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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`PATENT TRIAL AND APPEAL BOARD
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`PRAXAIR DISTRIBUTION, INC. AND NOxBOX LIMITED
`Petitioner
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`v.
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`MALLINCKRODT HOSPITAL PRODUCTS IP LTD., AND INO
`THERAPEUTICS, INC. d/b/a IKARIA, INC.
`Patent Owner
`
`_____________
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,431,163
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313–1450
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`
`
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`
`
`I.
`
`II.
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
`
`Table of Contents
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`Page
`
`INTRODUCTION ........................................................................................... 1
`
`OVERVIEW .................................................................................................... 1
`
`A.
`
`B.
`
`Summary of the ‘163 Patent .................................................................. 1
`
`Summary of the Prosecution History of the ‘163 Patent ...................... 6
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ................................. 9
`
`IV. PAYMENT OF FEES (37 C.F.R. § 42.103) ................................................... 9
`
`V. MANDATORY NOTICES (37 C.F.R. § 42.8) ............................................. 10
`
`A.
`
`B.
`
`C.
`
`Real-Parties-in-Interest ........................................................................ 10
`
`Related Matters .................................................................................... 10
`
`Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4)) .................................................. 12
`
`VI. THE BOARD SHOULD INSTITUTE IPR UNDER 35 U.S.C. § 325(d) .... 13
`
`VII. PERSON OF ORDINARY SKILL IN THE ART ........................................ 20
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`VIII. CLAIM CONSTRUCTION .......................................................................... 21
`
`A.
`
`Broadest Reasonable Interpretation Standard ..................................... 21
`
`IX. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. §§ 42.22(a) and 42.104(b)) .............. 22
`
`A. Ground 1: Claims 1, 2, 4, 6, 7, 9, 11-13, 15, 18, 20, 21, 23, and 25
`are Unpatentable Under 35 U.S.C. § 103(a) as Obvious Over
`Greenough and Jaypee ........................................................................ 25
`
`1.
`
`Overview of Prior Art Applied in Ground 1 ............................. 25
`
`2. Motivation to Combine Art Applied in Ground 1 .................... 27
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`3.
`
`4.
`
`5.
`
`Independent Claims 1 and 12 .................................................... 31
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`Independent Claims 6 and 20 .................................................... 40
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`Dependent Claims 2, 4, 7, 9, 11, 13, 15, 18, 21, 23, and 25 ..... 46
`
`B.
`
`Ground 2: Claims 3, 5, 8, 10, 14, 16, 17, 19, 22, and 24 are
`Unpatentable Under 35 U.S.C. § 103(a) as Obvious Over
`Greenough, Jaypee, and Widlitz .......................................................... 49
`
`X.
`
`CONCLUSION .............................................................................................. 52
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
`
`List of Exhibits
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`Ex. 1001: U.S. Patent No. 8,431,163 (“‘163 Patent”), filed October 15, 2012,
`
`issued April 30, 2013.
`
`Ex. 1002: Declaration of Dr. Edward Lawson.
`
`Ex. 1003: Curriculum vitae of Dr. Edward Lawson.
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`Ex. 1004: Waivers of Service of Summons in Case No. 2015-cv-00170.
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`Ex. 1005: Prosecution History of U.S. Patent No. 8,431,163.
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`Ex. 1006: A. Greenough & A. D. Miller, Neonatal Respiratory Disorders 149,
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`183–87, 392 (2nd ed. 2003) (“Greenough”).
`
`Ex. 1007:
`
`Jaypee, Pediatric & Neonatal Mechanical Ventilation 148–58
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`(Praveen Khilnani ed., 1st ed. 2006) (“Jaypee”).
`
`Ex. 1008: A. Widlitz et al, Pulmonary arterial hypertension in children,
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`European Respiratory Journal, (January 2003) (“Widlitz”).
`
`Ex. 1009: Prior Art Search Results from Cardinal Intellectual Property, Inc.
`
`Ex. 1010: Center for Drug Evaluation and Research, Application Number:
`
`NDA20845,
`
`INOmax, Final Printed Labeling, available at
`
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20845_inoma
`
`x_prntlbl.pdf (August 9, 2000). (“INOmax label”).
