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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`RIMFROST AS
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`Petitioner
`
`v.
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`AKER BIOMARINE ANTARCTIC AS
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`Patent Owner
`
`_______________________
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`Case: IPR2018-01730
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`U.S. Patent No. 9,072,752 B1
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`_______________________
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`DECLARATION OF ROBERT S. MCQUATE, Ph.D.
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`RIMFROST EXHIBIT 1044 Page 0001
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`1.
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`I have agreed to provide expert testimony in support of Rimfrost AS’s
`
`Petition for Inter Partes Review of U.S. Patent No. 9,072,752 B1. My Curriculum
`
`Vitae is attached hereto as Appendix A.
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`2.
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`For my work related to this Inter Partes Review, I serve as an independent
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`contractor engaged through GRAS Associates, LLC, from whom I receive
`
`compensation for my services. I am not directly compensated by either Hoffmann
`
`& Baron, LLP or the Petitioner. Other than through GRAS Associates, I have no
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`financial interest in this proceeding, and the potential for any future financial
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`benefit is unaffected by the content of my testimony or the outcome of this
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`proceeding. My compensation from GRAS Associates, LLC is not linked to the
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`outcome of the case.
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`
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`SUMMARY OF MY OPINIONS
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`3.
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`I have been asked to give my opinion as to whether, in 2006 and thereafter,
`
`persons ordinarily skilled in the art of ingredients extracted from plant and marine
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`and other sources and interested in krill- and/or krill oil-related information as food
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`ingredients or nutraceutical products for use in humans, when exercising
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`reasonable diligence, would have searched online for information regarding krill
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`substances, and in particular through the FDA’s directories of GRAS Notices for
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`
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`2
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`RIMFROST EXHIBIT 1044 Page 0002
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`krill related substances. In my opinion, they would have been able to do so. See
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`below.
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`4.
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`I have also been asked to give my opinion as to whether, in 2006 and
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`thereafter, persons ordinarily skilled in the art of ingredients (substances) extracted
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`from plant and marine and other sources and interested in krill- and/or krill oil-
`
`related information as food ingredients or nutraceutical products for use in humans,
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`when exercising reasonable diligence after locating through an Internet search
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`reference to a GRAS Notice identifying the GRAS Notice substance as “Krill-
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`derived lecithin”, would have been able to access, that is, obtain a copy of, the
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`GRAS Notice promptly through a Freedom of Information Act (FOIA) request. In
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`my opinion, they would have been able to do so. See below.
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`5.
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`In my opinion, persons ordinarily skilled in the art of ingredients extracted
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`from plant and marine and other sources and interested in krill- and/or krill oil-
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`related information as food ingredients or nutraceutical products for use in humans,
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`when exercising reasonable diligence, (1) would have no later than August 5, 2007,
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`been able to find reference to GRAS Notice 000226 (“GRN 226”) submitted by
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`Enzymotec, Ltd. regarding the substance entitled “Krill-derived Lecithin” (Exhibit
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`1048); (2) would have known to prepare and submit a FOIA request to the FDA to
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`obtain a copy of GRN 226; and (3) subsequently would have been able to promptly
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`obtain a copy of GRN 226 from the FDA through the FDA FOIA process.
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`3
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`RIMFROST EXHIBIT 1044 Page 0003
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`6.
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`Specifically, as discussed below in more detail, in my opinion, in 2006 and
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`thereafter, persons ordinarily skilled in the art of ingredients extracted from plant
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`and marine and other sources and interested in krill- and/or krill oil-related
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`information as food ingredients and nutraceutical products for use in humans,
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`when exercising reasonable diligence, would have known that GRAS notices were
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`indexed and were searchable by substance at the FDA website.
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`7.
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`Thus, by searching, inter alia, for “krill”, at least as early as August 5, 2007,
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`an interested individual, seeking information regarding krill- and/or krill oil-related
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`information as food ingredients or nutraceutical products used in humans, would
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`have necessarily ascertained the existence of GRAS Notice 226 (GRN 226),
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`submitted by Enzymotec, Ltd., regarding the substance identified as “Krill-derived
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`Lecithin” (Enzymotec, Exhibit 1048), and thereafter could have obtained a copy
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`through, inter alia, a FOIA request submitted to the FDA.
