`Appl. No.: 09/577,875
`Filed: .. May 25, 2000
`For: Preparation of Injectable
`Suspensions Having Improved
`Injectability
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`Art Unit: 1615
`Examiner: R. Bennett
`Atty. Docket:. 00166.0073.USOO
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`Decl~ration of Mark A. Tracy, Pb.D.
`Under 37 C.F.R. § 1.132
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`Conunissiorier for Patents
`Washington~ D.C. 20231
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`I, Mark A. Tracy, Ph.D., hereby declare and state as follows.
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`1.
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`I have a B.S. degree in Chemical Engineering, an M.S. degree in Chemical
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`Engineering, and a Ph.~. degree in Physical Chemistry. I have over fifteen years experience in
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`. qhemical engineering, chemistry, and controlled drug delivery technology. I am currently
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`employed by Alkermes, Inc. ("Alkermes") as a Director of Formulation Development. I have
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`1
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`· been employed by Alkermes since July 1992. A copy of my curriculum vitae is attached.
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`2.
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`· The above-captioned U.S. Patent Application No. 09/577,875 ('4fue '875
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`application") is owned by Alkermes Controlled Therapeutics Inc. l, a subsidiary of Alkennes. I
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`have read and understood the '875 application. I am familiar with the technology ofthe ·
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`· invention disclosed in the '875 application through my ed~cation and my work at Alkennes.
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`3.
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`I have read and understood U.S. Patent No." 5,656,299 to Kino eta/. ("the Kino
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`patent"). lbe Kino:patent does not explicitly disclose the viscosity of the injection vehic1es used
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`LUYE1018
`IPR of Patent No. 6,667,061
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`A(J1.11icants: Ramstack, eta!.
`Appl. No.: 09/577,875
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`·:,·
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`. in the Test -ExaJnples. The Kino patent does not provide any information about injectability, or
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`the relati~nship betwe~n injectability and viscosity of the injection vehicle.
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`. . A.
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`Test· Examples 1, 3, and 4 of the Kino patent use physiological saline as the·
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`injection ·vehicle. Based upon my knowledge and experience, the viscosity of the physiological ·.
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`saline inje~tion vehicle· as the fluid phase of a suspensi?n containing the micr~spheres of each of
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`Test Examples 1, 3, and 4. of cle. Kino patent is approximate~y one ( 1) centipoise ( cp) at 20°C,
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`5~
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`Test Example 2 of the .Kino patent. uses a 0.5o/o sodiwn carboxymethyl cellulose .
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`(CMC} solutio~ isotonized with ~annitol as the injection vehicle. Ba5~d upon my knowledge·
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`and experience, the CMC is the viscosity-controlling component of the injection vehicle of Test
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`Example 2 of the Kino patent. That CMC is the viscosity-controlling component.is exemplifi~d·
`by the two .injection vehicles discl~sed on page 10, lines 10-17 of the '875 application as ·
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`. originally filed. The Fonnula 1 i~jection vehicle described on page 10 of the '875 application.
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`. contains 1.5% CMC, and has a viscosity of approximately 27 cp at 20°C. The Formula 2·
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`. injection vehicle described on page 110 of the '875 application contains0.75o/o CMC, and has a
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`viscosity of approxima~ely 7 cp at 20°C. By reducing the CMC from 1.5% to 0.75~1o, the
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`viscosity dropped from 27 cp to 7 cp. Based upon my knowledge and experience, and the
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`disclosure on page. 10, lines 1.0-17 of tJ:le '875 application, the viscosity of the CM¢ injection
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`vehicle as the fluid phase of a suspension containing the microspheres of Test Example '2 of the
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`.. Kino patent is less than 7 cp at 20°C.
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`6.
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`I hereby declare that all statements made herein of my own knowledge are true
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`and that all statements made on information and belief are believed to be true; and further that
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`these statements were made with the knowledge that willful false statements and the like so
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`LUYE1018
`IPR of Patent No. 6,667,061
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`
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`- 3 -
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`Ap.t".tcants: Ramstack, et al.
`· Appl. No.: 09/577,875
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`made ate pWlishable by fine or imprisonment, or. both~ under § _1 OOl. of Title 18 of the United
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`Sates Code and that such willful false statements may jeopardize the validity of the above-
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`caption~d patent application or any patent issued thereon.
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`. (
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`Mark A. Tracy
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`LUYE1018
`IPR of Patent No. 6,667,061