Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESOURCES INC.
`Patent Owner
`
`
`CASE IPR: Unassigned
`
`Declaration of Dr. J. Thomas Brenna
`
`1
`
`
`
`
`
`
`
`
`
`
`
`000001
`
`
`Ex. 1042, Brenna Declaration
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESOURCES INC.
`Patent Owner
`
`
`CASE IPR: Unassigned
`
`Declaration of Dr. J. Thomas Brenna
`
`1
`
`
`
`
`
`
`
`
`
`
`
`000001
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`
`
`I, Dr. J. Thomas Brenna, state as follows:
`
`
`
`1.
`
`I have been retained by counsel for Petitioner Aker BioMarine AS to
`
`provide an expert declaration this action.
`
`2.
`
`I have reviewed U.S. Patent 8,278,351 (hereinafter ‘351 patent; Ex.
`
`1001) and the claims contained therein. It is my understanding that the ‘351 patent
`
`contains claims to krill extracts (claims 1-23); capsules, tablets, solutions, syrups
`
`or suspensions comprising the krill extracts (claims 24-46); foods, beverages or
`
`nutritional supplements comprising the krill extracts (claims 47-69); cosmetics
`
`comprising the krill extracts (claims 70-93); and Antarctic krill extracts (claim 94).
`
`The common feature of the independent claims (claims 1, 24, 47, 70 and 94) is the
`
`requirement of
`
`
`
`2
`
`000002
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`
`
`The dependent claims add limitations on other components of the
`
`composition such as omega-3 content, polyunsaturated fatty acid content, content
`
`of other lipid classes, metal content and antioxidant content.
`
`3.
`
`I have been asked to provide analysis and expert opinions on the
`
`following: whether any prior art reference teaches every element of any of the
`
`Claims of the ‘351; whether any single prior art reference or combination of
`
`references, renders any of the Claims of the ‘351 patent obvious.
`
`
`
`3
`
`000003
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`4.
`
`In connection with providing my opinions, I have further been asked
`
`
`
`to provide an overview of the technology of the ‘351 Patent.
`
`5.
`
`I hold a B.S. degree in Nutritional Biochemistry from the University
`
`of Connecticut (1980), an M.S. degree in Chemistry from Cornell University
`
`(1982), and a Ph.D. in Chemistry from Cornell University (1985).
`
`6.
`
`From 1985 to 1989, I served as a staff scientist in the Advanced
`
`Technology Development Laboratory at IBM Corporation, Endicott, New York,
`
`where I was the Founding Director of the Fourier Transform Mass Spectrometry
`
`Laboratory. From 1988 to 1989, I served as a faculty member at Binghamton
`
`University, Binghamton, New York, where I held the title of Adjunct Assistant
`
`Professor of Chemistry. From 1989 to 2000, I served as a faculty member in the
`
`Division of Nutritional Sciences at Cornell University, Ithaca, New York, where I
`
`held the titles of Assistant Professor and Associate Professor. In 2000, I became
`
`Professor of Human Nutrition and Professor of Chemistry and Chemical Biology at
`
`Cornell University. In 2006, I was appointed Adjunct Professor in the Department
`
`of Public Health Sciences at the University of Rochester College of Medicine and
`
`Dentistry, Rochester, New York.
`
`7.