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`8.
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`Upon the FDA’s “filing”, on May 31, 2007, of Enzymotec GRAS Notice
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`(GRN 226) (Exhibit 1048), GRN 226 became immediately available to the public
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`through, inter alia, a FOIA request submitted to the FDA. In my experience,
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`FOIA requests for complete GRAS notices, such as the GRN 226, are
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`uncomplicated because they do not contain much or, in many cases, any
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`confidential information that would require the FDA to segregate and redact any
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`information (such as, toxicology studies or detailed manufacturing processes or
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`
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`4
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`RIMFROST EXHIBIT 1044 Page 0004
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`dietary intake calculations) and, as such, the FDA would have promptly provided
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`the information to any member of the public submitting a FOIA request.
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`9.
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`No later than August 5, 2007, Enzymotec GRAS Notice 226 (GRN 226)
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`(Exhibit 1048) was indexed and was searchable by substance, e.g., a search for
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`krill-derived lecithin, krill and lecithin, or the component words, and such a search
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`would have yielded GRAS Notice 226. See Exhibit 1052
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`(https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/
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`opa-gras.html) and the discussion below.
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`10. Moreover, given FDA’s designated policy that was in place in 2007 as
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`reported in its Freedom of Information Annual Report 2007 (see Exhibit 1062,
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`https://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnualReports/ucm148025
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`.htm), the FDA would have fulfilled uncomplicated FOIA requests, such as one for
`
`GRN 226, within twenty business days. Consequently, an interested person who
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`searched the Internet and requested a copy by FOIA would have been able to
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`obtain a copy of GRN 226 by August 31, 2007.
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`
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`5
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`RIMFROST EXHIBIT 1044 Page 0005
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`BACKGROUND AND EXPERIENCE
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`11. As summarized within my Curriculum Vitae provided as Appendix A, I am
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`Co-Founder and Chief Regulatory Officer and former CEO of GRAS Associates,
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`LLC, a technical regulatory consulting firm that focuses on food regulatory issues
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`primarily involving matters falling within the jurisdiction of the US Food and Drug
`
`Administration (FDA). Prior to co-founding GRAS Associates, LLC in 2005, I
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`provided comparable technical regulatory services through R S McQuate &
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`Associates, Inc. dating from 1988. Food ingredient safety topics and food labeling
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`compliance matters constitute the majority of the project considerations on behalf
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`of clients that consist primarily of food companies interested in commercializing
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`ingredients to be incorporated into foods or finished food products.
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`12. My formal education was received within the fields of chemistry and
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`biochemistry; I received a B.S. in Chemistry from Lebanon Valley College prior to
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`earning my Ph.D. in chemistry from The Ohio State University (1973). My
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`doctoral research addressed chemical dynamics of vitamin B6 model systems. I
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`subsequently spent a year undertaking postdoctoral research in bio-inorganic
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`chemistry at New Mexico State University where I studied metalloenzyme
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`catalysis of biological reactions with specific attention directed toward carbonic
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`anhydrase.
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`6
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`RIMFROST EXHIBIT 1044 Page 0006
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`13. Over the course of my career, I have been Assistant Professor of Chemistry
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`at Willamette University where I taught introductory chemistry and advanced
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`inorganic chemistry while pursuing independent research in concert with students
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`on metalloenzymes and with metal ion catalysis of inter-ligand reactions. From
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`1991-1992, I served as Adjunct Professor of Food Science and Technology at
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`Oregon State University where I addressed food ingredient safety considerations
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`that were closely linked to FDA requirements. In 2005 and 2006, I resumed
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`teaching introductory chemistry on a part-time basis at Truckee Meadows
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`Community College.
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`14.
