IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`In the Inter Partes Review (IPR) of
`
`U.S. Patent No. 8,440,170
`
`DECLARATION OF Dr. Kinam Park
`
`I, Kinam Park, do hereby declare:
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`1.
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`I am making this declaration at the request of the Petitioners in the
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`matter of the Inter Partes Review (IPR) of U.S. Patent No. 8,440,170 (the “’170
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`Patent”), as set forth in the above caption.
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`2.
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`I am being compensated for my work in this matter at the rate of
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`$600.00 per hour. My compensation in no way depends on the outcome of this
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`proceeding.
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`A.
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`Education and Professional Background
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`3.
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`I am currently the Showalter Distinguished Professor of Biomedical
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`Engineering and Professor of Pharmaceutics at Purdue University.
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`4.
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`I have a Ph.D. in Pharmaceutics from the University of Wisconsin at
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`Madison, Wisconsin. I also completed post-doctoral training in Chemical
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`Engineering at the University of Wisconsin at Madison, Wisconsin.
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`5.
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`I began my independent research since 1986 when I became an
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`Bass and Spangenberg
`Exhibit 1002
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`Page 1 of 109
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`Assistant Professor at Purdue University. My research focus has been developing
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`various delivery systems for controlled drug delivery applications. I have served
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`on many scientific advisory boards and journal editorial boards. I have been the
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`Editor-in-Chief of the Journal of Controlled Release since 2005. Details of these
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`and other positions are listed on my curriculum vitae. I'm an inventor of 18 U.S.
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`Patents and have published over 250 papers in multiple peer-reviewed scientific
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`journals.
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`6.
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`I have experience in drug delivery systems, including oral
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`formulations (fast-dissolving tablets & gastric retention devices using smart
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`polymers & hydrogels), polymer micelles (for delivery of poorly soluble drugs),
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`drug-device combinations such as drug-eluting stents, and microparticles for long-
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`term drug delivery.
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`7.
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`A copy of my curriculum vitae is submitted herewith as Attachment
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`A to this Declaration.
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`B. Materials Considered
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`8.
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`The list of materials I considered in forming the opinions set forth in
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`this declaration includes the ’170 patent, the file history of the ’170 patent, the
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`Petition for Inter Partes Review of the ’170 patent, and the prior art including i)
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`PREVACID® (lansoprazole) Delayed-Release Capsules; PREVACID®
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`(lansoprazole) For Delayed-Release Oral Suspension; PREVACID® SoluTab™
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`2
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`(lansoprazole) Delayed-Release Orally Disintegrating Tablets (Ex. 1004 hereafter
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`“the Prevacid Label”) TAP Pharmaceuticals, Lake Forest Il, 60045 USA, 102-
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`004-R26 June 2007; ii) US 2006/0193909 to Stawski et al. entitled “Breath
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`Freshening Presses Tablets and Methods of Making and Using Same” Published
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`August 31, 2006. (Ex. 1005 hereafter “Stawski”); and iii) US 4,744,991 to
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`Serpelloni entitled “Speckled Sugarless Chewing-Gum and Process for its
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`Manufacture” issued May 17, 1988. (Ex. 1006 hereafter “Serpelloni”).
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`C.
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`Legal Standards
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`9.
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`In my opinion, given the disclosure of the ’170 patent, I consider a
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`person of ordinary skill in the art at the time of filing of this patent would have
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`either a Pharm. D. or a Ph.D. in pharmaceutics, chemistry, chemical engineering,
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`or a related discipline; or a Bachelor’s or Master’s degree in pharmacy/
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`pharmaceutics or a related field with about four years of experience relating to
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`formulation of compounds. A person of ordinary skill in the art may have
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`collaborated with others having expertise in, for example, methods of treating
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`diseases and administering medicines.
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`10.
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`I have been told that the obviousness inquiry is a question of law
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`based on four factual predicates: (1) "the scope and content of the prior art," (2) the
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`"differences between the prior art and the claims at issue," (3) "the level of ordinary
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`skill in the pertinent art," and (4) "secondary considerations" such as "commercial
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`3
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`success, long felt but unsolved needs, failure of others, etc. I have also been told
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`that the combination of familiar elements according to known methods is likely
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`to be obvious when it does no more than yield predictable results.
