`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
`
`Petition for Inter Partes Review
`Of U.S. Patent 8,278,351
`Exhibit
`ENZYMOTEC - 1042
`
`CASE IPR: Unassigned
`
`Declaration of Dr. J. Thomas Brenna
`
`1
`
`Petition for Inter Partes Review
`Of U.S. Patent 8,278,351
`Exhibit
`ENZYMOTEC - 1042
`
`
`
`
`
`(cid:19)(cid:19)(cid:19)(cid:19)(cid:19)(cid:20)
`
`
`
`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`
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`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
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`
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`2
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`000002
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`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
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`
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`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.
`
`
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`3
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`000003
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`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
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`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
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`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
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`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);
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`Biological Chemistry and Macromolecular Biophysics Study Section (2001–2007);
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`Metabolomics Panel, NIH Director’s Roadmap
`
`(2004); NCI
`
`Innovative
`
`
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`5
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`000005
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`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
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`
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`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
`
`
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`6
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`000006
`
`
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`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
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`•
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`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
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`7
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`000007
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`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
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`•
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`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
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`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
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`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
`
`
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`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
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`specification does not disclose what constitutes an effective amount.
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`The term “about” is defined in the specification at col. 21, line 61-63 as
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`specifying that when used with a numerical value, the value may vary by at least
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`+/- 50%.
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`22.
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`I understand that a patent or other publication must first qualify as
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`prior art before it can be used to invalidate a patent claim. I understand that
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`documents and materials that qualify as prior art can be used to render a claim
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`unpatentable as anticipated under 35 U.S.C. § 102 or as obvious under 35 U.S.C.
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`§ 103.
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`23.
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`I understand that the “priority date” of a patent is taken to be the date
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`on which it is filed. I further understand that a patent may be entitled to a priority
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`date that corresponds to the filing date of an earlier-filed patent or application if
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`two criteria are met: 1) the patent expressly claims priority to the earlier-filed
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`patent or application, and 2) the earlier-filed patent or application provides
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`adequate support for the patent’s claims under 35 U.S.C. § 112(a). I am aware
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`that patents may claim the benefit of priority of an earlier-filed patent or
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`application through one or more intermediate patents and/or applications. In such
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`a case, the patent is entitled to the priority date of the earlier-filed patent or
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`application if: 1) express claims of priority are made to the earlier filed patent or
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`application and to the intermediate patents and/or applications, and 2) each of the
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`patents and/or applications provide adequate support for the patent’s claims under
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`35 U.S.C. § 112(a).
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`24.
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`I understand that the priority date of each patent claim is to be
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`resolved independently of the priority dates of other claims. Indeed, different
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`priority dates may apply for different claims within a common patent.
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`25.
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`I further understand that the “critical date” for a patent is one year
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`
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`prior to its effective filing date. It is my understanding that the critical date is
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`significant because patents, systems, or documents that are public prior to the
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`critical date are prior art that can invalidate a patent claim regardless of the
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`purported date of invention.
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`26.
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`I understand that, once the claims of a patent have been properly
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`construed, the second step in determining anticipation of a patent claim requires a
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`comparison of the properly construed claim language to the prior art on a
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`limitation-by-limitation basis.
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`27.
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`I understand that a prior art reference “anticipates” a claim, and thus
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`renders the claim unpatentable, if all elements of the claim are disclosed in that
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`prior art reference, either explicitly or inherently (i.e., necessarily present or
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`implied).
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`28.
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`I understand that a claim is invalid under 35 U.S.C. § 102 of the
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`Patent Act:
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`•
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`(a) if the claimed invention was known or used by others in the
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`U.S., or was patented or published anywhere, before the applicant’s invention. I
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`understand that a U.S. or foreign patent qualifies as prior art to an patent claim if
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`the date of issuance of the patent is prior to the invention of the patent claim. I
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`further understand that a printed publication, such as an article published in a
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`magazine or trade publication or a U.S. or foreign patent application, also qualifies
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`as prior art to a patent claim if the date of publication is prior to the invention of
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`the patent claim.