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`I served within FDA’s Center for Food Safety & Applied Nutrition
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`(CFSAN) as a Consumer Safety Officer from 1977 to 1980 in its Washington, DC
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`headquarters. I was part of the Office of Compliance, Division of Food & Color
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`Additives where I worked on numerous food ingredient safety assignments to
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`ensure that the requisite FDA safety standard was met in authorizing the use of
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`food ingredients, i.e., food additives and substances considered to be Generally
`
`Recognized As Safe (GRAS), in human foods.
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`15. While at the FDA as a Consumer Safety Officer within CFSAN’s Division
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`of Food and Color Additives, one of my areas of responsibility included searching
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`for and compiling information on GRAS affirmation petitions (such petitions were
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`predecessor GRAS evaluations prior to 1997 when the FDA instituted the GRAS
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`
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`7
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`RIMFROST EXHIBIT 1044 Page 0007
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`notification process that is presently operational) in response to FOIA requests.
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`FOIA requests for complete GRAS affirmation petitions (and for that matter
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`complete GRAS notices submitted to the FDA since 1997) would have been
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`promptly provided to the requester since they usually do not contain much or any
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`confidential information (such as, toxicology studies or detailed manufacturing
`
`processes or dietary intake calculations) that may require segregation and
`
`redacting. For some of my time with CFSAN, as a Consumer Safety Officer, I
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`served as Division FOIA supervisor which required my pre-release review of
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`information gathered by fellow consumer safety officers regarding FOIA requests
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`assigned to them.
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`16. For approximately one year, I also served a special detail within the Division
`
`of Regulatory Guidance, also within the Office of Compliance, which was
`
`responsible for food labeling issues. While engaged on this special labeling
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`assignment, I resolved challenging regulatory interpretations associated with net
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`weight labeling requirements for packaged foods, and this effort yielded a Letter of
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`Commendation from the FDA commissioner.
`
`17. During my time at CFSAN, I also served on a joint FDA/USDA/FTC Food
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`Labeling Task Force that assessed the total food label; this effort yielded
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`recommendations for food label revisions and modifications that eventually
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`resulted in the passage of the Nutrition Labeling & Education Act and revised
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`
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`8
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`RIMFROST EXHIBIT 1044 Page 0008
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`nutrition labeling requirements. In 1980, I received FDA’s Award of Merit for my
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`contributions on the tri-agency food labeling Task Force.
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`18.
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`I transitioned into the private sector following my FDA experiences where I
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`assumed supervisory responsibilities with The Dial Company’s Regulatory
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`Compliance and Nutrition Group where broad-ranging regulatory issues---
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`including ingredient and product safety and product labeling---were addressed.
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`Besides FDA-regulated food products and USDA-regulated food products, The
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`Dial Company produced and sold an extensive variety of soaps and personal care
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`products, along with a line of consumer goods such as floor waxes. My technical
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`regulatory responsibilities were undertaken in concert with the Product
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`Development personnel within Research & Development, Marketing,
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`Manufacturing, and Legal. The integration with these key operations within the
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`Company provided in-depth awareness of the product development and
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`manufacturing concerns regarding the performance of different ingredients within
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`product formulations while also recognizing the key role to be played by
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`Marketing in their representations of the attributes of the finished goods and the
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`component ingredients. As Science Director with the National Soft Drink
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`Association, my primary focus was on ensuring the safety of ingredients (such as
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`aspartame and high fructose corn syrup) that were incorporated into soft drink
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`formulations, although select labeling issues surfaced as well. As Senior Vice
`
`
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`9
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`RIMFROST EXHIBIT 1044 Page 0009
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`President of Scientific and Regulatory Affairs for AminoPath Labs, my
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`responsibilities spanned regulatory concerns requiring FDA authorization for use
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`of innovative ingredients for use in medical foods and weight loss formulations, as
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`well as oversight of technical ingredient production, product development, and
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`business development for 5-6 food formulations and dietary supplement products.
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`19. From 1986-1996, I served as Executive Director of Oregon’s Advanced
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`Science & Technology Institute (ASTI). In this capacity, I represented Oregon
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`State University, the University of Oregon, Oregon Health & Science University,
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`and Portland State University in commercializing technologies and technical
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`innovations with the private sector.