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`I have also been told that the motivation to combine may be found in many
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`different places and forms. Thus, for example, a challenger is not limited to the
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`same motivation that the patentee had.
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`D.
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`Background and the ’170 Patent
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`11.
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`The ‘170 Patent is directed “to orally disintegrating tablets with
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`speckled appearance.” (Ex. 1001 abstract; col 1:14-16). The ‘170 Patent states that
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`“the orally disintegrating tablets with speckled appearance are readily and easily
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`identifiable by physicians, nurses, and patients.” (Id.). The ‘170 Patent indicates
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`that colored granules and excipients give tablets the “speckled appearance.” (Ex.
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`1001 col 3:44-46). The ‘170 makes no claim as to the active pharmaceutical
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`ingredient (API) useful in the so-called invention, listing hundreds of active
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`ingredients that could be used with the speckled tablet in a laundry list stretching
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`almost four full columns of the patent. (Ex. 1001 col 3: 48 – col 7:27).
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`E. Claim Construction
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`12.
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`I understand that the claims in an IPR proceeding are construed in
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`accordance with the broadest reasonable construction consistent with the
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`4
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`specification.
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`13.
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`I have been told that the claim term “speckled appearance” should
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`mean, with regard to a pharmaceutical tablet, a tablet that “has the look of being
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`covered with small spots or patches of color.” I have been told that the claim term
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`“colored granules” is properly construed as “small particles of a size from about 10
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`µM to about 1200 µM having or having been given color.” I have been told that
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`the claim term “pharmaceutically acceptable carrier” should be construed to mean
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`“a substance that can be included in the compositions of the invention and that
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`causes no significant adverse toxicological effects to a patient.” I agree with these
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`constructions because they are consistent with the broadest reasonable construction
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`as understood by one of ordinary skill in the art and the Specification of the ‘170
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`Patent. For example, it is well known and accepted that a “pharmaceutically
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`acceptable carrier” is generally known as an excipient that can be included in a
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`pharmaceutical compositions and that causes no significant adverse toxicological
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`effects to a patient.
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`F. Claim 1 of the ‘170 Patent is unpatentable as obvious over the
`Prevacid Label in view of Stawski under 35 U.S.C. § 103.
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`14.
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`It is my opinion that claim 1 of the ‘170 patent would have been
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`obvious to one of ordinary skill in the art in light of the teachings of the
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`Prevacid Label and Stawski.
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`15. The Prevacid Label teaches the claimed “orally disintegrating tablets
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`5
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`with speckled appearance”: “PREVACID SoluTab Delayed-Release Orally
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`Disintegrating Tablets, 15 mg, are white to yellowish white uncoated tablets with
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`orange to dark brown speckles”. (Ex. 1004, p. 10).
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`16.
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`It is my opinion that the combination of the Prevacid Label and
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`Stawski teaches the claimed “speckles comprising colored granules of a water-
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`soluble sugar.” The Prevacid Label teaches speckles comprising colored granules
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`(Ex. 1004 pg 10 “with orange to dark brown speckles”) and tablets containing
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`water soluble sugars (Ex. 1005 e.g. pg. 7 mannitol). Also, speckles comprising
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`colored granules of water-soluble sugar were well-known in the art at the time of
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`the invention. For example, Stawski that teaches tablets (Ex. 1005 Examples 3 A-
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`H) comprising colored granules of a water-soluble sugar:
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`The abrasive inclusions may be made from a number of
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`different materials, including crystalline sugars or polyols;
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`solid matrices of carbohydrates, polyols or mixtures; or
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`extruded carbohydrates, polyols, or mixtures; … . On the
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`one hand, solid matrices (such as from fluid bed coating or
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`spray drying) and extruded carbohydrates or polyols are
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`preferred because these inclusions may also contain
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`flavors and/or colors. When the inclusions include colors,
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`the abrasive particles may have a contrasting color from
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`the remainder of the compressible composition into which
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`they are added. (Ex. 1005 para [0085])
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`6
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`Stawski also discloses that “[t]he abrasive inclusions can include encapsulated or
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`entrapped favors and colors. They can also be hard crystals of sugars or polyols,
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`such as crystalline maltitol.” (Ex. 1005 para [0099]). Stawski further discloses that
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`“[t]he Palatinit inclusions [hydrogenated isomaltulose] in the above Examples 3 A-
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`H are replaced with blue colored mannitol inclusions (Roquette Pearlitol 500DC).”
