DECLARATION OF GLENN D. PRESTWICH, Ph.D.
`DECLARATION OF GLENN D. PRESTWICH, Ph.D.
`DECLARATION OF GLENN D. PRESTWICH, Ph.D.
`
`I, Glenn D. Prestwich, Ph. D., residing at 166 Downwind Drive, Eastsound,
`I, Glenn D. Prestwich, Ph. D., residing at 166 Downwind Drive, Eastsound,
`I, Glenn D. Prestwich, Ph. D., residing at 166 Downwind Drive, Eastsound,
`
`WA 98245, do hereby declare as follows:
`WA 98245, do hereby declare as follows:
`WA 98245, do hereby declare as follows:
`
`1.
`1.
`1.
`
`I have been asked by Panitch Schwarze Belisario & Nadel LLP to provide
`I have been asked by Panitch Schwarze Belisario & Nadel LLP to provide
`I have been asked by Panitch Schwarze Belisario & Nadel LLP to provide
`
`my opinion concerning the validity of U.S. Patent No. 8,450,475 (the '475
`my opinion concerning the validity of U.S. Patent No. 8,450,475 (the '475
`my opinion concerning the validity of U.S. Patent No. 8,450,475 (the '475
`
`patent) in connection with their petition for inter partes review (IPR) of the
`patent) in connection with their petition for inter partes review (IPR) of the
`patent) in connection with their petition for inter partes review (IPR) of the
`
`'475 patent (IPR Petition). I am being compensated for my time at the rate
``475 patent (IPR Petition). I am being compensated for my time at the rate
``475 patent (IPR Petition). I am being compensated for my time at the rate
`
`of $700 per hour for consulting, $400 per hour for travel, and $900 per hour
`of $700 per hour for consulting, $400 per hour for travel, and $900 per hour
`of $700 per hour for consulting, $400 per hour for travel, and $900 per hour
`
`for oral testimony. My opinion is not influenced in any way by the
`for oral testimony. My opinion is not influenced in any way by the
`for oral testimony. My opinion is not influenced in any way by the
`
`compensation that I receive and my compensation will not be affected by the
`compensation that I receive and my compensation will not be affected by the
`compensation that I receive and my compensation will not be affected by the
`
`outcome of this matter.
`outcome of this matter.
`outcome of this matter.
`
`Education, Experience, Publications and Awards
`Education, Experience, Publications and Awards
`Education, Experience, Publications and Awards
`
`2.
`2.
`2.
`
`I am Presidential Professor of Medicinal Chemistry and Special Presidential
`I am Presidential Professor of Medicinal Chemistry and Special Presidential
`I am Presidential Professor of Medicinal Chemistry and Special Presidential
`
`Assistant for Faculty Entrepreneurism at the University of Utah in Salt Lake
`Assistant for Faculty Entrepreneurism at the University of Utah in Salt Lake
`Assistant for Faculty Entrepreneurism at the University of Utah in Salt Lake
`
`City, UT. I also currently hold the titles of Research Professor of
`City, UT. I also currently hold the titles of Research Professor of
`City, UT. I also currently hold the titles of Research Professor of
`
`Biochemistry, Adjunct Professor of Chemistry and Adjunct Professor of
`Biochemistry, Adjunct Professor of Chemistry and Adjunct Professor of
`Biochemistry, Adjunct Professor of Chemistry and Adjunct Professor of
`
`Bioengineering at the University of Utah. I have set out my background
`Bioengineering at the University of Utah. I have set out my background
`Bioengineering at the University of Utah. I have set out my background
`
`experience below, further particulars of which are set out in my curriculum
`experience below, further particulars of which are set out in my curriculum
`experience below, fmiher particulars of which are set out in my curriculum
`
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`Page 1 of 99
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`Galderma/Q-
`Galderma/Q-
`Med
`Med
`
`EXHkBIT
`EXHkBIT
`220013
`220013
`
`ALL 2200 B
`ALL 2200 B
`PROLLENIUM V. ALLERGAN
`PROLLENIUM V. ALLERGAN
`IPR2019-01505, et al.
`IPR2019-01505, et al.