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`20. From 1998-2002, I was a Board Member and Consultant with the Advanced
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`Technology Program’s Chemistry and Materials Evaluation Board at the National
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`Institute of Standards and Technology.
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`21. My professional affiliations include long-standing membership with the
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`American Chemical Society and the Institute of Food Technologists, while also
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`having membership in the Regulatory Affairs Professional Society.
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`22. Appendix B contains a listing of Publications and Presentations covering my
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`professional career. I have co-authored several GRAS dossiers that have been
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`generated for clients over the past 12 years, and Appendix C contains a listing with
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`FDA website addresses for these submissions so interested parties can directly
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`
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`10
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`RIMFROST EXHIBIT 1044 Page 0010
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`access the full content of those GRAS notifications on which I have had direct
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`input.
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`
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`THE FDA, CFSAN AND GRAS NOTICES
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`23. The Food and Drug Administration, Office of Foods and Veterinary
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`Medicine, Center for Food Safety and Applied Nutrition (CFSAN), Office of Food
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`Additive Safety, is responsible for reviewing safety information for food
`
`ingredients and food packaging.
`
`24. As defined in Section 201(s) of the Federal Food, Drug and Cosmetic Act, a
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`substance to be added to food is subject to premarket approval by FDA unless it is
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`generally recognized, by experts who are qualified by scientific training and
`
`experience to evaluate its safety, to be safe under the conditions of its intended use
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`(GRAS is the acronym for generally recognized as safe).
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`25. GRAS conclusions for ingredients of interest may be presented to FDA with
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`a declaration that the substance with its intended conditions of use is GRAS, noting
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`that the substance is not subject to the premarket approval requirements based on
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`the expert conclusion that the substance is GRAS under the conditions of its
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`intended use. FDA regulations describe how to notify FDA through the
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`submission of a GRAS notice, and these regulations explain what the FDA does
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`when it receives a GRAS notice.
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`
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`11
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`RIMFROST EXHIBIT 1044 Page 0011
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`26. Before, during and after 2007, a GRAS notice could be submitted to the
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`FDA by a notifier, i.e., an interested party that is generally a company desiring to
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`document GRAS status for the substance of interest. The GRAS notice will
`
`contain the declaration for GRAS status and will also contain the requisite
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`supporting information and/or data on the substance and similar substances to
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`justify the safety conclusion. Upon receipt, the FDA assigns the GRAS notice a
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`GRN number and undertakes a preliminary assessment to ascertain whether or not
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`the notification is complete. If the FDA deems the notification to be complete,
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`FDA officially files the subject GRAS notice.
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`27. After filing, the GRAS notice is indexed, inter alia, by GRN number and by
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`substance (ingredient) on an online searchable directory (in 2007, the “Summary of
`
`All GRAS Notices”). In 2007, the online searchable directory webpage was
`
`located at url http://www.cfsan.fda.gov:80/~rdb/opa-gras.html.1
`
`28.
`
`Importantly, the GRAS Notice directory webpage expressly stated that:
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`Persons interested in obtaining additional data and information in the
`notice may obtain a copy of those data and information that are
`disclosable by requesting the information under the Freedom of
`
`
`1 Currently, the online directory is simply called “GRAS Notices” and is located at:
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`https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices.
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`
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`12
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`RIMFROST EXHIBIT 1044 Page 0012
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`Information Act (see FDA’s document entitled “How to Request
`Information or Make a Freedom of Information Request”).
`See, for example, from the Wayback Machine, Internet Archive, the August 5,
`
`2007 copy of http://www.cfsan.fda.gov:80/~rdb/opa-gras.html (the FDA’s
`
`Summary of All GRAS Notices webpage) below. See Exhibit 1052, p. 0001 which
`
`is a copy of the webpage
`
`https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/o
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`pa-gras.html (highlighting added).
