UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.
`Petitioner
`
`v.
`
`GALDERMA LABORATORIES, INC.
`Patent Owner
`
`
`
`U.S. Patent No. 8,603,506
`Issue Date: Dec. 10, 2013
`Title: Method of Treating Acne
`_______________
`
`Case IPR2015-01777
`_______________
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
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`
`
`
`
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`4825-7144-9130.7
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`

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`IPR2015-01777
`U.S. Patent No. 8,603,506
`
` Patent Owner Docket No.: 105153-0103
`
` TABLE OF CONTENTS
`
`
`
`
`
`I. 
`
`II. 
`
`INTRODUCTION ........................................................................................... 1 
`
`BACKGROUND ............................................................................................. 1 
`
`III.  OVERVIEW OF THE ’506 PATENT ............................................................ 4 
`
`IV.  PERSON OF ORDINARY SKILL IN THE ART .......................................... 7 
`
`V. 
`
`CLAIM CONSTRUCTION ............................................................................ 7 
`
`A. 
`
`B. 
`
`“Rosacea” .............................................................................................. 8 
`
`“Papules” and “Pustules” .................................................................... 10 
`
`VI.  THE PETITION FAILS TO SHOW A REASONABLE
`LIKELIHOOD THAT AT LEAST ONE CLAIM IS
`UNPATENTABLE ........................................................................................ 11 
`
`A.  All Grounds in the Petition rely on conclusory statements in the
`Payette Declaration (Ex. 1004) that are unsupported by the
`alleged prior art ................................................................................... 12 
`
`1. 
`
`2. 
`
`The Petitioner has provided no evidence a POSA at the
`’506 Patent’s priority date would have “known” rosacea
`to be “not bacterial” .................................................................. 13 
`
`The Petitioner has provided no evidence a POSA at the
`’506 Patent’s priority date would have been motivated to
`use a periodontitis treatment for the treatment of rosacea ........ 17 
`
`B. 
`
`Response to Ground 1: The Petitioner shows no reasonable
`likelihood that claims 1, 7, 8, 14, 15 and 20 are invalid over the
`combination of Sneddon (Ex. 1006), Golub (Ex. 1048),
`Torresani (Ex. 1010), and PERIOSTAT PDR (Ex. 1042) .................. 23 
`
`1. 
`
`There would have been no motivation to combine
`Sneddon and Torresani with Golub and PERIOSTAT
`PDR ........................................................................................... 25 
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`IPR2015-01777
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` Patent Owner Docket No.: 105153-0103
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`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`Ground 1 should be denied under § 325(d) because
`similar arguments were already addressed and overcome
`during original prosecution ....................................................... 29 
`
`The Petitioner does not sufficiently substantiate its
`inherency allegation regarding treating rosacea with no
`reduction of skin microflora over a six-month treatment ......... 30 
`
`The combination of Sneddon, Golub, Torresani, and
`PERIOSTAT PDR provides no reasonable expectation
`that papules and pustules of rosacea could be treated as
`claimed ...................................................................................... 34 
`
`The Petitioner’s allegations are wholly driven by
`hindsight .................................................................................... 36 
`
`The Petitioner attempts to rely on hypothetical and
`unproven alleged prior uses rather than printed
`publications ............................................................................... 41 
`
`The Petitioner does not demonstrate that claims reciting a
`doxycycline serum concentration in the range of about
`0.1 to about 0.8 μg/ml would have been obvious ..................... 42 
`
`C. 
`
`D. 
`
`E. 
`
`Response to Ground 2: The Petitioner shows no reasonable
`likelihood that claims 1, 8 and 15 are invalid over the
`combination of Golub (Ex. 1048), Torresani (Ex. 1010), and
`Jansen (Ex. 1034) ................................................................................ 43 
`
`Response to Ground 3: The Petitioner shows no reasonable
`likelihood that claims 7, 14 and 20 are invalid over the
`combination of Golub (Ex. 1048), Torresani (Ex. 1010), Jansen
`(Ex. 1034) and PERIOSTAT PDR (Ex. 1042) ................................... 46 
`
`“Secondary considerations” demonstrate nonobviousness of the
`claimed methods .................................................................................. 47 
`
`1. 
