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`Inter Partes Review of US 9,320,765
`Ex. 2013, 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: IPR2018-00295
`
`U.S. Patent No. 9,320,765 B2
`
`Declaration of Dr. Nils Hoem in Support of Patent Owner’s Motion to
`Amend
`
`1
`
`RIMFROST EXHIBIT 1106 Page 0001
`
`AKER EXHIBIT 2013 Page 1
`
`
`
`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
`
`
`
`
`
`
`
`
`I.
`
`Introduction
`
`I, Dr. Nils Hoem, state as follows:
`
`1.
`
`I have been asked by counsel for Petitioner Aker BioMarine AS to
`
`provide an expert declaration concerning certain proposed conditional amendments
`
`to the claims of U.S Patent No. 9,320,765 (hereinafter ‘765 patent; Ex. 1001). I am
`
`currently employed by Aker BioMarine AS.
`
`2.
`
`Specifically, I have been asked to analyze arguments made by
`
`Rimfrost AS and its expert, Dr. Stephen J. Tallon, in the petition for inter partes
`
`review (“IPR”) proceeding of the ’765 patent, Case No. IPR2018-00295, as well as
`
`the material prior art references discussed in the prosecution of the ’765 patent, and
`
`the support and disclosures provided by the patent’s original non-provisional
`
`application. I have additionally been asked to review the Motion to Amend
`
`submitted concurrently with this declaration, including the Claims Appendix
`
`therein, which sets forth the proposed substituted claims and the amendments to
`
`the original claims reflected therein.
`
`3.
`
`In forming my opinions, I have reviewed the materials identified in
`
`the paragraph above and in the following table.
`
`
`
`
`
`2
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`RIMFROST EXHIBIT 1106 Page 0002
`
`AKER EXHIBIT 2013 Page 2
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`
`
`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
`
`
`
`
`5.
`
`
`
`Exhibit
`
`Exhibit Description
`
`Number
`
`1001
`
`1002
`
`U.S. Patent No. 9,320,765 B2, filed September 6, 2013 (the ‘765 Patent)
`
`U.S. Provisional patent Application No. 61/024,072, filed January 28,
`
`2008 (‘072 Provisional)
`
`1003
`
`U.S. Provisional patent Application No. 60/983,446, filed October 29,
`
`2007 (‘446 Provisional)
`
`1004
`
`U.S. Provisional patent Application No. 60/975,058, filed September
`
`25, 2007 (‘058 Provisional)
`
`1005
`
`U.S. Provisional patent Application No. 60/920,483, filed March 28,
`
`1006
`
`1007
`
`2007 (‘483 Provisional)
`
`Declaration of Stephen Tallon (Tallon Decl.)
`
`Bottino, N.R., “The Fatty Acids of Antarctic Phytoplankton and
`
`Euphausiids. Fatty Acid Exchange among Trophic Levels of the Ross
`
`Sea”, Marine Biology, 27, 197-204 (1974) (Bottino)
`
`1008
`
`Budzińksi, E., P. Bykowiski and D. Dutkiewicz, 1985, “Possibilities of
`
`processing and marketing of products made from Antarctic krill”. FAO
`
`Fish. Tech. Pap., (268): 46. (Budzinski)
`
`
`
`3
`
`RIMFROST EXHIBIT 1106 Page 0003
`
`AKER EXHIBIT 2013 Page 3
`
`
`
`
`
`1009
`
`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
`
`Catchpole and Tallon, WO 2007/123424, published November 1, 2007,
`
`“Process for Separating Lipid Materials,” (Catchpole)
`
`1010
`
`Fricke et al., “Lipid, Sterol and Fatty Acid Composition of Antarctic
`
`Krill (Euphausia superba Dana),” LIPIDS 19(11): 821-827 (1984)
`
`(Fricke)
`
`1011
`
`Randolph, et al., U.S. Patent Application Publication No.
`
`US/2005/0058728 A1, “Cytokine Modulators and Related Method of
`
`Use” (Randolph)
`
`1012
`
`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)
`
`1013
`
`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)
`
`1014
`
`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).