`
`I have been principal investigator for over $15 million in sponsored
`
`Research Funding Awards to investigate the various aspects of nutrition and
`
`
`
`4
`
`000004
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`techniques of molecular biology and genetics, mass
`
`
`
`metabolism using
`
`spectrometry, and high precision isotope ratio mass spectrometry in antidoping
`
`science. I am currently a member of the 2015 Dietary Guidelines Advisory
`
`Committee appointed jointly by US Secretary of Health and Human Services
`
`Kathleen Sebelius and Secretary of Agriculture Tom Vilsack. I was the 2013
`
`recipient of the American Society for Nutrition Robert H. Herman Award, given
`
`each year to a clinical investigator whose research work has contributed
`
`importantly to the advancement of clinical nutrition, particularly the biochemical
`
`and metabolic aspects of human nutrition. I have also been selected to advise a
`
`number of scientific organizations, including:
`
`•
`
`panelist and author for the FAO/WHO Expert Consultation on Fats
`
`and Fatty Acids in Human Nutrition (2008–2011);
`
`•
`
`research proposal review on behalf of the National Institutes of Health
`
`for: Regional Comprehensive Metabolomics Resource Core program (2013,
`
`2012); Enabling Biomedical Technologies-Shared Research Instrumentation
`
`(2010; Study Section Chairman); NIGMS Large Scale Collaboration (2008);
`
`Biological Chemistry and Macromolecular Biophysics Study Section (2001–2007);
`
`Metabolomics Panel, NIH Director’s Roadmap
`
`(2004); NCI
`
`Innovative
`
`
`
`5
`
`000005
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`Technologies for Molecular Analysis of Cancer (2004); NIH Intramural Reviews
`
`(1997, 2009);
`
`
`
`•
`
`research proposal review for the World Antidoping Agency (WADA)
`
`Research grants program (2012, 2007);
`
`•
`
`research proposal
`
`review
`
`for
`
`the NSF Major Research
`
`Instrumentation, Chemistry Division (2006, 2004);
`
`•
`
`research proposal review for the Louisiana Board of Regents
`
`Chemical Instrumentation Review Panel (2008, 2005, 2002);
`
`
`
`•
`
`President-Elect/Vice President of the International Society for the
`
`Study of Fatty Acids and Lipids (ISSFAL);
`
`•
`
`Member of the National Healthy Mothers, Healthy Babies Coalition
`
`Maternal Nutrition Group (2007-present) and the European Commission-sponsored
`
`Perilip Group (2005);
`
`•
`
`Member of the Scientific Advisory Board for the Fats of Life
`
`Newsletter (2006-present);
`
`•
`
`Member of the Editorial Advisory Board for Rapid Communications
`
`in Mass Spectrometry (2002–present); and
`
`
`
`6
`
`000006
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`•
`
`Member of the Advisory Counsel for the NIH Center for Biomedical
`
`
`
`Accelerator Mass Spectrometry, Lawrence Livermore National Laboratory,
`
`Livermore, CA (1999–present).
`
`
`
`8.
`
`•
`
`I have co-organized numerous conferences and workshops, including:
`
`American Society for Mass Spectrometry 28th Asilomar Conferences
`
`on Mass Spectrometry: Mass Spectrometry in Food Safety and Quality (Monterey,
`
`California, 2012);
`
`•
`
`The 10th Fatty Acids and Cell Signaling (FACS) Workshop: DHA in
`
`Translational Medicine (New Orleans, LA, 2011);
`
`•
`
`A Celebration of DHA: Discovery, Achievement and Challenges for
`
`Global Health 40 Years On (Royal Society of Medicine, London, UK, 2010);
`
`•
`
`•
`
`The Workshop on DHA as an Essential Nutrient (Baltimore, 2008);
`
`Co-editor, PLEFA
`
`81(2):97–236
`
`(2009)
`
`(DHA Workshop
`
`Proceedings);
`
`•
`
`The 8th Fatty Acid and Cell Signaling (FACS) Workshop:
`
`Polyunsaturates, Inflammation and Brain Function (Quebec City, Canada, 2007);
`
`•
`
`•
`
`
`
`Guest Editor, PLEFA 77(6):225–366 (2007) (FACS-8 Proceedings);
`
`The 6th Congress of ISSFAL (Montreal, Canada) 2002; and
`
`7
`
`000007
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`•
`
`since 2002 the scientific advisory panel for the biennial International
`
`
`
`Symposium on Isotopomers.
`
`
`
`9.
`
`I have presented over 100 invited lectures, throughout the world, at
`
`universities, companies, and conferences, including Invited Speaker at the 10th
`
`International Mass Spectrometry Conference Symposium on Lipidomics, Kyoto,
`
`Japan, 2012.
`
`10.
`
`I have authored or co-authored more than 150 articles in peer-
`
`reviewed journals, have co-authored several book chapters, and co-edited two
`
`books,
`
`including “Lipid Analysis and Lipidomics: New Techniques and
`
`Applications”, AOCS Press, 2006.