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`
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`
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`13
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`RIMFROST EXHIBIT 1044 Page 0013
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`
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`29. After review by CFSAN, the FDA issues a response letter (the FDA’s
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`Letter), which provides details about the GRAS notice receipt and filing process,
`
`restates the GRAS claim, and indicates whether the FDA has any questions about
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`the GRAS notice claim and/or submission. See, for example, Exhibit 1049.
`
`30. Between 1997 and 2016, the relevant regulatory procedures in place at the
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`FDA governing GRAS notice claims for exemption from pre-market approval
`
`were detailed in the 1997 GRAS proposal, Exhibit 1051, Federal Register, Vol. 62,
`
`No. 74, pp. 18938-18964, April 17, 1997. This proposal, with the operational
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`procedures, was followed by the FDA from 1997 to 2016, and it provides, among
`
`other things, for the immediate public disclosure and availability of the notice and
`
`related documents.
`
`E. Public Disclosure and Accessibility
`1. Public Disclosure
`Proposed § 170.36(f)(1) provides that any GRAS exemption claim
`submitted under proposed § 170.36(c)(1) of this section be immediately
`available for public disclosure on the date the notice is received. . . . .
`* * * *
`
`2. Public Accessibility
`
`* * * *
`FDA has considered the best way to make the information from the
`proposed notification procedure readily accessible to the public. FDA
`has tentatively concluded that making both the GRAS exemption claim
`14
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`RIMFROST EXHIBIT 1044 Page 0014
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`provided under proposed § 170.36(c)(1) and all letters issued by the
`agency relevant to each claim easily accessible to the public is the most
`direct and administratively efficient way of meeting the needs of the
`public. Accordingly, under proposed § 170.36(f)(2), the following
`information would be readily accessible for public review and
`copying: (1) A copy of all GRAS exemption claims received under
`proposed § 170.36(c)(1); (2) a copy of all letters issued by the agency
`under proposed § 170.36(e); and (3) a copy of any subsequent letter
`issued by the agency.
`
`62 FR 18938, 18952-18953, Exhibit 1051, pp. 0015-0016 (emphasis added).
`
`31. The FDA’s practice of providing public access to a directory of GRAS
`
`Notices (providing, at least, the GRN number and substance name) and links to the
`
`FDA Letters and additional content from the GRAS notices was reinforced in a
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`December 2005/January 2006 publication authored by Paulette Gaynor, Ph.D., a
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`consumer safety officer in CFSAN’s Office of Food Additive Safety’s Division of
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`Biotechnology and GRAS Notice Review while she was serving as a contact for
`
`the GRAS notification program. Dr. Gaynor advised that information about GRAS
`
`notifications is made available to the public on the FDA/CSFAN’s “All GRAS
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`Notices Summary” webpage. The All GRAS Notices Summary initially provides
`
`the GRN number, the identification of the substances and whether the FDA’s letter
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`is pending. When the FDA issues its final determination following review of each
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`
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`15
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`RIMFROST EXHIBIT 1044 Page 0015
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`GRAS notification, the FDA website is subsequently updated with additional
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`information and links to documents on the FDA/CSFAN’s website.
`
`As part of the 1997 GRAS proposal [62 FR 18938], FDA also
`announced its intention to maintain an inventory of GRAS notices and
`the agency's response to those notices. In accordance with this, the
`Office of Food Additive Safety has created and maintains a web page
`titled ‘Summary of All GRAS Notices.’ The page lists all GRAS
`notices that FDA has received, describes FDA's responses, and
`provides hyperlinks to FDA's response letters and additional
`correspondence. The page is organized by year, and within the
`summary table for each year, there is a link to a table that provides more
`details about the GRAS notices received in that year, including: the
`name of the person who made the GRAS determination (notifier); the
`substance that is the subject the notice; a description of the intended
`use of the substance; the basis for the GRAS determination; and
`FDA's response to the notice.
`
`See, Gaynor, P, “How U.S. FDA's GRAS Notification Program Works”, Exhibit
`
`1050, p. 0003, p. 0004 (Reprinted by FDA with permission of the publishers from
`
`Food Safety Magazine December 2005/January 2006) (emphasis added).
