UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`______________________
`
`CASE IPR2014-00003
`U.S. Patent No. 8,278,351
`______________________
`
`PATENT OWNER’S RESPONSE TO PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 8,278,351
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`Table of Contents
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`
`I.
`II.
`III.
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`IV.
`V.
`VI.
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`Page
`INTRODUCTION ........................................................................................................ 1
`SUMMARY OF ARGUMENT ..................................................................................... 1
`BACKGROUND .......................................................................................................... 2
`A.
`The ‘351 Patent ............................................................................................... 2
`B.
`Technology Overview...................................................................................... 3
`LEGAL STANDARDS ................................................................................................. 7
`CONSTRUCTION OF THE TERMS IN THE ‘351 PATENT ....................................... 9
`THE ‘351 PATENT CLAIMS ARE ENTITLED TO A PRIORITY DATE OF
`JULY 27, 2001 BASED ON THE PROVISIONAL APPLICATION ........................... 14
`BEAUDOIN DOES NOT ANTICIPATE ANY OF CLAIMS 1, 4-6, 9, 12, 13, 19-
`24, 27-29, 32, 35, 36, OR 42-46 ............................................................................... 16
`A.
`Beaudoin Does Not Expressly or Inherently Anticipate Claims 1 and 24 ..... 17
`1.
`Beaudoin Requires a Heating Step To Obtain Krill Extracts ............. 17
`2.
`The Heating Step Distinguishes Beaudoin From the ‘351 Patent ..... 22
`3.
`Petitioner’s Recreation Evidence Fails to Prove Beaudoin
`Inherently Discloses the Claimed Phospholipids ............................... 25
`a.
`Petitioner’s Recreations Deviated From Beaudoin ................. 26
`b.
`The Claimed Phospholipid Was Not Detected in All
`Recreation Samples ............................................................... 29
`Petitioner Failed to Assess Key Characteristics of its
`Recreation Samples ............................................................... 30
`Beaudoin Does Not Disclose An Extract “Suitable for Human
`Consumption” .................................................................................... 31
`Beaudoin Does Not Expressly or Inherently Anticipate Claims 5 and 28 ..... 36
`B.
`VIII. THE COMBINATION OF FRICKE, BERGELSON, YASAWA, ITANO, AND
`THE WHO BULLETIN DOES NOT RENDER OBVIOUS ANY OF CLAIMS 1-
`6, 9, 12, 13, 19-29, 32, 35, 36, OR 42-46................................................................. 38
`A.
`The Cited References Do Not Teach Or Suggest the Features of
`Claims 1 and 24 ............................................................................................ 39
`1.
`Claimed Phospholipid ........................................................................ 39
`-i-
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`VII.
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`
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`
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`c.
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`4.
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`

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`“Suitable for human consumption” ..................................................... 42
`2.
`“krill extract” ....................................................................................... 46
`3.
`Claims 2, 3, 25, and 26 Are Nonobvious ...................................................... 47
`Claims 9 and 32 Are Nonobvious ................................................................. 50
`Claims 12, 13, 35, and 36 Are Nonobvious .................................................. 51
`One of Ordinary Skill In the Art Would Not Combine Fricke, Bergelson,
`Yasawa, Itano, and the WHO Bulletin ........................................................... 53
`1.
`One of Skill Would Not Combine Fricke or Bergelson with
`Yasawa, Itano, or the WHO Bulletin .................................................. 54
`Petitioner’s Combination Includes Krill and Non-Krill
`References That A Person of Skill Would Not Combine ................... 54
`One of Skill Would Not Combine Itano With Lipid Extraction
`References ........................................................................................ 57
`CONCLUSION ......................................................................................................... 58
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`2.
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`3.
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`B.
`C.
`D.
`E.
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`
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`IX.