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`(Ex. 1005 para [0105], emphasis added). Moreover, the “blue colored mannitol
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`inclusions” mentioned in Stawski were commercially available at the time of the
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`invention and known to be useful as claimed as indicated.
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`17. A preferred embodiment of Stawski includes speckles comprising colored
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`granules of a water-soluble sugar:
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`Pressed tablet 70 shown in FIG. 8 does not have distinct
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`layers, and may be formed all of one composition. The
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`composition comprises abrasive inclusions 75 to provide
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`an abrasive surface opposite the generally domed top
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`surface on the tablet. The abrasive inclusions in this
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`embodiment comprise solid matrices of carbohydrates,
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`solid matrices of polyols, extruded carbohydrates or
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`extruded polyols, and also carry a flavor. (Ex. 1005 para
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`[0063])
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`7
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`It would have been readily obvious to one of ordinary skill in the art that the
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`speckles disclosed by the Prevacid Label could have been comprised of colored
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`granules of a water-soluble sugar such as mannitol as taught by Stawski, as Stawski
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`specifically teaches the inclusions as being useful to “have a contrasting color from
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`the remainder of the … [tablet]” into which they are added. Further, as the
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`Prevacid Label also teaches water-soluble sugars, including mannitol, as
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`acceptable carriers, as well as various dyes, the use of a colored mannitol
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`composition would have been obvious to one of ordinary skill in the art with a
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`reasonable expectation that such would have been successful in producing a
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`speckled appearance in a tablet as disclosed by Stawski.
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`18.
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` It is my opinion that the Prevaid Label teaches the claimed “a
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`pharmaceutically acceptable carrier.” In particular, the Prevacid Label teaches
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`pharmaceutically acceptable carriers:
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`Each delayed-release orally disintegrating tablet contains
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`enteric-coated microgranules consisting of 15 mg or 30
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`mg of lansoprazole (active ingredient) and the following
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`
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`8
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`inactive
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`ingredients:
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`lactose
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`monohydrate,
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`microcrystalline
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`cellulose, magnesium
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`carbonate,
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`hydroxypropyl cellulose, hypromellose, titanium dioxide,
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`talc, mannitol, methacrylic
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`acid,
`
`polyacrylate,
`
`polyethylene glycol, glyceryl monostearate, polysorbate
`
`80, triethyl citrate, ferric oxide, citric acid, crospovidone,
`
`aspartamePhenylketonurics: Contains Phenylalanine 2.5
`
`mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.,
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`artificial strawberry flavor and magnesium stearate. (Ex.
`
`1004 pg 1)
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`It is also my opinion that Stawski also teaches pharmaceutically acceptable
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`carriers. (see Ex. 1005 paras [0092]-[0106] Examples 1-3).
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`Accordingly, it would have been readily obvious to one of ordinary skill in
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`the art that an orally disintegrating tablet with speckled appearance could have
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`been reasonably expected to have been derived from the disclosure of the Prevacid
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`Label in view of Stawski without undue experimentation.
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`
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`
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`G. Dependent Claims 2-4: The orally disintegrating tablets …
`wherein the water-soluble sugar is mannitol.
` It is my opinion that claims 2-4 of the ‘170 patent would have been
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`19.
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`obvious to one of ordinary skill in the art in light of the teachings of the Prevacid
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`Label and Stawski. Claim 2 recites “the water-soluble sugar is selected from the
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`group consisting of sucrose and polyalcohols”. Claim 3, which depends from claim
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`9
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`2, further limits the water-soluble sugars to “the group consisting of sucrose,
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`sorbitol, mannitol, xylitol, and fructose”. Finally, Claim 4, which depends from
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`claim 3, further limits the choice of water-soluble sugars to “mannitol”. Stawski
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`satisfies the claim limitations of claims 2, 3, and 4 because it specifically states that
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`the water-soluble sugar is mannitol. (Ex. 1005 ¶ [0105], “The Palatinit inclusions
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`in the above Examples 3 A-H are replaced with blue colored mannitol inclusions.”)
