Jacek Jaczynski Declaration
`Case No: IPR2014-00003
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
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`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`______________________
`
`CASE IPR2014-00003
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`U.S. Patent No. 8,278,351
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`______________________
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`DECLARATION OF DR. JACEK JACZYNSKI
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`1
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`NON-CONFIDENTIAL
`
`NEPN Ex. 2059
`Aker v. Neptune
`IPR2014-00003
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`
`Case No: IPR2014-00003
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`
`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
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`U.S. Patent No. 8,278,351
`
`______________________
`
`DECLARATION OF DR. JACEK JACZYNSKI
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`NON-CONFIDENTIAL
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`NEPN Ex. 2059
`Aker v. Neptune
`IPR2014-00003
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`INTRODUCTION
`I.
`I, Jacek Jaczynski, Ph.D., declare as follows:
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`Jacek Jaczynski Declaration
`Case No: IPR2014-00003
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`1.
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`Unless otherwise noted, I have personal knowledge of the matters stated
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`below, and, if called as a witness in a legal proceeding in the United States or elsewhere,
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`could and would testify competently thereto. All statements made herein on my personal
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`knowledge are true, and those statements made on information and believe are believed to
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`be true.
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`2.
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`I have been retained by the Patent Owner, Neptune Technologies and
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`Bioressources Inc. (“Patent Owner” or “Neptune”), in this matter. I understand Aker
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`Biomarine AS (“Petitioner” or “Aker”) filed a Petition for Inter Parties Review of U.S. Patent
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`No. 8,278,351 (“the ‘351 Patent”), and that the Patent and Trial and Appeal Board (“Board”)
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`has instituted this Inter Partes review to determine the patentability of certain claims of the
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`‘351 Patent based on two different alleged grounds of invalidity:
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` 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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` Claims 1-6, 9, 12, 13, 19-29, 32, 35, 36, and 42-46 as allegedly obvious
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`under 35 U.S.C. § 103(a)over the combination of Fricke, Bergelson, Yasawa,
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`Itano, and the WHO Bulletin.
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`This Declaration sets forth the results of my evaluation and my opinions regarding the
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`novelty and non-obviousness of the ‘351 Patent claims at issue in this proceeding.
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`I am being compensated at my customary hourly rate of $300 for my time
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`3.
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`spent on developing, forming, and expressing the facts and opinions in this declaration. My
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`compensation is not dependent on the content of my opinions, the results of my evaluation,
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`or the outcome of this proceeding.
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`4.
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`Below I provide my expert scientific opinions. In forming opinions in
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`connection with this matter, I considered a variety of materials, including the Petition for
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`Inter Partes Review of the ‘351 submitted by Petitioner and the declarations and other
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`exhibits submitted with Aker’s Petition, the ‘351 Patent, scientific publications, alleged prior
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`art, deposition transcripts, and other materials. A complete list of the materials considered
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`is attached hereto as Appendix A.
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`II.
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`QUALIFICATIONS
`5.
`I am a tenured Professor of Food Science and Technology at West Virginia
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`University in the Davis College of Agriculture, Natural Resources, and Design -- Division of
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`Animal and Nutritional Sciences. My appointment involves 50% research and 50%
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`teaching. I have been a professor at West Virginia University since 2002.
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`6.
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`I earned a Ph.D. in Food Science and Technology in 2002 from Oregon State
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`University, Seafood Research and Education Center. Immediately following my doctoral
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`work, I joined West Virginia University as a faculty member. For the past 15 years I have
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`been actively pursuing scientific research specializing in aquatic foods, with an emphasis on
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`krill. I have published nearly 20 book chapters and over 70 peer-reviewed articles on food
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`science and technology, many in high impact journals as indexed by Journal Citation
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`Reports®. For example, one of my peer-reviewed publications directly concerns solvent
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`extraction of krill oil. In addition, I am sole inventor of an issued patent (U.S. 7,763,717)
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`and the inventor of two other patent applications currently under examination. One focus of
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`my patent and patent applications is a method for isolating lipids from krill.
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`7.