`
`11. My research is highly interdisciplinary and currently focuses on the
`
`biochemistry, molecular biology and genetics of fat metabolism in humans using
`
`among other techniques, mass spectrometry.
`
`12. Over the past five years, research grants were made to Cornell
`
`University for my work on metabolism, including a five year investigator-initiated
`
`R01 grant from the US National Institutes of Health, which has continuously
`
`supported my research group at Cornell via nationally competitive grant programs
`
`for more than 20 years.
`
`
`
`8
`
`000008
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`13. A more detailed account of my work experience, publications, and
`
`
`
`other qualifications—as well as a list of cases during the last four years in which I
`
`have signed a Protective Order, have testified as an expert either at a trial, hearing,
`
`or deposition, or have submitted statements / opinions—is listed in my Curriculum
`
`Vitae.
`
`14.
`
`I am being compensated at my customary consulting rate of $475 per
`
`hour for my time spent on this matter, and I am also being reimbursed for
`
`reasonable expenses incurred with respect to this matter. My compensation is not
`
`contingent on the conclusions I reach in my expert report.
`
`15.
`
`I have reviewed and considered, in the preparation of this report, the
`
`documents in the below table.
`
`Exhibit
`
`Description
`
`No.
`
`1001
`
`U.S. Pat. No. 8,278,351 to Sampalis (“’351”)
`
`1002
`
`WO 00/23546 to Beaudoin (“Beaudoin I”)
`
`1003
`
`Canadian Application 2,251,265 to Beaudoin (“Beaudoin II”)
`
`1004
`
`Certified translation of Ex. 1070: Japanese Unexamined Patent
`
`
`
`9
`
`000009
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`Application Publication No. 02-215351, titled Krill Phospholipids
`
`Fractioning Method (“Maruyama,”); Certificate of Translation
`
`provided as Ex. 1071.
`
`1005
`
`Certified translation of Ex. 1072: Fisheries Agency, General Report
`
`on Research and Development of Techniques in Processing and
`
`Utilization of Marine Products, Chapter 6, Development of
`
`technology for recovery of valuable substances (astaxanthin) from
`
`krill, by Takao Fujita, pp. 273-307 (March 1985) (“Fujita”) ;
`
`Certificate of Translation provided as Ex. 1073.
`
`1006
`
`Fricke et al., Lipid, Sterol, and Fatty Acid Composition of Antarctic
`
`Krill, Lipids, Vol. 19, No. 11, pp. 821-827 (1984) (“Fricke”)
`
`1007
`
`Bottino, N.R., “Lipid Composition of Two Species of Antarctic
`
`Krill: Euphausia Superba and E. Crystallorophias,” Comp.
`
`Biochem. Physiol., 1975, Vol. 50B, pp. 479-484 (“Bottino”)
`
`1008
`
`Canadian Patent No. 1098900, titled Method for the Processing of
`
`Krill to Produce Protein, Lipids and Chitin (“Rogozhin”)
`
`1009
`
`Itano Refrigerated Food Co., Ltd., Bio & High Technology
`
`
`
`10
`
`0000010
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`Announcement and Natural Astaxanthin & Krill Lecithin, pp. 1-16
`
`(on or before December 28, 1994) (“Itano”)
`
`1010
`
`WO97/39759 to Stoll (“Stoll”)
`
`1011
`
`Final Prospectus dated May 11, 2001 (“Final Prospectus”)
`
`1012
`
`“Neptune Technologies & Bioressources Soon to Obtain a Major
`
`Patent in Over 30 Countries” (“2011 Press Release,”)
`
`1013
`
`Le Grandois et al., Investigation of Natural Phosphatidylholine
`
`Sources: Separation and Identification by Liquid Chromatography -
`
`Electrospray Ionization-Tandem Mass Spectrometry (LC-ESI-MS2)
`
`of Molecular Species, J. Agric. Food Chem., 57, 6014-20 (2009)
`
`(“Le Grandois”)
`
`1014
`
`Certified translation of Ex. 1074: Japanese Patent No. 60-153779,
`
`entitled “Nutritional Supplement” (“Fukuoka ”); Certificate of
`
`Translation provided as Ex. 1075
`
`1015
`
`Certified translation of Ex. 1076: Japanese Patent Publication No.