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`
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`TABLE OF AUTHORITIES
`
`Cases 
`ArcelorMittal France v. AK Steel Corp.,
`700 F.3d 1314 (Fed. Cir. 2012) .......................................................................................... 7
`Bettcher Indus. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) ............................................................................................ 8
`CFMT, Inc. v. YieldUp Int’l Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) .......................................................................................... 8
`Eli Lily and Co. v. Barr Labs., Inc.,
`251 F.3d 955 (Fed. Cir. 2001) .......................................................................................... 29
`Glaxo Group Ltd. v. Apotex, Inc.,
`376 F.3d 1339 (Fed. Cir. 2004) .......................................................................................... 8
`Glaxo Inc. v. Novopharm Ltd.,
`52 F.3d 1043 (Fed. Cir. 1995) .......................................................................................... 29
`In re Armodafinil Patent Lit.,
`939 F. Supp. 2d 456 (D. Del. 2013) ........................................................................... 22, 30
`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009) .......................................................................................... 9
`In re Rijckaert,
`9 F.3d 1531 (Fed. Cir. 1993) ............................................................................................ 53
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) .......................................................................................... 9
`K/S HIMPP v. Hear-Wear Techs., LLC,
`Case No. 2013-1549 (Fed. Cir. May 27, 2014) ................................................................ 44
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .......................................................................................... 9
`KSR Int’l Co. v. Teleflex Inc.,
`127 S.Ct. 1727 (2007) ........................................................................................................ 8
`
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`-iii-
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`
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`Leo Pharma. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) ...................................................................................... 8, 9
`Pfizer Inc. v. Teva Pharm. U.S.A., Inc.,
`882 F. Supp. 2d 643 (D. Del. 2012) ........................................................................... 25, 31
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ........................................................................................ 13
`Star Scientific, Inc. v. R.J. Reynolds Tobacco Co.,
`655 F.3d 1364 (Fed. Cir. 2011) ........................................................................................ 16
`Therasense, Inc. v. Becton, Dickinson & Co.,
`593 F.3d 1325 (Fed. Cir. 2010) .......................................................................................... 7
`Trintec Indus., Inc. v. Top-U.S.A. Corp.,
`295 F.3d 1292 (Fed. Cir. 2002) .......................................................................................... 8
`Statutes 
`35 U.S.C. § 102(b) ............................................................................................................ 1, 59
`35 U.S.C. § 103(a) ........................................................................................................ 1, 8, 59
`Other Authorities 
`M.P.E.P. § 2141.02 ............................................................................................................... 53
`M.P.E.P. § 2142 .................................................................................................................... 53
`M.P.E.P. § 2145 .................................................................................................................... 56
`Regulations 
`37 C.F.R. § 42.100(b) ............................................................................................................. 9
`37 C.F.R. § 42.120 ................................................................................................................. 1
`37 C.F.R. § 42.23(a) ............................................................................................................... 1
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`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.120, Patent Owner Neptune Technologies and
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`Patent Owner’s Response
`Case No: IPR2014-00003
`
`
`I.
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`Bioressources Inc. (“Patent Owner” or “Neptune”) Responds to the Petition for Inter Partes
`
`Review (“Petition”) of U.S. Patent No. 8,278,351 (“the ‘351 Patent”) filed by Aker Biomarine
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`AS (“Petitioner” or “Aker”).1 On March 24, 2014, the Patent and Trial and Appeal Board
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`(“Board”) instituted this Inter Partes review of the ‘351 Patent based on Aker’s Petition. The
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`Board subsequently modified its institution decision to narrow the review to two grounds of
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`alleged unpatentability:
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`
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`1. Claims 1, 4-6, 9, 12, 13, 19-24, 27-29, 32, 35, 36, and 42-46 as allegedly
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`anticipated under 35 U.S.C. § 102(b) by Beaudoin I (“Beaudoin”); and
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`
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`2. Claims 1-6, 9, 12, 13, 19-29, 32, 35, 36, and 42-46 as allegedly obvious under 35
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`U.S.C. § 103(a) over the combination of Fricke, Bergelson, Yasawa, Itano, and the WHO
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`Bulletin.2
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`II.
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`SUMMARY OF ARGUMENT
`Petitioner fails to establish by a preponderance of the evidence that its cited prior art
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`1 Petitioner did not submit statements of material facts in the Petition, and thus no response
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`is due pursuant to 37 C.F.R. § 42.23(a) and no facts are admitted.
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`2 IPR2014-00003, Decision – Petitioner’s Request for Rehearing, Paper 45 (hereinafter,
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`“Decision on Rehearing”), p. 9; IPR2014-00003, Paper 22 (hereinafter, “Institution
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`Decision”), pp. 27-28.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`renders any patented claims anticipated or obvious. As Petitioner concedes, none of these
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`references expressly disclose all elements of any patented claims. Petitioner argues
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`anticipation based on inherency, which requires a demanding standard of proof that
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`Petitioner cannot meet. Petitioner’s inherency arguments rest on flawed recreation
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`experiments that produced biased and inconsistent results.
