`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`
`
`Patent No. 9,358,240
`Issue Date: June 7, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
`
`Inter Partes Review No. 2017-01621
`____________________________________________________________
`
`SUPPLEMENTAL PATENT OWNER RESPONSE
`
`
`
`
`
`4848-4562-2378
`
`

`

`IPR2017-01621
`
`Supplemental Patent Owner Response
`
`
`
`
`
`TABLE OF CONTENTS
`
`
`
`I.
`
`II.
`
`III.
`
`INTRODUCTION ........................................................................................... 1
`
`SUMMARY OF ARGUMENT ....................................................................... 2
`
`PETITIONER HAS NOT ESTABLISHED THAT VOSWINCKEL,
`GHOFRANI, THE OPTINEB-IR MANUAL, OR THE EU
`COMMUNITY REGISTER ARE PRIOR ART ............................................. 2
`
`A.
`
`B.
`
`The OptiNeb-ir Manual was not publicly accessible. ........................... 3
`
`The EU Community Register was not publicly accessible. .................. 8
`
`IV. PETITIONER HAS NOT ESTABLISHED OBVIOUSNESS OVER
`GROUND 2 OR GROUND 3. ........................................................................ 9
`
`A. Ground 2 .............................................................................................. 10
`
`1.
`
`2.
`
`A POSA would not have been motivated to combine
`Voswinckel and the OptiNeb-ir Manual to achieve
`limitation [D]. ............................................................................ 10
`
`A POSA would not have been motivated to combine
`Voswinckel, the OptiNeb-ir Manual, and Patton to
`achieve limitations [B] or [C]. .................................................. 14
`
`B.
`
`Ground 3 .............................................................................................. 17
`
`1.
`
`2.
`
`A POSA would not have been motivated to combine
`Voswinckel and the EU Community Register to achieve
`limitations [B1] or [C]. ............................................................. 17
`
`A POSA would not have had a reasonable expectation of
`success in combining the EU Community Register and
`Ghofrani regarding limitation [D]. ............................................ 20
`
`C.
`
`Dr. Donovan’s testimony lacks credibility and relies on
`information outside the record. ........................................................... 21
`i
`
`4848-4562-2378
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`D.
`
`The objective indicia of non-obviousness weigh in favor of
`patentability. ........................................................................................ 23
`
`V.
`
`CONCLUSION .............................................................................................. 23
`
`
`
`
`
`
`
`4848-4562-2378
`
`ii
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Adobe Systems Inc v. William Grecia, IPR2018-00418 (PTAB June 21, 2018) ....... 8
`
`Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331 (Fed. Cir. 2016) .................3, 6
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375 (Fed. Cir. 2015) 2
`
`In re Cronyn, 890 F.2d 1158 (Fed. Cir. 1989) ........................................................... 6
`
`In re Lister, 583 F.3d 1307 (Fed. Cir. 2009) ............................................................. 3
`
`SAS Institute Inc. v. Iancu, 584 U.S. ___ (2018) ....................................................... 1
`
`Zetec, Inc. v. Westinghouse Elec. Co., IPR2014-00384 (PTAB July 23, 2014)11, 18
`
`STATUTES
`
`37 C.F.R. § 42.108 ................................................................................................... 10
`
`37 C.F.R. § 42.63(b) .................................................................................................. 5
`
`
`
`
`
`4848-4562-2378
`
`
`
`iii
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`Exhibit No.
`2001
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`2013
`
`2014
`
`2015
`2016
`2017
`
`EXHIBIT LIST
`
`Description
`Declaration of Dr. Richard Dalby
`Oxford Dictionary of English. 2nd ed. Revised. Oxford University
`Press, 2005 (excerpt).
`Newman, Stephen P. Respiratory drug delivery: essential theory and
`practice. Respiratory Drug Delivery Online, 2009 (excerpt).
`Hill, N., Therapeutic Options for the Treatment of Pulmonary
`Hypertension, Medscape Pulmonary Medicine 9(2) (2005).
`Exhibits Accompanying First Declaration of Dr. Roham Zamanian
`and Amendment and Reply filed in 12/591,200 (Nov. 9, 2015) (Ex.
`1162)
`Declaration of Dr. Edmund Elder and Exhibits Accompanying
`Second Declaration of Dr. Roham Zamanian Amendment and Reply
`filed in 12/591,200 (Feb. 2, 2016) (Ex. 1163)
`Finlay, Warren H. The Mechanics of Inhaled Pharmaceutical
`Aerosols: an Introduction. Academic Press, 2002 (excerpt).