`
`ALL 2200 B
`PROLLENIUM V. ALLERGAN
`IPR2019-01505, et al.
`
`

`

`vitae, which is attached to this Declaration. A complete list of my
`vitae, which is attached to this Declaration. A complete list of my
`vitae, which is attached to this Declaration. A complete list of my
`
`educational experience, work history, honors /awards, lectures and
`educational experience, work history, honors /awards, lectures and
`educational experience, work history, honors/awards, lectures and
`
`publications can be found in my curriculum vitae.
`publications can be found in my curriculum vitae.
`publications can be found in my curriculum vitae.
`
`3.
`3.
`3.
`
`I obtained a Bachelor of Science Degree (Honors) in Chemistry from the
`I obtained a Bachelor of Science Degree (Honors) in Chemistry from the
`I obtained a Bachelor of Science Degree (Honors) in Chemistry from the
`
`California Institute of Technology in Pasadena, California (1970) and a
`California Institute of Technology in Pasadena, California (1970) and a
`California Institute of Technology in Pasadena, California (1970) and a
`
`Ph.D. degree in Organic Chemistry from Stanford University in Palo Alto,
`Ph.D. degree in Organic Chemistry from Stanford University in Palo Alto,
`Ph.D. degree in Organic Chemistry from Stanford University in Palo Alto,
`
`California (1974).
`California (1974).
`California (1974).
`
`4.
`4.
`4.
`
`After obtaining my Ph.D., I worked for two and one -half years as a research
`After obtaining my Ph.D., I worked for two and one -half years as a research
`After obtaining my Ph.D., I worked for two and one-half years as a research
`
`scientist in Nairobi, Kenya on insect chemical communication, with the goal
`scientist in Nairobi, Kenya on insect chemical communication, with the goal
`scientist in Nairobi, Kenya on insect chemical communication, with the goal
`
`of identifying compounds in termites, ticks, tsetse flies, mosquitoes, and
`of identifying compounds in termites, ticks, tsetse flies, mosquitoes, and
`of identifying compounds in termites, ticks, tsetse flies, mosquitoes, and
`
`armyworms that would be useful for control of insect agricultural pests and
`armyworms that would be useful for control of insect agricultural pests and
`armyworms that would be useful for control of insect agricultural pests and
`
`insect disease vectors.
`insect disease vectors.
`insect disease vectors.
`
`5.
`5.
`5.
`
`From 1977 to 1996, I was appointed first as an Assistant Professor and,
`From 1977 to 1996, I was appointed first as an Assistant Professor and,
`From 1977 to 1996, I was appointed first as an Assistant Professor and,
`
`subsequently, Associate Professor, and then Full Professor of Chemistry at
`subsequently, Associate Professor, and then Full Professor of Chemistry at
`subsequently, Associate Professor, and then Full Professor of Chemistry at
`
`the State University of New York at Stony Brook, NY. From 1992 -1996, I
`the State University of New York at Stony Brook, NY. From 1992 -1996, I
`the State University of New York at Stony Brook, NY. From 1992-1996, I
`
`was also appointed as Professor of Biochemistry and Cellular Biology, and I
`was also appointed as Professor of Biochemistry and Cellular Biology, and I
`was also appointed as Professor of Biochemistry and Cellular Biology, and I
`
`was the Director of the New York State Center for Advanced Technology in
`was the Director of the New York State Center for Advanced Technology in
`was the Director of the New York State Center for Advanced Technology in
`
`Biotechnology, also called the Center for Biotechnology, at SUNY Stony
`Biotechnology, also called the Center for Biotechnology, at SUNY Stony
`Biotechnology, also called the Center for Biotechnology, at SUNY Stony
`
`Brook.
`Brook.
`Brook.
`
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`

`6.
`6.
`6.