`
`The claimed invention of the ’506 Patent satisfied a long-
`felt, unmet need for an effective treatment of papules and
`pustules of rosacea with reduced side effects ........................... 48 
`
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` Patent Owner Docket No.: 105153-0103
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`IPR2015-01777
`U.S. Patent No. 8,603,506
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`2. 
`
`3. 
`
`Commercial success of ORACEA® further establishes
`nonobviousness of the claimed methods .................................. 50 
`
`The Petitioner attempts to copy the 40 mg/day dosage
`claimed in the ’506 Patent, despite the availability of
`generic 50 mg and 100 mg doxycycline ................................... 51 
`
`VII.  THE PETITION SHOULD BE DENIED AS REDUNDANT OVER
`IPR2015-01782 .............................................................................................. 52 
`
`VIII.  CONCLUSION .............................................................................................. 59 
`
`
`
`
`
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` Patent Owner Docket No.: 105153-0103
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`
`TABLE OF AUTHORITIES
`
`IPR2015-01777
`U.S. Patent No. 8,603,506
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`
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`CASES
`
`Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc.,
`
`98 F.3d 1563 (Fed. Cir. 1996) ....................................................................... 48
`
`Berk-Tek, LLC v, Belden Inc.,
`
`IPR2013-0058, Paper 13 (P.T.A.B. May 2, 2013) .......................................... 8
`
`Cheese Sys., Inc. v. Tetra Pak Cheese & Powder Sys., Inc.,
`
`725 F.3d 1341 (Fed. Cir. 2013) ..................................................................... 25
`
`Coalition for Affordable Drugs V LLC v. Biogen MA Inc.,
`
`IPR2015-01136, Paper 23 (P.T.A.B. Sept. 2, 2015) ..................................... 41
`
`Crocs, Inc. v. Int'l Trade Comm'n,
`
`598 F.3d 1294 (Fed. Cir. 2010) ..................................................................... 47
`
`Ferrum Ferro Capital, LLC v. Allergan Sales, LLC,
`
`IPR2015-00858, Paper 10 (P.T.A.B. Sept. 21, 2015) ................................... 31
`
`Forest Labs., Inc. v. Ivax Pharms., Inc.,
`
`438 F. Supp. 2d 479 (D. Del. 2006),
`
`aff'd, 501 F.3d 1263 (Fed. Cir. 2007) ............................................................ 51
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig.,
`
`676 F.3d 1063 (Fed. Cir. 2012) .................................................. 35, 36, 42, 47
`
`In re Newell,
`
`891 F.2d 899 (Fed. Cir. 1989) ....................................................................... 33
`
`In re Rijckaert,
`
`9 F.3d 1531 (Fed. Cir. 1993) ......................................................................... 32
`
`In re Spormann,
`
`363 F.2d 444 (C.C.P.A. 1996) ....................................................................... 33
`
`
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` Patent Owner Docket No.: 105153-0103
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`IPR2015-01777
`U.S. Patent No. 8,603,506
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`
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`Institut Pasteur v. Focarino,
`
`738 F.3d 1337 (Fed. Cir. 2013) ..................................................................... 47
`
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`
`IPR2013-00324, Paper 19 (P.T.A.B. Nov. 21, 2013) ............................. 55, 56
`
`J.T. Eaton & Co. v. Atlantic Paste & Glue Co.,
`
`106 F.3d 1563 (Fed. Cir. 1997) ..................................................................... 50
`
`Leo Pharm. Prods., Ltd. v. Rea,
`
`726 F.3d 1346 (Fed. Cir. 2013) .............................................................. 35, 36
`
`Medtronic, Inc. v. Nuvasive, Inc.,
`
`IPR2014-00487, Paper 8 (P.T.A.B. Sept. 11, 2014) ..................................... 56
`
`Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH,
`
`139 F.3d 877 (Fed. Cir. 1998) ....................................................................... 37
`
`Par Pharmaceutical v. TWI Pharmaceuticals, Inc.,
