Inter Partes Review of US 9,375,453
`Ex. 2001, 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
`
`Declaration of Dr. Nils Hoem in Support of Patent Owner’s Response
`and Motion to Amend
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`AKER EXHIBIT 2001 Page 1
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
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`
`
`I. 
`
`TABLE OF CONTENTS
`Introduction .................................................................................................... 4 
`A.  Qualifications ........................................................................................ 5 
`B. 
`Legal Standards ................................................................................... 15 
`II.  RESPONSE TO GROUNDS FOR INSTITUTION IN IPR .................... 21 
`A. 
`‘453 Patent Claims and Basis for IPR ................................................. 21 
`B. 
`Claim Construction ............................................................................. 26 
`C.  Analysis ............................................................................................... 30 
`1. 
`Introduction ............................................................................... 30 
`2. 
`Prior Art Cited in Institution Decision ...................................... 35 
`a. 
`Breivik II (Ex. 1037). ..................................................... 35 
`b. 
`Catchpole (Ex. 1009). ..................................................... 38 
`c. Bottino II (Ex. 1038). ..................................................... 47 
`d. 
`Sampalis I (Ex. 1012). .................................................... 49 
`e. Sampalis II (Ex. 1013) .................................................... 51 
`f.
`Fricke 1984 (Ex. 1010) ................................................... 51 
`g. Randolf (Ex. 1011) ......................................................... 53 
`Obviousness Analysis ............................................................... 55 
`Claims 1-61 are not obvious because there is no
`a. 
`reasonable expectation of success and motivation
`to combine the references to arrive at the claimed
`methods for production of a defined krill oil.................. 55 
`b. Claims 1-61 are not obvious because a POSITA
`would not formulate for oral consumption or
`encapsulate krill oil with the claimed levels of
`ether phospholipids ......................................................... 65 
`c. Claims 23 to 29 and claims 55 to 61 are not
`obvious because the combined references do not
`teach the claim element of at least about 5% ether
`phospholipids .................................................................. 69 
`III.  SUPPORT FOR MOTION TO AMEND .................................................. 72 
`
`3. 
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`2
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`AKER EXHIBIT 2001 Page 2
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
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`A. 
`
`SUPPORT IN THE ORIGINAL DISCLSOURE FOR THE
`CONDITIONAL PROPOSED AMENDED CLAIMS....................... 73 
`1. Substitute Independent Claims 62 and 75 ................................. 74 
`2. Dependent Claims 63-74 and 76-84 ......................................... 79 
`3. 
`Claim Construction ................................................................... 80 
`4. 
`Patentability of the proposed substitute claims over the
`prior art ...................................................................................... 81 
`a. 
`Art at Issue in This Proceeding ...................................... 81 
`b. The Material Prior Art at Issue During Prosecution ....... 92 
`IV.  Conclusion .................................................................................................... 93 
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`3
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`AKER EXHIBIT 2001 Page 3
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`I.
`
`Introduction
`I, Dr. Nils Hoem, state as follows:
`
`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
`
`1.
`
`I have been asked by counsel for Petitioner Aker BioMarine AS to
`
`provide an expert declaration in this action. I am currently employed by Aker
`
`BioMarine AS.
`
`2.
`
`I have reviewed U.S. Patent 9,375,453 (hereinafter ‘453 patent; Ex.
`
`1001) and the claims contained therein. It is my understanding that the ‘453 patent
`
`contains claims to methods of making krill oil by extraction of a denatured
`
`Euphausia superba krill material with a polar solvent and then formulating the
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`extracted krill oil for oral consumption, for example, by encapsulation. The
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`extracted krill oil that is formulated for oral consumption comprises greater than
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`about 3%, 4% or 5% ether phospholipids w/w of said krill oil; from about 27% to
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`50% non-ether phospholipids w/w of said krill oil so that the amount of total
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`phospholipids in the composition is from about 30% to 60% w/w of said krill oil;
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`from about 20% to 50% triglycerides w/w of said krill oil, and astaxanthin esters in
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`amount of greater than about 100 mg/kg of said krill oil. Additional claim
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`limitations are directed to other lipid components of the krill oil.