`
`Ex. 1011: Pilbeam, Mechanical Ventilation, Special Techniques in Mechanical
`
`Ventilation, § 4: Nitric Oxide, (4th ed. 2006) (“Pilbeam”).
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`
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`Ex. 1012: M. Hoeper, et al., Definitions and Diagnosis of Pulmonary
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`Hypertension 62:25 J. of the American College of Cardiology D44
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`(2013) (“Hoeper”).
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`Ex. 1013: Royster, et al., Differences in Pulmonary Artery Wedge Pressures
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`Obtained by Balloon Inflation Versus Impaction Techniques, 61
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`Anesthesiology, 339 – 341 (1984) (“Royster”).
`
`Ex. 1014: Goyal et al., Efficacy of nitroglycerin inhalation in reducing
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`pulmonary arterial hypertension in children with congenital heart
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`disease, British Journal of Anaesthesia, 97(2): 208-14 (2006).
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`(“Goyal”).
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`Ex. 1015: Pozzoli, et al., Non-Invasive Estimation of Left Ventricular Filling
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`Pressures by Doppler Echocardiography, 3 Eur J Echocardiogr.,
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`3:75-79 (2002) (“Pozzoli”).
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`Ex. 1016: Plaintiff’s Opposition to Defendants’ Motion for Judgment on the
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`Pleadings for Counts I-V of Plaintiffs’ Complaint, Case No. 2015-cv-
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`00170, Docket No. 54.
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`Ex. 1017: December 4, 2013 Declaration of Dr. James S. Baldassarre Under 37
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`C.F.R. § 1.132 Submitted during prosecution of U.S. Patent No.
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`8,846,112.
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`Ex. 1018: Prosecution History of U.S. Patent No. 8,282,966.
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`
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
`
`Ex. 1019: Deposition Transcript for January 5, 2016 Deposition of Dr. Geoffrey
`
`L. Rosenthal in IPR2015-00529.
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`Ex. 1020: December 16, 2015 Notice of Abandonment in Application Serial No.
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`14/451,057.
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`Ex. 1021: December 1, 2015 Notice of Abandonment in Application Serial No.
`
`14/454,373.
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`Ex. 1022: March 14, 2016 Notice of Abandonment in Application Serial No.
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`14/482,704.
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`Ex. 1023: Definition
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`of
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`“Contraindication”
`
`on Medicine.net.com;
`
`https://web.archive.org/web/20060812144659/http://www.medterms.c
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`om/script/main/art.asp?articlekey=17824, (Aug. 12, 2006) 2 pages.
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`
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`
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`I.
`
`INTRODUCTION
`
`Praxair Distribution, Inc. and NOxBOX Limited (collectively “Petitioner”)
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`hereby request Inter Partes Review (“IPR”) of claims 1-25 of U.S. Patent No.
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`8,431,163 (“‘163 Patent”) (Ex. 1001) under 35 U.S.C. §§ 311–319.
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`Praxair Distribution, Inc. (“Praxair”) previously filed a petition seeking IPR
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`of the ‘163 Patent. However, at the time of filing that petition, Praxair did not
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`know about the new art cited in this petition. As the present petition is directed to
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`entirely new art and arguments, including specific recitations that patients with any
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`type of left ventricular dysfunction (“LVD”) should not be treated with inhaled
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`nitric oxide (“iNO”), the Board should institute trial in light of the discretion
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`permitted by 35 U.S.C. § 325(d). See infra Section VI.
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`II. OVERVIEW
`A.
`Summary of the ‘163 Patent
`Nitric oxide (“NO”) is a gaseous chemical compound used to treat patients
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`with severe breathing problems. Ex. 1002 at ¶ 13. In 1999, the U.S. Food and
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`Drug Administration (“FDA”) approved iNO to treat term and near-term infants
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`(born after the 34th week of gestation) with hypoxic respiratory failure associated
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`with clinical or echocardiographic evidence of pulmonary hypertension. Ex. 1001
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`at 1:18-22, 3:31-33; see also Ex. 1010. Pulmonary hypertension is characterized
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`by an increased pulmonary artery pressure and increased pulmonary vascular
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`resistance. See, e.g. Ex. 1001 at 5:20-25; Ex. 1002 at ¶ 13. Nitric oxide is a
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`1
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`
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`selective pulmonary vasodilator that increases the partial pressure of arterial
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`oxygen by dilating pulmonary vessels in ventilated areas of the lung, and directing
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`blood flow away from areas with low ventilation/perfusion ratios toward regions
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`with normal ratios. Ex. 1001 at 3:32-39; Ex. 1002 at ¶ 13.