`
`
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`H. Dependent Claims 5-7: The orally disintegrating tablets … the
`colored granules have a particle size from about 10 μm to about
`1200 μm (claim 5); wherein the colored granules have a particle
`size from about 200 μm to about 800 μm (claim 6); and wherein
`the colored granules have a particle size from about 300 μm to
`about 500 μm (claim 7).
`It is my opinion that claims 5, 6, and 7 of the ‘170 patent would have
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`20.
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`been obvious to one of ordinary skill in the art in light of the teachings of
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`Prevacid Label and Stawski. Claim 5, which depends from claim 1, recites a size
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`range of the colored granules “from about 10 μm to about 1200 μm.” Claims 6 and
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`7, which depend from claim 5, further restricts the size of the colored granules to
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`about 300 μm to about 500 μm. Stawski satisfies the limitations of claims 5, 6, and
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`7 because it teaches the claimed range of colored granules of a water-soluble sugar
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`by disclosing that blue, hydrogenated isomaltulose granules are sized to pass
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`through #20 sieve (~841 μm) but retained on a #40 sieve (~420 μm). (Ex. 1005 ¶
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`[0100]).
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`
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`10
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`I. Dependent Claims 8-9: The orally disintegrating tablets … the
`colored granules are present in an amount from about 0.1% w/w
`to about 50% w/w per tablet (claim 8); are present in an amount
`from about 1% w/w to about 30% w/w (claim 9).
`It is my opinion that claims 8 and 9 of the ‘170 patent would have been
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`21.
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`obvious to one of ordinary skill in the art in light of the teachings of Prevacid Label
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`and Stawski. Claim 8, which depends from claim 1, requires the colored granules
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`to be present in an amount from about 0.1% w/w to about 50% w/w per tablet.
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`Claim 9, which depends from claim 8, further restricts the amount to from about
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`1% w/w to about 30% w/w. “Stawski satisfies the limitations of claims 8 and 9
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`because it teaches that the colored granules are present in an amount from about
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`0.1% w/w to about 50% w/w per tablet, (Ex. 1005 at para [0100] “Palatinit
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`Inclusions 32.97%”) as well as an amount from about 0.1% w/w to about 30% w/w
`
`per tablet. (Ex. 1005 at para [0106] “Palatinit Inclusions 16.49%”).
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`J. Claim 1 of the ‘170 Patent is unpatentable as obvious over the
`Prevacid Label in view of Serpelloni under 35 U.S.C. § 103.
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`22.
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`It is my opinion that Claim 1 of the ‘170 Patent is unpatentable as
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`obvious over the Prevacid Label in view of Serpelloni.
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`23. The Prevacid Label teaches the claimed “orally disintegrating tablets
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`with speckled appearance”: “PREVACID SoluTab Delayed-Release Orally
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`Disintegrating Tablets, 15 mg, are white to yellowish white uncoated tablets with
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`orange to dark brown speckles”. (Ex. 1004, p. 10).
`
`
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`24.
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` It is my opinion that the combination of the Prevacid Label and
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`Serpelloni teaches the claimed “speckles comprising colored granules of a water-
`
`soluble sugar.” The Prevacid Label teaches speckles comprising colored granules
`
`(Ex. 1005 pg 10 “with orange to dark brown speckles”) and tablets containing
`
`water soluble sugars (Ex. 1005 e.g. pg. 7 mannitol). Also, speckles comprising
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`colored granules of water-soluble sugar were well-known in the art at the time of
`
`the invention. For example, Serpelloni teaches colored granules of water-soluble
`
`sugar. (Ex. 1006 col 1:29-31 “The speckled appearance is generally obtained by
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`means of solid sweetening particles, colored and possibly flavored.” (Ex. 1006, col
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`1: 35-36 “the colored particles are constituted essentially of sorbitol colored in the
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`mass.”) It would have been readily obvious to one of ordinary skill in the art that
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`the speckles disclosed by the Prevacid Label could have been comprised of the
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`colored granules of a water-soluble sugar such as taught by Serpelloni, as
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`Serpelloni specifically teaches colored water-soluble sugars imparting a “speckled
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`appearance” (Ex. 1006 col 1 29-31) to a gum-based composition. Further, as the
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`Prevacid Label also teaches water-soluble sugars as acceptable excipients, the use
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`of a colored water-soluble sugar composition would have been obvious to one of
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`ordinary skill in the art with a reasonable expectation that such would have been
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`successful in producing a speckled appearance in a tablet as claimed.