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`I serve on the Editorial Board for the Journal of Aquatic Food Product
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`Technology and as a peer-reviewer for several food science journals, such as Food
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`Chemistry and the Journal of Agriculture and Food Chemistry. I am a professional member
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`of the Institute of Food Technologists (“IFT”), the American Chemical Society, the World
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`Aquaculture Society, and Gamma Sigma Delta, an honorary society of agricultural
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`scientists. I served as a Chair of the Division of Aquatic Food Products of the IFT for the
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`2010-2011 term. For the past 10 years I have also taught food science-related courses at
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`West Virginia University, many of which enroll over 300 students annually. I am the
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`recipient of the following awards: Mid Career Davis College of Agriculture Award (2008),
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`Division of Animal and Nutritional Sciences Excellence in Teaching Award (2007), Davis-
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`Michael Scholar Award (2012), and Division of Animal and Nutritional Sciences Excellence
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`in Research Award (2007 and 2012). I have been nominated to the Benedum Distinguished
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`Professorship (2011). My curriculum vitae is attached as Appendix B.
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`TECHNOLOGY BACKGROUND
`8.
`Nutraceuticals or functional foods have existed for many years in various
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`Jacek Jaczynski Declaration
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`III.
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`forms. Nutraceuticals refer to nutrients having health benefits in humans. Nutraceuticals
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`are technologically developed and extracted from natural sources. One example is fish oil.
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`Research has indicated that fish oil, particularly its polyunsaturated, omega-3 fatty acids
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`EPA and DHA, offer health benefits.
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`9.
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`Dr. Fotini Sampalis, inventor of the ‘351 Patent, hypothesized that the EPA
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`and DHA in krill oil delivered superior benefits as compared to fish oil. However, both
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`before and after the time of Dr. Sampalis’s invention, krill was considered too difficult for
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`profitable harvesting given its delicate structure and rapid decay rate. The industry focused
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`instead on extracting omega-3 fatty acids from fish to produce fish oil. Dr. Sampalis broke
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`away from the industry focus on fish and fish oil to discover the claimed krill extracts.
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`10.
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`As a medical doctor, Dr. Sampalis designed and led numerous clinical trials in
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`the early 2000s that resulted in published papers demonstrating the superiority of krill oil as
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`compared to fish oil as a vehicle for delivering EPA and DHA to target systems in humans.1
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`1 E.g., NEPN Ex. 2058 Sampalis F, Bunea R, Pelland MF, Kowalski O, Duguet N, and
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`Dupuis S., Evaluation of the Effects of Neptune Krill Oil on the Management of
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`Premenstrual Syndrome, Alternative Medicine Review 8(2):171-9 (2003); NEPN Ex. 2056,
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`Bunea R, Farrah KE, Deutsch L., Evaluation of the effects of Neptune Krill Oil on the clinical
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`course of hyperlipidemia, Alternative Medicine Review 9(4):420-8 (2004); NEPN Ex. 2057,
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`These papers showed that krill oil had increased benefits as compared to fish oil with regard
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`to heart disease, PMS, and arthritis. Like fish oil, krill oil contains EPA and DHA. However,
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`it was observed that the EPA and DHA in krill oil are predominantly bound to phospholipids.
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`In contrast to krill oil, fish oil contains EPA and DHA predominantly bound to triglycerides.
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`Dr. Sampalis discovered that it was this phospholipid-bound EPA and DHA that resulted in
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`the delivery of superior health benefits.
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`11.
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`Bioavailability refers to the degree to which a nutrient will be absorbed by the
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`body. Bioefficacy refers to the degree to which a nutrient absorbed by the body will be
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`recognized at the target site to be incorporated into the target tissue. EPA and DHA are
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`more bioavailable and bioefficacious in humans when they are bound to phospholipids for
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`several reasons, including: (1) phospholipids are better absorbed through the gut than
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`triglycerides due to their chemical structure; (2) once absorbed, phospholipids are
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`incorporated in the exterior of chylomicrons (structures involved in lipid transport), rather
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`than buried in the interior of chylomicrons like triglycerides; (3) phospholipids are not
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`deposited in adipose tissue like triglycerides, and, therefore, are not utilized for energy in
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`beta-oxidation (i.e., fatty acids oxidation); (4) phospholipids are functional lipids in
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`membranes of target organs and tissues; as such they are likely recognized by the target
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`(cont’d)
`Deutsch L., Evaluation of the effects of Neptune Krill Oil on chronic inflammation and
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`arthritic symptoms, Journal of the American College of Nutrition 26(1):39-48 (2007).