`
`From 1996 -2002, I was the Chair of the Department of Medicinal Chemistry
`From 1996 -2002, I was the Chair of the Department of Medicinal Chemistry
`From 1996-2002, I was the Chair of the Department of Medicinal Chemistry
`
`at the University of Utah. In addition, from 1997 -2002, I directed the Center
`at the University of Utah. In addition, from 1997 -2002, I directed the Center
`at the University of Utah. In addition, from 1997-2002, I directed the Center
`
`for Cell Signaling, a Utah Center of Excellence dedicated to launching new
`for Cell Signaling, a Utah Center of Excellence dedicated to launching new
`for Cell Signaling, a Utah Center of Excellence dedicated to launching new
`
`start -up companies based on faculty technologies in cell signal research;
`start -up companies based on faculty technologies in cell signal research;
`start-up companies based on faculty technologies in cell signal research;
`
`three new companies were formed. From 2002 -2006, I directed a second
`three new companies were formed. From 2002 -2006, I directed a second
`three new companies were formed. From 2002-2006, I directed a second
`
`Utah Center of Excellence, the Center for Therapeutic Biomaterials, from
`Utah Center of Excellence, the Center for Therapeutic Biomaterials, from
`Utah Center of Excellence, the Center for Therapeutic Biomaterials, from
`
`which five new companies emerged.
`which five new companies emerged.
`which five new companies emerged.
`
`My academic duties have included teaching undergraduate and graduate
`My academic duties have included teaching undergraduate and graduate
`7. My academic duties have included teaching undergraduate and graduate
`7.
`7.
`
`courses in bioorganic chemistry, structural organic chemistry, medicinal
`courses in bioorganic chemistry, structural organic chemistry, medicinal
`courses in bioorganic chemistry, structural organic chemistry, medicinal
`
`chemistry, chemical ecology and site -targeted drug delivery. I have also
`chemistry, chemical ecology and site -targeted drug delivery. I have also
`chemistry, chemical ecology and site-targeted drug delivery. I have also
`
`been active in research directing graduate students, technicians, postdoctoral
`been active in research directing graduate students, technicians, postdoctoral
`been active in research directing graduate students, technicians, postdoctoral
`
`fellows and visiting faculty members. My university research and other
`fellows and visiting faculty members. My university research and other
`fellows and visiting faculty members. My university research and other
`
`scholarly duties have resulted in the publication of over 572 original
`scholarly duties have resulted in the publication of over 572 original
`scholarly duties have resulted in the publication of over 572 original
`
`scientific papers and over 60 book chapters and books. Of these, about 22%
`scientific papers and over 60 book chapters and books. Of these, about 22%
`scientific papers and over 60 book chapters and books. Of these, about 22%
`
`of the refereed publications and 28% of the books /book chapters are related
`of the refereed publications and 28% of the books /book chapters are related
`of the refereed publications and 28% of the books/book chapters are related
`
`to hyaluronic acid or hyaluronan. I am also a named inventor on some 66
`to hyaluronic acid or hyaluronan. I am also a named inventor on some 66
`to hyaluronic acid or hyaluronan. I am also a named inventor on some 66
`
`patents and patent applications in many areas, including the control of insect
`patents and patent applications in many areas, including the control of insect
`patents and patent applications in many areas, including the control of insect
`
`pests, cholesterol lowering agents, labeled phospholipids and
`pests, cholesterol lowering agents, labeled phospholipids and
`pests, cholesterol lowering agents, labeled phospholipids and
`
`phosphoinositides in drug discovery assays, anti -cancer and anti -angiogenic
`phosphoinositides in drug discovery assays, anti -cancer and anti -angiogenic
`phosphoinositides in drug discovery assays, anti-cancer and anti-angiogenic
`
`agents, signal transduction modifiers, mercury sensing chemicals, and the
`agents, signal transduction modifiers, mercury sensing chemicals, and the
`agents, signal transduction modifiers, mercury sensing chemicals, and the
`
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`compositions and uses for a wide variety of chemically modified hyaluronan
`compositions and uses for a wide variety of chemically modified hyaluronan
`compositions and uses for a wide variety of chemically modified hyaluronan
`
`(HA) derivatives. About half of my patent and patent application portfolio
`(HA) derivatives. About half of my patent and patent application portfolio
`(HA) derivatives. About half of my patent and patent application portfolio
`
`covers compositions of matter, methods of making, and methods for using
`covers compositions of matter, methods of making, and methods for using
`covers compositions of matter, methods of making, and methods for using
`
`chemically- modified HA derivatives as biomaterials for wound repair,
`chemically- modified HA derivatives as biomaterials for wound repair,
`chemically-modified HA derivatives as biomaterials for wound repair,
`
`adhesion prevention, drug delivery, tissue engineering, 3 -D cell culture, and
`adhesion prevention, drug delivery, tissue engineering, 3 -D cell culture, and
`adhesion prevention, drug delivery, tissue engineering, 3-D cell culture, and
`
`cell therapy or as anti -inflammatory compounds for treatment of
`cell therapy or as anti -inflammatory compounds for treatment of
`cell therapy or as anti-inflammatory compounds for treatment of
`
`inflammatory diseases of the eye, skin, bladder, gingiva, kidney, and other
`inflammatory diseases of the eye, skin, bladder, gingiva, kidney, and other
`inflammatory diseases of the eye, skin, bladder, gingiva, kidney, and other
`
`tissues.