`
`H08-231391, entitled “Medicine for Improvement of Dementia
`
`
`
`11
`
`0000011
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`Symptoms” (“Yasawa”); Certificate of Translation provided as Ex.
`
`1077.
`
`1016
`
`Suzuki, T. and Shibata, N., “The utilization of Antarctic krill for
`
`human food,” Food Rev. Int’l, 6:1, 119-147 (1990) (“Suzuki”)
`
`1017
`
`Bergelson (ed.), Lipid Biochemical Preparations, Chapter I.1, pp.
`
`1-13 (1980) (“Bergelson”)
`
`1018
`
`WHO News and Activities, Bulletin of the World Health
`
`Organization, 73(4), pp. 547-51 (1995) (“WHO Bulletin”)
`
`1019
`
`Bell and Dick, Molecular Species Composition of the Major Diacyl
`
`Glycerophospholipids from Muscle, Liver, Retina and Brain of Cod
`
`(Gadus morhua), Lipids, Vol. 26, No. 8, pp. 565-573 (1991)
`
`(“Bell and Dick”)
`
`1020
`
`Henderson et al., Lipid Composition of the Pineal Organ from
`
`Rainbow Trout (Oncorhynchus mykiss), Lipids, Vol. 29, No. 5,
`
`pp. 311-317 (1994) (“Henderson ”)
`
`1031
`
`Winther et al., Elucidation of Phosphatidylcholine Composition in
`
`
`
`12
`
`0000012
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`Krill Oil Extracted from Euphausia superba, Lipids 46(1):25-36
`
`(2011)(“Winther”)
`
`1037
`
`Grit et al., Int. J. Pharmaceutics 50:1-6 (1989)
`
`1038
`
`Herman and Groves, Pharmaceutical Research 10(5):774-776
`
`(1993)
`
`1039
`
`Watanabe et al., Effective Components in Cuttlefish Meal and Raw
`
`Krill for Improvement of Quality of Red Seabream Pagrus major
`
`Eggs, Nippon Suisan Gakkaishi 57(4):681-694 (1991)(“Watanabe”)
`
`1040
`
`Declaration of Dr. Richard van Breemen in Support of Inter Partes
`
`Review of U.S. Pat. No. 8,278,351 (“Van Breemen”)
`
`1041
`
`Declaration of Dr. Suzanne (“Budge”)
`
`1043
`
`Expert Witness Report of Dr. Theodore Welch submitted in relation
`
`to ITC Investigation No. 337-TA-877 (“Welch”)
`
`1044
`
`Declaration of Dr. Jeff Moore (“Moore”)
`
`1045
`
`Declaration of Dr. Albert Lee (“Lee”)
`
`
`
`13
`
`0000013
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`1047
`
`Declaration of Bjorn Ole Haugsgjerd submitted during inter partes
`
`reexamination of parent patent U.S. 8,030,348 (“Haugsgjerd Decl.”)
`
`1048
`
`Supplemental Declaration of Bjorn Ole Haugsgjerd submitted
`
`during inter partes reexamination of parent patent U.S. 8,030,348
`
`(“Haugsgjerd Supp. Decl.”)
`
`1049
`
`Declaration of Dr. Thomas Gundersen submitted during inter partes
`
`reexamination of parent patent U.S. 8,030,348 (“Gundersen Decl.”)
`
`1050
`
`Supplemental Declaration of Dr. Thomas Gundersen submitted
`
`during inter partes reexamination of parent patent U.S. 8,030,348
`
`(“Gundersen Supp. Decl.”)
`
`1051
`
`Declaration of Dr. Earl White submitted during prosecution of
`
`parent patent U.S. 8,030,348 (“2011 White Decl.”)
`
`1052
`
`Supplemental Declaration of Dr. Earl White submitted during
`
`prosecution of parent patent U.S. 8,278,351 (“White Supp. Decl.”)
