Ex. 2003 – report K300
`describes analysis of krill
`meal made by a meal
`process where krill is
`brought on board ship (in
`
`11
`
`Breivik II
`
`Breivik II generally
`discloses extraction of a
`lipid fraction (i.e., krill
`oil) from fresh krill. p.
`0003, l. 29-31.
`
`Breivik II does not
`describe storage of a
`krill meal for from 1 to
`36 months.
`
`
`AKER EXHIBIT 2001 PAGE 0011
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`phospholipases naturally
`present in krill and
`wherein said krill meal
`has been stored for
`period of from 1 to 36
`months; and
`
`extracting krill oil from
`said krill meal that has
`been stored from 1 to 36
`months with a polar
`solvent to provide a krill
`oil with greater than 30%
`phosphatidylcholine w/w
`
`this case the Atlantic
`Navigator), cooked,
`decanted, milled and
`dried; this process
`destroys the activity of
`lipases and
`phospholipases that
`naturally occur in krill.
`See 0022-24.
`
`Ex. 2011 and Ex. 2013 –
`the krill meal produced
`on board the Atlantic
`Navigator in May 2005
`was stored for 13 months.
`See Ex. 2011 at 0002 and
`Ex. 2013 at 0005-8.
`Ex. 2011 and Ex. 2013 –
`the krill meal was
`extracted with a polar
`solvent (ethanol) to
`provide a phospholipid-
`rich krill oil. The krill oil
`contained 25.3% w/w
`phosphatidylcholine,
`
`12
`
`Breivik II describes
`heating fresh krill just
`prior to extraction.
`
`
`
`Breivik II does not
`describe extraction from
`a krill meal produced by
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`phospholipases naturally
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0012
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`of said krill oil and
`astaxanthin esters.
`
`6.2% w/w
`lysophosphatidylcholine,
`and 117 mg/kg
`astaxanthin esters. See
`Ex. 2011 at 0002 and Ex.
`2013 at 0005-8.
`
`present in krill and that
`has been stored from 1-
`36 months.
`
`Breivik II describes
`extraction of fresh krill
`with polar solvents such
`as ethanol. See p. 0007-
`0008.
`
`Breivik II does not
`disclose
`phosphatidylcholine
`content.
`
`Breivik II does not
`disclose the astaxanthin
`content of the extracted
`krill oil. Based on prior
`art Neptune Krill Oil
`specification, Breivik
`indicates that astaxanthin
`ester should be greater
`than or equal to 1000
`
`13
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0013
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`2. The method of claim
`1, wherein said krill oil
`comprises less than 3%
`free fatty acids w/w of
`said krill oil.
`
`3. The method of claim
`1, wherein said krill oil
`comprises less than about
`2%
`lysophosphatidylcholine
`w/w of said krill oil.
`
`4. The method of claim
`1, wherein said process
`comprising treating krill
`to destroy the activity of
`the lipases and
`phospholipases naturally
`present in krill comprises
`grinding said krill prior
`to destroying the activity
`
`As admitted by Dr.
`Tallon, natural
`components of krill oil
`can be extracted in
`desired amounts by
`known methods.
`As admitted by Dr.
`Tallon,
`lysophosphatidylcholine
`is a natural component of
`krill oil which can be
`extracted in desired
`amounts by known
`methods.
`Ex. 2003 – report K300
`describes analysis of krill
`meal made by a meal
`process where krill is
`brought on board ship (in
`this case the Atlantic
`Navigator) and subjected
`to heating steps before or
`
`14
`
`mg/kg. See p. 0011, l.
`30.
`Breivik II does not
`disclose the free fatty
`acid content of the
`extracted krill oil.
`
`Breivik II does not
`disclose the
`lysophosphatidylcholine
`content of the extracted
`krill oil.
`
`Breivik II does not
`describe extraction from
`a krill meal produced by
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`phospholipases naturally
`present in krill and that
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0014
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`of said lipases and
`phospholipases naturally
`present in krill.
`
`after grinding steps. See
`0022-24.