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`organs and tissues more readily. As a result, krill oil is particularly efficient at delivering
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`EPA and DHA because those fatty acids are bound to phospholipids, as shown by recent
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`peer-reviewed articles demonstrating superior bioavailability of EPA and DHA from krill oil.
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`12. Neptune created the nutraceutical krill oil market and introduced its krill oil for
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`human consumption to the commercial market in 2003, 5 years before any of Neptune’s
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`competitors.2 Neptune’s competitors now market their products based on the superior
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`benefits of phospholipid-bound EPA and DHA,3 benefits that became known largely due to
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`Dr. Sampalis’ inventive efforts and seminal research.
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`13.
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`As Neptune, and much later, its competitors realized, krill oil contains “unique
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`and sensitive components” that require processing far more gentle than the traditional
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`method for extracting fish oil, i.e., by boiling.4 Extracted krill oil that is crude, i.e., unrefined,
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`will typically contain high concentrations of water and volatile matter. Applying high heat
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`such as boiling during extraction of krill oil, or during post-extraction refinement steps, can
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`cause degradation of the phospholipids, which as noted above, are a major component of
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`krill oil. Such degradation may occur, for example, as a result of hydrolysis or oxidation.
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`2 NEPN Ex. 2029, Brenna Tr. at 281:11-16; 285:1-11; 287:4-11.
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`3 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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`4 NEPN Ex. 2041, Enzymotec Introduction to Extraction Process, p. 3.
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`14. Hydrolysis refers to the degradation of phospholipids by breaking, for
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`example, the ester bonds attaching fatty acid chains to the glycerol backbone of the
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`phospholipid molecule, and thus releasing free fatty acids. This is discussed generally at
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`NEPN Ex. 2004, an excerpt of a widely used organic chemistry textbook, and shown
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`generally in the figure below:
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`In addition to phospholipids, the principles of hydrolysis apply to other lipids such as
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`triglycerides. The bond that holds fatty acids on the glycerol backbone of triglycerides or
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`phospholipids is the same covalent bond referred to as an ester bond.
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`To illustrate this, I have created a simple diagram below showing in red circles the ester
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`bonds in an exemplary triglyceride and a phospholipid molecule:
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` Triglyceride
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`Phospholipid – common structure
`(Phosphatidylethanolamine (PE))
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`Specifically, it is the ester bond that is degraded during hydrolysis of triglycerides or
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`phospholipids when they are subjected to heat in the presence of water and free fatty acids.
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`For purposes of analyzing the patentability of the ‘351 Patent claims over the cited prior art,
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`there is no relevant difference between hydrolysis of a phospholipid molecule and a
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`hydrolysis of a triglyceride molecule, and thus the Medina et al. and Herman and Groves
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`references provide relevant evidence of degradation that may occur as a result of
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`hydrolysis.5
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`15. Hydrolysis may cause release of free fatty acid chains, in which case the
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`degraded phospholipid becomes a lysophospholipid. Alternatively, hydrolysis can result in a
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`broken phosphate group, in which case the phospholipid ceases to exist and the resulting
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`5 NEPN Ex. 2006, Medina et al.; AKBM Ex. 1053, Jaczynski Dec. ‘348 Reexamination Part
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`I, p. 5.
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`molecule becomes a diglyceride. Increased hydrolysis will cause greater phospholipid
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`degradation, including increased breakage of phosphate groups.
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`16. Hydrolysis is driven by several factors, including water content and heat.
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`Following thermodynamic principles and first order reaction kinetics, the higher the
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`temperature, the greater the extent of hydrolysis is expected. The principle that hydrolysis
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`occurs upon heating is readily accepted in the field, especially in presence of water and a
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`high content of free fatty acids. Hydrolysis driven by heat is referred to as heat-induced
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`hydrolysis.