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`As to obviousness, Petitioner’s strained five-way combination contains inconsistent
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`teachings, rebutting any suggestion for one of skill to combine the references. None of
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`these references, alone or in combination, disclose all elements of any patented claims; in
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`fact, they teach away from the claimed krill extracts. For example, the primary references
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`use toxic solvents for lipid extraction which, as Beaudoin and Petitioner’s other cited art
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`teach, cannot be used in extracts intended for human consumption.
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`Patent Owner therefore respectfully submits that the Board should uphold the
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`patentability of claims 1-6, 9, 12, 13, 19-29, 32, 35, 36, and 42-46.
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`III.
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`BACKGROUND
`A.
`The ‘351 Patent
`The ‘351 Patent, “Natural Marine Source Phospholipids Comprising Polyunsaturated
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`Fatty Acids and Their Applications,” has 5 independent and 89 dependent claims. The ‘351
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`Patent describes and claims a krill extract that is suitable for human consumption and
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`comprises a phospholipid of the formula (I):
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`
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`wherein R1 and R2 (also called “sn-1” and “sn-2”) each independently represent a
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`docosahexaenoic acid (DHA) or an eicosapentanoic acid (EPA) residue, and X is
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`-CH2CH2NH3, -CH2CH2N(CH3) 3, or
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`.
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`These claimed species of phospholipid with EPA and/or DHA concurrently attached at the
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`sn-1 and sn-2 positions are referred to herein as the “claimed phospholipid.”
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`Technology Overview
`B.
`Krill is a crustacean similar to shrimp that contains a high content of phospholipids,
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`including those that bear the omega-3 fatty acids EPA and/or DHA, which provide a variety
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`of human health benefits. Both before and after the priority date of the ‘351 Patent, well into
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`the 2000s, krill was considered too difficult for profitable harvesting given its delicate
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`structure and rapid decay rate.3 The industry focused instead on extracting omega-3 fatty
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`acids from fish to produce fish oil.
`
`
`3 NEPN Ex. 2059, Jaczynski Decl. ¶ 9; NEPN Ex. 2038, Storro Tr. 218:8-219:3.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`Breaking away from the industry focus on fish and fish oil, Dr. Fotini Sampalis, the
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`inventor of the ‘351 Patent, recognized that krill uniquely contains EPA and DHA esterified
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`to phospholipids. This is distinct from fish oil and most other sources of omega-3s, which
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`contain DHA and EPA (1) bound to triglycerides, and/or (2) as free fatty acids, which are not
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`bound on larger bio-molecules. As a medical doctor, Dr. Sampalis understood that krill
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`phospholipids deliver EPA and DHA to the human body more efficiently than triglycerides or
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`free fatty acids. In fact, Petitioner (who entered the krill oil market over five years after
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`Patent Owner, the developer and pioneer of the market) markets its product based on the
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`superior benefits of phospholipid-bound EPA and DHA,4 benefits that became known largely
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`due to Dr. Sampalis’ inventive efforts.
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`To produce an oil rich in intact phospholipids (i.e. phospholipids with two attached
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`fatty acid chains) bearing EPA and/or DHA, Dr. Sampalis deviated from known marine oil
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`production methods. Specifically, Dr. Sampalis diverged from prior art methods by avoiding
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`application of high heat to extracted oil still in its crude form. Extracted krill oil that is crude,
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`i.e., unrefined, will typically contain high concentrations of water and volatile matter.5 As
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`such, applying high heat to crude krill oil may cause degradation of the phospholipids and/or
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`4 NEPN Ex. 2040, Aker webpage, “The Phospholipid Advantage,” p. 2 (“Superba™ Krill is
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`rich in phospholipid omega-3s EPA and DHA, which are more bio-efficient than other
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`marine oils.”).
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`5 NEPN Ex. 2059, Jaczynski Decl. ¶ 13.
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`fatty acids through processes such as hydrolysis and oxidation.