`tissues.
`tissues.
`
`8.
`8.
`8.
`
`Since 1980, I have been a consultant for a wide variety of pharmaceutical
`Since 1980, I have been a consultant for a wide variety of pharmaceutical
`Since 1980, I have been a consultant for a wide variety of pharmaceutical
`
`and companies specializing in the development of lipid kinase inhibitors,
`and companies specializing in the development of lipid kinase inhibitors,
`and companies specializing in the development of lipid kinase inhibitors,
`
`squalene epoxidase and oxidosqualene cyclase inhibitors, insect juvenile
`squalene epoxidase and oxidosqualene cyclase inhibitors, insect juvenile
`squalene epoxidase and oxidosqualene cyclase inhibitors, insect juvenile
`
`hormone antagonists, insect pheromone analogs, and biomaterials. My
`hormone antagonists, insect pheromone analogs, and biomaterials. My
`hormone antagonists, insect pheromone analogs, and biomaterials. My
`
`research activities in HA began in approximately 1989, and my first
`research activities in HA began in approximately 1989, and my first
`research activities in HA began in approximately 1989, and my first
`
`company, Clear Solutions Biotech, was launched with Jim Hayward,
`company, Clear Solutions Biotech, was launched with Jim Hayward,
`company, Clear Solutions Biotech, was launched with Jim Hayward,
`
`President of Collaborative Laboratories, in 1994 based on the hydrazide
`President of Collaborative Laboratories, in 1994 based on the hydrazide
`President of Collaborative Laboratories, in 1994 based on the hydrazide
`
`modification technology discovered in my laboratories. Since moving to
`modification technology discovered in my laboratories. Since moving to
`modification technology discovered in my laboratories. Since moving to
`
`Utah in 1996, I have co- founded and held management positions with
`Utah in 1996, I have co- founded and held management positions with
`Utah in 1996, I have co-founded and held management positions with
`
`several biotechnology start-up companies, as well as serving as a consultant
`several biotechnology start-up companies, as well as serving as a consultant
`several biotechnology start-up companies, as well as serving as a consultant
`
`for others. I founded and served as a Director, Chief Scientific Officer
`for others. I founded and served as a Director, Chief Scientific Officer
`for others. I founded and served as a Director, Chief Scientific Officer
`
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`

`

`(CSO), Chief Scientific Adviser, or Chief Executive Officer (CEO) for a
`(CSO), Chief Scientific Adviser, or Chief Executive Officer (CEO) for a
`(CSO), Chief Scientific Adviser, or Chief Executive Officer (CEO) for a
`
`number of these start -up companies.
`number of these start -up companies.
`number of these start-up companies.
`
`9.
`9.
`9.