`
`
`
`
`
`
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`RIMFROST EXHIBIT 1044 Page 0016
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`ENZYMOTEC - GRAS NOTICE NO. GRN 000226 (GRN 226)
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`32. Enzymotec, Ltd., as notifier, through its agent, and in accordance with
`
`proposed 21 CFR 170.36, submitted a “Notification of GRAS Determination for
`
`Krill-based Lecithin in Food” (GRAS Notice) dated May 26, 2007, with the FDA’s
`
`Office of Food Additive Safety, Center for Food Safety and Applied Nutrition
`
`(CFSAN). Enzymotec, Exhibit 1048, p. 0002.
`
`33.
`
`In the FDA Letter to Enzymotec’s agent dated January 3, 2008 (Exhibit
`
`1049), the FDA’s Office of Food Additive Safety (OFAS), Center for Food Safety
`
`and Applied Nutrition (CFSAN) acknowledged receipt of Enzymotec’s May 29,
`
`2007 notice (Exhibit 1048) and confirmed that CFSAN had filed Enzymotec’s
`
`notice on May 31, 2007. As per 21 CFR 170.36, upon filing, Enzymotec’s GRAS
`
`notice became immediately accessible to the public in accordance with designated
`
`FDA procedures discussed above.
`
`34. The FDA/CFSAN/OFAS designated Enzymotec’s notice as GRAS Notice
`
`No. GRN 000226, noting that the subject of Enzymotec’s notice was “lecithin
`
`derived from krill (krill-derived lecithin)”, and that Enzymotec’s notice had
`
`informed the “FDA of the view of Enzymotec that krill-derived lecithin is GRAS,
`
`through scientific procedures”. FDA Letter, Exhibit 1049, p. 0001.
`
`
`
`
`
`
`
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`RIMFROST EXHIBIT 1044 Page 0017
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`35. The FDA Letter stated in detail:
`
`The Food and Drug Administration (FDA) is responding to the notice,
`dated May 26, 2007, that you submitted on behalf of Enzymotec, Ltd.
`(Enzymotec) in accordance with the agency's proposed regulation,
`proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances
`Generally Recognized as Safe (GRAS); the GRAS proposal). FDA
`received the notice on May 29, 2007, filed it on May 31, 2007, and
`designated it as GRAS Notice No. GRN 000226.
`****
`****
`****
`In accordance with proposed 21 CFR 170.36(f), a copy of the text of
`this letter responding to GRN 000226, as well as a copy of the
`information in this notice that conforms to the information in the
`proposed GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is
`available for public review and copying on the homepage of the Office
`of
`Food
`Additive
`Safety
`(on
`the
`Internet
`at
`http://www.cfsan.fda.gov/~lrd/foodadd.html).
`
`FDA Letter, Exhibit 1049, pp. 0001 and 0003. As discussed above, the
`
`“cfsan” in the url refers to the FDA’s Center for Food Safety and Applied
`
`Nutrition.
`
`36. As indicated above, the Wayback Machine archived a copy of the “Summary of
`
`All GRAS Notices” webpage from August 5, 2007, which establishes that---at
`
`least as early as August 5, 2007---Enzymotec’s GRAS Notice 000226 was
`18
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`RIMFROST EXHIBIT 1044 Page 0018
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`

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`searchably indexed on the Internet by substance as “Krill-derived lecithin,”
`
`(GRN 226). See Exhibit 1052, p. 0001 (https://web.archive.org/web/ 2007
`
`0805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html) and below.
`
`
`
`37. Thus, Enzymotec’s GRAS Notice 000226 was publically available no later
`
`than August 5, 2007, through a simple Internet Search for the terms “krill” and/or
`
`“lecithin”. As noted above, any interested party could have then requested a copy
`
`of GRAS Notice 000226 (GRN 226) and all related documents through a Request
`
`for Information or, if necessary, a FOIA request.