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`Mallinckrodt Hospital Products IP Ltd., through its subsidiary INO
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`Therapeutics, Inc. (“Patent Owner”) is the exclusive supplier in the U.S. for iNO,
`
`which it sells under the brand INOmax®. Ex. 1001 at 3:31-44; see also Ex. 1010.
`
`The originally approved labeling for INOmax in the U.S. (as originally approved
`
`by the FDA in 1999), attached hereto as Exhibit 1010, recites:
`
`in conjunction with ventilatory support and other
`INOmax,
`appropriate agents, is indicated for the treatment of term and near-
`term (>34 weeks) neonates with hypoxic respiratory failure associated
`with clinical or echocardiographic evidence of pulmonary
`hypertension, where it improves oxygenation and reduces the need for
`extracorporeal membrane oxygenation.
`Ex. 1010 at 4; see also Ex. 1001 at 3:31-52. The FDA’s original prescribing
`
`information for INOmax also includes a “CONTRAINDICATIONS section” that
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`describes situations in which INOmax “should not be used.” Ex. 1001 at 3:44-48;
`
`Ex. 1010 at 4.
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`Nine years after the FDA approved INOmax for sale in the United States,
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`INO Therapeutics, Inc. filed the application that ultimately lead to the ‘163 Patent.
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`Ex. 1001 at cover; see also Ex. 1010.
`
`2
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`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`The ‘163 Patent does not purport to relate to any inventive method of
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`treating a patient with iNO or using iNO. Ex. 1002 at ¶ 11. To the contrary, it
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`discloses admittedly well-known diagnostic steps and analyses to determine
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`whether a patient with LVD is at risk of a Serious Adverse Event (“SAE”), such as
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`pulmonary edema, if treated with iNO, and excluding such patients from treatment
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`based on the assessed risk.1 Ex. 1001 at Abstract, 1:60-2:4; Ex. 1002 at ¶¶ 11, 12.
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`The purported invention of the ‘163 Patent is simply the allegedly new
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`recognition that patients with non-RTL LVD should be excluded from treatment
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`with iNO. Ex. 1001 at 9:13-22, 14:22-36, 14:52-15:3, 15:30-46, 16:19-39.
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`Despite Patent Owner’s assertion that this discovery is new and non-obvious, the
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`prior art cited in this Petition shows that LVD in all forms was described in the
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`literature as a contraindication (indeed, it is described in one of the cited references
`
`as an “absolute contraindication”) for treatment with iNO before June 30, 2009, the
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`earliest possible priority date (“EPD”) of the ‘163 Patent.
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`After the allegedly novel aspect of the ‘163 Patent is stripped away, the
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`claims of the ‘163 Patent are nothing more than well-known methods and
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`1 The ‘163 Patent describes a “Serious Adverse Event” or “SAE” as “a
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`significant hazard or side effect, regardless of the investigator’s opinion on the
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`relationship to the investigational product.” Ex. 1001 at 4:34-38.
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`3
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`
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`techniques (e.g., echocardiography,2 measuring wedge pressure,3 measuring blood
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`oxygen, etc.) for determining who can or cannot be safely treated with iNO. See,
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`e.g., Ex. 1001 at 4:62-64 (“Patients having pre-existing LVD may be described in
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`general as those with elevated pulmonary capillary wedge pressure”); id. at 5:6-10
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`(“Identifying patients with pre-existing LVD is known to those skilled in the
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`medicinal arts, and such techniques for example may include assessment of clinical
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`signs and symptoms of heart failure, or echocardiography diagnostic screening”);
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`id. at 5:13-14 (“Identifying patients with pre-existing PCWP is known to those
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`skilled in the medicinal arts”); id. at 6:25-43 (“In general, patients approved for
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`treatment of iNO are term and near-term (>34 weeks gestation) neonates having
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`hypoxic respiratory failure associated with clinical or echocardiographic evidence
`
`of pulmonary hypertension”. . . .); Ex. 1002 at ¶¶ 25-44. Such methods and
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`techniques are admitted as being well known in the art and thus qualify as admitted
`
`2 Echocardiography is the use of ultrasound waves to image and investigate the
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`heart. Ex. 1002 at n. 2.