`
`Ex. 2003 – report K300
`describes analysis of krill
`meal made by a meal
`process where krill is
`brought on board ship (in
`this case the Atlantic
`Navigator), cooked (i.e.,
`heated), decanted, milled
`and dried; this process
`destroys the activity of
`lipases and
`phospholipases. See
`0022-24.
`Chemical treatment is a
`standard way to destroy
`the activity of enzymes.
`
`5. The method of claim
`1, wherein said process
`comprising treating krill
`to destroy the activity of
`the lipases and
`phospholipases naturally
`present in krill comprises
`heating said krill.
`
`6. The method of claim
`1, wherein said process
`comprising treating krill
`to destroy the activity of
`the lipases and
`phospholipases naturally
`present in krill comprises
`
`15
`
`has been stored from 1-
`36 months, where the
`krill is ground before
`heating and prior to
`storage.
`Breivik II does not
`describe extraction from
`a krill meal produced by
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`phospholipases naturally
`present in krill and that
`has been stored from 1-
`36 months, where the
`krill is heated prior to
`storage.
`Breivik II does not
`describe extraction from
`a krill meal produced by
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0015
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`treating said krill with
`chemicals.
`
`7. The method of claim
`1, wherein said process
`comprising treating krill
`to destroy the activity of
`the lipases and
`phospholipases naturally
`present in krill comprises
`a combination of heating
`said krill and treating
`said krill with chemicals.
`
`Heat and chemical
`treatment is a standard
`way to destroy the
`activity of enzymes.
`
`8. The method of claim
`1, further comprising
`encapsulating said krill
`oil.
`
`Ex. 2011 – the extracted
`oil was suitable for
`encapsulation. See p.
`0003.
`
`16
`
`phospholipases naturally
`present in krill and that
`has been stored from 1-
`36 months, where the
`krill is treated with
`chemicals prior to
`storage.
`Breivik II does not
`describe extraction from
`a krill meal produced by
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`phospholipases naturally
`present in krill and that
`has been stored from 1-
`36 months, where the
`krill is treating by a
`combination of chemicals
`and heat.
`Breivik II does not
`disclose encapsulation.
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0016
`
`
`
`9. The method of claim
`3, wherein said krill
`is Euphausia superba.
`
`10. The method of claim
`1, wherein said krill oil
`comprises at least 40%
`phosphatidylcholine w/w
`of said krill oil.
`
`11. The method of claim
`1, wherein said
`astaxanthin esters are
`present in the krill oil at
`in an amount of at least
`100 mg/kg.
`
`
`
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`Ex. 2002 – The Atlantic
`Navigator fished for
`Euphausia superba in the
`Antarctic Ocean in 2005,
`which was used to make
`the krill meal for
`extraction.
`As admitted by Dr.
`Tallon,
`phosphatidylcholine is a
`natural component of
`krill oil which can be
`extracted in desired
`amounts by known
`methods.
`Ex. 2013 – the krill meal
`was extracted with a
`polar solvent (ethanol) to
`provide a phospholipid-
`rich krill oil containing
`117 mg/kg astaxanthin
`esters. See p. 0006.
`
`Breivik II discloses use
`of fresh Euphausia
`superba, which is an
`Antarctic krill. See p.
`0007-0008, examples.
`
`Breivik II does not
`disclose the
`phosphatidylcholine
`content of the extracted
`krill oil.
`
`Breivik II does not
`disclose the astaxanthin
`content of the extracted
`krill oil. Based on prior
`art Neptune Krill Oil
`specification, Breivik
`indicates that astaxanthin
`ester should be greater
`than or equal to 1000
`
`17
`
`AKER EXHIBIT 2001 PAGE 0017
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`12. The method of claim
`1, wherein said
`astaxanthin esters are
`present in the krill oil at
`in an amount of at least
`200 mg/kg.
`
`As admitted by Dr.
`Tallon, the ether
`phospholipids are natural
`components of krill oil
`which can be extracted in
`desired amounts by
`known methods.
`
`13. A method of
`production of Euphausia
`superba krill oil
`comprising:
`
`a) obtaining a Euphausia
`superba krill meal
`produced by a process
`comprising
`
`Ex. 2011 – notes describe
`extraction of krill oil
`from krill meal. See p.
