`
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`
`
`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
`oxytetracycline therapy for rosacea, 102 British J. Dermatology 443-45 (1980)
`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
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`1007
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`1008
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`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
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`Exhibit #
`1014
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`1015
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`1016
`1017
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`1018
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`1019
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`1020
`1021
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`1022
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`1023
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`1024
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`1025
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`1026
`1027
`
`1028
`
`1029
`
`Reference
`E-mail from PDR Customer Service Department to Lerner, David, Littenberg,
`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
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`Exhibit #
`1030
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`1031
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`1032
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`1033
`
`1034
`
`1035
`
`1036
`1037
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`1038
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`1039
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`1040
`1041
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`1042
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`1043
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`1044
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`1045
`
`1046
`
`1047
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`Reference
`Y.H. Thong & A. Ferrante, Inhibition of mitogen-induced human lymphocyte
`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
`membrane receptors, 62(2) Clin. exp. Immunol. 310-14 (1985)
`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.
`roy. Soc. Med. 742-45 (Aug. 1973)
`U.S. Patent No. 8,052,983
`R.K. Curley & J.L. Verbov, Stevens-Johnson syndrome due to
`tetracyclines ____ a case report (doxycycline) and review of the literature. 12(2)
`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
`1999)
`PERIOSTAT. (2000). In Physicians’ Desk Reference 944-46 (54th ed. 2000)
`Montvale, NJ: PDR Network
`ORACEA™ (2007). In Physicians’ Desk Reference 1000-100 (61st ed 2007),
`Retrieved from http://www.pdr.net
`A.K. Gupta & M.M Chaudhry, Rosacea and its management: an overview, 19(3)
`J. European Academy of Dermatology and Venereology 273-85 (2005)
`Complaint of Galderma Laboratories, Inc. in Civil Action No. 00670, filed on
`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
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`Exhibit #
`1048
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`1049
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`1050
`1051
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`1052
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`1053
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`1054
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`1055
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`1056
`1057
`
`1058
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`1059
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`1060
`
`1061
`
`1062
`
`1063
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`Reference
`L.M. Golub et al., Low-dose doxycycline therapy:Effect on gingival and
`eravicular fluid collagenase activity in humans, 25 J. Periodontal Research
`321-30 (1990)
`Clay Walker et al., Long-Term Treatment With Subantimicrobial Dose
`Doxycycline Exerts No Antibacterial Effects on the Subgingival Microflora
`Associated With Adult Periodontitis, 71(9) J. of Periodontology 1465-71 (Sept.
`2000)
`U.S. Patent No. 4,666,897 (Golub et. al.)
`Vibramycin®.(1974). In Physicians’ Desk Reference 942-43 (28th ed. 1974).
`Oradell, N.J.: PDR Network.
`Vital Therapies Incorporated.(2015). Management, Robert A. Ashely, M.A., Chief
`Technical Officer, Executive Vice President. Retrieved from
`http://vitaltherapies.com/corporate/management/
`Center for Drug Evaluation and Research, Fed. Food and Drug Admin.,
`Approval Package for Application Number: NDA 50-744, Trade Name:
`PERIOSTAT CAPSULES, 20MG (Sept. 30, 1998),
`www.accessdata.fda.gov/drugsatfda_docs/nda/98/50744_
`appltr.pdf
`Mark L. Nelson & Stuart B. Levy, The history of the tetracyclines, 1241 Annals
`N.Y. Academy Sciences 17-32 (2011)
`Alicia Mack, Examination of the Evidence for Off-Label Use of Gabapentin, 9(6)
`J. Managed Care Pharmacy 559-68 (Nov./Dec. 2003)
`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
`gangrenosum—a report of seven cases and review of the literature, 1(1) J.
`Dermatological Treatment 23–25 (June 1989)
`R.K. Joshi et al. Successful treatment of Sweet’s syndrome with doxycycline, 128
`British J. Dermatology 584-86 (1993)
`P. Senet et al., Minocycline for the treatment of cutaneous silicone granulomas,
`140 British J. Dermatology 985-87 (1999)
`Mark Allen Berk & Allan L. Lorincz, The Treatment of Bullous Pemphigoid
`With Tetracycline and Niacinamide. A preliminary report. 122(6) Archives
`Dermatology 670-74 (June 1986)
`Carl R. Thornfeldt & Andrew W. Menkes, Bullous pemphigoid controlled by
`tetracycline, 16(2)(1) J. American Academy Dermatology 305-10 (Feb. 1987)
`Isabelle Thomas et al., Treatment of generalized bullous pemphigoid with oral
`tetracycline, 28(1) J. American Academy Dermatology 74-77 (January 1993)
`David P. Fivenson et al., Nicotinamide and Tetracycline Therapy of Bullous
`Pemphigoid, 130 Arch. Dermatol. 753-58 (June 1994
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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
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`Exhibit #
`1064
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`1065
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`1066
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`1067
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`1068
`1069
`1070
`1071
`
`1072
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`1073
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`Reference
`Ronald M. Reisner, MD, Systemic Agents in the Management of Acne, California
`Medicine 28-34 (Jan. 1967)
`Marsha L. Chaffins et al., Treatment of pemphigus and linear IgA dermatosis
`with nicotinamide and tetracycline: a review of 13 cases, 28(6) J. Am. Acad.
`Dermatol. 998-1000 (June 1998)
`L. Reiche L et al., Combination therapy with nicotinamide and tetracyclines for
`cicatricial pemphigoid: further support for its efficacy, 23(6) Clin. and
`Experimental Dermatol. 254-57 (Nov. 1998)
`Howard Maibach, MD, Second-Generation Tetracyclines, A Dermatologic
`Overview: Clinical Uses and Pharmacology, 48(5) cutis 411-17 (Nov. 1991)
`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
`Manna], Feb. 22, 2013
`MONODOX®, VIBRAMYCIN®. (2000). In Physician’s Desk Reference 2082-
`2083, 2384-2386 (54th ed. 2000) Montvale, NJ: PDR Network
`
`
`Respectfully submitted,
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`
`Brian R. Tomkins
`Registration No. 58,550
`Counsel for Requestors
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`
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`BRT/dmf
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`4168806_1.docx
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