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`3 “Wedge pressure” is also sometimes referred to as pulmonary capillary wedge
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`pressure (“PCWP”), pulmonary artery occlusion pressure, or merely “wedge.”
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`Ex. 1002 at ¶ 19. Wedge pressure may be determined via measurement through
`
`cardiac catheterization or by extrapolation through echocardiography. Ex. 1002
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`at ¶¶ 12, 19-20.
`
`4
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`prior art in accordance with MPEP § 2129. See Intri–Plex Technologies, Inc. and
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`Mmi Holdings, Ltd., v. Saint–Gobain Performance Plastics Rencol Limited, Case
`
`No. IPR2014–00309, Paper 83 at 20-22 (PTAB March 23, 2015) (confirming that
`
`Admitted Prior Art is appropriate prior art for institution of inter partes reviews).
`
`Patent Owner has confirmed the admitted prior art nature of these techniques
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`in filings made to the United States District Court for the District of Delaware.
`
`The Patent Owner represented to the District of Delaware that, other than the step
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`of choosing to exclude patients with non-RTL dependent LVD from treatment with
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`iNO, all the steps of the patent claims “were well-known and practiced.” Ex.
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`1016, Dkt. No. 54 at 16 (“the individual analytical techniques” recited in the
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`claims of U.S. Patent No. 8,282,966 (“‘966 Patent”), as well as in the other patents
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`in the same family (including the ‘163 Patent), “were well-known and practiced”).
`
`These arguments thus confirm what the specification of the ‘163 Patent admits:
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`the analytical techniques recited in the claims of the ‘163 Patent were well known
`
`methods and techniques. See, e.g, Ex. 1001 at 4:62-64, 5:6-16, 6:25-43. The prior
`
`art references discussed in this Petition reinforce that concession, as the prior art
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`discloses all of the limitations of the ‘163 Patent, including the allegedly novel
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`exclusion step.
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`The prior art references relied on here all relate
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`to risks and
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`contraindications associated with treating patients with iNO, and particularly
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`5
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`
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`associated with treating neonatal patients. This petition identifies where printed
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`publication-type prior art teaches the use of well-known practices to determine
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`whether neonatal patients have non-RTL dependent LVD, and if so, that those
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`patients should be excluded from treatment with iNO. Accordingly, this petition
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`should be granted and trial instituted on claims 1-25 of the ‘163 Patent.
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`Summary of the Prosecution History of the ‘163 Patent
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`B.
`The application leading to the ‘163 Patent was filed on October 15, 2012.
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`Ex. 1001 at cover. The minimal substantive examination of the ‘163 Patent
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`involved the Examiner issuing a double patenting rejection over (i) the ‘966 Patent;
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`(ii) U.S. Patent No. 8,293,284; and (iii) co-pending U.S. Patent Application Serial
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`No. 13/683,417 (now U.S. Patent No. 8,795,741). Ex. 1005 at 139-143. The
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`Examiner did not reject any of the claims over the prior art because, as discussed
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`below, the claims already included elements (namely, 20 parts per million (“ppm”)
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`iNO and determining the wedge pressure was greater than or equal to 20 mm Hg)
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`that the Examiner believed distinguished the claims over the prior art, as he had
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`found in prosecutions for (i) the ‘966 Patent4 and (ii) U.S. Patent No. 8,293,284.
`
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`4 The Examiner noted, in a August 14, 2012 interview conducted during the
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`prosecution of the ‘966 Patent, that even in view of the previously-submitted
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`declarations, the independent claims needed to be further amended to define the
`
`6
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`Patent Owner filed terminal disclaimers to overcome the double patenting
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`rejections.