`0002.
`Ex. 2013 – analysis of
`krill oil obtained from
`extraction of krill meal.
`See p. 0005-8.
`Ex. 2003 – report K300
`describes analysis of krill
`meal made by a meal
`process where krill is
`
`18
`
`mg/kg. See p. 0011, l.
`30.
`Breivik II does not
`disclose the astaxanthin
`content of the extracted
`krill oil. Based on prior
`art Neptune Krill Oil
`specification, Breivik
`indicates that astaxanthin
`ester should be greater
`than or equal to 1000
`mg/kg. See p. 0011, l.
`30.
`Breivik II generally
`discloses extraction of a
`lipid fraction (i.e., krill
`oil) from fresh krill
`which can be Euphausia
`superba. p. 0003, l. 29-
`31.
`
`Breivik II does not
`describe storage of a
`krill meal for from 1 to
`36 months.
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0018
`
`
`
`treating Euphausia
`superba to destroy the
`activity of lipases and
`phospholipases naturally
`present in Euphausia
`superba and wherein
`said Euphausia
`superba krill meal has
`been stored from 1 to 36
`months; and
`
`b) extracting Euphausia
`superba oil from said
`krill meal that has been
`stored from 1 to 36
`months with a polar
`solvent to provide
`a Euphausia
`
`
`
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`
`Breivik II describes
`heating fresh krill just
`prior to extraction.
`
`Breivik II does not
`describe extraction from
`a krill meal produced by
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`
`brought on board ship (in
`this case the Atlantic
`Navigator), cooked,
`decanted, milled and
`dried; this process
`destroys the activity of
`lipases and
`phospholipases that
`naturally occur in krill.
`See 0022-24.
`
`Ex. 2011 and Ex. 2013 –
`the krill meal produced
`on board the Atlantic
`Navigator in May 2005
`was stored for 13 months.
`See Ex. 2011 at 0002 and
`Ex. 2013 at 0005-8.
`Ex. 2011 and Ex. 2013 –
`the krill meal was
`extracted with a polar
`solvent (ethanol) to
`provide a phospholipid-
`rich krill oil. The krill oil
`contained 25.3% w/w
`
`19
`
`AKER EXHIBIT 2001 PAGE 0019
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`superba krill oil
`comprising greater than
`30% phosphatidylcholine
`w/w of said Euphausia
`superba krill oil, less
`than 3% free fatty acids
`w/w of said Euphausia
`superba krill oil, and at
`least 100 mg/kg
`astaxanthin esters.
`
`phosphatidylcholine,
`6.2% w/w
`lysophosphatidylcholine,
`and 117 mg/kg
`astaxanthin esters. See
`Ex. 2011 at 0002 and Ex.
`2013 at 0005-8.
`
`As admitted by Dr.
`Tallon, free fatty acids
`are a natural component
`of krill oil which can be
`extracted in desired
`amounts by known
`methods.
`
`phospholipases naturally
`present in krill and that
`has been stored from 1-
`36 months.
`
`Breivik II describes
`extraction from fresh krill
`with polar solvents such
`as ethanol, where the
`fresh krill is heat treated
`just prior to extraction.
`See p. 0007-0008.
`
`Breivik II does not
`disclose
`phosphatidylcholine
`content.
`
`Breivik II does not
`disclose the astaxanthin
`content of the extracted
`krill oil. Based on prior
`art Neptune Krill Oil
`specification, Breivik
`indicates that astaxanthin
`
`20
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0020
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`ester should be greater
`than or equal to 1000
`mg/kg. See p. 0011, l.
`30.
`
`Breivik II does not
`disclose the free fatty
`acid content of the
`extracted krill oil.
`Breivik II does not
`disclose encapsulation.
`
`Breivik II does not
`disclose the
`phosphatidylcholine
`content of the extracted
`krill oil.
`
`Breivik II does not
`describe extraction from
`a krill meal produced by
`
`14. The method of claim
`13, further comprising
`encapsulating
`said Euphausia
`superba krill oil.
