IPR2015-01778
`Patent No. 8,603,506
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` Patent Owner Docket No.: 105153-0104
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`Paper No. ________
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`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
`
`
`
`Patent No. 8,603,506
`Issue Date: December 10, 2013
`
`Title: METHOD OF TREATING ACNE
`_______________
`
`Case IPR2015-01778
`____________________________________________________________
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`PATENT OWNER PRELIMINARY RESPONSE
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`4830-1252-5099.2
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`

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`IPR2015-01778
`Patent No. 8,603,506
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`
` Patent Owner Docket No.: 105153-0104
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`
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`TABLE OF CONTENTS
`
`I. 
`
`II. 
`
`INTRODUCTION ........................................................................................... 1 
`
`OVERVIEW OF THE ’506 PATENT ............................................................ 4 
`
`III. 
`
`PERSON OF ORDINARY SKILL IN THE ART .......................................... 5 
`
`IV.  CLAIM CONSTRUCTION ............................................................................ 6 
`
`A. 
`
`B. 
`
`C. 
`
`LEGAL STANDARD ........................................................................... 6 
`
`“ROSACEA” ......................................................................................... 6 
`
`“PAPULES” AND “PUSTULES” ........................................................ 8 
`
`V. 
`
`STANDARD OF REVIEW FOR INSTITUTION .......................................... 9 
`
`VI.  PETITION FAILS TO DEMONSTRATE A REASONABLE
`LIKELIHOOD OF SUCCESS ...................................................................... 10 
`
`1.  The Application Group Leading to the ’506 Patent describes
`treatment of “rosacea” .................................................................... 14 
`
`2.  The Application Group Leading to the ’506 Patent expressly
`describes papules and pustules of rosacea as a symptom to be
`treated in accordance with the claims ............................................ 17 
`
`3.  The Application Group Leading to the ’506 Patent describes
`treating papules and pustules of rosacea with doxycycline ........... 25 
`
`4.  The Application Group Leading to the ’506 Patent describes
`treating papules and pustules of rosacea with the claimed doses of
`doxycycline .................................................................................... 26 
`
`5.  The Application Group Leading to the ’506 Patent describes
`treating papules and pustules of rosacea “without administering a
`bisphosphonate compound” ........................................................... 28 
`
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`IPR2015-01778
`Patent No. 8,603,506
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` Patent Owner Docket No.: 105153-0104
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`6.  The Application Group Leading to the ’506 Patent provides an
`example of treating inflammatory papules and pustules—
`symptoms of acne rosacea .............................................................. 30 
`
`7.  The ’506 Patent’s discussion of “antibiotic” and “sub-antibiotic”
`dosing is unambiguous and inconsequential to written description32 
`
`8.  Whether the claimed method can also treat telangiectasia is
`immaterial ....................................................................................... 34 
`
`9.  Each Ground of Unpatentability in the Petition relies on
`unsupported, conclusory statements in the Payette Declaration (Ex.
`1004) ............................................................................................... 35 
`
`VII.  THE SPECIFICATION OF THE ’506 PATENT IS IDENTICAL TO
`EACH OF THE THREE NON-PROVISIONAL DOCUMENTS IN
`THE CONTINUOUS PRIORITY “CHAIN” CONSTITUTING THE
`“APPLICATION GROUP LEADING TO THE ’506 PATENT” ................ 37 
`
`VIII.  THE BOARD SHOULD DENY THE PETITION BASED ON ITS
`STATUTORILY VESTED DISCRETION .................................................. 39 
`
`A. 
`
`B. 
