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11/29/2018 | 11-29-2018-Patent_Owner | - Patent Owner Exhibit 2003: Declaration of Professsor Alexander M. Klibanov
- Patent Owner Exhibit 2004: Curriculum Vitae for Professor Alexander M. Klibanov
- Patent Owner Exhibit 2005: International Patent Application Publication No. WO 2011/014627 (¿¿¿Ahluwalia¿¿¿)
- Patent Owner Exhibit 2006: International Patent Application Publication No. WO 2009/108147 (¿¿¿Garrett I¿¿¿)
- Patent Owner Exhibit 2007: International Patent Application Publication No. WO 2010/105052 (¿¿¿Hani¿¿¿)
- Patent Owner Exhibit 2008: U.S. Patent No. 4,829,058 (¿¿¿Seydel I¿¿¿)
- Patent Owner Exhibit 2009: U.S. Patent No. 4,912,112 (¿¿¿Seydel II¿¿¿)
- Patent Owner Exhibit 2010: Wayback Machine Results for David Pascoe, Aczone Fails to
Impress for Rosacea, Rosacea Support Group (July 23, 2012), available at https://rosacea-support.org/aczone-fails-toimpress-for-rosacea.html
- Patent Owner Exhibit 2011: S. Puavilai et al., ¿¿¿Incidence of anemia in leprosy patients treated with dapsone,¿¿¿ J. Med. Assoc. Thailand 67(7): 404¿¿¿407 (1984) (¿¿¿Puavilai¿¿¿)
- Patent Owner Exhibit 2012: World Health Organization Alert No. 117, Antimalarial chlorproguanil-dapsone (LapDap¿¿¿) withdrawn following demonstration of post-treatment haemolytic anaemia in G6PD deficient patients in a Phase III trial of chlorproguanildapsone-artesunate (Dacart¿¿¿)
- Patent Owner Exhibit 2013: MaryAnn Steiner, ¿¿¿Dapsone Topical Gel for Acne,¿¿¿ J. Pharm. Soc. Wisc. 12(6): 67¿¿¿71 (2009) (¿¿¿Steiner¿¿¿)
- Patent Owner Exhibit 2014: ACZONE Gel, 5% Prescribing Information (2008) (¿¿¿2008 Aczone 5% PI¿¿¿)
- Patent Owner Exhibit 2015: Robert Lott et al., ¿¿¿Medication adherence among acne patients: A review.¿¿¿ J. Cosmetic Dermatology 9: 160¿¿¿166 (2010) (¿¿¿Lott¿¿¿)
- Patent Owner Exhibit 2016: Kirk A. James et al., ¿¿¿Emerging drugs for acne,¿¿¿ Expert Opin. Emerging Drugs 14(4): 649¿¿¿659 (2009) (¿¿¿James I¿¿¿)
- Patent Owner Exhibit 2017: Barry Coutinho, ¿¿¿Dapsone (Aczone) 5% Gel for the Treatment of Acne,¿¿¿ American Family Physician (Dec. 2010) (¿¿¿Coutinho¿¿¿)
- Patent Owner Exhibit 2018: Food and Drug Administration Inactive Ingredient Database (September, 2012)
- Patent Owner Exhibit 2019: H.C. Korting & C. Sch¿¿llmann, ¿¿¿Current topical and systemic approaches to treatment of rosacea,¿¿¿ JEADV 23: 876¿¿¿882 (2009) (¿¿¿Korting¿¿¿)
- Patent Owner Exhibit 2020: European Commission¿¿¿s Scientific Committee on Consumer Safety, Opinion on Diethylene Glycol Monoethyl Ether (DEGEE) (2010) (Part 2 of 2)
- Patent Owner Exhibit 2020: European Commission¿¿¿s Scientific Committee on Consumer Safety, Opinion on Diethylene Glycol Monoethyl Ether (DEGEE) (2010) (Part 1 of 2)
- Patent Owner Exhibit 2021: Food and Drug Administration Inactive Ingredient Database (December, 2012)
- Patent Owner Exhibit 2022: Declaration of Julie Harper, M.D.
- Patent Owner Exhibit 2023: Curriculum Vitae of Julie Harper, M.D.