`
` It would have been obvious to one of ordinary skill in the art to combine the
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`teachings of the speckled appearance in the Prevacid Label and Serpelloni to
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`achieve the claimed invention with a reasonable expectation of success. In
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`particular, one of ordinary skill in the art would have understood that the colored
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`granules taught by Serpelloni to achieve a speckled appearance in chewing gum
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`would have been reasonably expected to achieve the same function of imparting a
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`similar speckled appearance to tablets such as the tablet disclosed in the Prevacid
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`tablets.
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`25.
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`It is my opinion that the combination of the Prevacid Label and
`
`Serpelloni teaches the claimed “pharmaceutically acceptable carrier.” The
`
`Prevacid Label teaches pharmaceutically acceptable carriers:
`
`Each delayed-release orally disintegrating tablet contains
`
`enteric-coated microgranules consisting of 15 mg or 30
`
`mg of lansoprazole (active ingredient) and the following
`
`inactive
`
`ingredients:
`
`lactose
`
`monohydrate,
`
`microcrystalline
`
`cellulose, magnesium
`
`carbonate,
`
`hydroxypropyl cellulose, hypromellose, titanium dioxide,
`
`talc, mannitol, methacrylic
`
`acid,
`
`polyacrylate,
`
`polyethylene glycol, glyceryl monostearate, polysorbate
`
`80, triethyl citrate, ferric oxide, citric acid, crospovidone,
`
`aspartamePhenylketonurics: Contains Phenylalanine 2.5
`
`mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.,
`
`artificial strawberry flavor and magnesium stearate. (Ex.
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`1004 pg 1)
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`
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`13
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`Moreover, it is my opinion that Serpelloni is analogous art to the claimed invention
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`of the ‘170 patent because it is reasonably pertinent to the problem faced by the
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`inventor of the ‘170 patent. Serpelloni, like the ‘170 patent, addressed the problem
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`of forming a speckled appearance in a substance by including solid sweetening
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`colored granules of water-soluable sugar in the substance. (Ex. 1006 col 1:29-31).
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`Accordingly, it would have been readily obvious to one of ordinary skill in the art
`
`that an orally disintegrating tablet with speckled appearance could have been
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`reasonably expected to have been derived from the disclosure of the Prevacid
`
`Label in view of Serpelloni without undue experimentation.
`
`
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`K. Dependent Claims 2-3: The orally disintegrating tablets …
`wherein the water-soluble sugar is sugar is selected from the group
`consisting of sucrose, sorbitol, mannitol, xylitol, and fructose.
`
`26.
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`It is my opinion that Claims 2 and 3 of the ‘170 Patent are unpatentable
`
`as obvious over the Prevacid Label in view of Serpelloni.
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`27. Claim 2, which depends from claim 1, recites that “the water-soluble
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`sugar is selected from the group consisting of sucrose and polyalcohols.” Claim 3,
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`which depends from claim 2, further limits the water-soluble sugars to “the group
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`consisting of sucrose, sorbitol, mannitol, xylitol, and fructose.” Serpelloni satisfies
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`the limitations of claims 2 and 3 because it specifically teaches the colored, water-
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`soluble sugar is sorbitol (Ex. 1006 col 1:35-36 “the colored particles are
`
`
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`14
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`constituted essentially of sorbitol colored in the mass.”).
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`
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`L. Dependent Claims 5-6: The orally disintegrating tablets … the
`colored granules have a particle size from about 10 μm to about
`1200 μm (claim 5); and wherein the colored granules have a
`particle size from about 200 μm to about 800 μm (claim 6).
`It is my opinion that Claims 5 and 6 of the ‘170 Patent are unpatentable
`
`28.
`
`as obvious over the Prevacid Label in view of Serpelloni. Claim 5, which depends
`
`from claim 1, recites a size range of the colored granules of “from about 10 μm to
`
`about 1200 μm.” Claim 6, which depends from claim 5, further restricts the size of
`
`the colored granules to about 200 μm to about 800 μm. Serpelloni meets the
`
`limitations of claims 5 and 6 because it teaches that the colored granules have a
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`particle size from about 200 μm to about 800 μm. (Ex. 1006 col 1:45-46 teaches
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`colored particles wherein the “granulometry is generally from 500 to 1500 µm”).