`“Mechanical Ventilation.” American Journal of Respiratory and
`Critical Care Medicine 196(2):P3-4 (2017).
`Motion for Leave to File An Amended Complaint and Exhibits Filed
`in Civil Action No: 3:15-cv-05723 PGS-LHG
`Email Correspondence to Watson’s Counsel Serving Motion for
`Leave to File An Amended Complaint and attached Exhibits (Ex.
`2009).
`Consent Order Entering Motion for Leave to File An Amended
`Complaint in Civil Action No: 3:15-cv-05723 PGS-LHG
`Orange Book Listing for Tyvaso® (Accessed October 3, 2017)
`First Notice Letter Sent June 12, 2015 by Watson Regarding Orange
`Book Listed Tyvaso® Patents
`Issue Notifications for US Patent No. 9,399,507 and US Patent No.
`9,358,240
`FDA Form 3542, Listing US Patent No. 9,399,507 in Orange Book
`FDA Form 3542, Listing US Patent No. 9,358,240 in Orange Book
`Email Correspondence between United Therapeutics and Watson
`Regarding Proposed Schedule for Civil Action No: 3:15-cv-05723
`PGS-LHG in view of US Patent No. 9,399,507 and US Patent No.
`9,358,240
`
`4848-4562-2378
`
`iv
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`2018
`
`2019
`
`2020
`2021
`2022
`2023
`2024
`
`2025
`
`2026
`2027
`2028
`2029
`
`2030
`
`2031
`
`2032
`2033
`2034
`2035
`2036
`
`2037
`
`2038
`2039
`2040
`2041
`2042
`2043
`
`Second Notice Letter Sent June 29, 2016 by Watson Regarding
`Orange Book Listed Tyvaso® Patents
`Docket Navigator Summary Statistics on Unopposed Motions for
`Magistrate Judge Lois H. Goodman
`Declaration of Dr. Werner Seeger
`Bourge et al., Cardiovascular Therapeutics 31:38-44 (2013)
`Curriculum vitae of Dr. Richard Dalby
`Curriculum vitae of Dr. Lewis Rubin
`2002 Press Release Regarding Promotion of Robert Roscigno
`(accessed October 10, 2017)
`Shield Therapeutics Biography for Carl Sterritt (accessed October
`10, 2017)
`Declaration of Dr. Hossein A. Ghofrani
`Declaration of Dr. Frank Reichenberger
`Declaration of Dr. Freidrich Grimminger
`Excerpts from Deposition of Dr. Maureen Donovan in Civil Action
`No: 3:15-cv-05723 PGS-LHG
`Email Correspondence with Orange Book Staff Confirming Date of
`Listing for US Patent No. 9,399,507 and US Patent No. 9,358,240
`Email Correspondence with USTPO regarding Petitioner’s Request
`to File a Reply
`Feb. 23, 2018 Conference Call Transcript
`Transcript from March 28, 2018 Deposition of Dr. Scott Bennett
`Transcript from April 4, 2018 Deposition of Dr. Maureen Donovan
`Transcript from April 6, 2018 Deposition of Dr. DeForest McDuff
`Email Correspondence with Petitioner regarding Deposition of
`Christopher Butler
`Listing of Issues and Supplements of Circulation Accessible on
`Circulation Website (accessed April 17, 2018)
`Second Declaration of Dr. Richard Dalby
`US 4,319,155 (“Nakai”)
`Declaration of Dr. Aaron Waxman
`Curriculum vitae of Dr. Aaron Waxman
`Mosby’s Medical Dictionary. 7th ed. Mosby Elsevier, 2006 (excerpt).
