`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`RIMFROST AS
`
`Petitioner
`
`V.
`
`AKER BIOMARINE ANTARCTIC AS
`
`Patent Owner
`
`
`
`Case:
`
`lPR2018-01730
`
`U.S. Patent No. 9,072,752 Bl
`
`
`
`DECLARATION OF RAKESH KAPOOR, PH.D.
`
`RIMFROST EXHIBIT 1045 Page 0001
`
`
`
`Inter Partes Review of US. Patent No. 9,072,752 B1.
`
`2.
`
`I am not directly compensated by either Hoffmann & Baron, LLP or the
`
`Petitioner.
`
`l have no financial interest in this proceeding, and the potential for any
`
`future financial benefit is not affected by the content of my testimony or the
`
`outcome of this proceeding. My compensation from my employer, Bioriginal
`
`Food & Science Corp. (“Bioriginal”), is not in any way related to the outcome of
`
`the proceeding.
`
`3.
`
`I received my PhD. in Physiology1 from University of Saskatchewan,
`
`Saskatoon, Canada in 1993, my Masters in Pharmacognosy2 from the University of
`
`Delhi, India in 1983, and my Bachelors in Pharmacy from the University of Delhi,
`
`India in 1980. My Curriculum Vitae is attached hereto as Appendix A.
`
`4.
`
`As of 2007, I had advanced degrees in Physiology, Pharmacognosy and
`
`Pharmacy, and an understanding, through both my education and over ten years’ of
`
`applied experience, of biochemistry, organic chemistry, lipid chemistry, and
`
`I Physiology is the study of life and how living cells and tissues function, enabling
`
`organisms to live and interact with their environment.
`
`2 Pharmacognosy is the study of medicinal drugs derived from plants or other
`
`natural sources.
`
`RIMFROST EXHIBIT 1045 Page 0002
`
`RIMFROST EXHIBIT 1045 Page 0002
`
`
`
`nutrition, as well as practical experience in the field of extraction. For further
`
`details, see my Curriculum Vitae attached hereto as Appendix A.
`
`As Bioriginal states on its website: “Bioriginal is a global leader in
`
`delivering complete nutritional solutions to the Food and Nutraceutical industries.
`
`With over 20 years of global expertise, Bioriginal has carved out a niche by
`
`scientifically combining nutritional ingredients from all over the world, directly
`
`from the source, to create unique and efficacious solutions. Bioriginal is
`
`passionate about nutritional ingredients and the health benefits they provide,
`
`discovering, anticipating trends and pioneering within the Food and Nutraceutical
`
`industries since 1993. Bioriginal has developed proprietary methods and systems
`
`to provide customized turnkey solutions for our customers that help them compete
`
`and win in a highly competitive space. Bioriginal is headquartered in Saskatoon,
`
`Canada with facilities throughout the USA, Europe and Asia.”
`
`https://ww.bioriginal.comXabout-uSI.
`
`From 1997 to 2003, I was Product Development Manager at Bioriginal. As
`
`Product Development Manager my responsibilities included: developing
`
`formulations for soft gels, emulsions, flavored oils, etc.; educating customers on
`
`the benefits and use of omega—65 and omega-3s essential fatty acids; optimizing
`
`processes to manufacture herbal tinctures and herbal extracts; SOP development
`RIMFROST EXHIBIT 1045 Page 0003
`for unit operations in accordance with GMP; process scale up; developing
`
`
`
`and supervising of technical staff; developing technical and promotional material;
`
`providing regulatory advice to customers; and optimizing production process for
`
`standardized herbal extract, so as to make it economically viable and maximize the
`
`extraction of active principles.
`
`7.
`
`Currently, I am Director, Science & Technology at Bioriginal, a position I
`
`have held since 2003. As Director my responsibilities include: evaluation of new
`
`business opportunities; new technologies; management ofclinical research;
`
`training sales staff on scientific aspects of products; product development (flavored
`
`functional drink mixes, dietary supplements, emulsions, etc.,), process scale up,
`
`process optimization, equipment selection, for unit operations in accordance with
`
`GMP, process validation; analysis of scientific literature; providing regulatory
`
`advice to staff and customers; interacting with regulatory authorities, and, in
`
`connection with one ingredient, providing self-affirmed GRAS (Generally
`
`recognized as safe).