`
`1015
`
`Tanaka [II] et al., “Extraction of Phospholipids from Salmon Roe with
`
`
`
`4
`
`RIMFROST EXHIBIT 1106 Page 0004
`
`AKER EXHIBIT 2013 Page 4
`
`
`
`
`
`
`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
`
`Supercritical Carbon Dioxide and an Entrainer”, Journal of Oleo
`
`Science Vol. 53 (2004) No. 9, p. 17-424 (Tanaka II)
`
`1016
`
`Beaudoin et al., “Method of Extracting Lipids From Marine and Aquatic
`
`Animal Tissues,” U.S. Patent No. 6,800,299 B1 filed July 25, 2001
`
`(Beaudoin).
`
`1017
`
`Folch et al., “A simple method for the isolation and purification of total
`
`lipids from animal tissues,” J. Biol. Chem. (1957) 226:497-509 (Folch).
`
`1018
`
`Kochian et al., “Agricultural Approaches to Improving Phytonutrient
`
`Content in Plants: An Overview,” Nutrition Reviews”, Vol. 57, No. 9,
`
`September 1999: S13-S18.
`
`1019
`
`Porzio et al., “Encapsulation Compositions and Processes for Preparing
`
`the Same,” U.S. Patent No. 7,488,503 B1 filed March 31, 2004 (Porzio).
`
`1020
`
`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).
`
`1027
`
`Saether et al., “Lipolysis post mortem in North Atlantic krill”, Comp.
`
`Biochem. Physiol. Vol. 83B, No. 1, pp. 51-55, 1986 (Saether).
`
`1028
`
`Hawley’s Condensed Chemical Dictionary, p. 893, 13th ed., 1997
`
`(Hawley’s)
`
`
`
`5
`
`RIMFROST EXHIBIT 1106 Page 0005
`
`AKER EXHIBIT 2013 Page 5
`
`
`
`
`
`1029
`
`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
`
`Webster’s New Universal Unabridged Dictionary, 2nd ed., p. 732, 1983
`
`(Webster’s)
`
`1030
`
`Tehoharides, U.S. Patent Application Publication No. US/2006/0013765
`
`A1, “Anti-Inflammatory Compositions For Treating Multiple Sclerosis”
`
`(Tehoharides)
`
`1032
`
`Grantham, G.J., “The Utilization Of Krill”, UNDP/FAO Southern
`
`Ocean Fisheries Survey Programme (1977) (Grantham).
`
`1033
`
`Yoshitomi, U.S. Patent Application Publication No. US/2003/0113432
`
`A1, “Process for Making Dried Powdery and Granular Krill”
`
`(Yoshitomi).
`
`1035
`
`Breivik, U.S. Patent Application Publication No. US 2010/0143571 A1,
`
`“Process for Production of Omega-3 Rich Marine Phospholipids from
`
`Krill” (Exhibit 1035) (Breivik I)
`
`1036
`
`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 III) (Exhibit 1036)
`
`1037
`
`Breivik, WO 2008/060163 A1, “Process for Production of Omega-3
`
`Rich Marine Phospholipids from Krill,” International filing date
`
`November 15, 2007 (Breivik II) (Exhibit 1037)
`
`
`
`6
`
`RIMFROST EXHIBIT 1106 Page 0006
`
`AKER EXHIBIT 2013 Page 6
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`
`
`
`
`1038
`
`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
`
`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)
`
`1039
`
`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) (Grynbaum)
`
`1042
`
`Clarke, A., “The biochemical composition of krill, Euphausia superba
`
`Dana, from South Georgia”, Journal of Experimental Marine Biology
`
`and Ecology, Vol. 43, pp. 221-236 (1980) (Clarke)
`
`1046
`
`Watanabe, K., et al., “Studies on the utilization of Antarctic krill,
`
`Euphausia superba Dana - II. Analyses of nutritive components,” Bull.
`
`Tokai Reg. Fish. Res. Lab., 85, 13-30 (Watanabe)
`
`1048
`
`Enzymotec, GRAS Notification for Krill-based Lecithin in Food,
`
`1049
`
`1053
`
`1069
`
`1070
`
`
`
`(Enzymotec)
`
`FDA, Agency Response Letter GRAS Notice No. GRN 000226
`
`File History to U.S. Patent No. 9,320,765 B2, Serial No, 14/020,155
`
`(‘765 File History)
`
`Krill Bill Bottle and Capsules from IRL (Exhibit 1069).