`Leung, K, Louca E., & Coates, A. “Comparison of Breath-Enhanced
`to Breath-Actuated Nebulizers for Rate, Consistency, and
`Efficiency,” Chest, 126(5):1619-1627 (2004)
`
`4848-4562-2378
`
`v
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`2044
`
`2045
`
`2046
`2047
`
`2048
`2049
`2050
`
`2051
`
`2052
`2053
`2054
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`2061
`
`2062
`
`2063
`2064
`2065
`2066
`
`Rau, J.L., “Design Principles of Liquid Nebulization Devices
`Currently in Use,” Respir. Care, 47(11):1257-1275 (2002)
`Atkins, P.J. & T.M. Crowder. “The Design and Development of
`Inhalation Drug Delivery Systems,” Pharmaceutical Inhalation
`Aerosol Technology, 2nd Ed. (A.J. Hichey ed., CRC Press), Ch. 9
`(2003)
`Ventavis® Patient Brochure
`Rau, J.L. Respiratory Care Pharmacology. 6th Ed. Mosby, 2002
`(excerpt)
`Declaration of Dr. Robert Roscigno
`Excerpts from Tyvaso® NDA Integrated Summary of Efficacy (ISE)
`Clinical Investigation Report Synopsis for LungRx Study No: LRX-
`TRE-INH-0004
`Clinical Investigation Report Synopsis for LungRx Study No: LRX-
`TRE-INH-0007
`Letter from FDA confirming IND filing
`Declaration of Dr. Jeffrey Stec
`Curriculum vitae and Record of Prior Testimony of Dr. Jeffrey Stec
`Tyvaso® (treprostinil) An Inhaled Prostacyclin Analogue, Internal
`Presentation
`Classes of Heart Failure, American Heart Association (accessed
`April 19, 2017)
`FDA Approves TYVASO (Treprostinil) Inhalation Solution for the
`Treatment of Pulmonary Arterial Hypertension, July 30, 2009
`2014 Fourth-Quarter and Annual Financial Results, Investor
`Conference Call Q&A
`Voswinckel, R., et al., “Favorable Effects of Inhaled Treprostinil in
`Severe Pulmonary Hypertension: Results from Randomized
`Controlled Pilot Studies,” JACC, 48(6): 1672-1681(2006)
`Tyvaso®: Just Prescribed (accessed April 5, 2018)
`The World's Biggest Public Companies – United Therapeutics,
`Forbes (accessed April 26, 2018)
`America’s Best Small Public Companies, Forbes (accessed April 26,
`2018)
`Fastest-Growing Companies, Fortune (accessed April 26, 2018)
`United Therapeutics Corp., Morningstar (accessed March 29, 2017)
`Tyvaso 2014 Brand Plan, Internal
`2013 Marketing Plan, Internal
`
`4848-4562-2378
`
`vi
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`2067
`2068
`
`2069
`
`2070
`
`2071
`2072
`
`2073
`
`2074
`
`2075
`
`2076
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`2082
`2083
`
`2084
`
`2085
`2086
`
`Tyvaso Marketing Overview, August 19, 2015, Internal
`Pulmonary Arterial Hypertension (PAH) Therapeutics – Global Drug
`Forecasts and Treatment Analysis to 2020, Internal
`Frumkin L.R., “The Pharmacological Treatment of Pulmonary
`Arterial Hypertension” Pharmacol. Rev. 64:583-620 (2012)
`Khaybullina D., et al., “Riociguat (Adempas): a Novel Agent For the
`Treatment of Pulmonary Arterial Hypertension and Chronic
`Thromboembolic Pulmonary Hypertension,” Pharmacy and
`Therapeutics. 39(11):749-758.
`Project Clock Discussion Materials, February 3, 2016, Internal
`Actelion Delivers Outstanding 2014 Results, Actelion website
`(accessed April 26, 2018)
`Bloomberg L.P. WACC Report for UTHR (accessed March 14,
`2017)
`Pulmonary Arterial Hypertension Market Surveillance ATU: Wave 5
`(Q2 ’15) – Final Report, Fielded July 2015, Internal
`2014 Fourth-Quarter and Annual Financial Results, Investor
`Conference Call Q&A, Internal
`Second Declaration of Ms. Pilar Wyman
`Gagnon, M-A & Lexchin, J. “The Cost of Pushing Pills: A New
`Estimate of Pharmaceutical Promotion Expenditures in the United
`States,” PLoS Medicine. 5(1):epub (2008).