`
`773 F.3d 1186 (Fed. Cir. 2014) ..................................................................... 32
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ....................................................... 7
`
`
`Prism Pharma Co., Ltd. v. Choongwae Pharma Corp.,
`
`IPR2014-00315, Paper 14 (P.T.A.B. July 8, 2014) ....................................... 57
`
`SAS Institute, Inc. v. ComplementSoft, LLC,
`
`IPR2013-00581, Paper 15 (P.T.A.B. Dec. 30, 2013) ............................. 56, 58
`
`Tempo Lighting v. Tivoli,
`
`742 F.3d 973 (Fed. Cir. 2013) ......................................................................... 7
`
`Unilever, Inc. v. Procter & Gamble Co.,
`
`IPR2014-00506, Paper 17 (P.T.A.B. July 7, 2014) ....................................... 57
`
`
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` Patent Owner Docket No.: 105153-0103
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`IPR2015-01777
`U.S. Patent No. 8,603,506
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`STATUTES, RULES, AND OTHER AUTHORITIE
`
`35 U.S.C. § 312(a)(3) ............................................................................................... 12
`
`35 U.S.C. § 313 .......................................................................................................... 1
`
`35 U.S.C. § 314(a) ............................................................................ 4, 11, 12, 52, 55
`
`35 U.S.C. § 316(b) ................................................................................................... 55
`
`35 U.S.C. § 325(d) ...................................................................................... 29, 52, 55
`
`37 C.F.R. § 42.100(b) ................................................................................................ 7
`
`37 C.F.R. § 42.108(b) .............................................................................................. 52
`
`37 C.F.R. § 42.108(c) ................................................................................................. 4
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`
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`EXHIBITS
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`IPR2015-01777
`U.S. Patent No. 8,603,506
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`
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`Exhibit No.
`2001
`
`2002
`2003
`
`2004
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`
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`4825-7144-9130.7
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`Description
`Executed Affidavit in Support of Motion for Pro Hac Vice
`Admission of Evan Diamond (IPR2015-01777)
`Evan Diamond Bio (IPR2015-01777)
`Joseph B. Bikowski & Mitchel P. Goldman, Rosacea: Where Are
`We Now?, 3 J. DRUGS DERMATOLOGY 251 (2004)
`ORACEA® Label, rev. 2013
`Research Found. of State Univ. v. Mylan Pharms, Inc., 809 F. Supp.
`2d. 296 (D. Del. 2011)
`Answer to Complaint, Additional Defenses and Counterclaims,
`Galderma Labs., L.P. et al. v. Dr. Reddy’s Labs., Ltd. et al., C.A.
`No. 15-670-LPS (D. Del. Sept. 22, 2015)
`Jonathan Wilkin et al., Standard Classification of Rosacea: Report
`of the National Rosacea Society Expert Committee on the
`Classification and Staging of Rosacea, 46 J. AM. ACAD.
`DERMATOLOGY 584 (2002)
`Szlachcic et al., Helicobacter Pylori and Its Eradication in Rosacea,
`50 J. PHYSIOLOGY PHARMACOLOGY 777 (1999)
`Mark V. Dahl, Pathogenesis of Rosacea, in 17 ADVANCES IN
`DERMATOLOGY 29 (William D. James ed., 2001)
`N. Lacey et al., Mite-Related Bacterial Antigens Stimulate
`Inflammatory Cells in Rosacea, 157 BRIT. J. DERMATOLOGY 474
`(2007)
`Elizabeth Lazaridou et al., The Potential Role of Microorganisms in
`the Development of Rosacea, 9 J. GERMAN SOC’Y DERMATOLOGY 21
`(2011)
`Shamim A. Ansari, Resident Microflora and Antimicrobial Peptides
`of Skin, in INNATE IMMUNE SYSTEM OF SKIN AND ORAL MUCOSA:
`PROPERTIES AND IMPACT IN PHARMACEUTICS, COSMETICS, AND
`PERSONAL CARE PRODUCTS 83 (Nava Dayan & Philip W. Wertz
`eds., 2011)
`Committee on Research, Science and Therapy, The Pathogenesis of
`Periodontal Diseases, 70 J. PERIODONTOLOGY 457 (1999)
`Petition for Inter Partes Review, Dr. Reddy’s Labs., Ltd. v.