`
`8.
`
`At Bioriginal, I have advised, and continue to advise, technical people
`
`working in food industry on techniques of incorporation of omega—3 essential fatty
`
`acids into various food formulations including cheese, milk, salad dressings, butter,
`
`etc.
`
`I developed a process for the extraction of herbal materials to obtain maximal
`
`levels of active principle while optimizing production costs.
`
`I have also optimized
`
`RIMFROST EXHIBIT 1045 Page 0004
`
`RIMFROST EXHIBIT 1045 Page 0004
`
`
`
`production processes for fermented herbal liquors (Ayurvedz’c medicines), herbal
`
`tinctures, and emulsions.
`
`When investigating the uses and chemical composition ofpossible
`
`ingredients and their sources for use in connection with products developed for
`
`Bioriginal customers, I would conduct searches on various well—known on—line
`
`databases including PubMed,3 Scopus®4 and the FDA GRAS Notice database.
`
`GRAS Notices were useful as they often contained detailed information on the
`
`ingredients which had not been published elsewhere.
`
`Since at least 1999, I have used FDA GRAS Notices and related FDA
`
`generated information (eg, response letters) as a source of information regarding
`
`the uses, sources and chemical compositions of potential ingredients.
`
`11. Moreover, since at least 1999, ifa full GRAS Notice and/or an FDA
`
`response letter could not be downloaded from the FDA GRAS Notice database
`
`3 PubMed is a free resource that is developed and maintained by the National
`
`Center for Biotechnology Information (NCBI), at the US National Library of
`
`Medicine (NLM), located at the National Institutes of Health (NIH).
`
`4 Scopus® is an abstract and citation database of peer-reviewed literature:
`RIMFROST EXHIBIT 1045 Page 0005
`
`scientific journals, books and conference proceedings, owned by Elsevier.
`
`
`
`submitting a freedom of information act request (“F01A”) to the FDA.
`
`12.
`
`Therefore, if I was interested in obtaining information about the chemical
`
`composition and/or use of “krill”, and/or “krill oil” in 2007 (and other times), I
`
`would have searched the FDA GRAS Notice on-line database using the keywords,
`
`“krill” and/or “krill oil”. That search would have resulted in the identification of
`
`all GRAS Notices with any of those terms in their substance descriptions.
`
`Specifically, these searches would have identified all GRAS Notices associated
`
`with “krill” and/or “krill oil”, including the GRAS Notice for “Krill—derived
`
`lecithin”, as they were searchable by substance on the Internet. If the “Krill-
`
`derived lecithin” GRAS Notice and FDA response, if any, could not be directly
`
`downloaded from the FDA’s web site, I would have simply submitted a FOIA
`
`request to the FDA to obtain copies of the desired GRAS Notice and any
`
`associated FDA response.
`
`13.
`
`I declare under penalty of perjury under the laws of the United States of
`
`America that the foregoing is true and correct.
`
`Executed on this the 2 day of September 201 .
`
`
`
`Rakesh Kapoor
`
`RIMFROST EXHIBIT 1045 Page 0006
`
`RIMFROST EXHIBIT 1045 Page 0006
`
`
`
`
`APPENDIX A
`
`
`Curriculum vitae
`
`
`
`Rakesh Kapoor
`Bioriginal Food & Science Corp.
`102 Melville Street
`Saskatoon, SK
`S7J 0R1
`
`
`Work history:
`
`Industry:
`
`2003 – Present
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Director, Science and Technology,
`Bioriginal Food & Science Corp. 102 Melville Street,
`Saskatoon, SK., S7J 0R1, Canada.
`
`(Major business activity: Omega-3 and Omega-6 essential fatty
`acid rich oils for Nutraceutical/dietary supplement, food and
`pharmaceutical markets)
`
`Responsibilities include evaluation of new business
`opportunities, new technologies, managing clinical research,
`training sales staff on scientific aspects of products, product
`development (Flavored functional drink mixes, dietary
`supplements, emulsions, etc, scale up, process optimization,
`equipment selection, SOP development, process validation),
`analysis of scientific literature, and regulatory advise to staff.