`McDuff R.D. et al., “Thinking Economically about Commercial
`Success.” Landslide Magazine 9(4) (2017)
`David, J. & Stewart M.B. “Commercial Success: Economic
`Principles Applied to Patent Litigation.” Leonard G.K. & Stiroh
`L.J.(Ed.) Economic Approaches to Intellectual Property: Policy,
`Litigation, and Management. New York: National Economic
`Research Associates Inc. 196-207 (2005)
`Grabowski H. & Vernon J. “The Distribution of Sales Revenue from
`Pharmaceutical Innovation,” Pharmacoeconomics, 18 Suppl.1 (2000)
`US 8,410,121 (“the ’121 patent”)
`US 9,550, 716 (“the ’716 patent”)
`TRIUMPH I Phase II Clinical Trial Protocol, created by January 11,
`2005
`ClinicalTrials.gov entry for TRIUMPH trial, NCT00147199
`(accessed April 20, 2018)
`Declaration of Dean Bunce
`February 17, 2010 Withdrawal Letter
`vii
`
`4848-4562-2378
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`2087
`2088
`2089
`2090
`
`2091
`
`2092
`2093
`2094
`2095
`
`2096
`2097
`
`2098
`2099
`2100
`2101
`
`2102
`
`2103
`
`2104
`2105
`2106
`2107
`2108
`2109
`2110
`
`2111
`
`2112
`
`United Therapeutics Corporation 2017 10-K
`2012 Tyvaso Brand Plan, Internal
`Tyvaso Marketing Plan, December 2010, Internal
`GlobalData Advanced Export - Pulmonary Arterial Hypertension,
`April 2017
`St. Louis Federal Reserve, Consumer Price Index,
`https://fred.stlouisfed.org/series/CPIAUCSL (accessed April 5, 2017)
`Email from British Library regarding Voswinckel
`Declaration of Ms. Pilar Wyman
`Curriculum vitae of Pilar Wyman
`McLaughlin V.V. et al., “Addition of Inhaled Treprostinil to Oral
`Therapy for Pulmonary Arterial Hypertension: A Randomized
`Controlled Clinical Trial,” JACC, 18:1915-1922 (2010) (with
`appendix)
`Author & Subject Index for Circulation Supplement 17 (2004)
`Declaration of Dr. Werner Seeger Accompanying Amendment and
`Reply filed in 13/469,854 dated August 20, 2015
`Second Declaration of Dr. Werner Seeger
`Second Declaration of Dr. Hossein A. Ghofrani
`U.S. Application No. 60/800,016
`Services Agreement between Dr. Werner Seeger and LungRx dated
`Sept.23, 2003
`LungRx TRIUMPH Executive Committee Meeting Agenda dated
`October 22, 2003
`German language version of Ex. 1005 (also provided as Attachment
`2d to Ex. 1013)
`Bloomberg L.P. WACC Report for UTHR, 2003
`Second Declaration of Dr. Aaron Waxman
`Declaration of Mr. Aaron Trippe
`Curriculum vitae of Aaron Trippe
`Transcript from May 24, 2018 Deposition of Dr. Maureen Donovan
`British Library Catalog Entry for Circulation (accessed July 6, 2018)
`British Library Catalog Search Results for “Cardiology” (accessed
`July 3, 2018)
`British Library Catalog Search Results for “Cardiovascular system”
`(accessed July 3, 2018)
`British Library Catalog Search Results for Dewey 616.1 (accessed
`July 3, 2018)
`
`4848-4562-2378
`
`viii
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`2113
`
`2114
`
`2115
`
`2116
`
`2117
`2118
`
`2119
`
`2120
`
`2121
`
`2122
`
`2123
`
`2124
`
`2125
`
`Merck Manual – Professional Version – Evaluation of the Pulmonary
`Patient (accessed July 6, 2018)
`FDA Ventavis Label under Action Date 12/29/2004 (accessed July 2,
`2018)
`FDA Ventavis Label under Action Date 8/24/2005 (accessed July 2,
`2018)
`Williamson, A.A., “Period or Comma? Decimal Styles over Time
`and Place,” Science Editor 31(2):42-43 (2008)
`Additional Excerpts from Deposition of Dr. Maureen Donovan in
`Civil Action No: 3:15-cv-05723 PGS-LHG
`“The Internet Archive Turns 20: A Behind The Scenes Look At
`Archiving The Web,” retrieved from
`https://www.forbes.com/sites/kalevleetaru/2016/01/18/the-internet-
`archive-turns-20-a-behind-the-scenes-look-at-archiving-the-
`web/#1a67d0fc82e0, accessed on June 19, 2018
`The webpage “Alexa Crawls,” retrieved from
`https://archive.org/details/alexacrawls, accessed on June 19, 2018
`“About this capture” information for the .pdf located at
`https://web.archive.org/web/20040718112852/http://www.nebu-
`tec.de:80/PDF/GA_B_de.pdf
`The webpage at
`https://web.archive.org/web/20130801000000*/http://ec.europa.eu/he
`alth/documents/community-register/
`The webpage at
`https://web.archive.org/web/20131012140925/http://ec.europa.eu/hea
`lth/documents/community-register/
`The webpage at
`https://web.archive.org/web/20100815000000*/http://ec.europa.eu/he
`alth/documents/community-register/html/h255.htm
`The webpage at
`https://web.archive.org/web/20100818181435/http://ec.europa.eu/hea
`lth/documents/community-register/html/h255.htm
`The popup window resulting from the selection of the “EN” option in
`the “summary publ” menu of
`https://web.archive.org/web/20100818181435/http://ec.europa.eu/hea
`lth/documents/community-register/html/h255.htm for procedure
`listed as having a “close date procedure” of 8/09/2005
`
`4848-4562-2378
`
`ix
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`2126
`
`2127
`
`2128
`
`2129