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`17.
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`In addition, hydrolysis may be acid-induced. Acid-induced hydrolysis is based
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`on the principle that the higher concentration of free fatty acids in an extract, the lower the
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`temperature point is at which lipids are hydrolyzed. In other words, hydrolysis will occur at a
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`lower temperature in an extract containing a high concentration of free fatty acids. As water
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`content, heat, or free fatty acid content increases, hydrolysis will also increase.
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`18.
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`These principles of hydrolysis that I’ve discussed are well-established in the
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`scientific literature. For example, there is a classic handbook, Fats & Oils, by CE Stauffer
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`that teaches these principles. The diagram below from the 1999 edition of Fats & Oils
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`illustrates the “sliding scale” principle I have described regarding how heat and free fatty
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`acids influence the occurrence of hydrolysis:
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`As shown in Figure 2-4 above, the smoke point of soybean oil decreases as the free
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`fatty acid concentration increases. Smoke point is the threshold temperature at which wisps
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`of smoke will be observed, which is an indication that the lipids are being hydrolyzed. As
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`shown above, the smoke point of soybean oil with 10% free fatty acids is about 125°C.
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`While this diagram pertains to soybean oil rather than krill oil, soybean oil has the same
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`ester bonds as krill oil or any other oil, for that matter, and so the data shown in this diagram
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`are relevant to understanding how free fatty acid concentration in krill oil would affect
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`hydrolysis. For example, this diagram indicates that Beaudoin’s krill extracts, which
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`Beaudoin Table 14 shows to contain over 20% free fatty acids, would be subject to lipid
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`hydrolysis at temperatures below 100°C.
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`19.
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`Applying high heat to a krill lipid extract when oxygen is present may also
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`cause oxidation of the fatty acids. Long chain polyunsaturated fatty acids like EPA and
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`DHA are very sensitive to heat in the presence of oxygen, and heat can cause them to
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`degrade into a variety of intermediate by-products.
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`IV.
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`LEGAL STANDARDS AND LEVEL OF ORDINARY SKILL IN THE ART
`20. Counsel has informed me of certain legal standards to be applied in my
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`analysis. I am not an attorney, and so I am relying only on these standards as provided to
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`me by counsel.
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`21.
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`I have been advised that a patent claim is invalid as anticipated by a prior art
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`reference under 35 U.S.C. § 102 only where each and every limitation is found either
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`expressly or inherently in a single prior art reference. In other words, a prior art reference
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`must teach all the claim elements and the claimed arrangement in order to anticipate the
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`patent claim. My understanding is that if one element of the claim is missing either
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`expressly or inherently from a prior art reference, there is no anticipation.
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`22.
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`I have been advised that if a reference fails to expressly disclose one or more
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`elements of the patent claim, the reference may nevertheless anticipate the claim if the
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`missing elements are disclosed inherently. However, I have been advised that an element
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`is disclosed inherently only if it is “necessarily present” in the process or product described
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`in the prior art reference. I have also been advised that inherency may not be established
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`by a possibility, or even a probability, that a certain result may arise from a given set of
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`circumstances. I understand that it is impermissible to use the benefit of hindsight to
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`establish the inherency of any missing limitations.
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`23. My understanding is that a claimed invention is obvious if the differences
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`between it and the prior art are such that the subject matter as a whole would have been
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`obvious to a person of ordinary skill in the art at the time the invention was made.
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`24.
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`I have been advised that if a combination of two or more references is used to
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`argue that a claimed invention is obvious, there must be a reason, such as a teaching,
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`suggestion or motivation, that would have prompted a person of ordinary skill in the relevant
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`field to combine the elements in the way the claimed invention does. I also understand that
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`obviousness cannot properly be established through hindsight by using the invention as a
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`roadmap to find its prior art components. I have been advised that if the prior art teaches
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`away from combining known elements in the manner claimed by the invention at issue,
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`discovering a successful way to combine them is less likely to be obvious.
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`25.