`Obtained self affirmed GRAS status on one ingredient. I also
`contribute to IP policy development.
`
`1
`
`RIMFROST EXHIBIT 1045 Page 0007
`
`
`
`1997- 2003
`
`
`
`
`
`
`
`
`1985-88
`
`
`1983-85
`
`
`
`
`
`
`
`
`
`
`
`
`
`Product Development Manager,
`Bioriginal Food & Science Corp. 102 Melville Street,
`Saskatoon, SK., S7J 0R1, Canada.
`
`Responsibilities: Formulation Development (soft gel,
`emulsions, flavored oils), Process optimization (herbal
`tinctures, herbal extracts), SOP development, Process scale up,
`Analytical Method Developments, Organization of Clinical
`trials, Training and supervision of technical staff, Development
`of technical and promotional material, Presentation of new
`product concepts to customers, Regulatory advice to customers.
`Optimized production process for standardized herbal extract so
`as to make it economically viable and maximize the extraction
`of active principles.
`
`
`Development Scientist and Laboratory-In-charge,
`Dabur Research Foundation, India.
`
`Supervised 10 scientists in the area of Pharmaceutical
`Formulation Developments including capsules, ointments,
`herbal syrups, suspension, and fermented herbal liquors,
`standardization of medicinal plants (analytical method
`developments), Clinical Trials organization, monitoring and
`data analysis.
`
`
`Development Chemist
`Dabur India Ltd. India,
`
`Development of sustained release technology employing
`hydrocolloid matrix, Standardization of Medicinal plants,
`Analytical developments and development of protocols for
`clinical trials.
`
`
`
`2
`
`RIMFROST EXHIBIT 1045 Page 0008
`
`
`
`1981
`
`
`Production Supervisor (Parenteral department)
`Ranbaxy Laboratories Ltd. India.
`
`Supervised 40 workers in ampoule and vial washing
`department, supervisors for filling of liquid and dry powder
`injectable, and assisted in formulations.
`
`
`
`Academic Research:
`
`1996-97
`
`Epilepsy Canada/Parke Davis Research Fellow, Department
`of Pharmacology, College of Medicine, University of
`Saskatchewan, Saskatoon, Canada (Role of oxygen free
`radicals and nitric oxide in generalized tonic/clonic seizures
`of Grandmal type).
`
`Professional Research Associate, Department of
`Pharmacology, College of Medicine, University of
`Saskatchewan, Saskatoon, Canada. Study of mechanism of
`action of Botulinum neurotoxin
`
`Postdoctoral Fellow, Division of Hematology, College of
`Medicine, University of Saskatchewan, Saskatoon, Canada.
`(Role of oxygen free radicals in deterioration of red blood
`cells under normal storage conditions).
`
`Student Assistant, College of Pharmacy, University of
`Saskatchewan, Saskatoon, Canada. Teaching the techniques
`in drug compounding to second year Pharmacy students,
`evaluating lab reports.
`
`
`
`3
`
`RIMFROST EXHIBIT 1045 Page 0009
`
`
`1995-96
`
`
`1993-95
`
`
`1989-92.
`
`
`
`
`
`
`
`
`Miscellaneous:
`
`2018
`
`Member, Organizing Committee for 26th CAOCS Canadian
`Lipid & Bioresource Conference 2018. Organized scientific
`meeting from Sept 9 – 11th in Saskatoon. Worked with
`Local organizing committee for all aspects of organization of
`the conference in Saskatoon.
`
`Program Committee Vice Rep, Health and Nutrition
`Division, AOCS. Member, Award Committee, AOCS.
`
`Technical Chair, CAOCS (Canadian Section, American Oil
`Chemists Society. Organized scientific meeting from October
`2 – 4th in Saskatoon. Worked with Local organizing
`committee for all aspects of organization of the conference in
`Saskatoon.
`
`
`2004 – 08
`
`
`
`2005
`
`
`2005
`
`
`1984
`
`Organized Third International Conference on Gamma
`Linolenic acid at Salt Lake City during AOCS meeting.
`
`As a member of Local Organizing Committee of Indian
`Pharmaceutical Congress, 35th annual conference, organized
`plenary, and scientific sessions in close association with
`Chairman and volunteers.