`
`1053
`
`Declaration of Dr. Jacek Jaczynski from inter partes reexamination
`
`of the parent patent U.S. 8,030,348 (“Jaczynski Reexam. Decl.”)
`
`
`
`14
`
`0000014
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`1054
`
`Declaration of Dr. Yeboah submitted during inter partes
`
`reexamination of parent patent U.S. 8,030,348 (“Yeboah Reexam
`
`Decl.”)
`
`1055
`
`Supplemental Declaration of Dr. Earl White submitted during inter
`
`partes reexamination of parent patent U.S. 8,030,348 (“White Supp.
`
`Reexam. Decl.”)
`
`1056
`
`Declaration of Dr. Shahidi submitted during inter partes
`
`reexamination of parent patent U.S. 8,030,348 (Shahidi Reexam.
`
`Decl.”
`
`1057
`
`Declaration of Dr. Tina Sampalis submitted during inter partes
`
`reexamination of parent patent U.S. 8,030,348 (Sampalis”)
`
`1058
`
`Declaration of Dr. Yeboah submitted during prosecution of parent
`
`patent U.S. 8,278,351 (“Yeboah ‘351 Decl.”)
`
`1059
`
`Declaration of Dr. Shahidi submitted during prosecution of parent
`
`patent U.S. 8,278,351 (Shahidi ‘351 Decl.”)
`
`1060
`
`Declaration of Dr. Jaczynski submitted during prosecution of parent
`
`
`
`15
`
`0000015
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`patent U.S. 8,278,351 (Jaczynski ‘351 Decl.”)
`
`1061
`
`April 2, 2012 Response to Office Action, ‘351 patent
`
`1062
`
`Provisional Application No. 60/307,842 (Priority document for the
`
`‘351 patent)
`
`1063
`
`Office Action dated January 5, 2012, ‘351 patent
`
`1066
`
`Declaration of Dr. Van Breemen submitted during Ex parte
`
`Reexamination of the ‘351 patent (Van Breemen ‘351 Reexam.
`
`Decl.”
`
`1067
`
`Declaration of Dr. Van Breemen submitted during Inter partes
`
`Reexamination of the ‘348 patent (Van Breemen ‘348 Reexam
`
`Decl.”
`
`1068
`
`Medina et al., J. Amer. Oil Chem. Soc. 71(5):479-82 (1994)
`
`1069
`
`U.S. Patent No. 8,030,348
`
`1078
`
`Folch, et al., A Simple Method for the Isolation and Purification of
`
`Total Lipids from Animal Tissues. J. Biol. Chem., 226, 497-509
`
`
`
`16
`
`0000016
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`(1957)
`
`
`
`1079
`
`Declaration of Dr. Chong Lee submitted during inter partes
`
`reexamination of parent patent U.S. 8,030,348 (“Lee Reexam
`
`Decl.”)
`
`
`
`
`
`16.
`
`In this section I describe my understanding of certain legal standards.
`
`I have been informed of these legal standards by Petitioners’ attorneys. I am not
`
`an attorney, and I am relying only on instructions from Petitioners’ attorneys for
`
`these legal standards. I have applied these understandings in my analysis as
`
`detailed below.
`
`17.
`
`I understand that in order to receive a patent an inventor must invent
`
`or discover a new and useful process, machine, manufacture, or composition of
`
`matter.
`
`18.
`
`I understand that patent protection may be granted for any new and
`
`useful process, machine, manufacture, or composition of matter, or any new and
`
`useful improvement thereof.
`
`19. With respect to the level of ordinary skill in the art at the relevant
`
`times applicable to the ‘351 patent, I understand that factors such as the education
`
`
`
`17
`
`0000017
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`level of those working in the field, the sophistication of the technology, the types
`
`of problems encountered in the art, the prior art solutions to those problems, and
`
`the speed at which innovations are made may help establish the level of skill in the
`
`art.
`
`20.