`15. The method of claim
`13, wherein said krill oil
`comprises at least 40%
`phosphatidylcholine w/w
`of said Euphausia
`superba krill oil.
`
`16. The method of claim
`13, wherein said process
`comprising
`
`Ex. 2011 – the extracted
`oil was suitable for
`encapsulation. See p.
`0003.
`
`As admitted by Dr.
`Tallon,
`phosphatidylcholine is a
`natural component of
`krill oil which can be
`extracted in desired
`amounts by known
`methods.
`Ex. 2003 – report K300
`describes analysis of krill
`meal made by a meal
`
`21
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0021
`
`
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`process where krill is
`brought on board ship (in
`this case the Atlantic
`Navigator) and subjected
`to heating steps before or
`after grinding steps. See
`0022-24.
`
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`phospholipases naturally
`present in krill and that
`has been stored from 1-
`36 months, where the
`krill is ground before
`heating and prior to
`storage.
`
`Ex. 2003 – report K300
`describes analysis of krill
`meal made by a meal
`process where krill is
`brought on board ship (in
`this case the Atlantic
`Navigator F/N), cooked
`(i.e., heated), decanted,
`milled and dried; this
`process destroys the
`activity of lipases and
`
`Breivik II does not
`describe extraction from
`a krill meal produced by
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`phospholipases naturally
`present in krill and that
`has been stored from 1-
`36 months, where the
`
`treating Euphausia
`superba to destroy the
`activity of the lipases and
`phospholipases naturally
`present in Euphausia
`superba comprises
`grinding said Euphausia
`superba prior to
`destroying the activity of
`said lipases and
`phospholipases naturally
`present in Euphausia
`superba.
`17. The method of claim
`13, wherein said process
`comprising
`treating Euphausia
`superba to destroy the
`activity of the lipases and
`phospholipases naturally
`present in Euphausia
`superba comprises
`heating said Euphausia
`superba.
`
`22
`
`
`
`
`
`
`AKER EXHIBIT 2001 PAGE 0022
`
`
`
`
`
`
`
`
`18. The method of claim
`13, wherein said process
`comprising
`treating Euphausia
`superba to destroy the
`activity of the lipases and
`phospholipases naturally
`present in Euphausia
`superba comprises
`treating said Euphausia
`superba with chemicals.
`
`19. The method of claim
`13, wherein said process
`comprising
`treating Euphausia
`superba to destroy the
`activity of the lipases and
`phospholipases naturally
`present in Euphausia
`superba comprises a
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`krill is heated prior to
`storage.
`Breivik II does not
`describe extraction from
`a krill meal produced by
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`phospholipases naturally
`present in krill and that
`has been stored from 1-
`36 months, where the
`krill is treated with
`chemicals prior to
`storage.
`Breivik II does not
`describe extraction from
`a krill meal produced by
`a process comprising
`treating the krill to
`destroy the activity of
`lipases and
`phospholipases naturally
`present in krill and that
`
`phospholipases. See
`0022-24.
`Chemical treatment is a
`standard way to destroy
`the activity of enzymes.
`
`Heat and chemical
`treatment is a standard
`way to destroy the
`activity of enzymes.
`
`23
`
`AKER EXHIBIT 2001 PAGE 0023
`
`
`
`
`
`
`
`
`combination of heating
`said Euphausia
`superba and treating
`said Euphausia
`superba with chemicals.
`
`Inter Partes Review of US 9,816,046
`Ex. 2001, Tilseth Declaration
`
`has been stored from 1-
`36 months, where the
`krill is treating by a
`combination of chemicals
`and heat.
`
`18.
`
`I hereby declare that the conception and reduction to practice were
`
`performed in and around the countries of Norway and Sweden, both WTO member
`
`countries as of 1995. Therefore, I am informed that we are entitled to the same
`
`rights of priority in the United States with respect to the invention as if it had been
`
`made in the United States.
`
`19.
`
`I further declare that all statement made herein of my own knowledge
`
`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
`
`both, under section 1001 o
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