`Galderma Labs, Inc., IPR2015-01782 (P.T.A.B. 2015)
`
`vii
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`

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`IPR2015-01777
`U.S. Patent No. 8,603,506
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` Patent Owner Docket No.: 105153-0103
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`INTRODUCTION
`
`
`
`I.
`
`Patent Owner submits this preliminary response under 35 U.S.C. § 313 to
`
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (“Petitioner”)’s
`
`petition (“Petition”) for inter partes review (“IPR”) of claims 1, 7, 8, 14, 15, and
`
`20 of U.S. Patent No. 8,603,506 (“the ’506 Patent”). This preliminary response is
`
`filed timely within three months of the Board’s notice, mailed August 27, 2015,
`
`indicating that the Petition was accorded a filing date. For reasons set forth herein
`
`and in the accompanying exhibits, the Board should deny all grounds of invalidity
`
`asserted in the Petition.
`
`II. BACKGROUND
`
`Rosacea (also known as “acne rosacea”) 1 is a chronic disorder of the skin,
`
`which affects approximately 14 million Americans. Ex. 2003, p. 251. Rosacea
`
`can manifest as a range of symptoms, including (1) “papules and pustules,” (2)
`
`flushing and redness, known as “erythema,” and (3) visible blood vessels, known
`
`as “telangiectasia.” Ex. 1034, p. 144; Ex. 1001, col. 4, ll. 23-44. Historically, the
`
`
`1 It is undisputed that the terms “rosacea” and “acne rosacea” are synonymous. See
`
`Petition, p. 11 (acknowledging “acne rosacea” as an “antiquated” form of the term
`
`“rosacea”).
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`papules and pustules of rosacea were treated with a variety of topical gels and
`
`creams, or with oral therapies, including long-term administration of oral antibiotic
`
`drugs. Among these oral antibiotics were drugs in the tetracycline class, including
`
`doxycycline, which were administered in antibacterial dosages (e.g., typically 100-
`
`200 mg doxycycline per day). Ex. 2003, p. 252. While this treatment regimen
`
`could be effective, long-term use of tetracycline-class antibiotics frequently lead to
`
`undesirable side effects such as the emergence of antibiotic-resistant bacteria and
`
`the overgrowth of undesirable organisms such as yeasts. Ex. 1001, col. 3, ll. 31-
`
`36.
`
`The invention of the challenged claims of the ’506 Patent arose from the
`
`discovery by Robert Ashley of CollaGenex Pharmaceuticals, Inc. (“CollaGenex”)
`
`of an unprecedented method of treating papules and pustules of acne and rosacea
`
`by oral administration of a 40 mg daily dose of doxycycline that unexpectedly
`
`maintained efficacy of higher, antibacterial doses while avoiding the undesirable
`
`side effects of those higher doses. Ex. 1001, col. 3, ll. 26-50. Central to Mr.
`
`Ashley’s invention was the surprising discovery that Periostat®—20 mg
`
`doxycycline hyclate for twice daily administration, approved by the FDA as an
`
`adjunct therapy in treatment of the gum disease periodontitis—could be used to
`
`treat papules and pustules of acne and rosacea, despite conventional wisdom that
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`only higher, antibacterial dosages would be effective. Ex. 1001, col. 3, ll. 26-50;
`
`col. 5, ll. 59-63.