`
`
`
`M. Dependent Claims 8-9: The orally disintegrating tablets … the
`colored granules are present in an amount from about 0.1% w/w
`to about 50% w/w per tablet (claim 8); are present in an amount
`from about 1% w/w to about 30% w/w (claim 9).
`It is my opinion that Claims 8 and 9 of the ‘170 Patent are unpatentable
`
`29.
`
`as obvious over the Prevacid Label in view of Serpelloni. Claim 8, which depends
`
`from claim 1, requires that the colored granules are present in an amount from about
`
`0.1% w/w to about 50% w/w per tablet. Claim 9, which depends from claim 8,
`
`further restricts the amount to from about 1% w/w to about 30% w/w. Serpelloni
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`
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`15
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`meets the limitations of claims 8 and 9 because it teaches that the colored granules
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`are present in an amount from about 0.1% w/w to about 30% w/w per tablet. (Ex.
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`1006 col 1:32-34 “The proportion by weight represented by the colored particles
`
`with respect to the total weight of the chewing-gum is of the order of 0.5 to 3%,
`
`particularly 1%”; Table 1).
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`
`
`DECLARATION
`
`I declare that all statements made herein on my own knowledge are true and
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`that all statements made on information and belief are believed to be true, and
`
`further, that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of the United States Code.
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`Kinam Park, Ph.D.
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`16
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`Date: November 21, 2015
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`Page 16 of 109
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`CURRICULUM VITA
`
`KINAM PARK
`
`Purdue University
`Weldon School of Biomedical Engineering
`206 S. Martin Jischke Drive
`West Lafayette, IN 47907-2032
`
`Tel: 765 494-7759
`E-mail: kpark@purdue.edu
`http://kinam.com/
`
`November 2015
`
`
`Showalter Distinguished Professor of Biomedical Engineering
`Professor of Pharmaceutics
`
`B.S. in Pharmacy
`Ph.D. in Pharmaceutics
`Postdoc in Chem. Eng.
`
`1971-1975
`1979-1983
`1983-1985
`
`Seoul National University, Seoul, Korea
`University of Wisconsin , Madison, WI
`University of Wisconsin , Madison, WI
`
`
`TITLE:
`
`
`
`Education:
`
`
`
`
`
`Academic Appointments
`
`
`
`
`
`7/06 - present
`
`
`6/01 - present
`7/98 - present
`7/94 - present
`7/90 - 6/94
`2/86 - 6/90
`5/85 - 1/86
`
`
`4/83 - 4/85
`
`
`1/79 - 3/83
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`Showalter Distinguished Professor of Biomedical Engineering
`Purdue University
`President, Akina, Inc.
`Professor, Department of Biomedical Engineering, Purdue University
`Professor, Department of Pharmaceutics, Purdue University
`Associate Professor, Department of Pharmaceutics, Purdue University
`Assistant Professor, Department of Pharmaceutics, Purdue University
`Research Assistant Professor
`Department of Pharmaceutics, University of Utah
`Postdoctoral Research Associate
`Department of Chemical Engineering, University of Wisconsin
`Research Assistant
`Department of Pharmaceutics, University of Wisconsin
`Served in the Korean Army as a lieutenant
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`Page 17 of 109
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`Awards and Honors
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`NIH New Investigator Research Award (1986)
`Achievement Award in 1989 IBM Supercomputing Competition (1990)
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`Young Investigator Award: Controlled Release Society (1992)
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`Controlled Release Society-Merck Award for the Outstanding Paper in the Ag/Vet field (1997)
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`University Faculty Scholar, Purdue University (1999)
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`Clemson Award (the basic research category) of Society for Biomaterials (2001)
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`Research Achievement Award (Pharmaceutics and Drug Delivery Section) (2001)
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`Controlled Release Society-NanoSystems Outstanding Pharmaceutical Paper Award (2004)
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`Controlled Release Society Founders Award (2004)
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`Louis W. Busse Lectureship of School of Pharmacy, University of Wisconsin (2008)
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`Sigma Xi Research Award (the Purdue University Chapter) (2009)
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`Advisory Professor for Medical Science Research at Kyungpook National University (2009-2012)
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`The Nagai Foundation Tokyo Distinguished Lectureship (2010)
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`Purdue Cancer Research Award by Lafayette Lions Club (with Professor Ji-Xi Cheng) (2011)
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`Kyung Hee University International Scholar (2012)