`
`Krill Bill Online Purchase Order and Specification Pages from 2006
`
`7
`
`RIMFROST EXHIBIT 1106 Page 0007
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`AKER EXHIBIT 2013 Page 7
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`
`
`
`
`1071
`
`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
`
`Antarctica Select Krill Oil Online Literature and Purchase Order Form
`
`and linked FDA webpage from 2006
`
`1072
`
`Chen, U.S. Patent Application Publication No. US 2008/0021000 A1,
`
`for
`
`“Mixtures of and Methods of Use for Polyunsaturated Fatty Acid
`
`Containing Phospholipids and Alkyl Ether Phospholipids Species”,
`
`filing date July 19, 2006, publication date January 24, 2008
`
`1077
`
`Pure Encapsulations online literature for its Krill-plex NKO™ product,
`
`webpage from August 19, 2004.
`
`2002
`
`Yamaguchi et al., “Supercritical Carbon Dioxide Extraction of Oils
`from Antarctic Krill”, J. Agric. Food Chem. 1986, 34, 904-907
`
`
`2003
`
`Prescott et al., Platelet-Activating Factor and Related Lipid Mediators
`
`(2000) Annu. Rev. Biochem. 69:419-45
`
`2004
`
`Zimmerman et al., The platelet-activating factor signaling system and its
`
`regulators in syndromes of inflammation and thrombosis (2002) Crit.
`
`Care Med. 30(5):S294-S301
`
`2005
`
`Calder, n-3 Polyunsaturated fatty acids, inflammation, and
`
`inflammatory Diseases (2006) Am. J. Clin. Nutr. 83(suppl.):1505S-19S
`
`
`
`8
`
`RIMFROST EXHIBIT 1106 Page 0008
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`AKER EXHIBIT 2013 Page 8
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`
`
`
`
`2006
`
`2007
`
`2008
`
`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
`
`Fricke and Gercken, 1-O-Alkylglycerolipids in Antarctic Krill
`
`(Euphausia superba)(1986), Comp. Biochem. Physiol. 85B(1):131-134
`
`Reply Declaration of Dr. Stephen J. Tallon in IPR2017-00745
`
`Zierenberg et al., Intestinal absorption of polyenephosphatidylcholine in
`
`man, J. Lipid. Res. (1982) 23:1136-1142.
`
`2009
`
`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.
`
`2010
`
`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.
`
`2011
`
`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-
`
`2012
`
`2014
`
`2016
`
`2017
`
`
`
`28404.
`
`U.S. Appl. 14/020,155 as filed
`
`Petition filed by Rimfrost in related PGR2018-00033
`
`Japanese Abstract 04-057853 (Tokumori; Ex. 2016)
`
`US Pat. Publ. 2004/0241249 (Sampalis III)
`
`9
`
`RIMFROST EXHIBIT 1106 Page 0009
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`AKER EXHIBIT 2013 Page 9
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`
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`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
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`
`
`2018
`
`
`
`US Pat. Publ. 2006/0193962 (Kamiya).
`
`4. My opinions are based on my experience and knowledge of the
`
`relevant art, the documents identified above, as well as the documents discussed in
`
`this declaration.
`
`5.
`
`I have reviewed the conditional substitute claims. It is my
`
`understanding that these claims are based on original independent claim 25 and
`
`further limit original independent claim 25 by specifying the range of ether
`
`phospholipids in the encapsulated krill oil is from 5% to 8% and that the range of
`
`astaxanthin esters in the encapsulated krill oil is from 100 to 700 mg/kg of the krill
`
`oil. As explained in detail below, it is my opinion that the conditional substitute
`
`claims proposed in the Motion to Amend are supported by the original non-
`
`provisional application (Ex. 2012) and are patentable over the prior art at issue in
`
`this IPR Proceeding and the material art discussed during prosecution
`
`II. Qualifications
`
`6.
