`
`
`
`
`Brian R. Tomkins
`908.518.6380
`btomkins@lernerdavid.com
`
`August 20, 2015
`
`(Electronically Filed)
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P O Box 1450
`Alexandria, VA 22313-1450
`Inter Partes Review of U.S. Patent No.8,603,506
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
`
`Dear Patent Trial and Appeal Board:
`This transmittal letter identifies Exhibits 1001-1073, 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 1001-1073, as listed below:
`Exhibit #
`Reference
`1001
`U.S. Patent No. 8,603,506
`1002
`Specification of Application No. 60/281,916 filed Apr. 5, 2001
`1003
`Specification of Application No. 60/325,489 filed Sept. 26, 2001
`1004
`Declaration of Michael Payette, M.D.
`1005
`C.V. of Michael Payette, M.D.
`I. B. Sneddon, A CLINICAL TRIAL OF TETRACYCLINE IN ROSACEA, 78
`1006
`British J. Dermatology 649-52 (Jan.-Dec. 1966)
`R. Marks & J. Ellis, COMPARATIVE EFFECTIVENESS OF TETRACYCLINE
`AND AMPICILLIN IN ROSACEA A Controlled Trial, II(7733) Lancet 1049-52
`(Nov. 13, 1971)
`E.M. Saihan and J.L. Burton, A double-blind trial of metronidazole versus
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`P.G. Nielsen, A double-blind study of I% metronidazole cream versus systemic
`oxytetracycline therapy for rosacea, 109(1) British J. Dermatology 63-65 (1983)
`Claudio Torresani et al., Clarithromycin versus doxycycline in the treatment of
`rosacea, 36(12) International J. Dermatology 942-46 (Dec. 1997)
`Joseph B. Bikowski, Treatment of Rosacea With Doxycycline Monohydrate,
`66(2) Cutis 149-52 (Aug. 2000)
`U.S. Serial No. 13/277,789 Notice of Allowance, Oct. 9, 2013
`WO 2000/018230 (Ramamurthy et al.)
`
`1011
`
`1012
`1013
`
`4168806_1.docx
`
`1007
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`1008
`
`1009
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`1010
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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`August 20, 2015
`Page 2
`
`Exhibit #
`1014
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`1015
`
`1016
`1017
`
`1018
`
`1019
`
`1020
`1021
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`1022
`
`1023
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`1024
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`1025
`
`1026
`1027
`
`1028
`
`1029
`
`Reference
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`Krumholz & Mentlik Library (May 14, 2015, 13:04 EST) (on file with recipient)
`Beth A. Kapes, Doxycycline hyclate reduces comedones by 50 percent,
`Dermatology Times, 2001 Suppl. 22 (November (11)):S19
`U.S. Patent No. 7,211,267
`R. Russel Martin et al., Effects of Tetracycline on Leukotaxis, 129(2) J.
`Infectious Disease 110-16 (Feb. 1974)
`Gerd Plewig, M.D. & Erwin Schöpf, M.D., ANTI-INFLAMMATORY EFFECTS
`OF ANTIMICROBIAL AGENTS: AN IN VIVO STUDY, 65(6) J. Investigative
`Dermatology 532-36 (Dec. 1975)
`Nancy B. Esterly et al., THE EFFECT OF ANTIMICROBIAL AGENTS ON
`LEUKOCYTE CHEMOTAXIS, 70(1) J. Investigative Dermatology 51-55 (1978)
`U.S. Patent No. 7,232,572
`L.M. Golub et al., Minocycline reduces gingival collagenolytic activity during
`diabetes Preliminary observations and a proposed new mechanism of action,
`18(5) J. Periodontal Research 516-26 (1983)
`L.M. Golub et al., A Non-antibacterial Chemically-modified Tetracycline
`Inhibits Mammalian Collagenase Activity, 66(8) J. Dental Research 1310-14
`(Aug. 1987)
`Waldemar Pruzanski et al., INHIBITION OF ENZYMATIC ACTIVITY OF
`PHOSPHOLIPASES A2 BY MINOCYCLINE AND DOXYCYCLINE, 44(6)
`Biochemical Pharmacol. 1165-70 (1992)
`Ashok R. Amin et al., A novel mechanism of action of tetracyclines: Effects on
`nitric oxide synthases, 93(24) Proc. Nat’l Acad. Sci. USA. 14014-019 (Nov.
`1996)
`Ashok R. Amin et al., Post-transcriptional regulation of inducible nitric oxide
`synthase mRNA in murine macrophages by doxycycline and chemically modified
`tetracyclines, 410(2-3) FEBS Letters 259-64 (June 1997)
`U.S. Patent No. 7,014,858
`L.M. Golub et al., TETRACYCLINES INHIBIT CONNECTIVE TISSUE BREAKDOWN BY
`MULTIPLE NON-ANTIMICROBIAL MECHANISMS, 12(2) Advances in Dental
`Research 12-26 (Nov. 1998)
`Kari K. Eklund & Timo Sorsa, Tetracycline Derivative CMT-3 Inhibits Cytokine
`Production, Degranulation, and Proliferation in Cultured Mouse and Human
`Mast Cells, 878 Annals N.Y. Academy Sciences 689-91 (1999)
`Keith L. Kirkwood et al., Non-antimicrobial and Antimicrobial Tetracyclines
`Inhibit IL-6 Expression in Murine Osteoblasts, 878 Annals N.Y. Academy
`Sciences 667-70 (1999)
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`4168806_1.docx
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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`August 20, 2015
`Page 3
`
`Exhibit #
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`1037
`
`1038
`
`1039
`
`1040
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`Reference
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`proliferative responses by tetracycline analogues, 35(3) Clin. exp. Immunol.