`
`THE PETITION SHOULD BE DENIED BECAUSE IT IS A
`THINLY VEILED ATTEMPT TO CIRCUMVENT 35 U.S.C. §
`311(B) .................................................................................................. 39 
`
`THE PETITION SHOULD BE DENIED UNDER 35 U.S.C. § 325(D)
`AS DUPLICATIVE OF EXAMINATION ......................................... 42 
`
`IX.  CONCLUSION .............................................................................................. 45 
`
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` 
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`IPR2015-01778
`Patent No. 8,603,506
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`TABLE OF AUTHORITIES
`
`Cases 
`Alcon Research Ltd. v. Barr Labs., Inc.,
`745 F.3d 1180 (Fed. Cir. 2014) ........................................................................ 30
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) ........................................................................ 30
`Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ................................................. 14, 19
`Falkner v. Inglis,
`448 F.3d 1357 (Fed. Cir. 2006) ........................................................................ 30
`Hybritech Inc. v. Monoclonal Antibodies, Inc.,
`802 F.2d 1367 (Fed. Cir. 1986) ........................................................................ 19
`In re Cuozzo Speed Techs.,
`778 F.3d 1271 (Fed. Cir. 2015) .......................................................................... 6
`In re Gosteli,
`872 F.2d 1008 (Fed. Cir. 1989) ........................................................................ 19
`In re Johnson,
`558 F.2d 1008 (CCPA 1977) ........................................................................... 29
`In re Paulsen,
`30 F.3d 1475 (Fed. Cir. 1994) .......................................................................... 17
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) .......................................................................... 6
`Inphi Corporation v. Netlist, Inc.,
`No. 2015-1179 (Fed. Cir. Nov. 13, 2015) ........................................................ 29
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) .......................................................................... 10
`Research Found. of State Univ. v. Mylan Pharms., Inc.,
`809 F. Supp. 2d. 296 (D. Del. 2011) .................................................................. 1
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) ........................................................................ 29
`United States Steel Corp. v. Phillips Petroleum Co.,
`
`
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`IPR2015-01778
`Patent No. 8,603,506
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`865 F.2d 1247 (Fed. Cir. 1989) ........................................................................ 34
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) ........................................................................ 19
`
`Statutes 
`
`21 U.S.C. § 355(b)(2)(A)(IV) ............................................................................... 22
`35 U.S.C. § 102 .............................................................................................. 39, 42
`35 U.S.C. § 103 .............................................................................................. 39, 42
`35 U.S.C. § 112 .............................................................................................. 41, 42
`35 U.S.C. § 120 .............................................................................................. 40, 42
`35 U.S.C. § 132 ....................................................................................................... 3
`35 U.S.C. § 311 ............................................................................................. passim
`35 U.S.C. § 312(a)(3) .............................................................................................. 9
`35 U.S.C. § 315(e) .......................................................................................... 41, 42
`35 U.S.C. § 112 ............................................................................................. passim
`35 U.S.C. § 313 ............................................................................................ 1, 9, 10
`35 U.S.C. § 314(a) ...................................................................................... 9, 10, 42
`35 U.S.C. § 316(e) ................................................................................................. 10
`35 U.S.C. § 321 ................................................................................................ 4, 40
`35 U.S.C. § 325(d) ................................................................................................. 42
`
`Legislative Material 
`America Invents Act of 2011 (H. Rpt. 112-98, Pt. 1) ............................................ 42
`
`Rules and Regulations 
`
`37 C.F.R. § 42.100(b) .............................................................................................. 6
`37 C.F.R. § 42.104(b)(2) ....................................................................................... 41
`37 C.F.R. § 42.65................................................................................................... 35
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`IPR2015-01778
`Patent No. 8,603,506
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`
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`Other Authorities 
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` Patent Owner Docket No.: 105153-0104
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`MPEP § 2163 II(A)(2) ........................................................................................... 43
`MPEP § 2173.05(i) ................................................................................................ 29
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756 ........................................ 6
`
`Inter Partes Reviews 
`Daiichi Sankyo Co. Ltd. v. Alethia Biotherapeutics Inc.,
`IPR2015-00291 (P.T.A.B. 2015) ..................................................................... 39
`General Electric Co. v. Tas Energy, Inc.,
`IPR2014-00163 (P.T.A.B. 2014) .............................................................. 35, 37
`Harmonic, Inc. v. Avid Technology, Inc.,
`IPR2013-00252 (P.T.A.B. 2013) ..................................................................... 40
`Hughes Network Systems, LLC v. California Institute of Technology,
`IPR2015-00067 (P.T.A.B. 2015) ..................................................................... 10
`Polaris Wireless, Inc. v. TruePositions, Inc.,
`IPR2013-00323 (P.T.A.B. 2015) ..................................................................... 39
`Praxair Distribution, Inc. v. INO Therapeutic LLC,
`IPR2015-00893 (P.T.A.B. 2015) ..................................................................... 42
`Prism Pharma Co., LTD v. Choongwae Pharma Corp.,
`IPR2014-00315 (P.T.A.B. 2014) ..................................................................... 44
`Research in Motion Corp. v. MobileMedia Ideas, LLC,
`IPR2013-00036 (P.T.A.B. 2013) ..................................................................... 40
`Universal Remote Control, Inc. v. Universal Electronics, Inc.,
`IPR2013-00152 (P.T.A.B. 2013) ..................................................................... 40
`
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`IPR2015-01778
`Patent No. 8,603,506
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` Patent Owner Docket No.: 105153-0104
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`EXHIBITS
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`Exhibit No.