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`I understand that the anticipation and obviousness analysis is based on the
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`perspective of one of ordinary skill in the art at the time of the inventions claimed in the ‘351
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`Patent. Based on my understanding of the ‘351 Patent, my opinion is that a person of
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`ordinary skill in the relevant art would have at least a bachelor’s degree or equivalent in life
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`sciences, and have studied or worked in the life sciences for at least 5 years, concentrating
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`for at least 1 year on natural marine products. I understand that Petitioner has proposed the
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`level of ordinary skill in the art to require (1) an advanced degree in a field such as chemical
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`engineering, food engineering, pharmacology, analytical chemistry, biochemistry, organic
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`chemistry, biology, marine biology, or food chemistry, and (2) at least several years of
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`experience in preparing lipid extracts from biological or natural products, for example in an
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`industrial or research setting, and/or several years of experience in analytical chemistry.6
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`26. While in my opinion, one with ordinary skill in the relevant art should have
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`experience in lipid extraction from natural products (a position with which Dr. Brenna
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`appears to agree),7 all of my opinions set forth below regarding why the ’351 Patent claims
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`are not anticipated and are non-obvious over the cited prior art apply equally under both my
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`and Petitioner’s proposed definitions of the level of ordinary skill.
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`27.
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`I understand that a patentee may claim a “priority date” based on an earlier-
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`filed patent application if, when viewed from the perspective of a person of ordinary skill in
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`the art, the application reasonably conveys that the inventor had possession of the claimed
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`subject matter. I also am informed that this analysis is performed on a claim-by-claim basis.
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`I also understand that certain other requirements must be met, including co-inventorship,
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`and co-pendency. If the earlier-filed application sufficiently supports the patent claim at
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`issue, and if the patent includes an appropriate priority statement, then it is my
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`understanding that the claim is entitled to the priority date of the earlier filed application.
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`28.
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`I also am informed that while the earlier-filed application’s disclosure must
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`support the claim whose priority date is in dispute, this disclosure does not have to be
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`identical to that of patent at issue. I understand that there is no hard and fast rule regarding
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`6 Aker Petition at 6 (emphasis added).
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`7 NEPN Ex. 2037, Brenna Tr. at 48:7-49:7.
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`the level of detail required for sufficient disclosure, and that the sufficiency of the disclosure
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`may depend on factors such as the nature and scope of the invention, the complexity and
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`predictability of the subject matter, and the scope of the claim.
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`V.
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`PRIORITY DATE
`29.
`The ‘351 Patent is a continuation of U.S. Patent No. 8,030,348, which is a
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`national stage of International Patent Application No. PCT/CA2002/001185 filed on July 29,
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`2002 (“the PCT Application”), which claims priority to U.S. Provisional Patent Application
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`No. 60/307,842, filed on July 27, 2001 (the “Provisional”).
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`30.
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`In my opinion, the “Provisional” provides sufficient description of the claimed
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`invention to entitle the ‘351 Patent claims to the priority date of the Provisional. The
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`Provisional explains that the invention is directed to phospholipid compounds preferably
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`derived from krill, and that the most important of these phospholipid compounds are PC,
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`PE, and PI.8 Each of these phospholipids has two attachment locations for fatty acid
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`chains.9 In the extract of the invention, preferred fatty acids are polyunsaturated omega-3
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`fatty acids, and the most prevalent of these are DHA and EPA.10
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`31.
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`The Provisional examples and figures are consistent with that disclosure. In
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`the example of Table 3, PC is the most prevalent phospholipid, followed by PE, with
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`8 AKBM Ex. 1062, Provisional at pp. 000003, 0000010, Table 3.
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`9 Id. at p. 000001.
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`10 Id. at pp. 0000010-11.
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`significantly smaller minimum quantities for the remaining phospholipids (e.g., PI and PS).
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`Figures 3A to 3K are mass spectra of “fatty acids attached to phospholipids in the
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`composition of the present invention,” and include phospholipid-bound EPA at 3G, H, and I.
