`Dearn et al.
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` IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Confirmation No. 7301
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`Docket No.: ASZD-P02-617
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`(PATENT)
`
`‘
`Application No.: 10/854959
`.
`Filed: May 27, 2004
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`Art Unit: 1616
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`Examiner: Pryor, Alton Nathaniel
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`For: PHARMACEUTICAL FORMULATIONS
`CONTAINING ZOLMITRIPTAN
`
`Commissioner for Patents
`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`Declaration Under 37 C.F.R. § 1.132 at Dr. Ed Cahill
`
`Sir:
`
`I, Dr. Ed Cahill, of 24 Adey Road, Lyrmn, Cheshire WAI 39QX, United Kingdom, hereby declare as
`follows:
`
`1.
`
`I am a Manager of Product Development for As1IaZeneca.
`
`I have ten years of experience in the pharmaceutical industry developing both liquid and solid
`2.
`dosage forms. Ihave a Bachelor of Science Degree in Combined Science (Biochemistry) from the
`Polythenic ofNo1th London, an MSc degree in Toxicology from the University of Surrey, U.K., and a
`Ph.D. degree in the Pharmaceutical Sciences fiom the University of Nottingham, UK. In addition, I was
`a visiting lecturer from at John Moores University in Liverpool, U.K. and have authored six peer-
`reviewed scientific articles.
`
`Experiments.were performed under my direction (depicted as Exhibit A attached hereto), to
`3.
`compare the stabilityiof zolrnitriptan at different pHs using citric acid buffers.
`
`These experiments indicate that the amount of zolrnitriptan degradation products upon
`4.
`prolonged storage was significantly less at a pH below 6, for example at pH 5.0 and 3.0, as compared to
`pH 7.4 or to pH 7.0. ’
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`9835952_1.DOC
`
`
`
`
`Lannett Holdings, Inc. LAN 1017
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`
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`I hereby declare that all statements made herein of my own knowledge are true and that all
`5.
`statements made on information and belief are believed to be true; and further that these statements are
`made with knowledge that willful false statements and the like so made are punishable by fine or
`imprisonment, or both, under. Section 1001 of Title XVH1 of the United States Code and that willful false
`statements may jeopardize the validity of this Application for Patent or any patent issuing thereon.
`
`Ed Cahill
`
`Dated: H use 2005,’
`
`Signature:
`
`fly
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`9835952_1.DOC