`
`The challenged claims of the ’506 Patent thus cover a novel and inventive
`
`method for using doxycycline in a 40 mg daily dose to treat papules and pustules
`
`of the facial skin condition rosacea, with no reduction of skin microflora over a six
`
`month period. These claims cover Patent Owner’s product ORACEA®, which was
`
`first approved by the United States Food and Drug Administration (“FDA”) in
`
`2008 and is used today for the treatment of inflammatory lesions (papules and
`
`pustules) of rosacea. Ex. 2004, p. 1. ORACEA® remains the first and only FDA
`
`approved, orally administered, systemically delivered drug to treat rosacea, with
`
`reduced side effects as compared to prior treatments. See Ex. 2005, p. 300, ¶ 27;
`
`see also Ex. 2004, p. 1, “Dosing and Administration” section.
`
`Based on public assertions by the Petitioner, the Petitioner intends to market
`
`a 40 mg doxycycline product under the tradename ZENAVOD® that is covered by
`
`the ’506 Patent claims. Ex. 2006, p. 15, ¶¶ 24-26.
`
`The Petitioner’s asserted grounds for challenging these claims of the ’506
`
`Patent are generally based on the premise that a person of ordinary skill in the art
`
`(“POSA”) seeking to treat rosacea papules and pustules would have looked to
`
`literature regarding use of 40 mg daily doxycycline as an adjunct therapy in
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`IPR2015-01777
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`periodontitis treatment—a disease entirely different from rosacea—and would
`
`have combined that literature with a document consistent with the historical
`
`practice of using higher dose, antibacterial doxycycline therapy to treat rosacea
`
`papules and pustules.
`
`Yet, the Petition mischaracterizes the state of the prior art and fails to
`
`establish prima facie obviousness, let alone a reasonable likelihood that it would
`
`prevail on its obviousness theory. See 35 U.S.C. § 314(a) (IPR may not be
`
`instituted absent “a reasonable likelihood that the petitioner would prevail”); 37
`
`C.F.R. § 42.108(c).
`
`III. OVERVIEW OF THE ’506 PATENT
`
`The ’506 Patent issued from U.S. Patent Application No. 13/277,789; which
`
`is a continuation of U.S. Patent Application No. 11/876,478, issued as U.S. Patent
`
`No. 8,052,983; which is a continuation of U.S. Application No. 10/757,656 (now
`
`abandoned); which is a division of U.S. Patent Application No. 10/117,705, issued
`
`as U.S. Patent No. 7,211,267; which claims priority to U.S. Provisional
`
`Application Nos. 60/325,489, filed September 26, 2001, and 60/281,916, filed
`
`April 5, 2001.
`
`Claim 1 of the ’506 Patent recites:
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`A method for treating papules and pustules of rosacea in a
`human in need thereof, the method comprising
`administering orally to said human doxycycline, or a
`pharmaceutically acceptable salt thereof,
`in an amount that
`(i) is effective to treat the papules and pustules of rosacea;
`(ii) is 10-80% of a 50 mg dose of doxycycline per day; and
`(iii) results in no reduction of skin microflora during a six-
`month treatment, without administering a bisphosphonate
`compound.
`
`Claim 15 recites:
`
`A method for treating papules and pustules of rosacea in a
`human in need thereof, the method comprising administering
`orally to said human doxycycline, or a pharmaceutically
`acceptable salt thereof, in an amount of 40 mg per day, wherein
`the amount results in no reduction of skin microflora during a
`six-month treatment, without administering a bisphosphonate
`compound.
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`The specification of the ’506 Patent explains a need for alternative therapies
`
`for acne and rosacea, including treatment of inflammatory lesions (papules and
`
`pustules), with efficacy comparable to then-conventional antibiotic therapies, but
`
`that minimize undesirable side effects associated with the conventional therapies,
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`such as a reduction or elimination in healthy microbial flora. Ex. 1001, col. 3, ll.