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`Patent Owner’s Response
`Case No: IPR2014-00003
`
`
`Hydrolysis refers to the degradation of phospholipids by breaking, for example, the
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`ester bonds attaching fatty acid chains to the glycerol backbone of the phospholipid
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`molecule, and thus releasing free fatty acids.6 Release of free fatty acid chains results in a
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`degraded phospholipid with only one fatty acid attached, called a lysophospholipid.
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`Alternatively, hydrolysis can result in a broken phosphate group, in which case the
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`phospholipid ceases to exist and the resulting molecule becomes a diglyceride. Increased
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`hydrolysis will cause greater phospholipid degradation, including increased breakage of
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`phosphate groups.
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`Hydrolysis is driven by several factors, including temperature and water and free
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`fatty acid content.7 Following thermodynamic principles and first order reaction kinetics, the
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`higher the temperature, the greater the extent of hydrolysis expected. The principle that
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`hydrolysis occurs upon heating in the presence of water is readily accepted in the field,
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`especially in the presence of a high free fatty acid content. In general, the higher
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`concentration of free fatty acid in an extract, the lower the temperature point is at which
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`lipids are hydrolyzed. In other words, hydrolysis will occur at a lower temperature in an
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`extract containing a higher concentration of free fatty acids. As water content, heat, or free
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`fatty acid content increases, hydrolysis will also increase.
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`6 NEPN Ex. 2059, Jaczynski Decl. ¶¶ 14-18.
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`7 NEPN Ex. 2059, Jaczynski Decl. ¶ 16.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`Applying high heat to a krill lipid extract in the presence of oxygen may also cause
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`oxidation of the fatty acids.8 Long chain polyunsaturated fatty acids like EPA and DHA are
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`very sensitive to heat in the presence of oxygen, and heat can cause them to degrade into a
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`variety of oxidation by-products, including shorter chain, and less unsaturated, fatty acids.
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`Dr. Sampalis recognized these ways in which application of high heat to crude krill oil
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`could degrade the oil’s desirable phospholipids and omega-3 fatty acids. In particular, Dr.
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`Sampalis appreciated that hydrolysis was antithetical to her goal of obtaining a krill extract
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`rich in intact phospholipids bearing EPA and DHA. Accordingly, Dr. Sampalis avoided high
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`heat treatment of crude oil extracted from krill. Her innovation helped lead to her discovery
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`of the extracts claimed in the ‘351 Patent.
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`Neptune and, much later, its competitors, embraced the ‘351 Patent’s teachings
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`about the avoidance of high heat. For example, Enzymotec employs a “mild” process for
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`producing krill oil to protect the oil’s “unique and sensitive components,” which require more
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`delicate treatment than the boiling method traditionally used to extract fish oil.9
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`While Petitioner’s experts have criticized Neptune’s cited references regarding
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`hydrolysis on the basis that they show hydrolysis primarily of triglycerides rather than
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`phospholipids, none of Petitioner’s experts could identify a reason why hydrolysis would
`
`
`8 NEPN Ex. 2059, Jaczynski Decl. ¶ 19.
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`9 NEPN Ex. 2041, Enzymotec Introduction to Extraction Process, p. 3.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`proceed differently in a triglyceride molecule as opposed to a phospholipid molecule.10 The
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`bond that holds fatty acids on the glycerol backbone of triglycerides or phospholipids is the
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`same covalent bond referred to as an ester bond. Specifically, it is the ester bond that is
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`degraded during hydrolysis of triglycerides or phospholipids when they are subjected to heat
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`in the presence of water and free fatty acids. Therefore, the references cited by Neptune
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`are relevant.11 In fact, as relevant to this proceeding, there is no difference between
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`hydrolysis of phospholipid molecules as opposed to triglyceride molecules, and thus the
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`Medina et al. and Herman and Groves references provide relevant evidence of degradation
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`that may occur as a result of hydrolysis.12
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`IV.
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`LEGAL STANDARDS
`Anticipation requires that “each and every limitation is found either expressly or
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`inherently in a single prior art reference.” ArcelorMittal France v. AK Steel Corp., 700 F.3d
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`1314, 1322 (Fed. Cir. 2012) (internal quotation omitted). To anticipate, a reference must
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`also expressly or inherently disclose the way in which the claimed elements are combined.
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`Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010).
