`
`
`
`
`William L. Mentlik
`908.518.6305
`wmentlik@lernerdavid.com
`
`May 31, 2016
`
`(Electronically Filed)
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P O Box 1450
`Alexandria, VA 22313-1450
`
`Inter Partes Review IPR2016-01095 (U.S. Patent No. 6,667,061)
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
`
`
`Dear Patent Trial and Appeal Board:
`This transmittal letter identifies Exhibits 1001-1008, 1010, 1014-1023, being filed
`concurrently with the present Petition for Inter Partes Review. Pursuant to 37 C.F.R.
`§ 42.6(e)(4)(ii), the Certificate of Service attached to the end of the Petition for
`Inter Partes Review filed herewith, incorporates Exhibits 1001-1008, 1010, 1014-1023,
`as listed below:
`
`
`
`Exhibit # Reference
`U.S. Patent No. 6,667,061 (“the ’061 Patent”)
`1001
`Declaration of Dr. Patrick P. DeLuca
`1002
`Curriculum Vitae of Dr. Patrick P. DeLuca
`1003
`International Publication No. WO 99/01114 (“Goldenheim”)
`1004
`International Publication No. WO 95/13799 (“Ramstack”)
`1005
`U.S. Pharmacopeia Entry re: CMC, viscosity pp.274-75, 1840 (1994)
`1006
`EP Pharmacopoeia Entry re: CMC pp.547-48 (3d ed. 1997)
`1007
`1008
`Handbook of Pharmaceutical Excipients pp.78-81, 135-38, 294-98, 329-330,
`375-78, 420-21, 439-42, 477-80, 481-82 (2nd ed. 1994)
`Intentionally left blank
`U.S. Patent No. 5,656,299 (“Kino”)
`Intentionally left blank
`Intentionally left blank
`Intentionally left blank
`Herbert A. Lieberman et al. (eds.), Pharmaceutical Dosage Forms: Disperse
`Systems, Vol.2, pp.26-35, 40, 43-46, 261, 285-318 (2nd ed. rev. expanded 1996)
`
`1009
`1010
`1011
`1012
`1013
`1014
`
`4554960_1.docx
`9LUYE 7.1R-001
`
`
`
`
`
`
`
`
`
`
`
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`May 31, 2016
`Page 2
`
`
`
`Exhibit # Reference
`U.S. Patent No. 6,495,164 (“the ’164 Patent”)
`1015
`Serial No. 10/259,949, Office Action, Apr. 9, 2003
`1016
`Serial No. 10/259,949, Applicants’ Resp., May 14, 2003
`1017
`Serial No. 09/577,875, Declaration of Mark A. Tracy, May 17, 2002
`1018
`Serial No. 10/259,949, Notice of Allowability, July 24, 2003
`1019
`1020
`Kenneth E. Avis et al. (eds.), 1 (Chs.2, 4, 5) Pharmaceutical Dosage
`Forms:Parenteral Medications 17-25, 115-16, 140-43, 150-51, 173-75, 190-212
`(2nd ed. rev. expanded Marcel Dekker, Inc. 1992)
`Leon Lachman, PhD et al., The Theory and Practice of Industrial Pharmacy
`642-44, 783-84 (Lea & Febiger 3rd ed. 1986)
`Herbert A. Lieberman et al., Pharmaceutical Dosage Forms: Disperse Systems,
`Vol.1, pp.287-313 (2nd ed. rev. expanded 1996)
`Orange Book entries for RISPERDAL®
`
`1022
`1023
`
`1021
`
`Respectfully submitted,
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`
`
`William L. Mentlik
`Reg. No. 27,108
`
`
`WLM/dmf
`
`4554960_1.docx
`9LUYE 7.1R-001
`
`
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