`
`These companies include: Clear Solutions Biotech (Stony Brook, NY)
`These companies include: Clear Solutions Biotech (Stony Brook, NY)
`These companies include: Clear Solutions Biotech (Stony Brook, NY)
`
`(1994-2001 ); Echelon Biosciences, Inc. (CSO, 1997-2003; Science Advisor
`(1994- 2001); Echelon Biosciences, Inc. (CSO,1997 -2003; Science Advisor
`(1994- 2001); Echelon Biosciences, Inc. (CSO,1997 -2003; Science Advisor
`
`2004 - current); Sentrx Surgical, Inc. (Salt Lake City, UT)(CSO, 2004-
`2004 - current); Sentrx Surgical, Inc. (Salt Lake City, UT)(CSO, 2004-
`2004 - current); Sentrx Surgical, Inc. (Salt Lake City, UT)(CSO, 2004-
`
`2005); Carbylan Biosurgery, Inc. (Palo Alto, CA)(Science Advisor, 2005-
`2005); Carbylan Biosurgery, Inc. (Palo Alto, CA)(Science Advisor, 2005-
`2005); Carbylan Biosurgery, Inc. (Palo Alto, CA)(Science Advisor, 2005-
`
`2009); Sentrx Animal Care, Inc. (Salt Lake City, UT)(Science Advisor,
`2009); Sentrx Animal Care, Inc. (Salt Lake City, UT)(Science Advisor,
`2009); Sentrx Animal Care, Inc. (Salt Lake City, UT)(Science Advisor,
`
`2006 -current); Glycosan BioSystems, Inc. (Salt Lake City, UT) (CSO, 2006-
`2006 -current); Glycosan BioSystems, Inc. (Salt Lake City, UT) (CSO, 2006-
`2006-current); Glycosan BioSystems, Inc. (Salt Lake City, UT) (CSO, 2006-
`
`2011); GlycoMira Therapeutics (Salt Lake City) (CSO, 2008 - current);
`2011); GlycoMira Therapeutics (Salt Lake City) (CSO, 2008 - current);
`2011 ); GlycoMira Therapeutics (Salt Lake City) (CSO, 2008 - current);
`
`Metallosensors (Salt Lake City) (CEO, 2011 - 2014); Brickell Biotech (Ft.
`Metallosensors (Salt Lake City) (CEO, 2011 - 2014); Brickell Biotech (Ft.
`Metallosensors (Salt Lake City) (CEO, 2011 - 2014); Brickell Biotech (Ft.
`
`Lauderdale, FL) (Director, 2011 - 2013); OrthoCyte /BioTime (Alameda,
`Lauderdale, FL) (Director, 2011 - 2013); OrthoCyte /BioTime (Alameda,
`Lauderdale, FL) (Director, 2011 - 2013); OrthoCyte/BioTime (Alameda,
`CA)(Scientific Advisor, 2011 - current); Organovo (Scientific Advisory
`CA)(Scientific Advisor, 2011 - current); Organovo (Scientific Advisory
`CA)(Scientific Advisor, 2011 - current); Organovo (Scientific Advisory
`
`Board (SAB), 2008 - current); Modern Meadow (SAB, 2012 - current). Of
`Board (SAB), 2008 - current); Modern Meadow (SAB, 2012 - current). Of
`Board (SAB), 2008 - current); Modern Meadow (SAB, 2012 - current). Of
`
`these, the technologies for Clear Solutions Biotech, Sentrx Surgical,
`these, the technologies for Clear Solutions Biotech, Sentrx Surgical,
`these, the technologies for Clear Solutions Biotech, Sentrx Surgical,
`
`Carbylan Biosurgery, Sentrx Animal Care, Glycosan, GlycoMira, Brickell
`Carbylan Biosurgery, Sentrx Animal Care, Glycosan, GlycoMira, Brickell
`Carbylan Biosurgery, Sentrx Animal Care, Glycosan, GlycoMira, Brickell
`
`Biotech, and BioTime all involve technology for the chemical modification
`Biotech, and BioTime all involve technology for the chemical modification
`Biotech, and BioTime all involve technology for the chemical modification
`
`of HA that was licensed from my university laboratories and is the subject of
`of HA that was licensed from my university laboratories and is the subject of
`of HA that was licensed from my university laboratories and is the subject of
`
`pending, published or issued patents.
`pending, published or issued patents.
`pending, published or issued patents.
`
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`10.
`10.10.