`
`
`1984 & 1986 Management of cosmetic export project including
`production, inventory management, customs and excise
`documentation, and shipping arrangements. These were
`special projects where I was responsible for 24 hour, 7 day a
`week production of cosmetics for 5 - 6 months each time.
`During these projects, I supervised about 90 workers, and 4
`packing line supervisors and coordinated with purchasing,
`import, export, engineering and excise departments.
`
`
`
`
`
`
`
`
`
`4
`
`RIMFROST EXHIBIT 1045 Page 0010
`
`
`
`Awards and Scholarships:
`
`1996-97
`
`Parke Davis/Epilepsy Canada Clinical Research Fellowship
`
`First Prize, Young Investigator Award Competition, American
`College of Angiology, Florida, USA
`
`Postdoctoral Fellowship, Health Services Utilization and
`Research Commission, Saskatoon, Canada
`
`Arthur Smyth Memorial Scholarship, College of Medicine,
`University of Saskatchewan, Saskatoon, Canada
`
`College of Graduate Studies and Research Scholarship,
`University of Saskatchewan, Saskatoon, Canada
`
`1993
`
`1993-95
`
`1992-93
`
`1988-92
`
`
`1981-83
`
`
`1978-79
`
`
`1976-77
`
`
`
`
`
`
`Junior Research Fellowship, University Grants Commission,
`New Delhi, India
`
`Hakim Abdul Hameed Merit Scholarship, Hamdard College
`of Pharmacy, University of Delhi, India (on securing First
`position in Bachelor of Pharmacy First year examinations)
`
`Hakim Abdul Hameed Merit Scholarship, Hamdard College
`of Pharmacy, Board of Technical Education, India (on
`securing First position in Diploma in Pharmacy First year
`examinations).
`
`
`
`5
`
`RIMFROST EXHIBIT 1045 Page 0011
`
`
`
`Qualifications:
`
`Ph.D. (1993)
`
`
`
`Effect of Hemorrhagic Shock on myocardial
`function and oxygen free radical status in the
`myocardium. University of Saskatchewan,
`Saskatoon, Canada
`
`
`
`
`M. Pharm. (Pharmacognosy; 1983)
`
`
`
`
`Phytochemical and Pharmacological Investigations
`on Achyranthes aspera Linn. University of Delhi,
`India
`
`
`
`
`B. Pharmacy (1980)
`
`
`
`
`
`
`Diploma in Pharmacy (1977)
`
`
`
`
`
`Publications:
`
`In peer reviewed journals:
`In trade journals
`Book Chapters
`Abstracts and Meeting Presentations:
`Thesis
`
`Patents:
`
`
`
`
`
`University of Delhi, India
`
`
`
`Board of Technical Education, Delhi, India
`
`
`
`10
`3
`3
`21
`2
`
`
`US 9145534 B2
`
`
`
`
`
`
`
`
`
`6
`
`RIMFROST EXHIBIT 1045 Page 0012
`
`
`
`Memberships:
`
`1) 2000 – 2014
`
`Institute of Food Technologists
`
`2) 2000 – 2014
`
`Canadian Institute of Food Science and Technology
`
`3) 2000 – Present AOCS (American Oil Chemist Society).
`
`
`
`2003 – 2012, Vice Representative for AOCS Health
`and Nutrition Division Program Committee.
`
`
`4) 2000 – 2006
`
`Member, American Herbal Products Association
`
`5) 1999 – 2004
`
`Phytochemical society of North America.
`
`6) 1999 – 2004
`
`Saskatchewan Nutraceutical Network.
`
`
`
`7
`
`RIMFROST EXHIBIT 1045 Page 0013
`
`
`
`Full Length papers in peer reviewed journals:
`
`1. Kapoor R., Huang, Y-S (2006). Gamma Linolenic acid: an anti-
`inflammatory omega-6 fatty acids. Current Pharmaceutical
`Biotechnology 7(6):531-4.
`2. Kapoor R, Klimaszewaski, A and McColl J.M. Essential fatty acids
`and stress. Int. J. Integrative Med. 2001,
`3. Kapoor, R and Klimaszewaski, A. Efficacy of borage oil in patients
`with eczema. Br. J. Dermatol. 143:200-201, 2000. (letter to editor)
`4. Kapoor R, Kalra J, Prasad K. Cardiac depression and cellular injury
`in hemorrhagic shock and reinfusion: role of free radicals. Mol Cell
`Biochem 1997;176:291-301.