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`Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
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`2011
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`Executed Affidavit in Support of Pro Hac Vice Motion for Evan
`Diamond (IPR2015-01778)
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`Biography of Evan Diamond (IPR2015-01778)
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`ORACEA® Label, rev. 2013
`
`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)
`
`Notice of Paragraph IV Certification from Petitioner in support of its
`New Drug Application No. 208286 with respect to doxycycline 40
`mg capsules
`
`Diane M. Thiboutot, Acne Rosacea, 50(8) AMERICAN FAMILY
`PHYSICIAN 1691 (1994)
`
`Robert J. Signore, A Pilot Study of 5 Percent Permethrin Cream
`Versus 0.75 Percent Metronidazole Gel in Acne Rosacea, 56(3)
`CUTIS 177 (1995)
`
`Mehmet Ali Gürer at el., The Seroprevalance of Heliobacter Pylori
`and Nitric Oxide in Acne Rosacea, 41 INT’L J. OF DERMATOL. 768
`(2002)
`
`M.A. McAleer et al., The Pathophysiology of Rosacea, 144(6) G.
`ITAL. DERMATOL. VENEREOL. 663 (2009)
`
`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)
`
`Melody J. Cheung et al., Acneiform Facial Eruptions: A Problem for
`Young Women, 51(4) CANADIAN FAMILY PHYSICIAN 527 (2005)
`
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` Patent Owner Docket No.: 105153-0104
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`2012
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`2013
`
`2014
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`
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`Mark V. Dahl, Pathogenesis of Rosacea, in 17 ADVANCES IN
`DERMATOLOGY 29 (William D. James ed., 2001)
`
`U.S. Patent Application Publication No. 2004/0147492, based on
`U.S. Serial No. 10/757,656
`
`U.S. Serial Number 11/876,478—Amendment and Reply mailed on
`August 10, 2009 in response to the Office Action issued on February
`5, 2009
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`IPR2015-01778
`Patent No. 8,603,506
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`I.
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`INTRODUCTION
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` Patent Owner Docket No.: 105153-0104
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`Patent Owner submits this preliminary response under 35 U.S.C. § 313 to
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`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.’s (referred to
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`collectively at “Petitioner”) request for inter partes review (“IPR”) of claims 1, 7,
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`8, 14, 15, and 20 of U.S. Patent No. 8,603,506 (“the ’506 Patent,” Ex. 1001). This
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`preliminary response is timely filed within three months of the Board’s notice
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`(IPR2015-01778, Paper No. 4), mailed August 27, 2015, indicating that the
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`petition was accorded a filing date. For the reasons set forth herein and in the
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`accompanying exhibits, Petitioner’s request for IPR should be denied.