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`The Provisional also discloses example fatty acid compositions including DHA and EPA for
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`both total lipids (Table 1) and phospholipids (Table 4). DHA and EPA are among the fatty
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`acids making up the largest components of the total lipids of Table 1 (with EPA being the
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`largest component of all fatty acids). Additionally, DHA and EPA are among the two largest
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`components of the phospholipids of Table 4 (with DHA being the largest component of all
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`fatty acids).
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`32.
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`In addition, the Provisional teaches that polyunsaturated fatty acids, in
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`particular omega-3 fatty acids, preferably make up at least 15% w/w, more preferably at
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`least 40% w/w, and even more preferably at least 45% w/w, of the total lipids in the
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`extract.11 DHA and EPA (as well as other acids) are present in significant quantities, with
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`DHA and EPA generally making up the largest component of the fatty acids (preferably
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`accounting for at least 35% w/w (more preferably 37%) of the total lipid content of the
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`extract).12
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`33.
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`In my opinion, Drs. Brenna and van Breemen fail to explain why a person of
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`ordinary skill in the art would not understand from reading the Provisional that Dr. Sampalis
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`11 Id.
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`12 Id. at p. 0000011.
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`was in possession of the claimed phospholipids – namely phospholipids in the most
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`important form (PC, PE, and PI), having the preferred fatty acids of the most prevalent type
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`(polyunsaturated omega-3s, in the form of DHA and/or EPA), attached at each of the
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`phospholipids’ two fatty acid locations (R1 and R2). Both Drs. Brenna and van Breemen
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`provide a list of particular lines of text that they allege to be included in the ‘351 Patent
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`specification but not in the Provisional, but fail to explain the significance, if any, of these
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`particular words to their priority date opinions. Similarly, Drs. Brenna and van Breemen
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`claim that certain tables included in the ‘351 Patent specification show different composition
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`data than the tables provided in the Provisional, but the fact that these two documents
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`characterize different krill oils does not diminish the significance of the Provisional
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`disclosures.
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`34. Regardless, I note that all of my opinions and analysis below regarding the
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`prior art, and the novelty of the ‘351 Patent claims over the prior art, would not change
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`whether the ‘351 Patent claims’ priority date is determined to be July 27, 2001 or July 29,
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`2002.
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`VI.
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`CLAIM CONSTRUCTION
`35. Counsel has informed me that in this proceeding, claims are to be given their
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`broadest reasonable interpretation in light of the specification. Counsel has further informed
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`me that claim terms or clauses should be given their plain and ordinary meaning as
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`Jacek Jaczynski Declaration
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`understood by a person of ordinary skill in the art, absent a contrary teaching in the
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`specification.
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`36.
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`I have been asked to provide an opinion on the meaning of the term “suitable
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`for human consumption” as it appears in the claims of the ’351 Patent. In my opinion, the
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`plain meaning of “suitable for human consumption” as the term is used in the ‘351 Patent
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`refers to krill extracts that are safe and appropriate for humans to consume, including by
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`oral ingestion. The specification teaches that the claimed extract is preferably consumed
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`repeatedly or even regularly over an extended period of time.13 For example, the
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`specification provides an example of the beneficial use of the extract over a 1.5 month
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`period. 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.
`
`37.
`
`I have been asked to provide an opinion on the meaning of the term "a
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`concentration of free fatty acids of about 5% w/w” as it appears in claims 5 and 28. The
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`specification indicates that when the term “about” is used with a specific numerical value,
`
`i.e., “about 5%,” the value may vary by at least ± 50% unless “about” is otherwise defined
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`13 E.g., AKBM Ex. 1001, ‘351 Patent, Abstract, col. 20, Example 2, Example 3.
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`(e.g., “wherein about represents ±10%” as recited in claims 2 and 25).14 Accordingly, it is
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`my opinion that the meaning of the term "a concentration of free fatty acids of about 5%
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`w/w” is 2.5% w/w to 7.5% w/w. Specifically, because 50% of 5% is 2.5%, 5% w/w ± 50%
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`would yield 2.5% w/w to 7.5% w/w. One of skill would not understand 5% ± 50%, as used
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`in claim 5, to refer to a percentage range that is 5% plus or minus an absolute value of 50%.