`
`2130
`
`2131
`
`2132
`
`2133
`
`2134
`
`2135
`
`The Wayback Machine results for the webpage at popup window
`resulting from the selection of the “EN” option in the “summary
`publ” menu (EX. 2125)
`The popup window resulting from the selection of the “EN” option in
`the “decision docs” menu and “annex” menu of
`https://web.archive.org/web/20100818181435/http://ec.europa.eu/hea
`lth/documents/community-register/html/h255.htm for procedure
`listed as having a “close date procedure” of 8/09/2005
`The webpage at
`https://web.archive.org/web/*/http://ec.europa.eu/health/documents/c
`ommunity-register/2005/2005090510259/*
`The webpage at http://ec.europa.eu/health/documents/community-
`register/html/h255.htm as accessed on June 29, 2018
`The new tab resulting from the selection of the “ENG” option in the
`“decision docs” menu and “annex” menu of
`http://ec.europa.eu/health/documents/community-
`register/html/h255.htm for procedure listed as having a “close date
`procedure” of 8/09/2005
`The new tab resulting from the selection of the “ENG” option in the
`“summary publ” menu of
`http://ec.europa.eu/health/documents/community-
`register/html/h255.htm for procedure listed as having a “close date
`procedure” of 8/09/2005
`The Wayback Machine results for the webpage at the new tab
`resulting from the selection of the “ENG” option in the “summary
`publ” menu of http://ec.europa.eu/health/documents/community-
`register/html/h255.htm for procedure listed as having a “close date
`procedure” of 8/09/2005
`The webpage available at
`https://web.archive.org/web/20140115000000*/https://ec.europa.eu/t
`ransparency/regdoc/index.cfm?fuseaction=home
`The webpage available at
`https://web.archive.org/web/20140101160453/http://ec.europa.eu/tra
`nsparency/regdoc/index.cfm?fuseaction=home
`The webpage available at
`https://web.archive.org/web/20060513232957/http://ec.europa.eu/
`(dated May 13, 2006)
`
`4848-4562-2378
`
`x
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`2136
`
`2137
`
`2138
`
`2139
`
`2140
`
`2141
`
`2142
`
`2143
`
`2144
`
`2145
`
`2146
`
`The webpage available at
`https://web.archive.org/web/20060514064044/https://ec.europa.eu/in
`dex_en.htm (dated May 14, 2006)
`The webpage available at
`https://web.archive.org/web/20060613114419/http://europa.eu:80/do
`cuments/comm/index_en.htm (dated June 13, 2006)
`The webpage available at
`https://web.archive.org/web/20060615094022/http://ec.europa.eu:80/
`comm/secretariat_general/regdoc/registre.cfm (dated June 15, 2006)
`The webpage available at
`https://web.archive.org/web/20060920111254/http://ec.europa.eu/co
`mm/secretariat_general/regdoc/registre.cfm?CL=en (dated
`September 20, 2006)
`The webpage located at
`https://web.archive.org/web/20060615002523/http://ec.europa.eu/co
`mm/secretariat_general/regdoc/recherche.cfm?CL=en
`The webpage located at
`https://web.archive.org/web/20060615002523/http://ec.europa.eu:80/
`comm/secretariat_general/regdoc/liste.cfm?CL=en resulting from a
`search for “ventavis”
`The webpage located at
`https://web.archive.org/web/*/http://ec.europa.eu:80/comm/secretaria
`t_general/regdoc/*
`The .pdf located at
`https://web.archive.org/web/20060920103705/http://ec.europa.eu/co
`mm/secretariat_general/regdoc/rep/2/2006/EN/2-2006-737-EN-1-
`0.Pdf
`The webpage located at
`https://web.archive.org/web/20060617112044/http://ec.europa.eu:80/
`comm/secretariat_general/regdoc/recherche.cfm?CL=fr
`The webpage located at
`https://web.archive.org/web/20060615002523/http://ec.europa.eu:80/
`comm/secretariat_general/regdoc/liste.cfm?CL=en
`
`The webpage located at
`https://web.archive.org/web/20060827110233/http://ec.europa.eu/co
`mm/secretariat_general/regdoc/recherche.cfm?CL=da
`
`4848-4562-2378
`
`xi
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`2147
`
`2202
`
`2203
`2204
`2205
`2206
`2207
`2208
`2209
`2210
`
`The webpage located at
`https://web.archive.org/web/20060827112249/http://ec.europa.eu/co
`mm/secretariat_general/regdoc/recherche.cfm?CL=it
`2148-2200 RESERVED
`2201
`Claims of Abandoned U.S. Application No. 11/748,205
`Inventor Oaths filed in U.S. Application No. 12/591,200 (granted as
`the ’240 patent) and U.S. Application No. 13/469,854 (granted as the
`’507 patent)
`Dismissal of Complaint of Dr. Lewis Rubin and Motion for
`Attorney’s Fees
`Excerpts from Deposition of Dr. Lewis Rubin
`Transcript of teleconference between the parties and the Board, May
`10, 2018
`Declaration of Dean Bunce, dated May 17, 2018 (Not Filed)
`Declaration of James DiNatale, dated May 17, 2018 (Not Filed)
`Declaration of John Hess, dated May 17, 2018 (Not Filed)
`Declaration of James Michael, dated May 18, 2018 (Not Filed)
`Transcript of teleconference between the parties and the Board, June
`20, 2018
`
`
`
`
`
`4848-4562-2378
`
`xii
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`I.