`
`
`
`I have received peer and community recognition and numerous awards forI have received peer and community recognition and numerous awards for
`I have received peer and community recognition and numerous awards for
`
`
`my work, including the Alfred P. Sloan Research Award (1981 -85) andmy work, including the Alfred P. Sloan Research Award (1981 -85) and
`my work, including the Alfred P. Sloan Research Award (1981-85) and
`
`Camille and Henry Dreyfus Teacher-Scholar Award (1981-86). I received
`
`Camille and Henry Dreyfus Teacher -Scholar Award (1981 -86). I receivedCamille and Henry Dreyfus Teacher -Scholar Award (1981 -86). I received
`
`
`both the 1998 Paul Dawson Biotechnology Award and the 2008 Volwilerboth the 1998 Paul Dawson Biotechnology Award and the 2008 Volwiler
`both the 1998 Paul Dawson Biotechnology Award and the 2008 Volwiler
`
`
`Research Award of the American Association of Colleges of Pharmacy. I amResearch Award of the American Association of Colleges of Pharmacy. I am
`Research Award of the American Association of Colleges of Pharmacy. I am
`
`
`a Fellow of the American Institute for Medical and Biological Engineeringa Fellow of the American Institute for Medical and Biological Engineering
`a Fellow of the American Institute for Medical and Biological Engineering
`
`
`(2005- current), one of vSpring's Top 100 Entrepreneurs (2005, 2006), a(2005- current), one of vSpring's Top 100 Entrepreneurs (2005, 2006), a
`(2005-current), one ofvSpring's Top 100 Entrepreneurs (2005, 2006), a
`
`
`recipient of a TIAA -CREF "Greater Good" award (2006), a Utah Businessrecipient of a TIAA -CREF "Greater Good" award (2006), a Utah Business
`recipient of a TIAA-CREF "Greater Good" award (2006), a Utah Business
`
`
`Magazine "Health Care Hero" for 2006, and was awarded the Governor'sMagazine "Health Care Hero" for 2006, and was awarded the Governor's
`Magazine "Health Care Hero" for 2006, and was awarded the Governor's
`
`
`Medal for Science and Technology for 2006. I received the Utah Governor'sMedal for Science and Technology for 2006. I received the Utah Governor's
`Medal for Science and Technology for 2006. I received the Utah Governor's
`
`
`Medal for Science and Technology for 2006. In 2010, I received theMedal for Science and Technology for 2006. In 2010, I received the
`Medal for Science and Technology for 2006. In 2010, I received the
`
`
`University of Utah Distinguished Scholarly and Creative Research Award,University of Utah Distinguished Scholarly and Creative Research Award,
`University of Utah Distinguished Scholarly and Creative Research Award,
`
`
`as well as the 2010 "Rooster Prize" of the International Society foras well as the 2010 "Rooster Prize" of the International Society for
`as well as the 2010 "Rooster Prize" of the International Society for
`
`
`Hyaluronan Science for outstanding contributions to HA- derived products. .Hyaluronan Science for outstanding contributions to HA- derived products. .
`Hyaluronan Science for outstanding contributions to HA-derived products ..
`
`
`I was inducted as a 2013 Fellow of the National Academy of Inventors, and II was inducted as a 2013 Fellow of the National Academy of Inventors, and I
`I was inducted as a 2013 Fellow of the National Academy of Inventors, and I
`
`
`am the recipient of the 2014 Distinguished Innovation and Impact Award ofam the recipient of the 2014 Distinguished Innovation and Impact Award of
`am the recipient of the 2014 Distinguished Innovation and Impact Award of
`
`
`the University of Utah.the University of Utah.
`the University of Utah.
`
`
`During my 37 years as a faculty member, I have trained over 125 graduateDuring my 37 years as a faculty member, I have trained over 125 graduate
`11. During my 3 7 years as a faculty member, I have trained over 125 graduate
`11.11.
`
`
`
`and postdoctoral scientists, many undergraduate students, and mentored overand postdoctoral scientists, many undergraduate students, and mentored over
`and postdoctoral scientists, many undergraduate students, and mentored over
`
`
`20 adjunct and visiting faculty members. During this time, I have served on20 adjunct and visiting faculty members. During this time, I have served on
`20 adjunct and visiting faculty members. During this time, I have served on
`
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`

`16 editorial boards for prominent journals; my current editorial
`16 editorial boards for prominent journals; my current editorial
`16 editorial boards for prominent journals; my current editorial
`
`responsibilities that are relevant to HA science include: BioMatter,
`responsibilities that are relevant to HA science include: BioMatter,
`responsibilities that are relevant to HA science include: BioMatter,
`
`Macromolecular Biosciences, Current Opinion in Chemical Biology,
`Macromolecular Biosciences, Current Opinion in Chemical Biology,
`Macromolecular Biosciences, Current Opinion in Chemical Biology,
`
`Perspectives in Medicinal Chemistry, and Science Translational Medicine.