`
`3.
`
`I have been asked to provide analysis and expert opinions on the
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`following: whether the combination of references cited in this proceeding render
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`claims of the ‘453 patent obvious.
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`
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`4
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`AKER EXHIBIT 2001 Page 4
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
`
`4.
`
`In connection with providing my opinions, I have further been asked
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`to provide an overview of the technology of the ‘453 Patent and state of the art that
`
`existing before the ‘453 patent was filed.
`
`A. Qualifications
`5.
`I am a licensed pharmacist with master and doctorate degrees in
`
`pharmacology. I was Associate Professor at Oslo University from 1989-2002 and
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`European Director of Pharmacokinetics, Statistics and Data-Management at MDS
`
`Pharma Services, Hamburg Germany from 2004 to 2007. I am now Chief Scientist
`
`at Aker BioMarine. My educational background comprises skills in general,
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`organic, analytic and biological chemistry in combination with his work at Aker
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`BioMarine during the last 10 years have provided general and specialized insight
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`into the complex composition of krill oil as well as the raw materials from which it
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`has been extracted. In capacity of leading product development at Aker BioMarine,
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`I have substantial theoretical and practical insight into extraction, fractionation and
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`purification of krill oil and krill lipids. A more detailed account of my work
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`experience, publications, and other qualifications is listed in my Curriculum Vitae,
`
`attached as Exhibit 1.
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`6.
`
`I am being compensated by my normal salary for Aker BioMarine AS.
`
`My compensation is not contingent on the conclusions I reach in my expert report.
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`
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`5
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`AKER EXHIBIT 2001 Page 5
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
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`7.
`
`I have reviewed and considered, in the preparation of this report, the
`
`documents below.
`
`EXHIBI
`T NO.
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
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`1010
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`
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`EXHIBIT DESCRIPTION
`
`U.S. Patent No. 9,375,453, filed September 6, 2013 (‘453 Patent)
`
`U.S. Provisional Patent Application No. 61/024,072, filed January 28,
`2008 (‘072 Provisional)
`
`U.S. Provisional Patent Application No. 60/983,446, filed October
`29, 2007 (‘446 Provisional)
`
`U.S. Provisional Patent Application No. 60/975,058, filed September
`25, 2007 (‘058 Provisional)
`
`U.S. Provisional Patent Application No. 60/920,483, filed March 28,
`2007 (‘483 Provisional)
`
`Declaration of Stephen Tallon
`
`Bottino, N.R., “The Fatty Acids of Antarctic Phytoplankton and
`Euphausiids. Fatty Acid Exchange among Trophic Levels of the Ross
`Sea,” 1974, Marine Biology, 27, 197-204 (Bottino I)
`
`Budziński, E., P. Bykowski and D. Dutkiewicz, 1985, “Possibilities
`of processing and marketing of products made from Antarctic krill,”
`FAO Fish. Tech. Pap., (268):46, (Budzinski)
`
`Catchpole and Tallon, WO 2007/123424, published November 1,
`2007, “Process for Separating Lipid Materials,” (Catchpole)
`
`Fricke et al., “Lipid, Sterol and Fatty Acid Composition of Antarctic
`Krill (Euphausia superba Dana),” LIPIDS 19(11):821-827 (1984)
`(Fricke)
`
`6
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`AKER EXHIBIT 2001 Page 6
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
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`Randolph, et al., U.S. Patent Application Publication No.