`
`I understand that Petitioners’ have proposed the following definition
`
`of a person of ordinary skill in the art (POSA) at the time of the alleged invention:
`
`a person with an advanced degree in a field such as chemical engineering, food
`
`engineering, pharmacology, analytical chemistry, biochemistry, organic chemistry,
`
`biology, marine biology, or food chemistry, and at least (i) several years of
`
`experience in preparing lipid extracts from biological or natural products, for
`
`example in an industrial or research setting and/or (ii) several years of experience
`
`in analytical chemistry. A person of ordinary skill in the art may consist of a team
`
`of individuals with the foregoing education and experience. The more education
`
`one has, for example post-graduate degrees and/or study, the less industry
`
`experience is needed to attain an ordinary level of skill.” I agree with Petitioners’
`
`proposed definition because it is consistent with the literature, credentials of
`
`individuals working on lipid extractions, and the skill necessary to perform these
`
`extractions and interpret their results.
`
`
`
`18
`
`0000018
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`21.
`
`I consider myself to be an expert in the art of the ‘351 Patent at the
`
`
`
`time of the alleged inventions claimed therein under Petitioners’ definition of the
`
`term.
`
`I understand that the first step in comparing prior art to a patent claims is to
`
`properly construe the claims to determine claim scope and meaning. I understand
`
`that in Inter Partes Review proceedings the claims terms are presumed to take on
`
`their ordinary and customary meaning based on the broadest reasonable
`
`interpretation of the claim language. For example, when the broadest reasonable
`
`interpretation is applied:
`
`• The terms “Krill extract” and “Antarctic krill extract” read on any
`
`krill extract containing any amount of the claimed phospholipids.
`
`There is no element in the claims that distinguished Antarctic krill
`
`extracts from any other krill extract.
`
`• The claims read on extracts that contain any amount of the claimed
`
`phospholipids.
`
`• The term “suitable for human consumption” reads on any form of
`
`consumption by human (e.g., oral or topical administration) and
`
`places no limit on the amount that is consumed.
`
`
`
`19
`
`0000019
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`• The term “solution” reads on any solution (such as a krill oil)
`
`containing the claimed phospholipid molecules including lipid
`
`extracts in which the phospholipids are dissolved.
`
`• The term “food” reads on any substance (such as a krill oil) consisting
`
`of nutrients such as proteins, carbohydrates, and fats and used in the
`
`body of an organism to sustain growth, repair, and vital processes and
`
`to furnish energy.
`
`• The terms “cosmetic” reads on substance that can be applied
`
`externally to the skin and can include oils such as krill oil.
`
`• The phrase “extracted under conditions suitable for preserving an
`
`effective amount of a phospholipid . . .” reads on methods that
`
`preserve an amount effective for any purpose contemplated in the
`
`specification and does not limit the scope of the claims as the
`
`specification does not disclose what constitutes an effective amount.
`
`
`
`The term “about” is defined in the specification at col. 21, line 61-63 as
`
`specifying that when used with a numerical value, the value may vary by at least
`
`+/- 50%.
`
`22.
`
`I understand that a patent or other publication must first qualify as
`
`prior art before it can be used to invalidate a patent claim. I understand that
`
`
`
`20
`
`0000020
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`documents and materials that qualify as prior art can be used to render a claim
`
`unpatentable as anticipated under 35 U.S.C. § 102 or as obvious under 35 U.S.C.
`
`§ 103.
`
`23.
`
`I understand that the “priority date” of a patent is taken to be the date
`
`on which it is filed. I further understand that a patent may be entitled to a priority
`
`date that corresponds to the filing date of an earlier-filed patent or application if
`
`two criteria are met: 1) the patent expressly claims priority to the earlier-filed
`
`patent or application, and 2) the earlier-filed patent or application provides
`
`adequate support for the patent’s claims under 35 U.S.C. § 112(a). I am aware
`
`that patents may claim the benefit of priority of an earlier-filed patent or
`
`application through one or more intermediate patents and/or applications. In such
`
`a case, the patent is entitled to the priority date of the earlier-filed patent or
`
`application if: 1) express claims of priority are made to the earlier filed patent or
`
`application and to the intermediate patents and/or applications, and 2) each of the
`
`patents and/or applications provide adequate support for the patent’s claims under
`
`35 U.S.C. § 112(a).
`
`24.