`Perspectives in Medicinal Chemistry, and Science Translational Medicine.
`Perspectives in Medicinal Chemistry, and Science Translational Medicine.
`
`My university research programs for the past decade have focused on (i)
`My university research programs for the past decade have focused on (i)
`My university research programs for the past decade have focused on (i)
`
`chemical synthesis and uses of affinity reagents for biological studies of
`chemical synthesis and uses of affinity reagents for biological studies of
`chemical synthesis and uses of affinity reagents for biological studies of
`
`phosphoinositides; (ii) new reagents for lipid signaling in cell biology and
`phosphoinositides; (ii) new reagents for lipid signaling in cell biology and
`phosphoinositides; (ii) new reagents for lipid signaling in cell biology and
`
`cancer treatment; (iii) biomaterials for wound repair, cartilage repair, tissue
`cancer treatment; (iii) biomaterials for wound repair, cartilage repair, tissue
`cancer treatment; (iii) biomaterials for wound repair, cartilage repair, tissue
`
`engineering, cell therapy, scar -free healing, and toxicology and tumor
`engineering, cell therapy, scar -free healing, and toxicology and tumor
`engineering, cell therapy, scar-free healing, and toxicology and tumor
`
`xenograft models; and (iv) sulfated glycosaminoglycan analogues as
`xenograft models; and (iv) sulfated glycosaminoglycan analogues as
`xenograft models; and (iv) sulfated glycosaminoglycan analogues as
`
`inflammation modulators for clinical use.
`inflammation modulators for clinical use.
`inflammation modulators for clinical use.
`
`Level of Ordinary Skill in the Art of the `475 Patent
`Level of Ordinary Skill in the Art of the `475 Patent
`Level of Ordinary Skill in the Art of the '4 7 5 Patent
`
`12.
`12.
`12.
`
`I have been asked to opine on the level of ordinary skill in the art in relation
`I have been asked to opine on the level of ordinary skill in the art in relation
`I have been asked to opine on the level of ordinary skill in the art in relation
`
`to U.S. Pat. No. 8,450,475 (Exhibit 1001, "the '475 patent") at the time of
`to U.S. Pat. No. 8,450,475 (Exhibit 1001, "the `475 patent ") at the time of
`to U.S. Pat. No. 8,450,475 (Exhibit 1001, "the `475 patent ") at the time of
`
`the filing of the application therefor, i.e., in August 2008. As the title
`the filing of the application therefor, i.e., in August 2008. As the title
`the filing of the application therefor, i.e., in August 2008. As the title
`
`indicates, the art of the `475 patent is hyaluronic acid (HA) -based gels
`indicates, the art of the `475 patent is hyaluronic acid (HA) -based gels
`indicates, the art of the '475 patent is hyaluronic acid (HA)-based gels
`
`including lidocaine, and more specifically, soft tissue fillers containing HA
`including lidocaine, and more specifically, soft tissue fillers containing HA
`including lidocaine, and more specifically, soft tissue fillers containing HA
`
`crosslinked with 1,4- butanediol diglycidyl ether (HA- BDDE), uncrosslinked
`crosslinked with 1,4- butanediol diglycidyl ether (HA- BDDE), uncrosslinked
`crosslinked with 1,4-butanediol diglycidyl ether (HA-BDDE), uncrosslinked
`
`HA, and lidocaine. I understand that a person of ordinary skill in the art
`HA, and lidocaine. I understand that a person of ordinary skill in the art
`HA, and lidocaine. I understand that a person of ordinary skill in the art
`
`(POSITA) would have been one who is presumed to be aware of all
`(POSITA) would have been one who is presumed to be aware of all
`(POSIT A) would have been one who is presumed to be aware of all
`
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`pertinent art, thinks along conventional wisdom in the art, and is a person ofpertinent art, thinks along conventional wisdom in the art, and is a person of
`pertinent art, thinks along conventional wisdom in the art, and is a person of
`
`
`ordinary creativity.ordinary creativity.