`US/2005/0058728 A1, “Cytokine Modulators and Related Method of
`Use,”(Randolph)
`
`Sampalis [I] et al., “Evaluation of the Effects of Neptune Krill Oil™
`on the Management of Premenstrual Syndrome and Dysmenorrhea,”
`Altern. Med. Rev. 8(2):171-179 (2003) (Sampalis I)
`
`Sampalis [II] et al., WO 2003/011873, published February 13, 2003,
`“Natural Marine Source Phospholipids Comprising Flavonoids,
`Polyunsaturated Fatty Acids and Their Applications,” (Sampalis II)
`
`Tanaka [I] et al., “Platelet – Activating Factor (PAF) – Like
`Phospholipids Formed During Peroxidation of Phosphatidylcholines
`from Different Foodstuffs,” Biosci. Biotech. Biochem., 59(8) 1389-
`1393 (1995) (Tanaka I)
`
`Tanaka (II) et al., “Extraction of Phospholipids from Salmon Roe
`with Supercritical Carbon Dioxide and an Entrainer,” Journal of Oleo
`Science Vol. 53 (2004) No. 9, p. 17-424 (Tanaka II)
`
`Folch et al., “A simple method for the isolation and purification of
`total lipides from animal tissues,” J. Biol. Chem. (1957) 226: 497-509
`(Folch)
`
`Kochian et al., “Agricultural Approaches to Improving Phytonutrient
`Content in Plants: An Overview,” Nutrition Reviews, Vol. 57, No. 9,
`September 1999: S13-S18
`
`Bunea, et al., “Evaluation of The Effects of Neptune Krill Oil on the
`Clinical Course of Hyperlipidemia,” Altern Med Rev. 2004; 9:420–
`428 (Bunea)
`
`Complaint filed in Aker Biomarine Antarctic AS v. Olympic Holding
`AS, et al., Case No. 1:16-cv-00035
`
`7
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`
`
`1011
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`1012
`
`1013
`
`1014
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`1015
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`1017
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`1018
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`1020
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`1021
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`AKER EXHIBIT 2001 Page 7
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
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`Federal Register Notice of Institution of Investigation 337-TA-1019
`on September 16, 2016 by the ITC (81 Fed. Reg. pages 63805-63806)
`
`File History to U.S. Patent No. 9,034,388 B2, Serial No, 12/057,775
`(‘388 File History) 1024 Part 1 - Pages 1-450 1024 Part 2 - Pages
`451-900 1024 Part 3 - Pages 901-1350 1024 Part 4 - Pages 1351-1800
`1024 Part 5 - Pages 1801-2250 1024 Part 6 - Pages 2251-2700 1024
`Part 7 - Pages 2701-3083 1024 Part 8 - Pages 3084-3223
`
`Saether et al., “Lipolysis post mortem in North Atlantic krill,” Comp.
`Biochem. Physiol. Vol. 83B, No. 1, pp. 51-55, 1986 (Saether)
`
`Hawley’s Condensed Chemical Dictionary, p. 893, 13th ed., 1997
`(Hawley’s)
`
`Tehoharides, U.S. Patent Application Publication No.
`US/2006/0013905 A1, “Anti-Inflammatory Compositions for
`Treating Multiple Sclerosis,” (Tehoharides)
`
`Halliday, Jess, “Neptune-Degussa Deal to Develop Phospholipids,
`Adapt Krill Oil,” http://www.nutraingredients-
`usa.com/Suppliers2/Neptune-Degussa-deal-to-develop-
`phospholipids-adapt-krill-oil, December 12, 2005 (Neptune-
`DeGussa)
`
`Grantham, G.J., “The Utilization of Krill,” UNDP/FAO Southern
`Ocean Fisheries Survey Programme (1977) (Grantham)
`
`Yoshitomi, U.S. Patent Application Publication No.
`US/2003/0113432 A1, “Process for Making Dried Powdery and
`Granular Krill,” (Yoshitomi)
`
`Breivik, U.S. Patent Application Publication No. US 2010/0143571
`A1, “Process for Production of Omega-3 Rich Marine Phospholipids
`from Krill,” (Breivik)
`
`8
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`
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`1023
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`1024
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`1027
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`1028
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`1030
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`1031
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`1032
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`1033
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`1035
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`AKER EXHIBIT 2001 Page 8
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
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`Breivik, U.S. Provisional Patent Application No. 60/859,289,
`“Processes for production of omega-3 rich marine phospholipids from
`krill,” filed November 16, 2006 (Breivik ‘289 Provisional)
`
`Breivik, WO 2008/060163 A1, “Process for Production of Omega-3
`Rich Marine Phospholipids from Krill,” International filing date
`November 15, 2007 (Breivik II)
`
`Bottino, N.R., “Lipid Composition of Two Species of Antarctic Krill:
`Euphausia Superba and E. Crystallorophias,” Comp. Biochem.