`
`I am a licensed pharmacist with master and doctorate degrees in
`
`pharmacology. I was Associate Professor at Oslo University from 1989-2002 and
`
`European Director of Pharmacokinetics, Statistics and Data-Management at MDS
`
`Pharma Services, Hamburg Germany from 2004 to 2007. I am now Chief Scientist
`
`
`
`10
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`RIMFROST EXHIBIT 1106 Page 0010
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`
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`
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`at Aker BioMarine. My educational background comprises skills in general,
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`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
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`organic, analytic and biological chemistry in combination with his work at Aker
`
`BioMarine during the last 10 years have provided general and specialized insight
`
`into the complex composition of krill oil as well as the raw materials from which it
`
`has been extracted. In capacity of leading product development at Aker BioMarine,
`
`I have substantial theoretical and practical insight into extraction, fractionation and
`
`purification of krill oil and krill lipids. A more detailed account of my work
`
`experience, publications, and other qualifications is listed in my Curriculum Vitae,
`
`attached as Exhibit 1.
`
`7.
`
`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.
`
`8.
`
`I have reviewed and considered, in the preparation of this report, the
`
`documents in the below table.
`
` III. Legal Standards
`
`9.
`
`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
`
`analysis as detailed below.
`
`
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`11
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`5.
`
`I have been informed that under 35 U.S.C. § 112(a) the “specification
`
`shall contain a written description of the invention, and of the manner and process
`
`of making and using it, in such full, clear, concise, and exact terms as to enable any
`
`person skilled in the art to which it pertains, or with which it is most nearly
`
`connected, to make and use the same.” I also understand that the written
`
`description must include every feature or limitation of the claimed invention.
`
`6.
`
`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.
`
`7.
`
`I have been informed that, in conducting a written description
`
`analysis:
`
`(1) The written description analysis is based on an objective
`
`inquiry into the four corners of the specification.
`
`(1) This inquiry into the specification is done from the perspective
`
`of one of ordinary skill in the art.
`
`(2) The written description requirement does not require any
`
`particular form of disclosure, and support may be based on a
`
`combination of
`
`figures and disclosures
`
`throughout
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`the
`
`specification.
`
`
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`(3) The specification need not recite the claimed invention in haec
`
`verba, i.e., it need not use the same words, phrasings or
`
`presentation style as the claims.
`
`(4) A description that merely renders the invention obvious does
`
`not satisfy the written description requirement.
`
`(5) 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.
`
`(6)
`
`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.
`
`8.
`
`I have been informed that the written description question is not
`
`whether a POSITA presented with the ‘170 would have been enabled to make the
`
`Claimed Invention, but whether the ‘170 patent discloses the invention to the
`
`POSITA as something that was within the inventor’s possession.
`
`9.
`
`I have been informed that a claimed invention is not enabled under 35
`
`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.
`
`10.
`
`I have been informed that the assessment of undue experimentation is
`
`based on the level of skill in the art as of the effective filing date of the applications
`
`on which the ‘170 Patent claims priority. Thus, a specification enables a claimed
`
`invention when it does in fact teach those of ordinary skill in the art how to make
`
`and use the invention as broadly as it is claimed, without undue experimentation.
`
`11. Additionally, I have been informed that the full scope of the claimed
`
`invention must be enabled.
`
`12.
`
`I have been informed that a finding of undue experimentation must
`
`consider multiple factors to determine if there is sufficient evidence to support
`
`such a determination. I understand that these factors, which are referred to as the
`
`Wands factors, include:
`
`(1)
`
`(2)
`
`(3)
`
`(4)
`
`(5)
`
`(6)
`
`(7)
`
`the breadth of the claims;
`
`the nature of the invention;
`
`the state of the prior art;
`
`the level of one of ordinary skill;
`
`the level of predictability in the art;
`
`the amount of direction provided by the inventor;
`
`the existence of working examples; and
`14
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`(8)
`
`the quantity of experimentation needed to make or use the
`
`invention based on the content of the disclosure.
`
`13.
`
`I have been informed that the determination of non-enablement must
`
`be based on the evidence as a whole.
`
`14.
`
`I have been instructed by counsel on the law regarding obviousness,
`
`and understand that even if a patent is not anticipated, it will be unpatentable if the
`
`differences between the claimed subject matter and the prior art are such that the
`
`subject matter as a whole would have been obvious at the time the invention was
`
`made to a person of ordinary skill in the art (“POSITA”).
`
`15.
