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`CLIENT/MATTER NUMBER
`111163-0102
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`
`
`February 2, 2016
`
`Patent Trial and Appeal Board
`US Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313-1450
`(electronically filed)
`
`INTER PARTES REVIEW OF U.S. PAT. NO. 8,791,154
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
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`Dear Patent Trial and Appeal Board,
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`This letter incorporates by reference the certificate of service attached to the
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`end of the Petition for Inter Partes Review filed herewith, to Exhibits 1001-1063, as
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`listed below:
`
`Exhibit
`Ex. #
`1001 U.S. Patent No. 8,791,154 B2 (“’154 Patent”)
`1002 Declaration of Dr. Erning Xia
`1003 Declaration of Dr. Leonard Bielory
`1004 WO 2008/015695 A2 (“Bhowmick”)
`1005 YANNI et al., “The In Vitro and In Vivo Ocular Pharmacology of
`Olopatadine (AL-4943A), an Effective Anti-Allergic/Antihistaminic
`Agent,” Journal of Ocular Pharmacology and Therapeutics, Volume 12,
`Number 4, 1996, pp. 389-400 (“Yanni”)
`1006 U.S. Pat. No. 6,995,186 B2 (“Castillo”)
`1007 U.S. Pat. Pub. No. 2011/0082145 A1 (“Schneider”)
`
`BOSTON
`BRUSSELS
`CHICAGO
`DETROIT
`
`JACKSONVILLE
`LOS ANGELES
`MADISON
`MIAMI
`
`MILWAUKEE
`NEW YORK
`ORLANDO
`SACRAMENTO
`
`SAN DIEGO
`SAN DIEGO/DEL MAR
`SAN FRANCISCO
`SHANGHAI
`
`SILICON VALLEY
`TALLAHASSEE
`TAMPA
`TOKYO
`WASHINGTON, D.C.
`
`4837-5701-8669.1
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`FOLEY & L ARDN ER LLP
`February 2, 2016
`Page 2
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`1008 U.S. Pat. No. 5,641,805 B2(“Hayakawa”)
`1009
`Image File Wrapper for U.S. Patent No. 8,791,154 B2
`1010
`Image File Wrapper for U.S. Provisional Appl. No. 61/487,789
`1011
`Image File Wrapper for U.S. Provisional Appl. No. 61/548,957
`1012 WO 1999/018963 (“Lisi”)
`1013 WO 2002/024116 A1 (“Shahinian”)
`LOFTSSON et al., “Cyclodextrins in eye drop formulations: enhanced
`1014
`topical delivery of corticosteroids to the eye,” Acta Ophthamologica
`Scandinavica, 2002, pp. 144-150.
`1015 NANDI et al., “Synergistic Effect of PEG-400 and Cyclodextrin to
`Enhance Solubility of Progesterone,” AAPS PharmSciTech 2003; 4 (1),
`pp 1-5.
`1016 WO 2011/138801 A1 (“Khopade”)
`JANSOOK et al., “CDs as solubilizers: Effects of excipients and
`1017
`competing drugs,” International Journal of Pharmaceutics, 379, 2009,
`pp. 32-40.
`1018 HARADA, A., “Preparation and structures of supramolecules between
`cyclodextrins and polymers,” Coordination Chemistry Reviews, 148,
`1996, pp. 115-133.
`1019 WO 2012/159064A1 (“Gamache”)
`1020
`EP 0 799 044 B1 (“Yanni III”)
`1021 WO 2001/054687 A1 (“Yanni II”)
`1022 WO 2009/003199 A1 (“Pipkin”)
`1023 WO 2000/78396 A2 (“Graff”)
`1024 Curriculum Vitae for Dr. Erning Xia
`1025 Curriculum Vitae for Dr. Leonard Bielory
`1026 U.S. Pat. No. 7,687,646 B2 (“Bader”)
`1027 U.S. Pat. No. 4,871,865 (“Lever”)
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`4837-5701-8669.1
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`1028 U.S. Pat. No. 5,116,863 (“Oshima”)
`1029
`EP 0214779 B1 (“Lever”)
`1030 Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 (Fed. Cir. 2012)
`1031 Alcon Research, Ltd. v. Apotex Inc., 790 F. Supp. 2d 868 (S.D. Ind.
`2011)
`EP 0 235 796 B2 (“Oshima”)
`1032
`1033 ABELSON et al., “Combined Analysis of Two Studies Using the
`Conjunctival Allergen Challenge Model to Evaluate Olopatadine
`Hydrochloride, a New Ophthalmic Antiallergic Agent With Dual
`Activity,” American Journal of Ophthalmology, Volume 126, No. 6, pp.
`797-804.
`1034 WO 2004/024126 A1 (“Thompson”)
`1035 CHAUDHARI et al., “Solubility enhancement of hydrophobic drugs
`using synergistically interacting cyclodextrins and cosolvent,” Current
`Science, 1586 Vol. 92, No. 11, 10 June 2007; pp. 1586-1591.
`1036 ANSEL, Howard C., Pharmaceutical Calculations, 13th Ed., Wolters
`Kluwer, 2010, pp. 82-83
`PATANOL® Label
`1037
`PATADAY® Label
`1038
`PATANASE® Label
`1039
`1040 GENNARO, Alfonso R., Remington: The Science and Practice of
`Pharmacy, Philadelphia College of Pharmacy and Science, 1995, Vol.