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`The challenged claims of the ’506 Patent cover methods for treating papules
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`and pustules of the facial skin condition rosacea using the drug doxycycline in a 40
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`mg daily dose with no reduction of skin microflora over a six month treatment
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`period. These claims cover Patent Owner’s product ORACEA®, which was first
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`approved by the United States Food and Drug Administration (“FDA”) in 2008
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`and is indicated for “the treatment of inflammatory lesions (papules and pustules)
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`of rosacea.” Ex. 2003 at 1. ORACEA® remains the first and only FDA approved,
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`orally administered, systemically delivered drug to treat rosacea, with reduced side
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`effects compared to prior treatments. See Research Found. of State Univ. v. Mylan
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`Pharms., Inc., 809 F. Supp. 2d. 296, 300, ¶ 27 (D. Del. 2011); see also Ex. 2003 at
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`1, “Dosing and Administration” section. Based on public allegations by Petitioner,
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`the ’506 Patent claims also appear to cover a 40 mg doxycycline product that
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` Patent Owner Docket No.: 105153-0104
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`Petitioner has stated it intends to market under the tradename ZENAVOD®. Ex.
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`2010 at 15.
`
`At its core, Petitioner’s arguments do not relate to anticipation or
`
`obviousness per se, but constitute a written description challenge under 35 U.S.C.
`
`§ 112. To the extent the Board chooses to consider this argument, Petitioner has
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`failed to meet its burden to establish that any of the documents comprising its
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`Grounds—each published in 2007—are prior art to the ’506 Patent, which is
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`entitled to a priority date at least as early as its non-provisional application filed
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`April 5, 2002, if not earlier. As understood by a person of ordinary skill in the art
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`(“POSA”), the April 5, 2002 application disclosed every element of what is
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`claimed (including both descriptively and with clinical evidence): use of
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`doxycycline—including 40 mg—as an effective treatment for acne, including acne
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`rosacea (i.e., rosacea), and in particular, for treating inflammatory papules and
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`pustules with no reduction in skin microflora over a six-month treatment, and
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`without a bisphosphonate. Ex. 1001 at 4:24-43, 19:39-20:36. There is no question
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`that the specification of the ’506 Patent describes rosacea as one of the conditions
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`to be treated (Petition at 22) or that the specification provides an actual example of
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`treating inflammatory papules and pustules using the claimed invention, to achieve
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`the claimed results (Petition at 23, 47).
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`IPR2015-01778
`Patent No. 8,603,506
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`While Petitioner attempts to phrase its Grounds in terms of anticipation or
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` Patent Owner Docket No.: 105153-0104
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`obviousness allegations regarding purported “prior art” (e.g., Petition at 7), that is
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`just a fig leaf to cover its true allegations – a pure section 112 challenge that should
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`not be considered by the Board. Notably, Petitioner admits its central allegation to
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`be that “[t]he challenged claims of the ’506 Patent find no written description
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`support in the specification of the ’506 Patent . . .” See Petition at 7.
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`As will be explained herein, this is not a case where alleged “new matter” in
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`the specification of the ’506 Patent creates an opening for some intervening prior
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`art – and Petitioner admits as much. See Petition at 7 (“Petitioner is not arguing
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`that the claims are invalid because they constitute new matter and/or violate 35
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`U.S.C. §§ 112 and 132, per se.”). Nor is this a case where Petitioner asserts that
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`the application from which the ’506 Patent issued adequately described the claimed
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`invention, but its earlier priority applications did not. To the contrary, the
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`specification of the ’506 Patent (and the application from which it issued) is
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`identical to at least its April 5, 2002 non-provisional priority application, filed
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`many years before publication of the purported “prior art” of Petitioner’s various
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`Grounds. Petitioner should not be allowed to assert what is transparently a
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`challenge to the written description support of the challenged patent itself, rather
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`than a challenge to the support of an earlier priority application. If such challenges
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`were permitted, it would vitiate the intended statutory distinction between the
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`IPR2015-01778
`Patent No. 8,603,506
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`limited scope of IPRs and the broader scope of proceedings such as Post-Grant
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` Patent Owner Docket No.: 105153-0104
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`Reviews under 35 U.S.C. § 321.