`
`I understand that a POSITA provides a reference point from which the
`
`prior art and claimed invention should be viewed. This reference point prevents
`
`one from using his or her own insight or hindsight in deciding whether a claim is
`
`obvious. Thus, “hindsight reconstruction” cannot be used to combine references
`
`together to reach a conclusion of obviousness.
`
`16.
`
`I also understand that an obviousness determination includes the
`
`consideration of various factors such as (1) the scope and content of the prior art,
`
`(2) the differences between the prior art and the Claims, (3) the level of ordinary
`
`skill in the pertinent art, and (4) the existence of secondary considerations of non-
`
`obviousness.
`
`
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`17. Secondary considerations must be examined to determine whether a
`
`certain invention would have been obvious to one of ordinary skill in the art. I
`
`understand that secondary considerations of non-obviousness are part of the
`
`obviousness inquiry under § 103, and that some examples of secondary
`
`considerations that tend to show non-obviousness include:
`
`(1)
`
`any long-felt and unmet need in the art that was satisfied by the
`
`invention of the patent;
`
`(2)
`
`(3)
`
`any failure of others to achieve the results of the invention;
`
`any commercial success or lack thereof of the products and processes
`
`covered by the invention;
`
`(4)
`
`(5)
`
`(6)
`
`any deliberate copying of the invention by others in the field;
`
`any taking of licenses under the patent by others;
`
`any expression of disbelief or skepticism by those skilled in the art
`
`upon learning of the invention;
`
`any unexpected results achieved by the invention;
`
`any praise of the invention by others skilled in the art; and
`
`any lack of contemporaneous and independent invention by others.
`
`(7)
`
`(8)
`
`(9)
`
`
`
`18.
`
`I understand that the factfinder(s) must determine whether potential
`
`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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`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
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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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`19. With respect to the level of ordinary skill in the art at the relevant
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`times applicable to the ‘765 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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`20.
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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.”
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`Declaration of Dr. Stephen Tallon, Exhibit 1006, hereinafter "Tallon Decl." ¶ 29).
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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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`21.
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`I consider myself to be a POSITA in the art of the ‘765 Patent at the
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`time of the alleged inventions claimed therein under Petitioner’s definition of the
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`term. I have applied the understanding of a POSITA to my opinions in this
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`declaration.
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`IV. SUPPORT IN THE ORIGINAL DISCLSOURE FOR THE
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`CONDITIONALL PROPOSED AMERNDED CLAIMS
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`22. The ‘765 Patent is titled “Bioeffective Krill Oil Compositions.” I
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`understand that the ‘765 patent is assigned to Aker Biomarine Antarctic AS.
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`23. The ‘765 patent was filed as U.S. Patent Appln. Serial No. 14/020,155
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`(Ex. 2012; “the ‘155 application”) and is a continuation of Application No.
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`12/057,775, filed on March 28, 2008, now U.S. Patent No. 9,034,388. The ‘765
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`patent claims priority to U.S. Provisional Application No. 60/920,483, filed on
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`March 28, 2007, U.S. Provisional Application No. 60/975,058, filed on September
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`25, 2007, U.S. Provisional Application No. 60/983,446, filed on October 29, 2007,
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`and U.S. Provisional Application No. 61/024,072, filed on January 28, 2008.I note
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`that original filed specification of the ‘765 patent (Ex. 2012) is identical to the
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`specification of the parent application U.S.S.N. 12/057,775.
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`RIMFROST EXHIBIT 1106 Page 0018
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`24. Below, I identify the follow portions of the ‘155 application (Ex.
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`2012) that provide § 112 support for the proposed substitute claims. As
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`demonstrated below, APOSITA would have understood based on the disclosures of
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`the ‘155 application that the inventors possessed the encapsulated krill oil
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`compositions defined in the conditional substitute claims at the time the application
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`was filed.
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`A. Substitute Independent Claim 49
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`25. The ‘155 application supports the preamble of proposed substitute
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`claim 49, “Encapsulated krill oil.” Tallon Decl. ¶¶ 69-70. Specifically, Example 5
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`of the ‘155 application discloses that “[t]he asta oil obtained in example 1 was
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`blended with the polar lipids obtained in example 4 in a ratio of 46:54 (v/v). Next
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`the ethanol was removed by evaporation and a dark red and transparent product
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`was obtained. The product was analyzed and the results can be found in Tables
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`20A-C. Furthermore, the product was encapsulated into soft gels successfully.” Ex.