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`•
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`(b) if the invention was patented or published anywhere, or was
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`in public use, on sale, or offered for sale in this country, more than one year prior
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`to the filing date of the patent application. I understand that a U.S. or foreign
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`patent qualifies as prior art to a patent claim if the date of issuance of the patent is
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`more than one year befores the filing date of the patent claim. I further understand
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`that a printed publication, such as an article published in a magazine or trade
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`publication or a U.S. or foreign patent application, also qualifies as prior art to a
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`patent claim if the publication occurs more than one year before the filing date of
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`the patent.
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`•
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`(e), if an invention described by that claim was described in (1)
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`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
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`granted on an application for a patent by another that was filed in the U.S. before
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`the date of invention for such a claim. I understand that a U.S. patent qualifies as
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`prior art to a patent claim if the application for that patent was filed in the United
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`States before the invention date of the patent claim.
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`•
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`(f) if the invention was invented by another prior to the claimed
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`invention; and
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`•
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`(g)(2) if, prior to the date of invention for the claim, the
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`invention was made in the U.S. by another who had not abandoned, suppressed or
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`concealed the invention.
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`29.
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`I have been instructed by counsel on the law regarding obviousness,
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`and understand that even if a patent is not anticipated, it will be unpatentable if the
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`differences between the claimed subject matter and the prior art are such that the
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`subject matter as a whole would have been obvious at the time the invention was
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`made to a person of ordinary skill in the pertinent art.
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`30.
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`I understand that a person of ordinary skill in the art provides a
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`reference point from which the prior art and claimed invention should be viewed.
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`This reference point prevents one from using his or her own insight or hindsight in
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`deciding whether a claim is obvious. Thus, “hindsight reconstruction” cannot be
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`used to combine references together to reach a conclusion of obviousness.
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`31.
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`I also understand that an obviousness determination includes the
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`
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`consideration of various factors such as (1) the scope and content of the prior art,
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`(2) the differences between the prior art and the Claims, (3) the level of ordinary
`
`skill in the pertinent art, and (4) the existence of secondary considerations of non-
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`obviousness.
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`32.
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`I have been informed and understand that the obviousness analysis
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`requires a comparison of the properly construed claim language to the prior art on
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`a limitation-by-limitation basis. A claimed invention is obvious under any of the
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`following circumstances:
`
`(a) it is no more than a combination of prior art elements
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`according to known methods that yield predictable results. I
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`understand that when a patent simply arranges old elements with each
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`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
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`further my understanding that a proper obviousness analysis focuses
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`on what was known or obvious to a person of ordinary skill in the art.
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`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
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`provide a reason for combining the elements in the manner claimed;
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`(b) it is a simple substitution of one known element for another
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`
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`that obtains predictable results;
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`(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;
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`(e) it is “obvious to try” — choosing from a finite number of
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`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
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`the result is likely the product not of innovation but of ordinary skill
`
`and common sense which led to a reasonable expectation of success;
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`(f) known work in one field of endeavor prompts variations of it
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`for use in either the same field or a different one based on design
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`incentives or other market forces, if the variations would have been
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`predictable to one of ordinary skill in the art; and
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`(g) there is some teaching, suggestion, or motivation in the
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`
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`prior art that would have led one of ordinary skill to modify the prior
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`art reference or to combine prior art reference teachings to arrive at
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`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
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`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
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`engineering practice or application of a well known principle in the
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`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
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`two references, if as a matter of engineering skill or practice in the
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`field it would be known to do so.
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`33.
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`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.
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`34.
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`I also understand that, when considering a reference for purposes of
`
`
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`an obviousness analysis, the reference must be taken for everything it teaches.
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`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
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`part of the obviousness inquiry under § 103, and that some examples of secondary
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`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)
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`any failure of others to achieve the results of the invention;
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`any commercial success or lack thereof of the products and processes
`
`covered by the invention;
`
`(4)
`
`(5)
`
`(6)
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`any deliberate copying of the invention by others in the field;
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`any taking of licenses under the patent by others;
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`any expression of disbelief or skepticism by those skilled in the art
`
`upon learnin