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`II. 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 (now U.S. Patent No.
`
`8,052,983, Ex. 1036); which is a continuation of U.S. Application No. 10/757,656
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`(now abandoned); which is a division of U.S. Patent Application No. 10/117,705
`
`(now U.S. Patent No. 7,211,267, Ex. 1016); which claims priority to U.S.
`
`Provisional Application Nos. 60/325,489 (Ex. 1003), filed September 26, 2001,
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`and 60/281,916 (Ex. 1002), filed April 5, 2001.
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`Independent claim 1 of the ’506 Patent 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 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.
`
`Similarly, independent 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
`
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`IPR2015-01778
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`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.
`
`As the specification of the ’506 Patent explains, “there is a need for an
`
`effective treatment of acne which causes fewer undesirable side effects produced
`
`by the systemically-administered antibiotics used in conventional acne therapy.”
`
`Ex. 1001 at 3:37-41. The specification of the ’506 patent demonstrates that the
`
`claimed methods fulfilled this need in the art.
`
`The specification likewise contains a working example of treating papules
`
`and pustules with doxycycline in the claimed dosing ranges for a six month time
`
`period with no reduction in skin microflora and without co-administration of a
`
`bisphosphonate compound, precisely as claimed. Ex. 1001 at 19:39-20:36.
`
`III. PERSON OF ORDINARY SKILL IN THE ART
`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 treating
`
`patients in a hospital, clinic, and/or private setting.” Petition at 36; Ex. 1004 at ¶ 4.
`
`Patent Owner does not fully agree with Petitioner’s determination, but will adopt
`
`Petitioner’s description for purposes of this Preliminary Response.
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`
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`IPR2015-01778
`Patent No. 8,603,506
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`IV. CLAIM CONSTRUCTION
`A. Legal Standard
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` Patent Owner Docket No.: 105153-0104
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`A claim in inter partes review is given its “broadest reasonable construction
`
`in light of the specification.” See 37 C.F.R. § 42.100(b); Office Patent Trial
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`Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012). See In re Cuozzo
`
`Speed Techs., 778 F.3d 1271, 1282 (Fed. Cir. 2015) (holding that broadest
`
`reasonable interpretation standard “was properly adopted by PTO regulation” for
`
`IPR proceedings). Claim terms are generally given their ordinary and customary
`
`meaning, as would be understood by one of ordinary skill in the art in the context
`
`of the entire disclosure. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`
`(Fed. Cir. 2007). Consistent with this standard, claim terms should be defined 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.
`
`Given the unambiguous usage of each of the following claim terms, the
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`terms should be accorded their ordinary and customary meaning. However, to the
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`extent that the Board believes construction is required, Patent Owner proposes the
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`following claim constructions for purposes of this proceeding:
`
`B.
`
`“Rosacea”
`
`The claim term “rosacea” was a well-understood term in the art and should
`
`be given its plain and ordinary meaning, as construed by the POSA at the time of
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`IPR2015-01778
`Patent No. 8,603,506
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`the invention. The language of the claims, specification, and prosecution history of
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` Patent Owner Docket No.: 105153-0104
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`the ’506 Patent confirm that the plain and ordinary meaning of the claim term
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`“rosacea” controls here. For example, in the Response filed September 19, 2012,
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`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,
`edema,
`papules,
`pustules,
`ocular
`lesions,
`and
`rhinophyma. In most cases, some rather than all of these
`stigmata appear in any given patient.
`
`Ex. 2004 at 584.
`
`The specification of the ’506 Patent also discloses that “acne,” which the
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`specification describes as including “acne rosacea” (i.e., rosacea), can include
`
`symptoms of papules and pustules, and that acne rosacea can also be characterized
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`by symptoms of erythema and telangiectasia. Ex. 1001 at 4: 23-43. The claims of
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`IPR2015-01778
`Patent No. 8,603,506
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`the ’506 Patent likewise are directed to treatment of “papules and pustules of
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` Patent Owner Docket No.: 105153-0104
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`rosacea.”