`
`INTRODUCTION
`
`
`
`United Therapeutics Corporation (“UTC”) supplements its Patent Owner
`
`Response (paper 40) by addressing newly-instituted Grounds 2 and 3. The Board
`
`initially instituted trial on Ground 1 (Paper 10, “Institution Decision”), and on
`
`April 30, 2018, citing SAS Institute Inc. v. Iancu, 584 U.S. ___ (2018), instituted
`
`trial on additional Grounds 2 and 3 (Paper 42) of the Watson Laboratories, Inc.
`
`(“Petitioner”) Petition. The instituted grounds for claims 1-9 are:
`
`Ground
`1
`2
`3
`
`References
`Voswinckel, Patton, and Ghofrani
`Voswinckel, the OptiNeb-ir Manual1, and Patton
`Voswinckel, the EU Community Register2, and Ghofrani
`
`UTC relies on its POR for Ground 1 and the overlap with the newly instituted
`
`grounds.3,4
`
`
`1 Opti-Neb-ir® Operating Instructions, Model ON-100/2 (2005) (Ex. 1006).
`
`2 Annexes to Commission Decision C(2005)3436 of 05 September 2005: Annex III
`
`– Ventavis® Labelling and Package Leaflet (Ex. 1009).
`
`3 In a June 20, 2018 email, the panel agreed that UTC may refer back to arguments
`
`raised in the POR.
`
`4 UTC preserves its positions that instituting trial on the two additional grounds
`
`was not required, the Petition was not timely filed, and the Board improperly relied
`
`
`
`4848-4562-2378
`
`1
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`II.
`
`SUMMARY OF ARGUMENT
`
`UTC urges the Board to confirm claims 1-9 patentable over because: (i) four
`
`of the five Petitioner references do not qualify as prior art; (ii) Petitioner has failed
`
`to establish obviousness where critical claim limitations are missing from the prior
`
`art and to identify sufficient motivation to arrive at the invention; and (iii)
`
`objective indicia demonstrate nonobviousness.
`
`III. PETITIONER HAS NOT ESTABLISHED THAT VOSWINCKEL,
`GHOFRANI, THE OPTINEB-IR MANUAL, OR THE EU
`COMMUNITY REGISTER ARE PRIOR ART
`
`Petitioner bears the burden of demonstrating each of the relied-upon
`
`references qualifies as prior art. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`
`800 F.3d 1375, 1379 (Fed. Cir. 2015). As the POR shows, neither Voswinckel nor
`
`Ghofrani qualify as prior art. POR, 15-29. The second Declaration of Ms. Wyman
`
`further demonstrates that, due to inadequate indexing, Petitioner has not shown
`
`Voswinckel’s public accessibility. Ex. 2076, ¶4-6. Petitioner provides no record
`
`indicating when the supplement containing the Voswinckel abstract was
`
`catalogued, and the abstract itself within that supplement was never catalogued.
`
`The eventual cataloguing and shelving of the undifferentiated supplement was only
`
`
`on Petitioner’s Reply in its institution decision (see Paper 45 and POR, 62-63), but
`
`does not repeat its arguments in detail here.