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`On February 4, 2013, the Examiner issued a notice of allowance including
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`the following Examiner’s statement of reasons for allowance:
`
`Applicant’s amendments have overcome the rejections of record. The
`instantly claimed subject matter is free of the art. See US Patents
`8282966 and 8293284 for a complete rationale.
`Ex. 1005 at 472, emphasis added; see also Ex. 1018.5
`
`
`wedge pressure as “greater than or equal to 20 mm Hg” in order to “put the case
`
`in condition for allowance.” Ex. 1018 at 51.
`
`5 On August 31, 2012, the Examiner issued a notice of allowance for the ‘966
`
`Patent including the following reasons for allowance:
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`[T]he cited art of record does not teach or suggest, alone or in
`combination, the patient population of a child in need of the
`administration of 20 ppm iNO and determining the [wedge pressure]
`as greater than or equal to 20 mm Hg in the method as instantly
`claimed to reduce the risk of occurrence of pulmonary edema.
`
`Ex. 1018 at 986, emphasis added. The same day, Patent Owner filed comments
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`asserting that “the Examiner’s statement of reasons for allowance . . . are just
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`some of many reasons that the present claims are allowable over the cited art of
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`record.” Ex. 1018 at 1001.
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`7
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`
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`On February 15, 2013, Patent Owner responded to the statement of reasons
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`for allowance with general comments indicating that it did not concede that the
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`rationale from the prosecutions of the ‘966 Patent and U.S. Patent No. 8,293,284
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`fully applied to the present case. Ex. 1005 at 501. Patent Owner identified no
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`additional rationale as to why the claims were allowable over the prior art.
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`Patent Owner submitted several declarations during examination of other
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`related patents (e.g., the ‘966 Patent and U.S. Patent No. 8,293,284) to overcome
`
`various claim rejections by arguing that the INOT22 study results rendered the
`
`claims novel and nonobvious because the study was allegedly the first time that
`
`anyone had seen a patient with LVD who was not dependent on right-to-left
`
`shunting of blood harmed by treatment with iNO. See, e.g. Ex. 1018 at 74-77. The
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`factual premise of these declarations is demonstrably untrue. See, e.g., Ex. 1002 at
`
`¶¶ 9, 15-18, 21. As shown below, prior art publications disclosed that LVD was a
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`contraindication to iNO treatment.6
`
`6 Patent Owner has argued to this Board that the INOT22 study renders the
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`claims of the ‘163 patent novel. See, e.g., IPR2015-00525, Patent Owner
`
`Preliminary Response, Paper No. 8 at 2 (“…the evidence submitted during
`
`prosecution demonstrating that those of extraordinary skill, much less ordinary
`
`skill, in the art were unaware that neonates with LVD should be excluded from
`
`iNO therapy.”) However, this Petition explicitly shows that Patent Owner’s
`
`8
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`Petitioner certifies that (1) the ‘163 Patent, issued on April 30, 2013, is
`
`available for IPR; (2) Petitioner is not barred or estopped from requesting an IPR
`
`on the grounds identified in this Petition; (3) Petitioner has not filed any complaint
`
`relating to the ‘163 Patent and (4) Petitioner is filing this petition within one year
`
`of being served with a complaint for infringement. See Ex. 1004 (waiver of
`
`service filed March 26, 2015); see also The Brinkmann Corporation v. A&J
`
`Manufacturing, LLC, Case IPR2015-00056, Paper 10 at p. 6-7 (PTAB Mar. 23,
`
`2015); Motorola Mobility LLC v. Arnouse, Case IPR2013-00010, Paper 20 at p. 6
`
`(PTAB Jan. 30, 2013). This Petition is filed in accordance with 37 C.F.R. §
`
`42.106(a). Concurrently filed herewith is a Power of Attorney and an Exhibit List
`
`per 37 C.F.R. § 42.10(b) and § 42.63(e), respectively.
`
`IV. PAYMENT OF FEES (37 C.F.R. § 42.103)
`In accordance with 37 C.F.R. § 42.15 and § 42.103, Petitioner authorizes the
`
`USPTO to charge any required fees to Deposit Account 02–1818.
`
`
`statements regarding the INOT22 study are incorrect: at least Greenough and
`
`Jaypee teach that neonates with LVD should be excluded from treatment.