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`In the Petition, Petitioner does not clearly state what it believes the
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`construction of “rosacea” should be, or explain why any particular construction
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`apart from the plain and ordinary meaning is needed here. Instead, under the
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`heading “Claim Construction” and subheading “Rosacea,” Petitioner simply lists
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`certain statements from the specification of the ’506 Patent, without further
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`explanation, and does not discuss the prosecution history of the ’506 Patent or
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`understanding of a POSA at the relevant time as it relates to the claim term
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`“rosacea.” Petition at 30-31. Accordingly, it appears that Petitioner does not
`
`contest that “rosacea” should be construed in accordance its plain and ordinary
`
`meaning to a POSA.
`
`C.
`
`“Papules” and “Pustules”
`
`While the Petition lists the terms “papules” and “pustules” under the heading
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`“Claim Construction,” it is not apparent from the Petition exactly what Petitioner
`
`believes the proper construction of those terms to be. Petition at 31-32. Nor does
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`Petitioner explain why any particular construction apart from the plain and
`
`ordinary meaning is needed here. Id. Petitioner acknowledges that nothing in the
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`specification of the ’506 Patent provides that the terms “papules” and “pustules”
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`IPR2015-01778
`Patent No. 8,603,506
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`should be construed differently than their plain and ordinary meaning. See Petition
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` Patent Owner Docket No.: 105153-0104
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`at 31-32.
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`Petitioner also acknowledges that the prosecution history included
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`descriptions from the applicant of the terms “papules” and “pustules” consistent
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`with their understanding in the art. See id. And, as Petitioner admits, “[p]apules
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`and pustules are extremely common to both common acne (acne vulgaris) and
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`rosacea (as well as other skin disorders), and . . . the resulting papules and pustules
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`in both diseases share common underlying properties . . . .” See Petition at 32.
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`Accordingly, the terms papules and pustules should be given their plain and
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`customary meanings.
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`V.
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`STANDARD OF REVIEW FOR INSTITUTION
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`The Board may not grant a petition for IPR unless the Board “determines
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`that the information presented in the petition filed under section 311 and any
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`response filed under section 313 shows that there is a reasonable likelihood that the
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`petitioner would prevail.” 35 U.S.C. § 314(a).
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`Importantly, section 314(a) requires the Board’s determination to be based
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`on “information presented in the petition.” Likewise, the petitioner has a statutory
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`obligation under section 312(a)(3) to identify “with particularity, each claim
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`challenged, the grounds on which the challenge to each claim is based, and the
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`evidence that supports the grounds for the challenge to each claim.” Thus, it is not
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` Patent Owner Docket No.: 105153-0104
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`for the Board to fill in gaps omitted by the Petitioner.
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`Equally important is section 314(a)’s requirement that the Board’s
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`determination take into account “information presented in . . . any response filed
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`under section 313.” (emphasis added) In other words, the Board’s determination
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`must be based on the totality of the written evidence presented at the pre-trial
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`stage.
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`Ultimately, the focus of the inquiry under section 314(a) is whether the
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`petitioner “would prevail”—i.e., win on the merits based exclusively on the
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`“information presented in the petition . . . and any response.” Likewise, it is
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`Petitioner’s burden to establish that the cited references are eligible as prior art
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`under 35 U.S.C. § 311(b). 35 U.S.C. § 316(e); Mahurkar v. C.R. Bard, Inc., 79
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`F.3d 1572, 1576 (Fed. Cir. 1996); Hughes Network Systems, LLC v. California
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`Institute of Technology, IPR2015-00067, Paper 18 at 11 (P.T.A.B. 2015).