`
`4848-4562-2378
`
`2
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`under extremely broad identifiers (“cardiology” and “cardiovascular system”). Id.;
`
`Ex. 2109.
`
`Further, Petitioner has not demonstrated that the OptiNeb-ir Manual or the
`
`EU Community Register is a printed publication. As discussed in the POR and
`
`Petitioner concedes, whether a document is a “printed publication” qualifying as
`
`prior art hinges on “public accessibility,” which is the “touchstone in determining
`
`whether a reference constitutes a printed publication.” Blue Calypso, LLC v.
`
`Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (internal quotations omitted);
`
`Pet. 9. Indexing in a “meaningful way,” together with evidence that the indexing
`
`occurred by the critical date, may be necessary before the burden shifts to UTC to
`
`prove otherwise. In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009). Petitioner
`
`does not meet its burden for the OptiNeb-ir Manual or the EU Community
`
`Register.
`
`A. The OptiNeb-ir Manual was not publicly accessible.
`Petitioner has not demonstrated public accessibility of the OptiNeb-ir
`
`Manual (Exhibit B-4 to Ex. 1014), the English translation of which is purportedly
`
`Exhibit 1006. Five critical deficiencies exist.
`
`First, no record evidence—only attorney argument in Petition footnote 6—
`
`shows the “OptiNeb-ir Manual” translated as Exhibit 1006 corresponds to Exhibit
`
`B-4. Exhibit B-4 reports a different nebulization output rate compared to the
`
`4848-4562-2378
`
`3
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`OptiNeb-ir Manual translated as Exhibit 1006. Exhibit B-4 reports a rate of “< 0,6
`
`ml/min” (the comma being the European equivalent of a decimal point (Ex. 2116)),
`
`whereas the OptiNeb-ir Manual translated as Exhibit 1006 reports “0.6 ml/min.”
`
`Excerpt from Ex. 1006, 28
`
`Excerpt from Ex. 1014, 198
`
`
`This discrepancy is critical given Dr. Donovan’s heavy reliance on the 0.6 mL/min
`
`rate in Exhibit 10065 and suggests the OptiNeb-ir Manual translated as Exhibit
`
`1006 is not a translation of Exhibit B-4 from German to English.6 See 37 C.F.R. §
`
`42.63(b).
`
`
`5 See, e.g. Ex. 1002, ¶92, 172-177 (performing calculations of the supposed
`
`“derived” teachings of Voswinckel based on the 0.6 mL rate in Exhibit 1006).
`
`6 Should Petitioner maintain that the OptiNeb Manual translated as Exhibit 1006 is
`
`a translation of Exhibit B-4, the “true and correct translation” certification is false
`
`in view of this discrepancy. Ex. 1006, 33.
`
`4848-4562-2378
`
`4
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`Second, even if Exhibit 1006 were a proper translation of Exhibit B-4,
`
`Petitioner does not provide evidence of which date, on which “crawl”, and in
`
`which frame Exhibit 1006 (or Exhibit B-4) was captured and accessible to a person
`
`of ordinary skill in the art (“POSA”). Petitioner relies on printouts of “frames” of
`
`the Nebu-Tec website taken from the Internet Archive and a declaration from
`
`Christopher Butler (Ex. 1014). Pet. 16-18. Without pointing to a specific “frame”
`
`from the website or any other evidence, Petitioner concludes without support that
`
`the OptiNeb-ir Manual was publicly accessible by June 2004. Pet. 18.
`
`In fact, the Butler Declaration confirms the date assigned by the Internet
`
`Archive applies to the HTML file, not to images or “frames” therein, which may
`
`not have been archived on the same date as the HTML file. Ex. 1014, ¶5. The
`
`Nebu-Tec website has “frames” displaying different content; thus, the date
`
`associated with the page on the Archive applies to the “frameset” but not the
`
`content within any frame. Id. at ¶5-6. Accordingly, showing that a “frame”
`
`displays certain content does not demonstrate the content was available on that
`
`date. Despite Petitioner’s assertion about accessibility (Pet. 18, FN 7), Petitioner
`
`does not demonstrate on which “crawl” on which date and in which frame Exhibit
`
`1006 was captured and accessible to a POSA.
`
`Third, Petitioner provided no evidence the OptiNeb-ir Manual was indexed,
`
`i.e., that any “frame” directed one to the OptiNeb-ir Manual. Indexing is “an
`
`4848-4562-2378
`
`5
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`important question for determining if a reference stored on a given webpage in
`
`cyberspace is publicly accessible” particularly regarding whether a POSA,
`
`exercising reasonable diligence, would have been able to locate the reference. Blue
`
`Calypso, 815 F.3d at 1349. As UTC’s expert explains, even availability of a
`
`document through a link that could cause it to be captured for the Internet Archive
`
`does not mean the link was indexed on the main page or by a search engine in the
`
`2002-2006 timeframe, allowing it to be found by a POSA. Ex. 2106, ¶4-8.