`
`9
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`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
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`V. MANDATORY NOTICES (37 C.F.R. § 42.8)
`A. Real-Parties-in-Interest
`Petitioner certifies that Praxair Distribution, Inc., with its head office at 28
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`McCandless Ave, Pittsburgh, PA 15201; NOxBOX Limited, a company
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`incorporated and registered in the United Kingdom with company number
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`09563860 whose registered office is at 139-141 Watling Street, Gillingham, Kent,
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`ME7 2YY; and Praxair, Inc., with its worldwide headquarters at 39 Old Ridgebury
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`Rd., Danbury, CT 06810, are the real parties-in-interest.
`
`B. Related Matters
`Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioner states that on February 19,
`
`2015, Patent Owner filed a complaint averring that Praxair’s Abbreviated New
`
`Drug Application (“ANDA”) infringes the ‘163 Patent under 35 U.S.C. §
`
`271(e)(2). Praxair waived service on March 26, 2015. Ex. 1004. The lawsuit is
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`pending in the United States District Court for the District of Delaware and is
`
`captioned: INO Therapeutics LLC et al. v. Praxair Distribution, Inc. et al., Civil
`
`Action No. 1:15-cv-00170 (GMS). In that case, Praxair Distribution, Inc. and
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`Praxair, Inc. filed a Motion for Judgement on the Pleadings seeking a ruling that all
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`the claims of the ‘163 Patent (as well as the other patents in the same family) were
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`directed to non-patentable subject matter under 35 U.S.C. § 101. Exhibit 1016 is
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`Patent Owner’s opposition to that Motion, which was filed on January 27, 2016.
`
`10
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`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
`
`In January 2015, Praxair filed a petition requesting IPR of the ‘163 Patent in
`
`IPR2015-00525 (“the ‘525 IPR”). On July 29, 2015, the Patent Trial and Appeal
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`Board (“Board”) denied that petition. ‘525 IPR, Paper 12. Praxair also filed three
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`other petitions directed to patents in the same family as the ‘163 Patent that were
`
`denied on July 29, 2015 in the same decision that denied the ‘525 IPR. See
`
`IPR2015-00522, Paper 12; IPR2015-00524, Paper 12; IPR2015-00526, Paper 12.
`
`As described below, the Board should nonetheless institute this petition under 35
`
`U.S.C. § 325(d). See Section VI.
`
`On January 5, 2015, Praxair filed a petition requesting IPR of U.S. Patent
`
`No. 8,846,112, also in the same family as the ‘163 Patent, in IPR2015-00529. The
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`Board instituted review of that patent on July 29, 2015. IPR2015-00529, Paper
`
`No. 12. That proceeding is currently pending, with a final written decision
`
`expected in the July/August 2016 timeframe.
`
`Petitioner is concurrently requesting IPR of U.S. Patent Nos. 8,282,966;
`
`8,293,284; 8,795,741; and 8,846,112, which are in the same family as the ‘163
`
`Patent.
`
` One pending U.S. patent application claims priority to the ultimate parent
`
`application of the ‘163 Patent: U.S. Application Serial No. 13/683,444 filed on
`
`November 21, 2012, which has been on appeal from a final rejection in the Patent
`
`Office since August 12, 2013. Three other applications claim priority to the
`
`11
`
`
`
`Petition for Inter Partes Review of U.S_ Patent No. 8,431,163
`
`ultimate parent application of the ‘163 Patent
`
`(U.S_ Application Serial Nos.
`
`14/451,057, 14/454,373, and 14/482,704), but all are abandoned by virtue of Patent
`
`Owner not filing responses to office actions based on, among other references,
`
`Greenough and Jaypee. See Ex. 1020, Ex. 1021, Ex. 1022.
`
`C.