`Physiol., 1975, Vol. 50B, pp. 479 to 484 (Bottino II)
`
`Grynbaum, M., et al. “Unambiguous detection of astaxanthin and
`astaxanthin fatty acid esters in krill (Euphausia superba Dana),” J.
`Sep. Sci., 28, 1685–1693 (2005)
`
`Bruheim, U.S. Patent Application Publication No. US2008/0274203
`A1, published November 6, 2008 (this is the publication of patent
`application serial no. 12/057,775 which issued as U.S. Patent No.
`9,034,388)
`
`U.S. Patent No. 9,034,388 B2, filed May 28, 2008 (‘388 Patent)
`
`Enzymotec, GRAS Notice No. GRN 000226 for “Krill-based
`Lecithin in Food,” and “Krill-derived lecithin,”
`https://www.fda.gov/downloads/Food/Ingredients Packaging
`Labeling/GRAS/Notice Inventory/ucm263930.pdf, dated May 26,
`2007 and filed by the FDA May 31, 2007, see Exhibit 1049
`(Enzymotec)
`
`FDA, Agency Response Letter GRAS Notice No. GRN 000226,
`https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/Noti
`ceInventory/ucm153881.htm, January 3, 2008
`
`Notice of Commission Determination ending Investigation 337-TA-
`1019, dated May 23, 2017
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`9
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`1036
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`1037
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`1038
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`1039
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`1043
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`1047
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`1048
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`1049
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`1054
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`1055
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`1059
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`1063
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`1069
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`1070
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`1071
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
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`File History to U.S. Patent No. 9,375,453 B2, Serial No, 14/020,162
`(‘453 File History) 1055 Part 1 - Pages 1-400 1055 Part 2 - Pages
`401-800 1055 Part 3 - Pages 801-1109
`
`Markman Order (Public Version), Order 13, U.S. International Trade
`Commission, In the Matter of Certain Krill Oil Products and Krill
`Meal for Production of Krill Oil Products, Inv. No. 337-TA-1019,
`dated April 13, 2017
`
`File History to U.S. Patent No. 9,644,170 B2, Serial No, 15/180,439
`(‘170 File History) Part 1 - Pages 1-400 1063 Part 2 - Pages 401-800
`1063 Part 3 – Pages 801-1107
`
`Krill Bill Bottle and Capsules from IRL
`
`Krill Bill Online Purchase Order and Specification Pages from 2006
`(https://web.archive.org/web/20060715103715/http://www.krillbill.co
`m:80/purchase.htm;
`https://web.archive.org/web/20060715103809/http://www.krill
`bill.com/profile.htm)
`
`Antarctica Select Krill Oil Online Literature and Purchase Order
`Form and linked FDA webpage from 2006
`(https://web.archive.org/web/20060816050841/http://www.aquasourc
`eproducts.com:80/store/;
`https://web.archive.org/web/20060816051010/http://www.aquasource
`products.com:80/krill_oil.html;
`https://web.archive.org/web/20060506115548/
`http://www.aquasourceproducts.com:80/resources.html?osCsid=aee4
`bb3df08470be3a75bc598448dabc;
`https://web.archive.org/web/20060513152744/http://vm.cfsan.fda.gov
`/~dms/ds-oview.html)
`
`1072
`
`Chen, U.S. Patent Application Publication No. US 2008/0021000 A1,
`for “Mixtures of and Methods of Use for Polyunsaturated Fatty Acid-
`
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
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`Containing Phospholipids and Alkyl Ether Phospholipids Species”,
`filing date July 19, 2006, publication date January 24, 2008
`
`Neptune, GRAS Notice [No. GRN 000242] for “High Phospholipid
`Krill Oil”
`https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/
`GRAS/NoticeInventory/ucm269133.pdf, dated January 18, 2008 and
`filed by the FDA February 4, 2008 (Neptune GRAS)
`
`Affidavit of Christopher Butler, Office Manager of Internet Archive,
`dated November 8, 2017, for Rimfrost Exhibits 1070 and 1071,
`regarding Krill Bill, Aquasource and FDA related webpages from
`2006
`
`Del. District Court Stay of 16-cv-00035, pending resolution of IPRs,
`Order dated September 6, 2017
`
`Mayzaud et al, “Changes in lipid composition of the Antarctic krill
`Euphausia superba in the Indian sector of the Antarctic Ocean:
`influence of geographical location, sexual maturity stage and
`distribution among organs” Marine Ecology Progress Series, Vol.