`
`I understand that the priority date of each patent claim is to be
`
`resolved independently of the priority dates of other claims. Indeed, different
`
`priority dates may apply for different claims within a common patent.
`
`
`
`21
`
`0000021
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`25.
`
`I further understand that the “critical date” for a patent is one year
`
`
`
`prior to its effective filing date. It is my understanding that the critical date is
`
`significant because patents, systems, or documents that are public prior to the
`
`critical date are prior art that can invalidate a patent claim regardless of the
`
`purported date of invention.
`
`26.
`
`I understand that, once the claims of a patent have been properly
`
`construed, the second step in determining anticipation of a patent claim requires a
`
`comparison of the properly construed claim language to the prior art on a
`
`limitation-by-limitation basis.
`
`27.
`
`I understand that a prior art reference “anticipates” a claim, and thus
`
`renders the claim unpatentable, if all elements of the claim are disclosed in that
`
`prior art reference, either explicitly or inherently (i.e., necessarily present or
`
`implied).
`
`28.
`
`I understand that a claim is invalid under 35 U.S.C. § 102 of the
`
`Patent Act:
`
`•
`
`(a) if the claimed invention was known or used by others in the
`
`U.S., or was patented or published anywhere, before the applicant’s invention. I
`
`understand that a U.S. or foreign patent qualifies as prior art to an patent claim if
`
`the date of issuance of the patent is prior to the invention of the patent claim. I
`
`
`
`22
`
`0000022
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`further understand that a printed publication, such as an article published in a
`
`magazine or trade publication or a U.S. or foreign patent application, also qualifies
`
`as prior art to a patent claim if the date of publication is prior to the invention of
`
`the patent claim.
`
`•
`
`(b) if the invention was patented or published anywhere, or was
`
`in public use, on sale, or offered for sale in this country, more than one year prior
`
`to the filing date of the patent application. I understand that a U.S. or foreign
`
`patent qualifies as prior art to a patent claim if the date of issuance of the patent is
`
`more than one year befores the filing date of the patent claim. I further understand
`
`that a printed publication, such as an article published in a magazine or trade
`
`publication or a U.S. or foreign patent application, also qualifies as prior art to a
`
`patent claim if the publication occurs more than one year before the filing date of
`
`the patent.
`
`•
`
`(e), if an invention described by that claim was described in (1)
`
`an application for a patent, published under the Patent Act, by another that was
`
`filed in the U.S. before the date of invention for such a claim or (2) a U.S. patent
`
`granted on an application for a patent by another that was filed in the U.S. before
`
`the date of invention for such a claim. I understand that a U.S. patent qualifies as
`
`
`
`23
`
`0000023
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`prior art to a patent claim if the application for that patent was filed in the United
`
`States before the invention date of the patent claim.
`
`•
`
`(f) if the invention was invented by another prior to the claimed
`
`invention; and
`
`•
`
`(g)(2) if, prior to the date of invention for the claim, the
`
`invention was made in the U.S. by another who had not abandoned, suppressed or
`
`concealed the invention.
`
`29.
`
`I have been instructed by counsel on the law regarding obviousness,
`
`and understand that even if a patent is not anticipated, it will be unpatentable if the
`
`differences between the claimed subject matter and the prior art are such that the
`
`subject matter as a whole would have been obvious at the time the invention was
`
`made to a person of ordinary skill in the pertinent art.
`
`30.
`
`I understand that a person of ordinary skill in the art provides a
`
`reference point from which the prior art and claimed invention should be viewed.
`
`This reference point prevents one from using his or her own insight or hindsight in
`
`deciding whether a claim is obvious. Thus, “hindsight reconstruction” cannot be
`
`used to combine references together to reach a conclusion of obviousness.
`
`
`
`24
`
`0000024
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`31.
`
`I also understand that an obviousness determination includes the
`
`
`
`consideration of various factors such as (1) the scope and content of the prior art,
`
`(2) the differences between the prior art and the Claims, (3) the level of ordinary
`
`skill in the pertinent art, and (4) the existence of secondary considerations of non-
`
`obviousness.
`
`32.