`
`7-40, and col. 4, ll. 24-43. The specification explains that, while tetracyclines had
`
`been proposed to have anti-inflammatory activities, the state-of-the-art still
`
`required use of antibacterial tetracycline doses to treat papules and pustules. Ex.
`
`1001, col 3, ll. 14-26. Thus, as the specification explains, nothing in the prior art
`
`taught such treatment using dosages intended to avoid antibiotic effects. Ex. 1001,
`
`col 3, ll. 27-30. The specification further identifies the use of 40 mg doxycycline
`
`daily (e.g., 20 mg doxycycline twice daily) as an “especially preferred
`
`embodiment,” and provides clinical data showing that this 40 mg daily dose was
`
`effective in treating inflammatory lesions (papules and pustules) of acne while
`
`resulting in no reduction of skin microflora or increase in resistance counts as
`
`compared to placebo over a six-month treatment. Ex. 1001, col. 5, ll. 59-63; col.
`
`19, l. 37 to col. 20, l. 44; and claim 15.
`
`Thus, the specification of the ’506 Patent explains that the claimed methods
`
`covering a 40 mg daily dosage of doxycycline fulfilled the need in the art—a
`
`therapy that is effective to treat the papules and pustules of rosacea, while resulting
`
`in no reduction of skin microflora during a six-month treatment.
`
`
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`IPR2015-01777
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`IV. PERSON OF ORDINARY SKILL IN THE ART
`
`The Petitioner alleges that the person of ordinary skill in the art would have
`
`been a licensed and practicing dermatologist with as little as one year of experience
`
`treating patients in a hospital, clinic, and/or private setting. Patent Owner does not
`
`fully agree with the Petitioner in this regard, but will adopt the Petitioner’s
`
`description for purposes of this Preliminary Response. Even under the Petitioner’s
`
`description of a POSA, the Petitioner has failed to show a reasonable likelihood
`
`that it can prove any of the claims at issue to have been obvious to a POSA at the
`
`relevant time in view of the Petitioner’s alleged prior art Grounds.
`
`V. CLAIM CONSTRUCTION
`
`In an inter partes review, “[a] claim in an unexpired patent shall be given its
`
`broadest reasonable construction in light of the specification of the patent in which
`
`it appears.” 37 C.F.R. § 42.100(b). Under this standard, the language of the
`
`claims, the specification and the prosecution history all serve as intrinsic evidence
`
`for purposes of claim construction. Tempo Lighting v. Tivoli, 742 F.3d 973, 977
`
`(Fed. Cir. 2013). Moreover, claims are construed from the perspective of one of
`
`ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415
`
`F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). And this Board has held that “[t]here
`
`is a ‘heavy presumption’ that a claim term is given its ordinary and customary
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`meaning.” Berk-Tek, LLC v, Belden Inc., IPR2013-00058, Paper 13, 14 (P.T.A.B.
`
`May 2, 2013). Consistent with this standard, below Patent Owner defines relevant
`
`claim terms in the context of the language of the claims, the specification, the
`
`prosecution history, and the understanding in the art at the time of the invention.
`
`“Rosacea”
`
`A.
`The claim term “rosacea” was a well-understood term in the art and should
`
`be given its plain and ordinary meaning, as construed by a POSA at the time of the
`
`invention. The language of the claims, specification, and prosecution history of the
`
`’506 Patent confirm that the plain and ordinary meaning of the claim term
`
`“rosacea” controls here. For example, in the Response filed September 19, 2012,
`
`the applicant cited a publication by Wilkin et al. that described rosacea as a “well
`
`recognized” syndrome that may encompass a variety of possible symptoms,
`
`including papules and pustules:
`
`Rosacea is well recognized as a chronic cutaneous
`disorder primarily of the convexities of the central face
`(cheeks, chin, nose and central
`forehead), often
`characterized by remissions and exacerbations. Based on
`present knowledge, it is considered a syndrome, or
`typology, encompassing various combinations of such
`cutaneous signs as flushing, erythema, telangiectasia,
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`and
`lesions,
`ocular
`pustules,
`papules,
`edema,
`rhinophyma. In most cases, some rather than all of these
`stigmata appear in any given patient.