`173: 149-162 (1998) (Mayzaud)
`
`Aker GRAS [No. GRN 000371], “Notification of GRAS
`Determination of Krill Oil”, December 14, 2010.
`https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GRASNo
`tices&id=371
`
`U.S. Patent No. 9,644,170 B2, filed June 13, 2016 (‘170)
`
`Marathe, et al., Inflammatory Platelet-activating Factor-like
`Phospholipids in Oxidized Low-Density Lipoproteins Are
`Fragmented Alkyl Phosphatidylcholines, J Biol Chem. 1999 Oct
`1;274(40):28395-28404
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`11
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`1075
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`1076
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`1078
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`1084
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`1089
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`1093
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`1094
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`AKER EXHIBIT 2001 Page 11
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
`
`Stremler, et al., Human Plasma Platelet-activating Factor
`Acetylhydrolase - Oxidatively Fragmented Phospholipids as
`Substrates, (1991) J. Biol. Chem. 266, 11095–11103
`
`Britton, G., Structure and properties of carotenoids in relation to
`function, FASEB J, 9, 1551-1558, 1995
`
`Yuan, “Characteristics and chromatographic separation of astaxanthin
`and its esters from the microalga Haematococcus pluvialos,” Doctoral
`Thesis, The University of Hong Kong, 1999
`(http://dx.doi.org/10.5353/th_b3123971)
`
`Mimoun-Benarroch, et al., The Bioavailability of Astaxanthin is
`Dependent on both the Source and the Isomeric Variants of the
`molecule, Bulletin of University of Agricultural Sciences and
`Veterinary Medicine Cluj-Napoca: Food Science and Technology,
`Volume 73, Number 2, 2016, pp. 61-69(9)
`
`Higuera-Ciapara, et al., Astaxanthin: A Review of its Chemistry and
`Applications, Crit Rev Food Sci Nutr. 2006;46(2):185-96
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`
`
`
`1095
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`1098
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`1100
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`1101
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`1102
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`Lambertsen, et al., Method of Analysis of Astaxanthin and its
`Occurrence in some Marine Products, J. Sci. of Food and Agriculture,
`1971, Vol. 22, February
`
`Foss, et al., Natural occurrence of enantiomeric and Meso astaxanthin
`
`7∗-crustaceans including zooplankton, Comparative Biochemistry
`
`and Physiology Part B: Comparative Biochemistry, Volume 86, Issue
`2, 1987, Pages 313-314
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`EXHIBIT DESCRIPTION
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`EXHIBIT
`NO.
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
`
`Declaration of Dr. Nils Hoem in Support of Patent Owner’s
`Response
`Yamaguchi, K. et al. “Supercritical Carbon Dioxide Extraction of
`Oils from Antarctic Krill”, J. Agric. Food Chem. 1986, 34, 904-907
`Prescott, S. et al. “Platelet-Activating Factor and Related Lipid
`Mediators”, Annu. Rev. Biochem. 2000. 69:419-45
`Zimmerman, G. et al. “The platelet-activating factor signaling
`system and its regulators in syndromes of inflammation and
`thrombosis”, Crit. Care Med 2002, Vol. 30, No. 5 (Suppl): S294-
`S301
`Calder, P. “n-3 Polyunsaturated fatty acids, inflammation, and
`inflammatory diseases1-3”, Am. J. Clin. Nutr. 2006; 83(suppl):
`1505S-19S
`Fricke, H. et al. “1-O-Alkylglycerolipids in Antarctic Krill
`(Euphausia Superba DANA)”, Comp. Biochem. Physiol. Vol. 85B,
`No. 1, pp. 131-134, 1986
`Reply Declaration of Dr. Stephen J. Tallon, IPR2017-00745, U.S.
