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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Applicant(s): Robert A. Ashley
`Serial No.: 11/876,4 78
`Filed: October 22, 2007
`Page 21of34
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`Independent Claim 46 has been added to specifically recite treating rosacea, wherein the
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`rosacea is characterized by inflammatory lesions. The non-antibiotic tetracycline compound is
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`administered in an amount that is effective to treat the inflammatory lesions of rosacea.
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`Dependent Claim 4 7 recites that the inflammatory lesions are papules, pustules, nodules, or
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`combinations thereof. Support for these claims is found in the specification at page 6, lines 29-
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`30. Dependent Clams 48 and 49 recite specific non-antimicrobial tetracycline compounds.
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`Independent Claim 50 has been added to specifically recite treating rosacea, wherein the
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`rosacea is characterized by erythema. The non-antibiotic tetracycline compound is administered
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`in an amount that is effective to treat the erythema of rosacea. Support for these claims is found
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`in the specification at page 7, line 4. Dependent Clams 51 and 52 recite specific non(cid:173)
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`antimicrobial tetracycline compounds.
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`There are four sub-types of rosacea. Rosacea patients can have any one, or occasionally
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`more than one, of these sub-types. One sub-type affects the eyes and is called "ocular rosacea."
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`Others subtypes affect the facial skin and are herein called facial rosacea. 1 In particular,
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`"papulopustular rosacea" is characterized by facial papules and pustules; and
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`"erythematotelangiectatic rosacea" is mainly characterized by facial erythema. Clearly, ocular
`rosacea and facial rosacea are distinct medical conditions. 2
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`The National Rosacea Society recently assembled a committee to develop a standard classification
`system of rosacea. Their report, authored by Wilkin, et al., appeared in J. Am. Acad. Dermatol. 46, 584-587 (2002).
`This authoritative report identified four specific sub-types of rosacea. Subtype I is called "erythematotelangiectatic
`rosacea," and is characterized by flushing and persistent central facial erythema. Subtype 2 is called
`"papulopustular rosac;ea," and is characterized by transient papules and/or pustules. Subtype 3 is called "phymatous
`rosacea," and is characterized by thickening skin, irregular surface nodularities, and enlargement, e.g., rhinophyma.
`Subtype 4 is called "ocular rosacea," and is characterized exclusively by ocular manifestations. The Wilkin report is
`attached as exhibit A.
`2
`(a) In addition to evidence provided in footnote I, facial rosacea and ocular rosacea are treated by
`physicians in different specialties with different Board certifications, i.e., dermatologists and ophthalmologists,
`respectively.
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`(b) Moreover, the agency that approves drugs in the United States, namely the Center for Drug
`Evaluation and Research (CDER) of the Food and Drug Administration, evaluates drugs for facial rosacea and
`ocular rosacea in different divisions. Facial rosacea is evaluated in the Division of Dermatologic and Dental
`Products. Ocular rosacea is evaluated in the Division of Anti-Infection and Ophthalmologic Products. For the
`examiner's convenience, a chart of the organization of the CDER showing the separate divisions ofDermatologic
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`Galderma Laboratories, Inc. Ex 2014
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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