`
`Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4))
`
`Lead Counsel
`
`Backu Counsel
`
`Margaux Nair
`Benjamin E. Weed
`Reg. No. 68,897
`Reg. No. 65,939
`benjamin.weed.PTAB@klgates.com margauxnair.PTAB@klgates_com
`K&L Gates LLP
`K&L Gates LLP
`
`70 W. Madison St., Suite 3100
`Chicago, IL 60602
`T: (312) 781-7166
`F: 312 345-1843
`
`70 W. Madison St., Suite 3100
`Chicago, IL 60602
`
`F: 312 827-8057
`
`Backu Counsel
`
`Backu Counsel
`
`T: (312)807-4280
`
`
`
`Admission
`
`Michael J. Abernathy
`Pro
`Hac
`Vice
`To Be Requested
`mike_abemathy@morganlewis.com
`Morgan, Lewis & Bockius LLP
`77 West Wacker Dr., Fifth Floor
`Chicago, IL 60601
`T: (312) 324-1447
`F: 312 324-1001
`
`Sanj ay K. Murthy
`Reg. No. 45,976
`sanjay.murthy@morganlewis.com
`
`Morgan, Lewis & Bockius LLP
`77 West Wacker Dr., Fifth Floor
`Chicago, IL 60601
`T: (312) 324-1448
`F: 312 324-1001
`
`Backu Counsel
`
`Maria E. Doukas
`
`Reg. No. 67,084
`maria.doukas@morganlewis.com
`Morgan, Lewis & Bockius LLP
`77 West Wacker Dr., Fifth Floor
`
`Chicago, IL 60601
`T: (312) 324-1454
`F: 312 324-1001
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
`
`Petitioner consents to service by email.
`
`VI. THE BOARD SHOULD INSTITUTE IPR UNDER 35 U.S.C. § 325(d)
`Praxair previously filed a Petition for IPR of the ‘163 Patent on January 5,
`
`2015. ‘525 IPR, Paper 1. In that proceeding, Patent Owner filed a Preliminary
`
`Response on May 4, 2015. ‘525 IPR, Paper 8. The Board issued a Decision
`
`declining to institute trial on July 29, 2015. ‘525 IPR, Paper 12. Notwithstanding
`
`the ‘525 IPR, this Petition demonstrates a reasonable likelihood that at least one of
`
`the challenged claims is unpatentable (37 C.F.R. § 42.108(c)), and the Board
`
`should institute trial in view of the discretion permitted by 35 U.S.C. § 325(d).
`
`35 U.S.C. § 325(d) is titled “MULTIPLE PROCEEDINGS” and provides:
`
`In determining whether to institute or order a proceeding under this
`chapter, chapter 30, or chapter 31, the Director may take into account
`whether, and reject the petition or request because, the same or
`substantially the same prior art or arguments previously were
`presented to the Office.
`
`The Board frequently addresses this section when deciding whether to exercise its
`
`Congressionally-granted discretion and institute a second petition directed to a
`
`previously-challenged patent. See, e.g., Ericsson Inc. et al. v. Intellectual Ventures
`
`I LLC, Case IPR2015-01367, Paper 6 at 5-6 (PTAB Dec. 9, 2015). Here, the
`
`Board should decline to exercise its discretion, and should institute trial.
`
`13
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
`
`The instant Petition is based on an entirely new theory with regard to the
`
`allegedly patentable exclusion claimed in the ‘163 Patent. That theory involves
`
`using the teachings of the Greenough and Jaypee references previously unknown
`
`to Petitioner and previously unconsidered by the Examiner or the Board, which
`
`teach that LVD is an absolute contraindication7 from treatment with iNO.
`
`Greenough, Jaypee and additional secondary reference Widlitz have never been
`
`7 The March 14, 2011 definition for “contraindication” from Medicine.Net is
`
`listed in a reference on the face of the ‘163 Patent and found in the file history.
`
`The definition provided from the same source in 2006, 3 years before the EPD
`
`is: “Contraindication: A condition which makes a particular treatment or
`
`procedure potentially inadvisable. A contraindication may be absolute or
`
`relative . . .” Ex. 1023, Definition of “Contraindication” on Medicine.net.com;
`
`https://web.archive.org/web/20060812144659/http://www.medterms.com/script
`
`/main/art.asp?articlekey=17824, (Aug. 12, 2006) 2 pages. The same definition
`
`goes on to describe “absolute contraindication,” as “a situation which makes a
`
`particular treatment or procedure absolutely inadvisable.” Id. As described in
`
`the ‘163 Patent, the contraindications listed on the label for the INOmax® drug
`
`product appear to be a general or relative contraindications, as it states that
`
`“INOmax® should not be used. . .” instead of saying “must not” or “cannot”.