`
`Ex. 2007, p. 584.
`
`The specification of the ’506 Patent also discloses that “acne,” including
`
`“acne rosacea” (i.e., rosacea), can include symptoms of papules and pustules, and
`
`that acne rosacea can also be characterized by symptoms of erythema and
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`telangiectasia. Ex. 1001, col. 4, ll. 23-43. The claims of the ’506 Patent likewise
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`are directed to treatment of “papules and pustules of rosacea.”
`
`The Petitioner does not clearly state what it believes the construction of
`
`“rosacea” should be, or explain why any particular construction apart from the
`
`plain and ordinary meaning is merited here. Instead, under the heading “Claim
`
`Construction” and subheading “Rosacea,” the Petitioner simply lists certain
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`statements from the specification of the ’506 Patent, without further explanation,
`
`and does not discuss the prosecution history of the ’506 Patent or understanding of
`
`a POSA at the relevant time as it relates to the claim term “rosacea.” Accordingly,
`
`it appears the Petitioner agrees that “rosacea” should be construed in accordance its
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`plain and ordinary meaning.
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`“Papules” and “Pustules”
`
`B.
`The terms “papules” and “pustules” were well-understood terms in the art
`
`and also should be construed according to their plain and ordinary meaning. As
`
`the Petitioner acknowledges, nothing in the specification of the ’506 Patent
`
`provides that the terms “papules” and “pustules” should be construed differently
`
`than their plain and ordinary meaning. Petition, p. 23. In the Response filed
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`September 19, 2012, the applicant explained that “papules and pustules are
`
`inflammatory lesions that occur only on skin” and “are features of facial rosacea,”
`
`which definition was consistent with quoted medical literature describing
`
`“papules” as, e.g., “small rounded bumps rising from the skin that are each usually
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`less than 1cm in diameter,” and literature describing a “pustule” as, e.g., “a small
`
`collection of pus in the top layer of skin (epidermis) or beneath it in the dermis.”
`
`Ex. 1070, p. 6. And, as the Petitioner admits, “[p]apules and pustules are
`
`extremely common to both common acne (acne vulgaris) and rosacea (as well as
`
`other skin disorders), and . . . the resulting papules and pustules in both diseases
`
`share common underlying properties . . . .” Petition, pp. 23-24.
`
`While the Petitioner does not contest that the terms “papules” and “pustules”
`
`should be construed by their plain and ordinary meaning, the Petition does
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`reference statements from Dr. Payette’s Declaration (See Petition, p. 23) regarding
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`these terms, e.g., related to underlying causes of papules. It is unclear from the
`
`Petition if these statements are intended to provide a construction of these terms;
`
`nevertheless, to the extent that these statements can be read as attempting to
`
`construe the terms “papules” and “pustules” by reference to Dr. Payette’s
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`Declaration, the Petitioner is incorrect. Nothing in the claims, specification, or file
`
`history suggests that the applicant meant to limit or define the terms “papules” or
`
`“pustules” in accordance with these opinions quoted in the Petition. Moreover, the
`
`statement from Dr. Payette regarding “a papule” cites to an extrinsic publication
`
`with seven paragraphs under the heading “Papules,” of which Dr. Payette crop-
`
`quotes two sentences. Ex. 1004 ¶ 19; Ex. 1056, p. 27. The Petitioner fails to
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`explain why the terms “papules” and “pustules” should be defined according to Dr.
`
`Payette’s selective statements from the extrinsic evidence, or whether the
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`Petitioner is asserting such a construction at all.