`
`
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`

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`38. As discussed above, in general, a FOIA request for a complete GRAS notice,
`
`such as GRN 226, would have been considered to be an uncomplicated request.
`
`This is especially true in the case of Enzymotec’s GRAS Notice 000226 (GRN
`
`226) (Exhibit 1048), since it does not contain confidential or trade secret
`
`information (other than---arguably---production run batch numbers, which would
`
`have added at most a day or two to the FOIA process). Furthermore, the entire
`
`GRAS 000226 dossier is only about 35 pages long. Thus, such an FOIA request for
`
`this uncomplicated GRAS notification would have been promptly provided to the
`
`requester through a FOIA request process.
`
`39. Moreover, it has been my experience that individuals and researchers, such
`
`as those in the food ingredient or nutraceutical industries routinely check the
`
`FDA’s website for GRAS notice filings either to ascertain what the competition is
`
`doing or to obtain useful information regarding substances of interest, such as
`
`related ingredients that were being considered for GRAS status.
`
`40. Moreover, a person interested in krill- and/or krill oil-related information
`
`who searched the Internet using the search terms “krill” and “krill oil”, no later
`
`than September 25, 2007, would have landed on Enzymotec’s website---if they
`
`were not already monitoring the website for competitive reasons---and would have
`
`found information which would have independently motivated them to search the
`
`FDA’s GRAS Notice inventory. See, e.g., Exhibit 1060, pp. 0001-0003.
`
`
`
`20
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`

`

`41. On one of its webpages from September 25, 2007, Enzymotec discloses that
`
`one of its three cardio-care product ingredients was:
`
` Krill Oil - A propreitary [sic] complex of Krill oil.
`
`Exhibit 1060, p. 0001 (emphasis added) (https://web.archive.org/web/
`
`20070925024350/http://www.enzymotec.com/PageIndex.asp?cc=01020403), and
`
`see below (highlighting added).
`
`
`
`
`
`42. While on another Enzymotec webpage, also from September 25, 2007, it is
`
`noted that:
`
`the
`to ensure
`is
`An essential part of product development
`legal/regulatory status of the ingredients. Enzymotec is globally active
`21
`
`RIMFROST EXHIBIT 1044 Page 0021
`
`
`
`

`

`in its efforts to ensure GRAS . . . legal status required for the marketing
`and distribution of the ingredients.
`Exhibit 1060, p. 0003 (emphasis added) (https://web.archive.org/web/
`
`20070925024521/http://www.enzymotec.com/Page.asp?cc=01020408), and see
`
`below (highlighting added).
`
`43.
`
`In my opinion, once GRN 226 was added to the “Summary of All GRAS
`
`Notices” (no later than August 5, 2007) and after Enzymotec’s website referenced
`
`its GRAS activities (no later than September 25, 2007), an Internet search for
`
`
`
`
`
`22
`
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`
`

`

`information related to krill and/or krill oil and/or krill/lecithin, would have resulted
`
`in links to Enzymotec’s webpages, even if it did not immediately link to the FDA’s
`
`GRAS Notice Inventory for Enzymotec’s GRN 226. Further, a review of those
`
`webpages would necessarily have provided additional motivation to search for
`
`GRAS notice filings at the FDA for information related to krill and/or lecithin
`
`and/or lecithin derived or extracted from krill.
`
`CONCLUSION
`
`44.
`
`It is my opinion that the Enzymotec GRAS Notice No. GRN 000226
`
`(Exhibit 1048) for krill-derived lecithin was filed and indexed by FDA and thus
`
`was searchable on the Internet no later than August 5, 2007, at which point it was
`
`immediately accessible to the public disclosure through, inter alia, a FOIA request
`
`to the FDA.
`
`45.