`
`Ex. 1001 at 3:53-56 (emphasis added).
`
`14
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
`
`considered with regard to the claims of the ‘163 Patent, and the theory of
`
`combination presented here has never been considered with regard to the claims of
`
`the ‘163 Patent. Accordingly, this Petition unquestionably does not raise the
`
`“same” “prior art or arguments.” 35 U.S.C. § 325(d).
`
`The prior art and arguments relied on herein also are not substantially the
`
`same as those previously considered by the Office. 35 U.S.C. § 325(d). The
`
`theory described herein is completely different than the theory presented in the
`
`‘525 IPR, as the reference(s) relied on to exclude patients with LVD from
`
`treatment with iNO explicitly contraindicate patients with LVD from iNO
`
`treatment and do not merely suggest that patients with LVD may want to avoid
`
`iNO treatment.8 The art and arguments relied on herein also are substantially
`
`different from those previously considered by the Office because all of the
`
`references unquestionably relate to neonates; by contrast, some of the references
`
`previously relied on arguably related to other categories of patients.
`
`Greenough explicitly teaches that neonates with LVD are contraindicated
`
`from receiving iNO treatment. Ex. 1006 at 187. Given the Board’s prior finding
`
`that the art in the ‘525 IPR was deficient with regard to the explicit teaching of
`
`excluding neonatal patients with LVD from iNO treatment, the reliance on
`
`8 Therefore, these references squarely address the primary deficiency identified
`
`by the PTAB in the Denial of Institution in the ‘525 IPR. ‘525 IPR, Paper 12.
`
`15
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
`
`Greenough here renders the instant Grounds substantially different than those
`
`previously considered by the Board. The arguments presented here are of a
`
`different character and advance a different theory and thus are substantially
`
`different from arguments and prior art previously presented. See Int’l Bus. Machs
`
`Corp. v. Intellectual Ventures II LLC, Case IPR2015-01323, Paper 12 at 5-7
`
`(PTAB Dec. 8, 2015).9 The substantial difference between the prior art and
`
`arguments here is further emphasized by Praxair’s decision not to request rehearing
`
`in the ‘525 IPR; the theories and art presented here were not included in the ‘525
`
`IPR Petition and thus could not have been raised in a rehearing request. 37 C.F.R.
`
`§ 42.72(c)-(d). Medtronic, Inc. v. Mark A. Barry, Case IPR2015-00780, Paper 7 at
`
`9 The Board has declined to exercise its § 325(d) discretion where different
`
`disclosures were relied upon in previously presented prior art for which review
`
`was denied. See, e.g., Samsung Elecs. Am., Inc. v. LED Tech Devel., LLC, Case
`
`IPR2014-00590, Paper 23 at 8 (PTAB Sept. 3, 2014); Valeo N. Am., Inc. et al.
`
`v. Magna Elec., Inc., Case IPR2014-01203, Paper 13 at 10-11 (PTAB Jan. 28,
`
`2015); Oxford Nanopore Techs. Ltd. v. Univ. of Wash. et al., Case IPR2015-
`
`00057, Paper 10 at 20-21 (PTAB April 27, 2015); Atlas Copco Airpower N.V. v.
`
`Kaeser Kompressoren SE, Case IPR2015-01421, Paper 8 at 6-8 (PTAB Dec.
`
`28, 2015); Valeo N. Am., Inc. et al. v. Magna Elec. Inc., Case Nos. IPR2015-
`
`01410 and IPR2015-01414, Paper 7 at 11-13 (PTAB Dec. 28, 2015).
`
`16
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,431,163
`
`9, n. 4 (PTAB Sept. 9, 2015) (declining to exercise discretion where Petitioner
`
`filed second petition with art and arguments that could not have been raised in
`
`rehearing).
`
`These references were also not available to Praxair at the time of filing of
`
`the ‘525 IPR. Greenough and Jaypee were only recently discovered; in fact,
`
`despite the dozens of references Patent Owner found and cited to the PTO during
`
`examination, it was not until after the IPRs were filed that these references were
`
`located. Tellingly, when faced with rejections based on Greenough and/or Jaypee
`
`that occurred because t
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