`
`VI. THE PETITION FAILS TO SHOW A REASONABLE LIKELIHOOD
`THAT AT LEAST ONE CLAIM IS UNPATENTABLE
`
`The Board may not grant a petition for IPR unless it “determines that the
`
`information presented in the petition filed under section 311 and any response filed
`
`under section 313 shows that there is a reasonable likelihood that the petitioner
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`would prevail.” 35 U.S.C. § 314(a).
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`Importantly, § 314(a) requires the Board’s determination to be based on
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`“information presented in the petition.” Likewise, the Petitioner has a statutory
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`obligation under § 312(a)(3) to identify “with particularity, each claim challenged,
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`the grounds on which the challenge to each claim is based, and the evidence that
`
`supports the grounds for the challenge to each claim.” Thus, it is not for the Board
`
`to fill in gaps omitted by the Petitioner. The evidentiary burden falls squarely on
`
`the Petitioner.
`
`Equally important is § 314(a)’s requirement that the Board’s determination
`
`take into account “information presented in . . . any response filed under section
`
`313.” In other words, the Board’s determination must be based on the totality of
`
`the written evidence presented at the pre-trial stage.
`
`Ultimately, the focus of the inquiry under § 314(a) is whether the Petitioner
`
`“would prevail”—i.e., win on the merits based exclusively on the “information
`
`presented in the petition . . . and any response.” See 35 U.S.C. § 314(a).
`
`A. All Grounds in the Petition rely on conclusory statements in the
`Payette Declaration (Ex. 1004) that are unsupported by the
`alleged prior art
`
`The arguments in the Petition fail to demonstrate that the Petitioner “would
`
`prevail” because they are grounded in unsupported assumptions regarding the state
`
`of the art and mischaracterizations of references cited in the Petition and in the
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`Payette Declaration (Ex. 1004). Two of these assumptions and
`
`mischaracterizations are foundational to all of the Petitioner’s asserted Grounds for
`
`obviousness: (1) the Petitioner’s assertion that rosacea was understood at the time
`
`of invention to be “non-bacterial” and (2) the Petitioner’s assertion that rosacea
`
`and periodontitis were recognized to utilize common inflammatory pathways and,
`
`thus, treatment methods for these diseases were expected to be interchangeable.
`
`With respect to each of these assertions, here Patent Owner not only demonstrates
`
`that the Petitioner has not provided sufficient evidence that a POSA at the time of
`
`invention would have accepted these assertions, but also points to pertinent prior
`
`art (including statements within the Petitioner’s own alleged prior art) that
`
`contradicts the Petitioner’s assertions, and which the Petitioner has ignored without
`
`justification.
`
`1.
`
`The Petitioner has provided no evidence a POSA at the ’506
`Patent’s priority date would have “known” rosacea to be “not
`bacterial”
`
`Critical to the Petitioner’s obviousness analysis, in all three asserted
`
`Grounds, is the allegation that “it was known that rosacea in general, and its
`
`papules and pustules specifically, were. . . not bacterial.” See, e.g., Petition, pp. 6
`
`(“Introduction and Summary of Argument”), 33 (“Ground 1”), 50 (“Ground 2”);
`
`see also Ex. 1004 (Payette Declaration), ¶ 26 (“the pathogenesis of the papules and
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`pustules of rosacea was known to be primarily inflammatory in nature, not
`
`bacterial”). The Petitioner relies on this allegedly “known” fact, i.e., that rosacea
`
`was “not bacterial,” to argue that a POSA would have been motivated to treat
`
`papules and pustules of rosacea with amounts of doxycycline that provided only
`
`anti-inflammatory activity and were not effective antibiotically. See, e.g., Petition,
`
`p. 33 (“At the most basic level, the fact that the papules and pustules of rosacea
`
`were known to be inflammatory, and not bacterial, would raise concerns for
`
`dermatologists about needlessly continuing to dose an antibacterial amount of
`
`doxycycline when other options were readily available.”).
`
`Yet the Petitioner has presented no evidence demonstrating that a POSA
`
`provided with the full scope and content of the prior art circa 2001 would