`
`Under that reasoning, claim 5 would cover of a range of minus 45% to plus 55% free fatty
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`acids, which is nonsensical because an extract cannot have a negative amount of free fatty
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`acids. Low levels of free fatty acids, i.e., 2.5-7.5%, also indicate that phospholipids have not
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`undergone substantial hydrolysis during production of the extract. As described above,
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`hydrolysis causes the degradation of phospholipids by breaking ester bonds and thus
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`releasing free fatty acids. Accordingly, a low free fatty acid level is consistent with a core
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`teaching of the ‘351 patent, namely recovery of intact phospholipids in a krill extract. A high
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`free fatty acid level, on the other hand (e.g., around 55%), would indicate that significant
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`hydrolysis has occurred in the course of producing the krill extract, and therefore the
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`phospholipids have degraded and the extract is less desirable.
`
`38.
`
`I have been asked to provide an opinion on the meaning of the term "about
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`40% w/w, wherein about represents ± 10%” as it appears in claims 2 and 25. It is my
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`opinion that the meaning of the term is 36% w/w to 44% w/w. A person of ordinary skill in
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`the art would understand that because 10% of 40% is 4%, 40% w/w ± 10% would yield 36%
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`14 See id. col. 21:62-67.
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`w/w to 44% w/w. For the same reasons discussed above with respect to claims 5 and 28,
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`one of skill would not interpret “about” as recited in claims 2 and 25 to mean 40% plus or
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`minus an absolute value of 10%.
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`39.
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`I have been asked to provide an opinion on the meaning of the term "about
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`45% w/w, wherein about represents ± 20%” as it appears in claims 3 and 26. It is my
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`opinion that the meaning of the term is 36% w/w to 54% w/w. A person of ordinary skill in
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`the art would understand that because 20% of 45% is 9%, 45% w/w ± 20% would yield 36%
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`w/w to 54% w/w. For the same reasons discussed above with respect to claims 5 and 28,
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`one of skill would not interpret “about” as recited in claims 3 and 26 to mean plus or minus
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`an absolute value of 20%.
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`40.
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`I have been asked to provide an opinion on the meaning of the term “capsule,
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`tablet, solution, syrup, or suspension” as it appears in claim 24. The ‘351 Patent teaches
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`that “tablets or capsules” refer to oral preparations for the claimed krill extract, and that
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`“solutions, syrups or suspensions” refers to lipid preparations for oral administration.”15 My
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`opinion is therefore that the term “capsule, tablet, solution, syrup, or suspension” as used in
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`claim 24 refers to a preparation of the claimed extract for oral administration. My
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`interpretation is consistent with the specification and the sequence of independent claims 1,
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`24, and 70, i.e., claim 1 recites the claimed krill extract and the following independent claims
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`recite particular preparations of the extract of claim 1, i.e., preparations for oral
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`15 AKBM Ex. 1001, ‘351 Patent, col. 20:10-22.
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`administration (claim 24), food, beverages, or supplements (claim 47), and cosmetics (claim
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`70).
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`VII. BEAUDOIN I DOES NOT ANTICIPATE ANY OF CLAIMS 1, 4-6, 9, 12, 13, 19-24, 27-
`29, 32, 35, 36, OR 42-46
`41.
`It is my opinion that Beaudoin I (“Beaudoin”) does not anticipate claims 1, 4-6,
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`9, 12, 13, 19-24, 27-29, 32, 35, 36, or 42-46 of the ‘351 patent.
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`A.
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`42.
`
`Beaudoin does not expressly or inherently disclose the claimed
`phospholipid
`The ‘351 Patent describes and claims a krill extract that is suitable for human
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`consumption and comprises a phospholipid of the formula (I):
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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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`I will refer to these claimed species of phospholipid with EPA and/or DHA concurrently
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`attached at the sn-1 and sn-2 positions as the “claimed phospholipid.”
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`Beaudoin does not disclose any phospholipid with EPA and/or DHA attached,
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`43.
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`let alone with EPA and/or DHA concurrently attached at both the sn-1 and sn-2 positions as
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`the claims require. Petitioner does not allege that Beaudoin expre
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