`5. Kapoor R, Prasad K. Role of polymorphonuclear leukocytes in
`cardiovascular depression and cellular injury in hemorrhagic shock
`and reinfusion. Free Radic Biol Med 1996;21:609-18.
`6. Kapoor R, Prasad K. Beneficial effects of antioxidants in
`hemorrhagic shock. Angiology 1995;46:281-97.
`7. Prasad K, Kapoor R, Lee P. Purpurogallin, a scavenger of
`polymorphonuclear leukocyte-derived oxyradicals. Mol Cell
`Biochem 1994;139:27-32.
`8. Kapoor R, Prasad K. Role of oxyradicals in cardiovascular
`depression and cellular injury in hemorrhagic shock and reinfusion:
`effect of SOD and catalase. Circ.Shock 1994;43:79-94.
`9. Prasad K, Kapoor R, Kalra J. Methionine in protection of
`hemorrhagic shock: role of oxygen free radicals and hypochlorous
`acid. Circ.Shock 1992;36:265-76.
`10. Kapoor R, Kalra J, Prasad K. Beneficial effects of methionine on
`myocardial hemodynamic and cellular functions in hemorrhagic
`shock. Angiology 1992;43:294-305.
`Papers in Trade Journals:
`
`
`
`8
`
`RIMFROST EXHIBIT 1045 Page 0014
`
`
`
`1.
`
`2.
`
`3.
`
`Kapoor R., Gamma linolenic acid: a natural antiinflammatory
`agent – Part 1 Natural Pharmacy 2006
`Kapoor, R., Westcott, N., Reaney, M., and Jones, S. Conjugated
`linoleic acid - Seven decades of achievement II: Physiological
`properties . Inform 14:482-484, 2003
`Reaney, M., Westcott, N., Kapoor, R. and Jones, S. . Conjugated
`Linoleic Acid - Seven Decades of Achievement. inform 13: 802-
`07, 2002
`
`
`
`
`Book Chapters:
`
`1. Rakesh Kapoor, Martin Reaney, and Neil D. Westcott. Conjugated
`Linoleic Acid Oils in Fereidoon Shahidi (Ed). Bailey's Industrial Oil
`and Fat Products, Volume 3, EDIBLE OIL AND FAT PRODUCTS:
`SPECIALTY OILS AND OIL PRODUCTS, Part 2, 6th Edition
`2. Rakesh Kapoor and Harikumar Nair. Gamma Linolenic Acid Oils. in
`Fereidoon Shahidi (Editor). Bailey's Industrial Oil and Fat Products,
`Volume 3, EDIBLE OIL AND FAT PRODUCTS: SPECIALTY OILS
`AND OIL PRODUCTS, Part 2, 6th Edition
`3 Rakesh Kapoor. Gamma linolenic acid” the health effects. In C.C.
`Akoh and O-M Lai (eds) Healthful lipids. AOCS Press. Champaigne, IL,
`USA. Pp 301-334.
`
`
`
`
`
`
`
`
`
`
`
`
`9
`
`RIMFROST EXHIBIT 1045 Page 0015
`
`
`
`Invited Presentations:
`1. Kapoor, R. Lignans and Alpha-linolenic Acid as Anticancer Food
`Constituents. 2nd International Conference in the Series "Functional
`Foods: Prevention and Disease Treatment" November 15-16, 2005 -
`Dallas, Texas, USA
`
`
`2. Kapoor, R. Stabilized flax fiber product for functional food
`applications. 20th Annual CAOCS Meeting, Oct. 2 – 4, 2005.
`Saskatoon, SK., Canada.
`
`
`3. Kapoor, R. Essential Fatty Acids: Synergistic Ingredients for
`Condition Specific Formulations, 6th International Conference and
`Exhibition on Nutraceuticals and Functional Foods. October 16 - 19,
`2005, Anaheim, CA
`
`
`4. Kapoor R. GLA: Natural Leukotriene modulator. 5th International
`Conference and Exhibition on Nutraceuticals and Functional Foods.