`1., pp. 613-627
`1041 GENNARO, Alfonso R., Remington: The Science and Practice of
`Pharmacy, Philadelphia College of Pharmacy and Science, 1995, Vol.
`2., pp. 1563-1576
`LIDE, David R., CRC Handbook of Chemistry and Physics, CRC Press,
`2006, pp. 6-4 – 6-5.
`1043 ABELSON and ANDERSON, “Demystifying Dumulcents,” Review of
`Ophthalmology, November 2006, pp. 122-125.
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`1042
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`1044
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`LOFTSSON, et al., “The effect of water-soluble polymers on the
`aqueous solubility and complexing abilities of β-cyclodextrin,”
`International Journal of Pharmaceutics, 1998, Vol. 163, pp. 15-21
`1045 U.S. Patent Publication US 2009/0156568 A1 (“Hughes”)
`1046 U.S. Pat. No. 5,985,310 (“Castillo III”)
`1047 U.S. Pat. No. 7,977,376 B2 (“Singh I”)
`1048 U.S. Pat. No. 8,399,508 B2 (“Singh II”)
`1049 U.S. Pat. No. 7,402,609 B2 (“Castillo II”)
`1050 WADE, et al., “Ophthalmic antihistamines and H1–H4 receptors,”
`Current Opinion in Allergy and Clinical Immunology, 2012, Vol. 12,
`No. 5, pp. 510–516
`1051 CHOI, et al., “Late-phase reaction in ocular allergy,” Current Opinion in
`Allergy and Clinical Immunology, 2008, Vol 8, pp. 438–444.
`1052 U.S. Pat. Pub. 2004/0198828 (“Abelson 2004”)
`LEONARDI, et al., “Double-masked, randomized, placebo-controlled
`1053
`clinical study of the mast cell-stabilizing effects of treatment with
`olopatadine in the conjunctival allergen challenge model in humans,”
`Clin Ther 2003; 25, pp. 2539–2552.
`PROUD, et al., “Inflammatory mediator release on conjunctival
`provocation of allergic subjects with allergent provocation of allergic
`subjects with allergen,” Mediator generation in ocular allergy, 1989,
`Vol. 85. No. 5, pp. 896-905
`SHARIF, et al., “Characterization of the Ocular Antiallergic and
`Antihistaminic Effects of Olopatadine (AL-4943A), a Novel Drug for
`Treating Ocular Allergic Diseases,” The Journal OF Pharmacology and
`Experimental Therapeutics, 1996, Vol. 278, No. 3, pp. 1252-1261
`LOFTSSON, et al., “Pharmaceutical Applications of Cyclodextrins. 1.
`Drug Solubilization and Stabilization,” Journal of Pharmaceutical
`Sciences, October 1996, Vol. 85, No. 10, pp. 1017-1025
`21 C.F.R. §349.12
`Polyvinylpyrrolidone K 30,
`
`1057
`1058
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`1054
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`1055
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`1056
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`1059
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`http://www4.mpbio.com/ecom/docs/proddata.nsf/(webtds2)/102787
`SWEI, et al., “Viscosity Correlation for Aqueous Polyvinylpyrrolidone
`(PVP) Solutions,” Journal of Applied Polymer Science, 2003, Vol. 90,
`pp. 1153-1155
`68 Fed. Reg. 106, 32981-32983
`1060
`1061 U.S. Pat. No. 6,316,483 B1 (“Haslwanter”)
`1062 U.S. Pat. Pub. No. 2010/0010082 A1 (“Chong”)
`1063 U.S. Pat. Pub. No. 2009/0136598 (“Chapin”)
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`The Commissioner is hereby authorized to charge any additional fees which
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`may be required regarding this Application under 37 C.F.R. §§ 1.16-1.17, or credit
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`any overpayment, to Deposit Account No. 19-0741. Should no proper payment be
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`enclosed herewith, as by the credit card payment instructions in EFS-Web being
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`incorrect or absent, resulting in a rejected or incorrect credit card transaction, the
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`Commissioner is authorized to charge the unpaid amount to Deposit Account No. 19-
`
`0741. If any extensions of time are needed for timely acceptance of papers submitted
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`herewith, Applicant hereby petitions for such extension under 37 C.F.R. §1.136 and
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`authorizes payment of any such extensions fees to Deposit Account No. 19-0741.
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`4837-5701-8669.1
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`
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`4837-5701-8669.1
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`Best regards,
`
`
`
`/Joseph P. Meara/
`
`Joseph P. Meara
`Registration No. 44,932
`
`FOLEY & L ARDN ER LLP
`February 2, 2016
`Page 6
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`FOLEY & L ARDN ER LLP
`February 2, 2016
`Page 7
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`CERTIFICATE OF SERVICE
`
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`The undersigned hereby certifies that a copy of the foregoing cover letter was
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`served on February 2, 2016 by placing a copy into USPS Express Mail directed to the
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`attorney of record for the patent at the following address:
`
`ALCON
`IP LEGAL
`6201 SOUTH FREEWAY
`FORT WORTH TX 76134
`
`
`
`
`By: /Joseph P. Meara/
`Joseph P. Meara
`Registration No. 44,932
`Counsel for Petitioner
`
`
`4837-5701-8669.1