`
`Mr. Butler (who is not a POSA) does not indicate how he came upon Exhibit
`
`B-4 or how the OptiNeb-ir Manual was indexed or could be accessed by a POSA.
`
`Rather, he presents “frames” in Exhibits A-1, A-2, and A-3 and the content
`
`accessed by the corresponding frames in Exhibits B-1, B-2, and B-3. Ex. 1014, ¶6-
`
`7. An additional PDF is provided as Exhibit B-4, but the Butler Declaration does
`
`not clarify with which “frame” it is associated, or the series of links via which the
`
`PDF could be accessed. Id. at ¶6. The Petition’s unsubstantiated conclusion that
`
`the manual could be “found…by clicking on the Support page and then clicking on
`
`the OptiNeb® Instruction Guide” (Pet. 17) is attorney argument. In fact, all
`
`“printouts of the individual constituent archived” “Support” frame demonstrate no
`
`links present on that page, much less links to Exhibit B-4. Ex. 1014, 87, 179. No
`
`evidence demonstrates the OptiNeb-ir Manual was accessible as of June 2004.
`
`4848-4562-2378
`
`6
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`Fourth, Exhibit B-4 was captured by Alexa Internet and not by any software
`
`of the Internet Archive. Ex. 2106, ¶10; Ex. 2120 (showing capture by Alexa
`
`Internet for Exhibit B-4). The Butler Declaration cannot attest to its authenticity,
`
`as the “crawl” of the manual was donated by Alexa Internet and the Butler
`
`Declaration offers no explanation regarding chain of custody, operation of Alexa
`
`Internet, or any other information to support authenticity.
`
`Finally, Dr. Donovan’s reliance on the OptiNeb device is impermissibly
`
`broader than the OptiNeb Manual presented as Exhibit 1006. In her deposition
`
`during the Civil Action, Dr. Donovan acknowledged that there are several models
`
`of the OptiNeb device, each with different capabilities and functionalities. Ex.
`
`2029. And in her second deposition in this proceeding, Dr. Donovan admitted that
`
`her conclusions were not based on considering the model described in Ex. 1006 but
`
`she relied on “other information” not provided or identified by Petitioner relating
`
`to “other specifications” ostensibly available on the Nebu-Tec website as of an
`
`unspecified date and she never herself accessed the German manual or English
`
`translation. Ex. 2108, 74:22-76:3; 26:8-14.
`
`Altogether, Petitioner has not carried its burden to show the OptiNeb-ir
`
`Manual was available as a single printed publication relating to a particular
`
`nebulizer as of a certain date. See Adobe Systems, Inc. v. William Grecia,
`
`IPR2018-00418, Paper 7, 7-13 (PTAB June 21, 2018) (Petitioner failed to prove
`
`4848-4562-2378
`
`7
`
`

`

`IPR2017-01621
`
`
`
`Supplemental Patent Owner Response
`
`report on internet archive available as a printed publication through a similar
`
`Butler declaration with no evidence regarding indexing or the ability to find it).
`
`Indeed, in its exhibit listing for the OptiNeb-ir Manual, Petitioner lists the date of
`
`availability as 2005. Pet. p. v (Ex. 1006).
`
`The EU Community Register was not publicly accessible.
`
`B.
`Petitioner relies on Dr. Donovan, referring to present-day websites, to allege
`
`public accessibility of the EU Community Register. Ex. 1002, ¶99-100. The
`
`Board already confirmed this was insufficient to establish public accessibility.
`
`Institution Decision, 14-21. Dr. Donovan further confirmed that with respect to the
`
`Ventavis label: “I don’t have specific knowledge of this being available online [as
`
`of 2005].” Ex. 2108, 100:7-9; Ex. 2105, ¶21. Indeed, Dr. Donovan admitted she
`
`had not actually carried out the steps recited in her declaration nor was she able to
`
`authenticate Ex. 1009 as the document she allegedly obtained. Ex. 2108, 103:19-
`
`104:24, 108:25-109:24.
`
`Further, a review of the Internet Archive (on which Petitioner relies for prior
`
`availability) demonstrates there is no identifiable usable prior art date for the EU
`
`Community Register. UTC’s expert examined the