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`Visiting Professor of Heilongjiang University of Chinese Medicine, China (2012)
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`Visiting Professor of Ajou University, Korea (2013)
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`Thomson Reuters’ list of “The World’s Most Influential Scientific Minds: 2014 (2014)
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`Korean-American Society in Biotech and Pharmaceuticals (KASBP)-Daewoong Award (2014)
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`Ashland Inc. Distinguished Lecturer at the University of Kentucky (2015)
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`Controlled Release Society Distinguished Service Award (2015)
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` Willis A. Tacker Prize for Outstanding Taching in Weldon School of Biomedical Engineering (2015)
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`The 2015 Purdue Innovator Hall of Fame Inductee (2015)
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`Controlled Release Society-3M Drug Delivery Systems Graduate Student Outstanding Research Award
`in Drug Delivery (Yoon Yeo: Controlled Release Society, 2003)
`AAPS Outstanding Graduate Student Research Award in Pharmaceutical Technologies
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`(Mentoring Yong Qiu: American Association of Pharmaceutical Scientists, 2003)
`AAPS Outstanding Graduate Student Research Award in Pharmaceutical Technologies
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`(Mentoring Yoon Yeo: American Association of Pharmaceutical Scientists, 2004)
`Drug Delivery Special Interest Group Outstanding Contribution to the Society for Biomaterials
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`(Eunah Kang: Society for Biomaterials 2007)
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`Professional Activities
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`Advisory Board
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`Advisory Board of the Molecular Modeling Conference (1994)
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`Advisory Panel on Polymeric Excipients, USP (1995-1999)
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`ACS Books Advisory Board (1997-2000)
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`Advisory Panel on Current Drugs (1997-1999)
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`2
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`Board of Governors of the Controlled Release Society (1993-1996)
`Fellow, American Association for Pharmaceutical Scientists (AAPS) (1993)
`President of the Korean-American Pharmaceutical Scientists Association (1995-97)
`Fellow, American Institute for Medical and Biological Engineering (1996)
`Fellow, Biomaterials Science and Engineering of the Society for Biomaterials (2000)
`President of the Controlled Release Society (2001-2002)
`Fellow, Controlled Release Society (2010)
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`Page 18 of 109
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`Scientific Advisory Board, International Symposium on the Frontiers in Biomedical Polymers
`Applications (2000-2001)
`Scientific Advisory Board, International Symposium on Recent Advances in Drug Delivery Systems
`(2000-2001)
`Advisory Panel on Excipients: Substance and Characterization Expert Committee, USP (2000-2005)
`Scientific Program Committee of the 2nd Pharmaceutical Sciences World Congress (PSWC) (2004)
`Scientific Advisory Board, Delsite, Inc. (2004-2008)
`Scientific Advisory Board, International Nanomedicine and Drug Delivery Symposium (2005-)
`Scientific Advisory Board, Soleira Laboratories (2006-2008)
`Scientific Advisory Board, Boston Scientific (2006-2008)
`Scientific Advisory Board, Lohmann Therapie-Systeme AG (2006-2012)
`Scientific Advisory Board, European Symposium on Controlled Drug Delivery (2006-2009)
`Scientific Advisory Board, China International Pharmaceutical Technologies Conference 2007 (2006-
`2008)
`Scientific Organizing Committee for Micro 2007, the 16th International Symposium on
`Microencapsulation (2007)
`International Advisory Board, CIMTEC 2008 the 3rd International Conference on Smart Materials,
`Structures and Systems (2007-2008)
`Dean's Faculty Advisory Committee, Purdue University, College of Engineering (2007-2013)
`Engineering Named Professorships Committee, Purdue University, College of Engineering (2007-
`2014)
`Provost Search Committee, Purdue University (2007-2008)
`Board of Directors & Chairman of Fellowship Committee, CRS Foundation (2008-2013)
`International Advisory Board, CIMTEC 2010 the 5th Forum on New Materials & 9th International
`Conference on Medical Applications of Novel Biomaterials and Nano-biotechnology (2009-2012)
`Drug Delivery Scientific Advisory Board, Genentech (2010-2015)
`The International Symposium on Biomaterials and the China-Japan-Korea (Asia 3) Foresight Joint
`Symposium on Gene Delivery, Guilin, Guangxi, China (2010-2011)
`Chairman, Dean's Faculty Advisory Committee, Purdue University, College of Engineering (2010-
`2012)
`International Scientific Advisory Board, School of Pharmacy at Queen’s University Belfast (2011)
`Scientific Committee, the 19th International Symposium on Microencapsulation, Pamplona, Spain
`(2012-2013).