`Patent No. 9,078,905, dated January 24, 2018
`
`Zierenberg et al., Intestinal absorption of
`polyenephosphatidylcholine in man, J. Lipid. Res. (1982) 23:1136-
`1142
`Blank et al., Meats and fish consumed in the American diet contain
`substantial amounts of ether-linked phospholipids. J Nutr. (1992)
`122(8):1656-61
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`2001
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`2002
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`2003
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`2004
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`2005
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`2006
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`2009
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
`
`Hartvigsen et al., 1-O-Alkyl-2-(w-oxo)acyl-sn-glycerols from Shark
`Oil and Human Milk Fat Are Potential Precursors of PAF Mimics
`and GHB. Lipids (2006) 41, 679–693
`Marathe et al., Inflammatory Platelet-activating Factor-like
`Phospholipids in Oxidized Low-Density Lipoproteins Are
`Fragmented Alkyl Phosphatidylcholines. J. Biol. Chem. (1999)
`274(40):28395-28404
`U.S. Appl. 14/020,162 as filed
`Petition for Post Grant Review, U.S. Patent No. 9,644,170, Case No.
`PGR2018-00033
`Patent Abstract JP 04-057853 published February 25, 1992
`JP4057853 (Tisueno et al.)
`US Patent No. 4814111 (Kearns et al.)
`US Publication No. 20060078625 (Rockway)
`US Patent No. 8057825 (Sampalis III)
`WO 2007/136281
`Transcript of Deposition of Dr. Stephen Tallon, April 2, 2019
`Reserved
`Transcript of Deposition of Dr. Stephen Tallon, December 12, 2018
`Petitioner’s Demonstrative Exhibit from IPR2018-00295
`Transcript of Deposition of Dr. Stephen Tallon, August 29, 2018
`
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`2010
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`2011
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`2012
`2013
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`2014
`2015
`2016
`2017
`2018
`2019
`2020
`2021
`2022
`2023
`2024
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`
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`B.
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`Inter Partes Review of US 9,375,453
`Ex. 2001, Hoem Declaration
`
`Legal Standards
`8.
`In this section I describe my understanding of certain legal standards.
`
`I have been informed of these legal standards by Patent Owners’ attorneys. I am
`
`not an attorney, and I am relying only on instructions from Patent Owners’
`
`attorneys for these legal standards. I have applied these understandings in my
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`analysis as detailed below.
`
`9.
`
`I have been informed that under 35 U.S.C. § 112(a) the “specification
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`shall contain a written description of the invention, and of the manner and process
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`of making and using it, in such full, clear, concise, and exact terms as to enable any
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`person skilled in the art to which it pertains, or with which it is most nearly
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`connected, to make and use the same.” I also understand that the written
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`description must include every feature or limitation of the claimed invention.
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`10.
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`I have been informed that the written description must convey clearly
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`to those skilled in the art, that, as of the filing date sought, the applicant was in
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`possession of the invention claimed.
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`11.
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`I have been informed that, in conducting a written description
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`analysis:
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`(1) The written description analysis is based on an objective inquiry
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`into the four corners of the specification.
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`(1) This inquiry into the specification is done from the perspective
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`of one of ordinary skill in the art.
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`(2) The written description requirement does not require any
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`particular form of disclosure, and support may be based on a
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`combination of
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`figures and disclosures
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`throughout
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`the
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`specification.
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`(3) The specification need not recite the claimed invention in haec
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`verba, i.e., it need not use the same words, phrasings or
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`presentation style as the claims.
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`(4) A description that merely renders the invention obvious does not
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`satisfy the written description requirement.
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`(5) The level of detail required to satisfy the written description
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`requirement depends on (i) the nature and scope of the claims
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`and (ii) the complexity and predictability of the relevant
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`technology.
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`(6)
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`Factors to be taken under consideration include the existing
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`knowledge in the particular field, the extent and content of the
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`prior art, the maturity of the science or technology, and the
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`predictability of the aspect at issue.