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`2012 at 41; Tallon Decl. ¶¶ 69-70.
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`26. The ‘155 application supports “a capsule containing a safe and
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`effective amount of Euphausia superba krill oil,” as recited in proposed substitute
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`claim 49. Tallon Decl. ¶¶ 99-102. Additionally, the ‘155 application discloses, “In
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`another embodiment of the invention, the krill oil compositions are found to be
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`19
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`RIMFROST EXHIBIT 1106 Page 0019
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`AKER EXHIBIT 2013 Page 19
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`effective and safe for the treatment of metabolic syndrome in humans.” Ex. 2012 at
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`23; Tallon Decl. ¶¶ 99-102.
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`27. The ‘155 application also supports a “krill oil comprising from 5% to
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`8% ether phospholipids w/w of said krill oil,” as recited in proposed substitute
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`claim 49. Tallon Decl. ¶¶ 92-93. Specifically, the ‘155 application discloses, “In
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`some preferred embodiments, the krill oil compositions of the present invention
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`comprise from about 1%, 2%, 3% or 4% to about 8%, 10%, 12% or 15% w/w ether
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`phospholipids or greater than about 4%, 5%, 6%, 7%, 8%, 9% or 10% ether
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`phospholipids.” Ex. 2012 at 15; Tallon Decl. ¶¶ 92-93.
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`28. Additionally, Example 7 and accompanying Table 22 of the ‘155
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`application disclose compositions that contain 15.4% ether phospholipids (13.0%
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`(AAPC) + 0.9% (LAAPC) + 1.5% (AAPE)) as a percentage by weight of
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`phospholipids. Ex. 2012 at 43-45. Because phospholipids make up 47.9% of the
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`Example 7 krill oil, ether phospholipids comprise approximately 7.4% by weight
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`of this krill oil (i.e., 15.4% x .479 = 7.38%). Ex. 2012 at 43-45; Tallon Decl. ¶¶ 44-
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`49. Indeed, Petitioner confirms that the inventive subject matter of the ‘155
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`application “includes krill oil extracts with an ether phospholipid content of 7.4%
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`by weight of krill oil. (Exhibit 1001).” Petition, IPR2018-00295 Paper 2 at 8.
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`29. Furthermore, Dr. Tallon states, “It is my opinion that none of the
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`referenced priority documents (Exhibits 1002, 1003, 1004, 1005, 1024, or 1047)
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`contain any written description of the complete range, or even a substantial portion
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`Inter Partes Review of US 9,320,765
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`of the range of ether phospholipid percentages by w/w of krill oil claimed, at least
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`not for percentages greater than 8%. The ‘765 Patent does not enable one of
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`ordinary skill, without undue experimentation to make a krill oil composition
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`containing an ether phospholipids content greater than about 8% w/w krill oil.”
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`Tallon Decl. ¶ 49. Therefore, it would appear that Petitioner’s expert agrees that
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`“krill oil comprising from 5% to 8% ether phospholipids w/w of said krill oil,” as
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`recited in proposed substitute claim 49, is fully supported by the ‘155 application.
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`30. The ‘155 application also supports “from about 27% to 50% non-ether
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`phospholipids w/w of said krill oil so that the amount of total phospholipids in the
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`composition is from about 30% to 60% w/w of said krill oil,” as recited in
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`proposed substitute claim 49. Tallon Decl. ¶¶ 145, 146, 281, 282. The ‘155
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`application discloses, “In some embodiments, the present invention provides
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`methods of making a Euphausia superba krill oil composition
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`comprising…combining said polar extract and said neutral extract to
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`provide Euphausia superba krill oil comprising from about 30% to 60% w/w
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`phospholipids…In some embodiments, the methods further comprise the step of
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`encapsulating the Euphausia superba krill oil.” Ex. 2012 at 7-8. Regarding “from
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`about 27% to 50% non-ether phospholipids,” the ‘155 application discloses, “In
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`some embodiments, the krill oil compositions comprise…from about 30%, 33%,
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`40%, 42%, 45%, 48%, 50%, 52%, 54%, 55% 56%, 58% to about 60% non-ether
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`phospholipids.” Ex. 2012 at 15; Tallon Decl. ¶¶ 145, 146, 281, 282.