`
`Anticipation by inherent rather than express disclosure requires clear and convincing
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`10 E.g., NEPN Ex. 2037, Brenna Tr. 107:18-108:1; NEPN Ex. 2035, Haugsgjerd Tr. 54:18-
`
`55:9.
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`11 NEPN Ex. 2059, Jaczynski Decl. ¶ 14.
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`12 Id.; NEPN Ex. 2006, Medina et al.; AKBM Ex. 1038, Herman and Groves.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`proof that the missing descriptive material is “necessarily present, not merely probably or
`
`possibly present, in the prior art.” Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292,
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`1295 (Fed. Cir. 2002) (internal quotations omitted). The mere fact that a certain thing may
`
`result from a given set of circumstances is not sufficient to prove inherent anticipation.
`
`Bettcher Indus. v. Bunzl USA, Inc., 661 F.3d 629, 639 (Fed. Cir. 2011). In addition, one
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`cannot use the benefit of hindsight to establish the inherency of a claimed limitation. Glaxo
`
`Group Ltd. v. Apotex, Inc., 376 F.3d 1339, 1348-49 (Fed. Cir. 2004).
`
`A patent is invalid as obvious only “if the differences between the claimed invention
`
`and the prior art are such that the claimed invention as a whole would have been obvious
`
`before the effective filing date of the claimed invention to a person of ordinary skill in the art
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`to which the claimed invention pertains.” 35 U.S.C. § 103(a). To invalidate a claim for
`
`obviousness, the prior art must teach or suggest each and every claimed feature. CFMT,
`
`Inc. v. YieldUp Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003). Significantly, “a patent
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`composed of several elements is not proved obvious merely by demonstrating that each of
`
`the elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 127
`
`S.Ct. 1727, 1741 (2007). To prove obviousness based on more than one reference, one
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`must show that (1) a person of ordinary skill in the art would have been motivated to
`
`combine the references, and (2) there would have been a reasonable expectation of
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`successfully achieving the claimed invention from such combination. See Leo Pharma.
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`Prods., Ltd. v. Rea, 726 F.3d 1346, 1355-57 (Fed. Cir. 2013); see also In re Kubin, 561 F.3d
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`1351, 1359 (Fed. Cir. 2009) (“courts should not succumb to hindsight claims of
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`obviousness”).
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`Moreover, secondary considerations “can be the most probative evidence of
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`nonobviousness” and are useful to “avert the trap of hindsight.’” Leo Pharma., 726 F.3d at
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`1358 (internal citation omitted). These secondary considerations may include commercial
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`success, copying, and prior art that teaches away from the claimed inventions. See, e.g.,
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`Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1370 (Fed. Cir. 2012).
`
`V.
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`CONSTRUCTION OF THE TERMS IN THE ‘351 PATENT
`The claims at issue should be given their broadest reasonable interpretation in light
`
`of the specification. 37 C.F.R. § 42.100(b); see also In re Translogic Tech., Inc., 504 F.3d
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`1249, 1257 (Fed. Cir. 2007) (under the broadest reasonable construction standard, claims
`
`terms are given their ordinary and customary meaning as would be understood by one of
`
`ordinary skill at the time of the invention). In accordance with these standards, Patent
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`Owner submits that the following claim terms should be construed as set forth below.13
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` “Suitable for human consumption” (claims 1 and 24 and their dependents). By
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`its plain meaning, the term refers to krill extracts that are safe and appropriate for humans to
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`consume, including by oral ingestion.14 The specification teaches that the claimed extract is
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`13 Any claim terms or clauses not expressly construed herein should be given their plain and
`
`ordinary meaning as understood by a person of ordinary skill in the art.
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`14 NEPN Ex. 2059, Jaczynski Decl. ¶ 36.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`preferably consumed repeatedly or even regularly over an extended period of time.15 For
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`example, the specification suggests use of the claimed extracts in “foods, beverages,
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`energy bars, sports drinks, supplements.”16 The specification further discloses use of the
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`claimed extracts “in the treatment or prevention of a variety of disease states,” and
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`describes an exemplary beneficial use of the extracts over a 1.5 month period.17
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`Given the specification’s teachings that the claimed krill extracts are intended to
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`increase levels of DHA and EPA in the body through regular consumption of supplements,
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`food, or other preparations, one of skill would not interpret the claims to cover an extract
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`suitable for only a single instance of consumption (but no more). As such, an extract that is
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`(1) untested on humans, or (2) contains an unknown quantity of residual solvent or other
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`volatile matter, cannot be presumed suitable for human consumption.18
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`Petitioner suggests that “suitable for consumption” broadly covers “any form of
`
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`15 E.g., AKBM Ex. 1001, ‘351 Patent, Abstract, col. 20, Example 2 (col. 24), Example 3 (col
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`26).