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`12.
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`I have been informed that the written description question is not
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`
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`whether a POSITA presented with the ‘170 would have been enabled to make the
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`Claimed Invention, but whether the ‘170 patent discloses the invention to the
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`POSITA as something that was within the inventor’s possession.
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`13.
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`I have been informed that a claimed invention is not enabled under 35
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`U.S.C. § 112(a) if the specification does not teach those of ordinary skill in the art
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`how to make and use the invention as broadly as it is claimed, without undue
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`experimentation.
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`14.
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`I have been informed that the assessment of undue experimentation is
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`based on the level of skill in the art as of the effective filing date of the applications
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`on which the ‘170 Patent claims priority. Thus, a specification enables a claimed
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`invention when it does in fact teach those of ordinary skill in the art how to make
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`and use the invention as broadly as it is claimed, without undue experimentation.
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`15. Additionally, I have been informed that the full scope of the claimed
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`invention must be enabled.
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`16.
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`I have been informed that a finding of undue experimentation must
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`consider multiple factors to determine if there is sufficient evidence to support such
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`a determination. I understand that these factors, which are referred to as the Wands
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`factors, include:
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`(1)
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`the breadth of the claims;
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`(2)
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`(3)
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`(4)
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`(5)
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`(6)
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`(7)
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`(8)
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`the nature of the invention;
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`the state of the prior art;
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`the level of one of ordinary skill;
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`the level of predictability in the art;
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`the amount of direction provided by the inventor;
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`the existence of working examples; and
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`the quantity of experimentation needed to make or use the
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`invention based on the content of the disclosure.
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`17.
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`I have been informed that the determination of non-enablement must
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`be based on the evidence as a whole.
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`18.
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`I have been instructed by counsel on the law regarding obviousness,
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`and understand that even if a patent is not anticipated, it will be unpatentable if the
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`differences between the claimed subject matter and the prior art are such that the
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`subject matter as a whole would have been obvious at the time the invention was
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`made to a person of ordinary skill in the art (“POSITA”).
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`19.
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`I understand that a POSITA provides a reference point from which the
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`prior art and claimed invention should be viewed. This reference point prevents
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`one from using his or her own insight or hindsight in deciding whether a claim is
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`obvious. Thus, “hindsight reconstruction” cannot be used to combine references
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`together to reach a conclusion of obviousness.
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`20.
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`I also understand that an obviousness determination includes the
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`consideration of various factors such as (1) the scope and content of the prior art,
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`(2) the differences between the prior art and the Claims, (3) the level of ordinary
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`skill in the pertinent art, and (4) the existence of secondary considerations of non-
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`obviousness.
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`21. Secondary considerations must be examined to determine whether a
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`certain invention would have been obvious to one of ordinary skill in the art. I
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`understand that secondary considerations of non-obviousness are part of the
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`obviousness inquiry under § 103, and that some examples of secondary
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`considerations that tend to show non-obviousness include:
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`(9)
`any long-felt and unmet need in the art that was satisfied by the
`invention of the patent;
`(10) any failure of others to achieve the results of the invention;
`(11) any commercial success or lack thereof of the products and processes
`covered by the invention;
`(12) any deliberate copying of the invention by others in the field;
`(13) any taking of licenses under the patent by others;
`(14) any expression of disbelief or skepticism by those skilled in the art
`upon learning of the invention;
`(15) any unexpected results achieved by the invention;
`(16) any praise of the invention by others skilled in the art; and
`(17) any lack of contemporaneous and independent invention by others.
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`22.
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`I understand that the factfinder(s) must determine whether potential
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`evidence of secondary considerations is relevant. In particular, the factfinder(s)
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`must ascertain whether a nexus connects the secondary consideration, e.g.,
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`commercial success, to a claimed invention and determine the probative value of
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`secondary-considerations evidence for rebutting a prima facie case of obviousness.