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`VI. PETITION FAILS TO DEMONSTRATE A REASONABLE
`LIKELIHOOD OF SUCCESS
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`All four grounds of unpatentability raised in the Petition are predicated on an
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`unsustainable allegation that the ’506 Patent claims are not entitled to a priority
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`date earlier than its actual filing date of October 20, 2011. The Petition alleges:
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`[E]ach of these grounds depends upon a determination of the earliest
`effective date to be accorded to the various challenged claims.
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`Specifically none of the claims of the ’506 Patent is entitled to a date
`earlier than the actual filing date of October 20, 2011.
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`Petition at 4.
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`Although a concern over lack of written description was never raised by the
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`Office during prosecution of the ’506 Patent, Petitioner maintains that the claims of
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`the ’506 Patent are not adequately described in any of its four priority applications:
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`parent application serial no. 11/876,478 filed October 22, 2007, now U.S. Patent
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`8,052,983 (the “’983 Patent,” Ex. 1036); great grandparent application serial no.
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`10/117,709 filed April 5, 2002, now U.S. Patent 7,211,267 (the “’267 Patent,” Ex.
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`1016); as well as the second provisional application serial no. 60/325,489 (the
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`“’489 Provisional,” Ex. 1003) filed September 26, 2001 and the first provisional
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`application serial no. 60/281,916 (the “’916 Provisional,” Ex. 1001) filed April 5,
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`2001. See Ex. 1001 1. The relationship of the priority applications (collectively,
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`“Priority Documents”) is graphically illustrated below:
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`As is detailed more thoroughly in Section VII below, all of the language in
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`the specifications leading to the ’506 Patent finds verbatim support in each of the
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`applications in the continuous priority chain leading back to Ser. No. 10/117,709
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`filed on April 5, 2002, if not earlier. For convenience, the entire continuous chain
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`of co-pending applications that includes Ser. Nos. 13/277,789, 11/876,478,
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` Patent Owner Docket No.: 105153-0104
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`10/757,656, and 10/117,709 is hereafter referenced as “the Application Group
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`Leading to the ’506 Patent.” As shown below, the claims of the ’506 Patent find
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`adequate support in the Application Group Leading to the ’506 Patent and
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`therefore enjoy a filing date at least as early as April 5, 2002. 1 Therefore, all of the
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`grounds of unpatentability in the Petition must fail because each prior art document
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`in the petition was published after this filing date.
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`Moreover, Petitioner’s written description arguments are not only fatally
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`flawed, they are also disingenuous. Petitioner dismisses the relevance of clinical
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`data reported in the specification of the Application Group Leading to the ’506
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`Patent because it describes treatment of inflammatory papules and pustules in acne
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`vulgaris, rather than such papules and pustules in rosacea. See Petition at 22-23;
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`Ex. 1001 at 19:39-20:36. But Petitioner’s stance here runs directly contrary to
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`Petitioner’s assertions made elsewhere—but withheld from the Board in its
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`Petition—that “the prior art, and the disclosure of the ’506 Patent itself, makes
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` 1
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` While Patent Owner can further establish priority to provisional applications
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`filed in 2001, for purposes of this Preliminary Response, it is sufficient to establish
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`a priority date of at least April 5, 2002, as none of the alleged prior art in
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`Petitioner’s four grounds was published earlier than this date.
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`the correlation between acne and rosacea indisputable,” and that “the prior art is
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` Patent Owner Docket No.: 105153-0104
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`replete with statements made concerning the similarities accompanying acne and
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`the inflammation accompanying rosacea.” Ex. 2005 at 34. Petitioner’s
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`contradictory statements lack due candor to the Board and demonstrate Petitioner’s
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`failure to consider the perspective of a POSA at the time of filing or “the content of
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`the prior art” in its analysis. See Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.,
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`598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).
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`Petitioner also lacks credibility when it asserts that a POSA would not have
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`equated the treatment of inflammatory papules and pustules of acne vulgaris with
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`the treatment of inflammatory papules and pustules of rosacea, while in two other
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`co-pending petitions (IPR2015-01777 and -01782), Petitioner argues for alleged
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`obviousness of the claims of the ’506 Patent in view of prior art related to the use
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`of dox