`
`I have been informed and understand that the obviousness analysis
`
`requires a comparison of the properly construed claim language to the prior art on
`
`a limitation-by-limitation basis. A claimed invention is obvious under any of the
`
`following circumstances:
`
`(a) it is no more than a combination of prior art elements
`
`according to known methods that yield predictable results. I
`
`understand that when a patent simply arranges old elements with each
`
`performing the same function it had been known to perform and
`
`yields no more than one of ordinary skill in the art would reasonably
`
`expect from such an arrangement, the combination is obvious. It is
`
`further my understanding that a proper obviousness analysis focuses
`
`on what was known or obvious to a person of ordinary skill in the art.
`
`Accordingly, I understand that any need or problem known in the field
`
`of endeavor at the time of invention and addressed by the patent can
`
`provide a reason for combining the elements in the manner claimed;
`25
`
`
`
`0000025
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`(b) it is a simple substitution of one known element for another
`
`
`
`that obtains predictable results;
`
`(c) it uses known techniques to improve similar devices
`
`(methods, or products) in the same way;
`
`(d) it applies a known technique to a known device (method, or
`
`product) ready for improvement to yield predictable results;
`
`(e) it is “obvious to try” — choosing from a finite number of
`
`identified, predictable solutions, with a reasonable expectation of
`
`success. For example, when there is a design need or market pressure
`
`to solve a problem and there are a finite number of identified,
`
`predictable solutions, a person of ordinary skill has good reason to
`
`pursue the known options within his or her technical grasp because
`
`the result is likely the product not of innovation but of ordinary skill
`
`and common sense which led to a reasonable expectation of success;
`
`(f) known work in one field of endeavor prompts variations of it
`
`for use in either the same field or a different one based on design
`
`incentives or other market forces, if the variations would have been
`
`predictable to one of ordinary skill in the art; and
`
`
`
`26
`
`0000026
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`(g) there is some teaching, suggestion, or motivation in the
`
`
`
`prior art that would have led one of ordinary skill to modify the prior
`
`art reference or to combine prior art reference teachings to arrive at
`
`the claimed invention. In other words, even if one reference does not
`
`show the whole of the invention, if it would have been obvious to a
`
`person of ordinary skill in the art at the relevant time to add the
`
`missing pieces to the invention (for example as a matter of standard
`
`engineering practice or application of a well known principle in the
`
`field), then a single reference can render a claim invalid even if it does
`
`not show the whole invention. Moreover, a combination of two or
`
`more references can render a claim invalid as obvious whether or not
`
`there is an explicit suggestion in one of the references to combine the
`
`two references, if as a matter of engineering skill or practice in the
`
`field it would be known to do so.
`
`33.
`
`I understand that a claim can be obvious in light of a single reference,
`
`without the need to combine references, if the elements of the claim that are not
`
`found explicitly or inherently in the reference can be supplied by the common
`
`sense of one of skill in the art.
`
`
`
`27
`
`0000027
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`34.
`
`I also understand that, when considering a reference for purposes of
`
`
`
`an obviousness analysis, the reference must be taken for everything it teaches.
`
`35. And as stated above, secondary considerations must be examined to
`
`determine whether a certain invention would have been obvious to one of ordinary
`
`skill in the art. I understand that secondary considerations of non-obviousness are
`
`part of the obviousness inquiry under § 103, and that some examples of secondary
`
`considerations that tend to show non-obviousness include:
`
`(1)
`
`any long-felt and unmet need in the art that was satisfied by the
`
`invention of the patent;
`
`(2)
`
`(3)
`
`any failure of others to achieve the results of the invention;
`
`any commercial success or lack thereof of the products and processes
`
`covered by the invention;
`
`(4)
`
`(5)
`
`(6)
`
`any deliberate copying of the invention by others in the field;
`
`any taking of licenses under the patent by others;
`
`any expression of disbelief or skepticism by those skilled in the art
`
`upon learning of the invention;
`
`(7)
`
`(8)
`
`(9)
`
`
`
`any unexpected results achieved by the invention;
`
`any praise of the invention by others skilled in the art; and
`
`any lack of contemporaneous and independ
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