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`23. With respect to the level of ordinary skill in the art at the relevant
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`times applicable to the ‘453 patent, I understand that factors such as the education
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`level of those working in the field, the sophistication of the technology, the types
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`of problems encountered in the art, the prior art solutions to those problems, and
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`the speed at which innovations are made may help establish the level of skill in the
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`art.
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`24.
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`I understand that Petitioners’ have proposed the following definition
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`of a person of ordinary skill in the art (POSITA) at the time of the alleged
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`invention: a POSITA “would have held an advanced degree in marine sciences,
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`biochemistry, organic (especially lipid) chemistry, chemical or process
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`engineering, or associated sciences with complementary understanding, either
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`through education or experience, of organic chemistry and in particular lipid
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`chemistry, chemical or process engineering, marine biology, nutrition, or
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`associated sciences; and knowledge of or experience in the field of extraction. In
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`addition, a POSITA would have had at least five years’ applied experience.”
`20
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`Declaration of Dr. Stephen Tallon, Exhibit 1006, hereinafter "Tallon Decl." ¶ 31).
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`For the purposes of this Report, I will adopt Petitioners’ proposed definition
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`because it is consistent with the literature, credentials of individuals working on
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`lipid extractions, and the skill necessary to perform these extractions and interpret
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`their results.
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`25.
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`I consider myself to be a POSITA in the art of the ‘453 Patent at the
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`time of the alleged inventions claimed therein under Petitioners’ definition of the
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`term.
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`II. RESPONSE TO GROUNDS FOR INSTITUTION IN IPR
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`A.
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`‘453 Patent Claims and Basis for IPR
`26. The ‘453 Patent is titled “Methods for Producing Bioeffective Krill
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`Oil Compositions.” I understand that the ‘453 patent is assigned to Aker
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`Biomarine Antarctic AS.
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`27. The application for the ’453 Patent was filed as a continuation of U.S.
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`patent application Ser. No. 12/057,775, filed Mar. 28, 2008, which claims the
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`benefit of U.S. Provisional Patent Application No. 60/920,483, filed Mar. 28, 2007,
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`U.S. Provisional Patent Application No. 60/975,058, filed Sep. 25, 2007, U.S.
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`Provisional Patent Application No. 60/983,446, filed Oct. 29, 2007, and U.S.
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`Provisional Patent Application No. 61/024,072, filed Jan. 28, 2008.
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`
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`28. The ‘453 patent has two independent claims, claims 1 and 33, and 61
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`total claims. Claim 1 specifies:
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`
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`1. A method of production of polar krill oil from Euphausia superba
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`comprising:
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`a) treating the Euphausia superba to denature lipases and
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`phospholipases to provide a denatured krill product;
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`b) contacting the denatured krill product with a polar solvent to
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`extract a polar krill oil comprising phospholipids, said polar krill oil
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`comprises greater than about 3% ether phospholipids w/w of said polar krill
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`oil; from about 27% to 50% non-ether phospholipids w/w of said polar krill
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`oil so that the amount of total phospholipids is from about 30% to 60% w/w
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`of said polar krill oil; from about 20% to 50% triglycerides w/w of said polar
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`krill oil, and astaxanthin esters in amount of greater than about 100 mg/kg of
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`said polar krill oil; and
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`c) formulating said polar krill oil with a carrier for oral consumption.
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`
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`Claim 33 specifies:
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`33. A method of production of polar krill oil from Euphausia
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`superba comprising:
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`a) treating the Euphausia superba to denature lipases and
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`phospholipases to provide a denatured krill product;
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`b) contacting the denatured krill product with a polar solvent to
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`extract a polar krill oil comprising phospholipids, and said polar krill oil
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`comprises greater than about 3% ether phospholipids w/w of said polar krill
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`oil; from about 27% to 50% non-ether phospholipids w/w of said polar krill
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`oil so that the amount of total phospholipids is from about 30% to 60% w/w
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`of said polar krill oil, from about 20% to 50% triglycerides w/w of said polar
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`krill oil, and astaxanthin esters in amount of greater than about 100 mg/kg of
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`said polar krill oil; and
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`c) encapsulating said polar krill oil in a soft gel capsule.
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`
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`The claims dependent on claims 1 and 33 add