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`16 Id., col. 20:34-36.
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`17 Id., col. 20: 42-57; col. 26 (Example 3).
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`18 NEPN Ex. 2059, Jaczynski Decl. ¶ 36; NEPN Ex. 2029, Brenna ITC Tr. 112:9-113:1 (“No,
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`I don’t think it’s safe [to consume a krill oil] containing an unknown amount of residual
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`solvent.”).
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`consumption by a human (e.g., oral or topical administration).”19 Patent Owner disagrees
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`that mere suitability for topical application, as opposed to suitability for oral ingestion, is
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`sufficient. While the specification discloses preparations of the extracts for external use, the
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`“suitability for human consumption” requirement applies equally to all claimed preparations
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`of the extract, including in food, oral, and cosmetic preparations.20 Thus, any interpretation
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`of “suitable for human consumption” must cover extracts intended for oral ingestion.
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`Patentee could have chosen to claim more broadly an extract suitable for human
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`“application” or “use,” but elected to claim and describe an extract suitable for human
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`consumption including, if not primarily, by oral ingestion.
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` “a concentration of free fatty acids of about 5% w/w” (claims 5 and 28). As
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`Petitioner and the Board have noted, the specification states that when “about” is used with
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`a specified numerical value, the value may vary by at least ± 50%, unless “about” is
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`otherwise defined, e.g., “wherein about represents ± 10%” (claims 2, 25).21
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`Claims 5 and 28 do not define “about,” so based on the specification, one would
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`understand claims 5 and 28 to require a concentration of free fatty acids of about 5% ±
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`
`19 IPR 2014-00003, Paper 6, AKBM Petition for Inter Partes Review (hereinafter, “AKBM
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`Petition”), p. 9.
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`20 See AKBM Ex. 1001, ‘351 Patent, claims 24, 47, and 70.
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`21 Institution Decision p. 8.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`50%. However, one of skill would not understand 5% ± 50%, as used in claim 5, to cover a
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`range that is 5% plus or minus an absolute value of 50%.22 Under that reasoning, claim 5
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`would cover a range of -45% to 55% free fatty acid, which is nonsensical because an
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`extract cannot have a negative amount of free fatty acids.
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`Instead, one of skill would understand that as used in claim 5, about 5% ± 50%
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`means plus or minus 50% of 5%. 50% of 5% is 2.5%, and therefore 5% w/w ± 50% means
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`a range of 2.5% (5% minus 2.5%) to 7.5% (5% plus 2.5%).
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`One of skill would further understand that 2.5% to 7.5% is the correct interpretation
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`based on the specification. Low levels of free fatty acids, i.e., 2.5-7.5%, indicate that
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`phospholipids have not undergone substantial hydrolysis during production of the extract.
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`As described above, hydrolysis causes the degradation of phospholipids by breaking ester
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`bonds and thus releasing free fatty acids. Accordingly, a low free fatty acid level is
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`consistent with a core teaching of the ‘351 patent, namely, recovery of intact phospholipids
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`in a krill extract. A high free fatty acid level, on the other hand, would indicate that
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`significant hydrolysis has occurred in the course of producing the krill extract, and therefore
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`the phospholipids have degraded and the extract is less desirable.23
`
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`22 NEPN Ex. 2059, Jaczynski Decl. ¶ 37.
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`23 NEPN Ex. 2059, Jaczynski Decl. ¶ 37.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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` "about 40% w/w, wherein about represents ± 10%” (claims 2 and 25). A
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`person of ordinary skill would interpret this term to mean 40% plus or minus 10% of the
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`value of 40%, i.e., 40% plus or minus 4%.24 One of skill would interpret “about … plus or
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`minus” the same way for all claims that contain this limitation. See Phillips v. AWH Corp.,
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`415 F.3d 1303, 1314–15 (Fed. Cir. 2005) (“Because claim terms are normally used
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`consistently throughout the patent, the usage of a term in one claim can often illuminate the
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`meaning of the same term in other claims.”). It would be illogical to interpret “about … plus
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`or minus” one way for claims 5 and 28 and a different way for claims 2 and 25. As
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`discussed above with respect to claims 5 and 28, one of skill would not interpret “about” as
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`recited in claims 2 and 25 to mean 40% plus or minus an absolute value of 10%.