`
`It is my opinion that, in 2007, and at other times, persons ordinarily skilled
`
`in the art of ingredients extracted from plant and marine and other sources and
`
`interested in “krill” and/or “krill oil” as a food ingredient or nutraceutical product,
`
`when exercising reasonable diligence, would have searched the Internet, in general,
`
`and the FDA’s “Summary of All GRAS Notices” webpage, specifically, for same,
`
`would have, thus, necessarily located reference to GRAS Notice No. GRN 000226
`
`(GRN 226) for “krill-derived lecithin” and would have requested and obtained the
`
`
`
`23
`
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`
`

`

`entire GRAS Notice GRN 226 from the FDA including the utilization of the FOIA
`
`request process.
`
`46.
`
`It is also my opinion, that, given FDA’s designated policy that was in place
`
`in 2007, the FDA would have fulfilled the uncomplicated GRAS Notice No. GRN
`
`000226 (GRN 226) FOIA request Within twenty business days. Consequently, it is
`
`also my opinion that the content of GRAS Notice GRN 226 would have been
`
`accessible to an interested person (who searched the Internet and requested a copy
`
`by FOIA) by August 31, 2007, or a few days later.
`
`47.
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`,
`Executed on this the
`
`,, H;
`/ 7 day of September 2018.
`
`
`
`Robert S. McQuate, Ph.D.
`
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`

`

`APPENDIX A
`
`ROBERT S. MCQUATE
`1630 Dutch Ravine Court
`Reno, NV 89521-5160
`Phone: 541-728-1492
`Email: McQuate@charter.net
`
`
`
`WORK HISTORY
`
`Co-Founder, Chief Regulatory Officer (former CEO), GRAS Associates, LLC, Bend, OR
`2006 – Present
`President & CEO, R. S. McQuate & Associates, Inc., Bend, OR
`1988 -- Present
`Chemistry Professor, Truckee Meadows Community College, Reno, NV
`2005 – 2006
`Senior Vice President, Scientific & Regulatory Affairs, AminoPath Labs, LLC, Portland, OR
`2000 -- 2005
`Board Member & Consultant, National Institute of Standards & Technology, Advanced
`1998 -- 2002
` Technology Program, Gaithersburg, MD
`1986 – 1996
`Executive Director, Advanced Science & Technology Institute, Eugene & Corvallis, OR
`1991 -- 1992
`Adjunct Professor, Food Science & Technology, Oregon State University, Corvallis, OR
`1983 -- 1986
`Science Director, National Soft Drink Association, Washington, DC
`1980 -- 1983
`Senior Regulatory Scientist and Group Leader of Regulatory & Nutrition, The Dial Company, Inc.,
`
`
`Scottsdale, AZ
`1977 -- 1980
`Consumer Safety Officer, Food and Drug Administration, Center for Food Safety & Applied
` Nutrition, Division of Food and Color Additives, Washington, DC
`1974 -- 1977
`Assistant Professor of Chemistry, Willamette University, Salem, OR
`
`
`EDUCATION
`
`• Postdoctoral Research Fellow with Professor R. G. Wilkins, New Mexico State University,
` Las Cruces, NM
`• Ph.D. in Chemistry, The Ohio State University, Columbus, OH
`• B.S. in Chemistry with Honors, Lebanon Valley College, Annville, PA
`
`PROFESSIONAL EXPERIENCE
`
`
`
`
`CONSULTING SERVICES
` CEO/CRO, GRAS Associates, LLC; President & CEO, R. S. McQuate & Associates, Inc.
`• Founder of consulting firms including aggressive marketing and business development of respective practices.
`• Expanded client listing to ~ 140 prior to sale of GRAS Associates
`• Generate regulatory strategies to achieve food ingredient marketplace acceptance for clients.
`Interpret FDA’s Red Book on food additive & GRAS safety evaluations in designing food ingredient
`•
` testing regimens.
`• Provide food ingredient safety evaluations, focusing on independent GRAS evaluations, food &
` color additive petitions, new dietary ingredient compilations, and associated FDA submissions.
`• Serve on Expert Panels with particular orientation toward chemical composition and food ingredient
` specifications.
`• Utilize quantitative risk assessment tools to ascertain likely food ingredient risks.
`• Assess compositional information on ingredients---including complex na