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`31. The ‘155 application also supports “from about 20% to 50%
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`triglycerides w/w of said krill oil,” as recited in proposed substitute claim 49.
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`Tallon Decl. ¶¶ 53, 283. More specifically, the ‘155 application discloses “In some
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`embodiments, the present invention provides methods of making a Euphausia
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`superba krill oil composition comprising…contacting Euphausia superba with a
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`neutral solvent to provide a neutral extract comprising triglycerides and
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`astaxanthin; combining said polar extract and said neutral extract to provide
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`Euphausia superba krill oil comprising…from about 20% to 50% triglycerides…In
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`some embodiments, the methods further comprise the step of encapsulating
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`the Euphausia superba krill oil.” Ex. 2012 at 7-8; see also, Ex. 2012, Tables 13
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`and 21.
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`32. The specification of the ‘155 application also supports encapsulated
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`krill oil compositions containing “astaxanthin esters in amount of from 100 mg/kg
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`to 700 mg/kg of said krill oil,” as recited in proposed substitute claim 49. Tallon
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`Decl. ¶¶ 290, 300, 311, 312. More specifically, the ‘155 application discloses “In
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`some embodiments, the krill oil compositions comprise greater than about 100,
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`200, 300, 400, or 500 mg/kg astaxanthin esters and up to about 700 mg/kg
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`22
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`RIMFROST EXHIBIT 1106 Page 0022
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`astaxanthin esters. ” Ex. 2012 at 16-17; see also, Ex. 2012, Tables17C, 19C and
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`20C.
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`33. Additionally, Petitioner acknowledges support for “astaxanthin esters
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`in amount of from 100 mg/kg to 700 mg/kg of said krill oil” in the specification of
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`the ‘765 patent in a related case, PGR2018-00033, challenging U.S. Patent No.
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`9,644,170 (also a continuation of U.S. Patent No. 9,034,388). In that case,
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`Petitioner acknowledges, “The independent and dependent claims encompass
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`astaxanthin esters amounts far greater than 0.25% (i.e., 2,500 mg/kg), the highest
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`amount arguably supported by the ‘170 patent. (Tallon Decl. (Exhibit 1006), ¶¶
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`103-10).” Ex. 2014 PGR2018-00033 Petition. Accordingly, Patent Owner
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`respectfully asserts that “astaxanthin esters in amount of from 100 mg/kg to 700
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`mg/kg of said krill oil,” as recited in proposed substitute claim 49, is fully
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`supported by the ‘155 application.
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`B. Dependent Claims 50-56
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`34. The specification of the ‘155 application supports all features of the
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`proposed substitute dependent claims 50-56. Proposed dependent claims 50, 51
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`and 52 further limit the astaxanthin ester ranges to 200, 300 and 400 to 700 mg/kg
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`astaxanthin esters, respectively. These claims limitations are supported as
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`described above. See, Ex. 2012 at 16-17; see also, Ex. 2012, Tables 17C, 19C, and
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`20C. Proposed claims 53 and 54, which relate to omega-3 fatty acid content (20-
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`35%) and attachment to phospholipids, are supported by the specification. See,
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`Inter Partes Review of US 9,320,765
`Ex. 2013, Hoem Declaration
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`Ex. 2012 at 15. Proposed claim 55, designates the capsule as a soft gel capsule, is
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`supported by the specification. See, Ex. 2012 at 18. Proposed claim 56, which
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`provides that the encapsulated krill oil may further comprise a plant phytonutrient,
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`is supported by the specification. See, Ex. 2012 at 20.
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`V. Claim Construction
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`35. I understand that Patent Owner and I have offered claim
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`constructions for certain terms that appear in the proposed substitute claims. It is
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`my opinion that those constructions are not necessary to demonstrating the
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`patentability of the proposed substitute claims over the prior art in light of the new
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`limitations contained in the proposed substitute claims. In the context of the
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`proposed substitute claims, the meaning of the new limitations—taken as whole—
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`is discernible to those of ordinary skill in the art. That fact does not in any wa
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