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`Therefore, “about 40%” as used in claims 2 and 25 should be interpreted as 36-44% w/w.
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`Dr. Brenna, Petitioner’s expert opining on anticipation and obviousness and allegedly
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`one of skill in the art, agreed that when he prepared his declaration, he interpreted claim 2
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`to require a phospholipid concentration of 36-44% w/w.25
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` “about 45% w/w, wherein about represents ± 20%” (claims 3 and 26). For the
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`same reasons discussed above with respect to claims 2 and 25, a person of ordinary skill
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`24 NEPN Ex. 2059, Jaczynski Decl. ¶ 38.
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`25 NEPN Ex. 2037, Brenna Tr. 136:6-14. Petitioner also agreed with this construction in the
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`2013 litigation between the parties at the International Trade Commission.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`would interpret this term to mean 45% plus or minus 20% of the value of 45%, i.e., 45% plus
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`or minus 9%. Therefore, claims 3 and 26 should be interpreted to require a phospholipid
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`concentration in the range of 36-54% w/w.26
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`
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`“capsule, tablet, solution, syrup, or suspension” (claim 24 and its
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`dependents). The specification teaches that this term refers to an oral preparation of the
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`claimed extract.27 Dr. Brenna agreed in his deposition that “solution, syrup, or suspension”
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`as used in claim 24 refers to examples of a liquid preparation for oral administration.28
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`VI.
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`
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`THE ‘351 PATENT CLAIMS ARE ENTITLED TO A PRIORITY DATE OF JULY 27,
`2001 BASED ON THE PROVISIONAL APPLICATION
`The ‘351 Patent is entitled to a priority filing date of July 27, 2001, because it is a
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`continuation of U.S. Patent No. 8,030,348, which is a national stage of International Patent
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`App. No. PCT/CA2002/001185 (“the PCT Application”), which claims priority to U.S.
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`Provisional Patent App. No. 60/307,842, filed on July 27, 2001 (the “Provisional”). Petitioner
`
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`26 NEPN Ex. 2059, Jaczynski Decl. ¶ 39.
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`27 AKBM Ex. 1001, ‘351 Patent, col. 20:10-22 (“Thus, the extract may be formulated for oral
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`administration … pharmaceutical or nutraceutical compositions may take the form of, for
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`example, tablets or capsules … Liquid preparations for oral administration may take the
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`form of, for example, solutions, syrups or suspensions ….”); NEPN Ex. 2059, Jaczynski
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`Decl. ¶ 40.
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`28 NEPN Ex. 2037, Brenna Tr. 245:20-246:2.
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`Patent Owner’s Response
`Case No: IPR2014-00003
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`argues the Provisional does not provide adequate written description support for the
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`claimed phospholipid, and therefore the ‘351 Patent claims are not entitled to the priority
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`date of the Provisional. Petitioner argues that the ‘351 Patent claims’ priority date should be
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`no earlier than the date of the PCT Application, July 29, 2002.29
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`Petitioner fails to establish that one of skill would not recognize that the inventor had
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`possession of the claimed phospholipid based on the Provisional.30 The Provisional
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`describes an invention directed to phospholipid compounds preferably derived from krill,
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`and that the most important of these phospholipid compounds are PC, PE, and PI.31 Each
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`of these phospholipids has attached “two chains of fatty acids.”32 The Provisional indicates
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`that polyunsaturated omega-3 fatty acids are “most preferred,” and that EPA and DHA are
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`among the most prevalent omega-3 fatty acids in the extract of the invention.33
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`The Provisional examples and figures support these disclosures. For example,
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`Table 3 shows PC as the most prevalent phospholipid, followed by PE, with significantly
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`smaller minimum quantities for the remaining phospholipids (e.g., PI and PS). Figures 3A to
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`3K provide mass spectra of “fatty acids attached phospholipids in the composition of the
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