`ordinary creativity.
`
`13.
`13.13.
`
`
`
`In my opinion, with respect to the `475 patent, a POSITA would haveIn my opinion, with respect to the `475 patent, a POSITA would have
`In my opinion, with respect to the '475 patent, a POSITA would have
`
`
`education and experience concerning preparation and /or use of crosslinkededucation and experience concerning preparation and /or use of crosslinked
`education and experience concerning preparation and/or use of crosslinked
`
`
`HA, such as that used in soft tissue fillers, as of 2008, with varying levels ofHA, such as that used in soft tissue fillers, as of 2008, with varying levels of
`HA, such as that used in soft tissue fillers, as of 2008, with varying levels of
`
`
`education and experience. Such a person would have a B.S. or M.S. in theeducation and experience. Such a person would have a B.S. or M.S. in the
`education and experience. Such a person would have a B.S. or M.S. in the
`
`
`fields of biochemistry, polymer chemistry, medicinal chemistry,fields of biochemistry, polymer chemistry, medicinal chemistry,
`fields of biochemistry, polymer chemistry, medicinal chemistry,
`
`
`pharmaceutical chemistry, or a related field, with several years of practicalpharmaceutical chemistry, or a related field, with several years of practical
`pharmaceutical chemistry, or a related field, with several years of practical
`
`
`clinical, academic or industrial experience within these fields, or a Ph.D. inclinical, academic or industrial experience within these fields, or a Ph.D. in
`clinical, academic or industrial experience within these fields, or a Ph.D. in
`
`
`those fields but with reduced practical experience. Alternately, the POSITAthose fields but with reduced practical experience. Alternately, the POSITA
`those fields but with reduced practical experience. Alternately, the POSITA
`
`
`could have an M.D. in dermatology, plastic surgery, and /or a relatedcould have an M.D. in dermatology, plastic surgery, and /or a related
`could have an M.D. in dermatology, plastic surgery, and/or a related
`
`
`specialty appropriate to the clinical use of dermal fillers.specialty appropriate to the clinical use of dermal fillers.
`specialty appropriate to the clinical use of dermal fillers.
`
`
`The `475 PatentThe `475 Patent
`The '475 Patent
`
`14.
`14.14.
`
`
`
`I understand that the `475 patent purports to provide a soft tissue fillerI understand that the `475 patent purports to provide a soft tissue filler
`I understand that the '475 patent purports to provide a soft tissue filler
`
`
`containing HA -BDDE, uncrosslinked HA and lidocaine that has enhancedcontaining HA -BDDE, uncrosslinked HA and lidocaine that has enhanced
`containing HA-BDDE, uncrosslinked HA and lidocaine that has enhanced
`
`
`stability relative to conventional HA -based compositions "when subjected tostability relative to conventional HA -based compositions "when subjected to
`stability relative to conventional HA-based compositions "when subjected to
`
`
`sterilization techniques such as autoclaving, and /or when stored for longsterilization techniques such as autoclaving, and /or when stored for long
`sterilization techniques such as autoclaving, and/or when stored for long
`
`
`periods at ambient temperature. Methods for preparing such HA -basedperiods at ambient temperature. Methods for preparing such HA -based
`periods at ambient temperature. Methods for preparing such HA-based
`
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`compositions are also provided as well as products made by such methods."
`compositions are also provided as well as products made by such methods."
`compositions are also provided as well as products made by such methods."
`
`(`475 patent, 2:42 -49).
`(`475 patent, 2:42 -49).
`('475 patent, 2:42-49).
`
`15.
`15.
`15.
`
`I agree with the `475 patent that since the first HA -based filler was approved
`I agree with the `475 patent that since the first HA -based filler was approved
`I agree with the '475 patent that since the first HA-based filler was approved
`
`by the U.S. Food and Drug Administration (FDA) in December 2003, "this
`by the U.S. Food and Drug Administration (FDA) in Dece