`443-46 (1979)
`A. Naess et al., In vivo and in vitro effects of doxycycline on leucocyte
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`Hirohko Akamatsu et al., Effect of Doxycycline on the Generation of Reactive
`Oxygen Species: A Possible Mechanism of Action of Acne Therapy with
`Doxycycline, 72(3) Acta Dermo-Venereologica 178-79 (1992)
`Y. Ueyama et al., Effects of antibiotics on human polymorphonuclear leukocyte
`chemotaxis in vitro, 32(2) British J. Oral Maxillofacial Surgery 96-99 (1994)
`Thomas Jansen MD & Gerd Plewig MD, Rosacea: classification and treatment,
`90(3) J. Royal Society Med. 144-50 (Mar. 1997)
`R. Marks, Histogenesis of the Inflammatory Component of Rosacea, 66(8) Proc.
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`U.S. Patent No. 8,052,983
`R.K. Curley & J.L. Verbov, Stevens-Johnson syndrome due to
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`Clinical and Experimental Dermatology 124-25 (Mar. 1987)
`R.M. Truëb & G. Burg, Acute Generalized Exanthematous Pustulosis due to
`Doxycycline, 186(1) Dermatology 75-78 (1993)
`Lori E. Shapiro et al., Comparative Safety of Tetracycline, Minocycline, and
`Doxycycline, 133(10) Archives of Dermatology 1224-30 (Oct. 1997)
`Application Serial No. 11/876,478 Specification, filed Oct. 22, 2007
`Jerry D. Smilack M.D., The Tetracyclines, 74(7) Mayo Clinic Proc. 727-29 (July
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`PERIOSTAT. (2000). In Physicians’ Desk Reference 944-46 (54th ed. 2000)
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`A.K. Gupta & M.M Chaudhry, Rosacea and its management: an overview, 19(3)
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`July 31, 2015, in the United States District Court for the District of Delaware
`Webster’s Ninth New Collegiate Dictionary 852, 958 (1983), “papules” and
`“pustules,” respectively
`Stedman’s Medical Dictionary 1023, 1175 (24th ed 1982), “papules” and
`“pustules,” respectively
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`4168806_1.docx
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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`August 20, 2015
`Page 4
`
`Exhibit #
`1048
`
`1049
`
`1050
`1051
`
`1052
`
`1053
`
`1054
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`1055
`
`1056
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`Reference
`L.M. Golub et al., Low-dose doxycycline therapy:Effect on gingival and
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`321-30 (1990)
`Clay Walker et al., Long-Term Treatment With Subantimicrobial Dose
`Doxycycline Exerts No Antibacterial Effects on the Subgingival Microflora
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`Alicia Mack, Examination of the Evidence for Off-Label Use of Gabapentin, 9(6)
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`Thomas B. Fitzpatrick et al., Dermatology in General Medicine (3rd ed. 1987)
`John Berth-Jones MRCP et al., The successful use of minocycline in pyoderma
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`R.K. Joshi et al. Successful treatment of Sweet’s syndrome with doxycycline, 128
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`140 British J. Dermatology 985-87 (1999)
`Mark Allen Berk & Allan L. Lorincz, The Treatment of Bullous Pemphigoid
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`Carl R. Thornfeldt & Andrew W. Menkes, Bullous pemphigoid controlled by
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`David P. Fivenson et al., Nicotinamide and Tetracycline Therapy of Bullous
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`4168806_1.docx
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`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`August 20, 2015
`Page 5
`
`Exhibit #
`1064
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`1065
`
`1066
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`1067
`
`1068
`1069
`1070
`1071
`
`1072
`
`1073
`
`Reference
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`Marsha L. Chaffins et al., Treatment of pemphigus and linear IgA dermatosis
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`Howard Maibach, MD, Second-Generation Tetracyclines, A Dermatologic
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`U.S. Serial No. 13/277,789 Fifth Preliminary Amendment, Apr. 30, 2012
`U.S. Serial No. 13/277,789 Official Action, May 14, 2012
`U.S. Serial No. 13/277,789 Resp. to May 14, 2012 Office Action, Sept. 19, 2012
`U.S. Serial No. 13/277,789 Resp. to November 19, 2012 Final Office Action and
`Substance of February 7, 2013 Interview in Reply to February 19, 2013
`Interview Summary, Feb. 22, 2013
`U.S. Serial No. 13/277,789 Declaration under 37 C.F.R. § 1.132 [of Vasant
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`MONODOX®, VIBRAMYCIN®. (2000). In Physician’s Desk Reference 2082-
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`
`
`Respectfully submitted,
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`
`Brian R. Tomkins
`Registration No. 58,550
`Counsel for Requestors
`
`
`
`BRT/dmf
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`4168806_1.docx
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