`International Advisory Board, 20th International Symposium on Microencapsulation. IMS2015 Boston
`(2014)
`External Advisor for the Center of Biological Research Excellence at the University of South Carolina
`(2014-2015)
`Chair, the Annual Meeting Programme Committee for the Controlled Release Society conference in
`2016.
`Faculty Awards and Recognition (FAR) committee, College of Engineering representative (2015-
`2018)
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`Editorial Board
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`Journal of Biomaterials Science- Polymer Edition (1993-)
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`Journal of Bioactive and Compatible Polymers (1993-)
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`Journal of Controlled Release (1997-2005)
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`Colloids and Surfaces B: Biointerfaces (1997-)
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`Archives of Pharmacal Research (1998-)
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`PharmSci (official electronic journal of AAPS) (1999-2009)
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`PharmSciTech (official electronic journal of AAPS) (2001-2009)
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`Drug Delivery Technology (2002-)
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`Advanced Drug Delivery Reviews (2003-)
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`3
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`Page 19 of 109
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`Biomaterials Research (2003-)
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`Encyclopedia of Pharmaceutical Technology (2003-)
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` Macromolecular Research (2004-)
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`Journal of Pharmacy and Pharmacology (2004-)
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`Journal of Biopharmaceutics and Biotechnology (2005-)
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`CRS Books (2006-)
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`Drugs in Pharmaceutical Sciences Series, Taylor & Francis & Informa (2007-)
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`Journal of Drug Delivery Science and Technology (2008-)
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`Nanomedicine: Nanotechnology, Biology and Medicine (2010-2011)
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`Nano Reviews (2010-)
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`Drug Delivery and Translational Research (2010-)
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`Frontiers in Drug Delivery Biotechnology (2010-)
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`Experimental Biology and Medicine (2012-2015)
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`Journal of Hydrogels (2013-)
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`Biomaterials Research (2014-)
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`Journal of Drug Delivery Science and Technology (2015-)
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`Regenerative Engineering and Translational Medicine (2015-)
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`Journal Editor
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`Associate Editor, Pharmaceutical Research (1995-2004)
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`Book Review Editor, Pharmaceutical Research (1996-2004)
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`Guest Editor, Colloids and Surfaces B: Biointerfaces (1998-1999)
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`Guest Editor, Advanced Drug Delivery Reviews (2001-2002)
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`Editor, Americas, Journal of Controlled Release (2005)
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`Editor-in-Chief, Journal of Controlled Release (2005-)
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`NIH Study Section
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`NIH Pharmacology Study Section member (1996-2001, 2003)
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`NIH Bioengineering, Technology, and Surgical Sciences Study Section member (2005-2009)
` Member, College of CSR Reviewers, NIH (2010-2011)
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`Special Reviewer of NIH Study Sections
` Surgery and Bioengineering Study Section (1991, 1995-1997, 1999, 2004)
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` Surgery, Anesthesiology, & Trauma Study Section (1992-1994)
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` Special Study Section SSS-8 (1995)
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` Pharmacology Special Study Section, Chairman (2001, 2002, 2003)
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` National Cancer Institute Special Emphasis Panel (2005)
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` Member of NIH SBIR special study sections
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` Diabetes and Digestive and Kidney Diseases (1990, 1991, 1993), Pharmacology (1990, 1992,
`1993), Physiological Sciences (1990), Reproductive Endocrinology (1990-1992, 1994-