- Patent Owner Exhibit 2024: John Kraft & Anatoli Freiman, Management of acne, 183 Canadian Med. Assoc. J. E430¿¿¿E435 (2011) (¿¿¿Kraft¿¿¿)
- Patent Owner Exhibit 2025: Meghan I. Dubina & Alan B. Fleisher Jr., Interaction of Topical Sulfacetamide and Topical Dapsone with Benzoyl Peroxide, 145 JAMA Dermatology 1027¿¿¿1029 (2009) (¿¿¿Dubina¿¿¿)
- Patent Owner Exhibit 2026: Stephen Titus & Joshua Hodge, Diagnosis and Treatment of Acne, 86 Am. Family Physician 734¿¿¿740 (2012) (¿¿¿Titus¿¿¿)
- Patent Owner Exhibit 2027: John S. Strauss, Biology of the Sebaceous Gland and the Pathophysiology of Acne Vulgaris, in Pathophysiology of Dermatologic Diseases, Second Edition, N. A. Soter and H. Baden eds., McGraw-Hill, New York 195¿¿¿210 (1991) (Strauss)
- Patent Owner Exhibit 2028: William D. James, Acne, 352 New Eng. J. Medicine 1463¿¿¿1472 (2005) (¿¿¿James II¿¿¿)
- Patent Owner Exhibit 2029: Ayumi Naito et al., Topical retinoids for acne vulgaris (Protocol), 3 The Cochrane Library (John Wiley & Sons 2008) (¿¿¿Naito¿¿¿)
- Patent Owner Exhibit 2030: Physicians¿¿¿ Desk Reference 2967¿¿¿2969 (2011) (excerpt)
- Patent Owner Exhibit 2031: Physicians¿¿¿ Desk Reference 2765¿¿¿2767 (2012) (excerpt)
- Patent Owner Exhibit 2032: Gabriella Fabbrocini et al., Resveratrol-Containing Gel for the Treatment of Acne Vulgaris, 12 Am. J. of Clinical Dermatology 131¿¿¿141 (2011) (¿¿¿Fabbrocini¿¿¿)
- Patent Owner Exhibit 2033: James Q. Del Rosso, The Use of Sodium Sulfacetamide 10%-Sulfur 5% Emollient Foam in the Treatment of Acne Vulgaris, 2 J. Clinical and Aesthetic Dermatology 26¿¿¿29 (2009) (¿¿¿Del Rosso¿¿¿)
- Patent Owner Exhibit 2034: Janusz Marcinkiewicz et al., Topical taurine bromamine, a new candidate in the treatment of moderate inflammatory acne vulgaris¿¿¿A pilot study, 18 Eur J. Dermatology 433¿¿¿439
(2008) (¿¿¿Marcinkiewicz¿¿¿)
- Patent Owner Exhibit 2035: rwrwer
- Patent Owner Exhibit 2035: Yuko Takenaka et al., Glycolic acid chemical peeling improves inflammatory acne eruptions through its inhibitory and bactericidal effects on Propionibacterium acnes, 39 J. Dermatology 350¿¿¿354 (2012)
- Patent Owner Exhibit 2036: P. Marazzi et al., Clinical evaluation of Double Strength IsotrexinTM versus Benzamycin¿¿ in the topical treatment of mild to moderate acne vulgaris, 13 Journal of Dermatological Treatment 111¿¿¿117 (2002)
- Patent Owner Exhibit 2037: N. Kellett et al., Conjoint analysis: a novel, rigorous tool for determining patient preferences for topical antibiotic treatment for acne. A randomized controlled trial, 154 British Journal of Dermatology 524¿¿¿532 (2006)
- Patent Owner Exhibit 2038: Frank C. Powell, Rosacea, 352 New Eng. J. Med. 793¿¿¿803 (2005)
- Patent Owner Exhibit 2039: Aczone 7.5% PI
- Patent Owner Exhibit 2040: Dina Anderson, Finding a Place for Topical Anti-inflammatory Acne Therapy, Practical Dermatology 17¿¿¿18 (July 2009)
- Patent Owner Exhibit 2041: Michael Ghods et al., The Role of Dapsone Gel in the Acne Armamentarium, The Dermatologist (June 10, 2010), available at https://www.the-dermatologist.com/content/role-dapsonegel-acne-armamentarium (¿¿¿Ghods¿¿¿)
- Patent Owner Exhibit 2042: David Pascoe, Aczone Fails to Impress for Rosacea, Rosacea Support Group (July 23, 2012), available at https://rosaceasupport.org/aczone-fails-to-impress-for-rosacea.html
(¿¿¿Pascoe¿¿¿)
- Patent Owner Exhibit 2043: Clinical Study Report¿¿¿ACZ ROS 01, A phase II, randomized, partial-blind, parallel-group, active- and vehiclecontrolled, multicenter study of the safety and efficacy of Aczone (dapsone) Gel, 5% (Part 1 of 2)
- Patent Owner Exhibit 2043: Clinical Study Report¿¿¿ACZ ROS 01, A phase II, randomized, partial-blind, parallel-group, active- and vehiclecontrolled, multicenter study of the safety and efficacy of Aczone (dapsone) Gel, 5% (Part 2 of 2)
- Patent Owner Exhibit 2044: AZC ROS 01 Web Results Summary, A phase II, randomized, partial-blind, parallel-group, active- and vehicle-controlled, multicenter study of the safety and efficacy of Aczone
(dapsone) Gel, 5% in subjects with papulopustular rosacea
- Patent Owner Exhibit 2045: Otto H. Mills et al., Comparing 2.5%, 5%, and 10% Benzoyl Peroxide on Inflammatory Acne Vulgaris, 25 Int¿¿¿l J. Dermatology 664¿¿¿667 (1986) (¿¿¿Mills¿¿¿)
- Patent Owner Exhibit 2046: John V. Ashurst et al., Pathophysiological Mechanisms, Diagnosis, and Management of Dapsone-Induced Methemoglobinemia, 110 J. Am. Osteopathic Assoc. 16¿¿¿20 (2010) (¿¿¿Ashurst¿¿¿)
- Patent Owner Exhibit 2047: J.S. Chun et al., Dapsone hypersensitivity syndrome with circulating 190-kDA and 230-kDA autoantibodies, 34 Clinical and Experimental Dermatology e798¿¿¿e801 (2009) (¿¿¿Chun¿¿¿)
- Patent Owner Exhibit 2048: U.S. Patent Publication No. 2011/0135584 (¿¿¿Mallard¿¿¿)
- Patent Owner Exhibit 2049: U.S. Patent Publication No. 2011/0003894 (¿¿¿Louis¿¿¿)
- Patent Owner Exhibit 2050: NDA 21-794 FDA approval letter (July 7, 2005)
- Patent Owner Exhibit 2051: NDA 21-794 FDA approval letter (March 14, 2008)
- Patent Owner Exhibit 2052: Deposition of Elaine S. Gilmore, M.D., Ph.D., taken November 16, 2018
- Patent Owner Exhibit 2053: Deposition of Bozena B. Michniak-Kohn, Ph.D., taken November 20, 2018
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