`November 7-10, 2004, San Francisco, CA
`
`
`5. Kapoor R. Flax Oil: The Nutritional Importance. A conference of
`specialty oils. Apr 30 – May 1, 2005, Salt Lake City, Utah, USA.
`
`
`6. Kapoor R. GLA: A Functional Ingredient. 95th AOCS Annual
`Meeting and Expo, May 9-12, 2004, Cincinnati, Ohio, USA
`
`
`7. Kapoor, R. and Green, R. Natural emulsifiers for Food and Dietary
`Supplements. 95th AOCS Annual Meeting and Expo, May 9-12,
`2004, Cincinnati, Ohio, USA
`
`
`8. Kapoor R. Trans fats: health effects and strategy to reduce in food
`supply. National Association of Flavors and Food Ingredient
`Systems (NAFFS) Technical Meeting April 13, 2004
`
`
`9. Kapoor R. LignaMax®: The Natural Phytoestrogen. 4th International
`Conference on Functional Foods and Nutraceuticals, September
`2003, Las Vegas, USA.
`
`
`
`
`
`10
`
`RIMFROST EXHIBIT 1045 Page 0016
`
`
`
`10. Kapoor R. Proposed cGMPs in Manufacturing, Packing, or Holding
`Dietary Supplements. IFT Annual Meeting July 12 – 16, 2003.
`Chicago, IL, USA
`
`
`11. Kapoor R. Essential Fatty Acids and Functional Foods. 93rd AOCS
`Annual Meeting and Expo, May 2002.
`
`
`12. Kapoor R. Essential Fatty Acids in Specialty Formulations. 3rd
`International Conference and Exhibition on Nutraceuticals and
`Functional Foods. 2002
`
`
`13. Kapoor R. Essential fatty acids and condition specific products.
`Saskatchewan Nutraceutical Network Annual Meeting, Saskatoon,
`2002.
`
`
`14. Kapoor R. Omega-6 Fatty Acids: Are They Really Bad?
`Presentation at 3rd Short Course on Functional Foods and
`Nutraceuticals. Texas A&M University, College Station, Texas,
`USA 2002.
`
`
`15. Kapoor R. Essential fatty acids in functional foods. Workshop on
`development of functional foods. Food Development Centre, Portege
`La Prairie, MB, Canada Feb. 2002
`
`
`16. Kapoor R. EFAs in Cancer: Lecture to 4th year Nutrition Students at
`U of S, College of Pharmacy and Nutrition. March 2001
`
`
`17. Kapoor R. Functional Fats or Essential Fats. Presentation at 2nd
`Short Course on Functional Foods and Nutraceuticals. Feb. 2001
`Texas A&M University, College Station, Texas, USA.
`
`
`18. Kapoor R. EFAs in Functional Foods. 2nd International Conference
`on Functional Foods and Nutraceuticals, Nov. 2001, Portland, USA
`
`
`19. Kapoor R. Gamma Linolenic acid (GLA): What We Know and What
`We Need to Know. Short course on Functional Foods and
`Nutraceuticals. Feb. 2000, Texas A&M University, College Station,
`Texas, USA
`
`
`
`
`
`11
`
`RIMFROST EXHIBIT 1045 Page 0017
`
`
`
`20. Kapoor, R. GLA: Current state of affairs: First International
`Conference on Functional Foods and Nutraceuticals, Houston, Texas,
`May 2000
`
`
`21. Kapoor, R., Pillai, K., Zafar, R., Qadri, J. Antisecretory properties of
`Achyranthes aspera Linn. 35th Indian Pharmaceutical Congress,
`Hyderabad, India, 1983.
`
`
`
`Thesis:
`
`1. 1993: Role of oxygen free radicals on myocardial function and
`contractility during hemorrhagic shock and reperfusion. Ph.D.
`Thesis, University of Saskatchewan, Saskatoon, Canada
`
`
`2. 1983: Pharmacological evaluation of Achyranthes aspera Linn.
`Master of Pharmacy (Pharmacognosy) thesis, University of Delhi,
`Delhi, India
`
`
`
`
`
`12
`
`RIMFROST EXHIBIT 1045 Page 0018
`
`