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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. 8,795,741
`
`
`
`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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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
`
`Table of Contents
`
`Page
`
`I.
`II.
`
`INTRODUCTION ........................................................................................... 1
`OVERVIEW .................................................................................................... 1
`A.
`Summary of the ‘741 Patent .................................................................. 1
`B.
`Summary of the Prosecution History of the ‘741 Patent ...................... 6
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ................................. 8
`IV. PAYMENT OF FEES (37 C.F.R. § 42.103) ................................................... 9
`V. MANDATORY NOTICES (37 C.F.R. § 42.8) ............................................... 9
`A.
`Real-Parties-in-Interest .......................................................................... 9
`B.
`Related Matters ...................................................................................... 9
`C.
`Counsel Information ............................................................................ 11
`VI. THE BOARD SHOULD INSTITUTE IPR UNDER 35 U.S.C. § 325(d) .... 12
`VII. PERSON OF ORDINARY SKILL IN THE ART ........................................ 20
`VIII. CLAIM CONSTRUCTION .......................................................................... 20
`A.
`Broadest Reasonable Interpretation Standard ..................................... 20
`IX. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. §§ 42.22(a) and 42.104(b)) .............. 21
`A. Ground 1: Claims 1-2, 4, 6-14, 17-23, 31, 32, 34-35, 37-40, and
`42-44 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 ............................. 26
`2. Motivation to Combine Art Applied in Ground 1 .................... 28
`3.
`Independent Claims 1 and 9 ...................................................... 32
`a)
`Part (a) of Independent Claims 1 and 9 .......................... 32
`b)
`Part (b) of Independent Claims 1 and 9 .......................... 34
`c)
`Part (c) of Independent Claims 1 and 9 .......................... 34
`d)
`Part (d) of Independent Claims 1 and 9 .......................... 37
`e)
`Part (e) of Independent Claims 1 and 9 .......................... 37
`
`i
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`4.
`
`5.
`
`6.
`
`Independent Claim 24 ............................................................... 39
`a)
`Part (a) of Independent Claim 24 ................................... 39
`b)
`Part (b) of Independent Claim 24 ................................... 40
`c)
`Part (c) of Independent Claim 24 ................................... 41
`d)
`Part (d) of Independent Claim 24 ................................... 42
`e)
`Part (e) of Independent Claim 24 ................................... 42
`Independent Claims 34 and 37 .................................................. 42
`a)
`Part (a) of Independent Claims 34 and 37 ...................... 43
`b)
`Part (b) of Independent Claims 34 and 37 ...................... 44
`c)
`Part (c) of Independent Claims 34 and 37 ...................... 44
`d)
`Part (d) of Independent Claims 34 and 37 ...................... 45
`e)
`Part (e) of Independent Claims 34 and 37 ...................... 45
`Claims 2, 4, 6-8, 10-14, 17-23, 25-33, 35, 38-40, and 42-44 ... 46
`a)
`Dependent Claims 2, 14, and 27 ..................................... 47
`b)
`Dependent Claims 4, 17, 35, and 42 ............................... 47
`c)
`Dependent Claims 10-12, 18-21, 38-40, 43, and 44 ....... 48
`d)
`Dependent Claims 6, 7, 22, 23, 29, and 31-33 ............... 49
`e)
`Dependent Claims 8, 13 and 30 ...................................... 51
`f)
`Dependent Claims 25 and 26 .......................................... 52
`Ground 2: Claims 3, 5, 15, 16, 28, 36, and 41 are Unpatentable
`Under 35 U.S.C. § 103(a) as Obvious Over Greenough, Jaypee,
`and Widlitz ........................................................................................... 52
`CONCLUSION .............................................................................................. 55
`
`B.
`
`X.
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`
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`
`ii
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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
`
`List of Exhibits
`
`Ex. 1001: U.S. Patent No. 8,795,741 to Baldassarre (“‘741 Patent”), filed
`
`November 21, 2012, issued August 5, 2014.
`
`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. 8,795,741.
`
`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”).
`
`iii
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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`Ex. 1012: M. Hoeper, et al., Definitions and Diagnosis of Pulmonary
`
`Hypertension 62:25 J. of the American College of Cardiology D44
`
`(2013) (“Hoeper”).
`
`Ex. 1013: Royster, et al., Differences in Pulmonary Artery Wedge Pressures
`
`Obtained by Balloon Inflation Versus Impaction Techniques, 61
`
`Anesthesiology, 339 – 341 (1984) (“Royster”).
`
`Ex. 1014: Goyal et al., Efficacy of nitroglycerin inhalation in reducing
`
`pulmonary arterial hypertension in children with congenital heart
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`disease, British Journal of Anaesthesia, 97(2): 208-14 (2006).
`
`(“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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`iv
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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`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.
`
`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”
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`on Medicine.net.com;
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`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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`v
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
`
`I.
`
`INTRODUCTION
`
`Praxair Distribution, Inc. and NOxBOX Limited (collectively “Petitioner”)
`
`hereby request Inter Partes Review (“IPR”) of claims 1 to 44 of U.S. Patent No.
`
`8,795,741 (“‘741 Patent”) (Ex. 1001) under 35 U.S.C. §§ 311–319.
`
`Praxair Distribution, Inc. (“Praxair”) previously filed a petition seeking IPR
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`of the ‘741 Patent. However, at the time of filing that petition, Praxair did not
`
`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
`
`type of left ventricular dysfunction (“LVD”) should not be treated with inhaled
`
`nitric oxide (“iNO”), the Board should institute trial despite the discretion
`
`permitted by 35 U.S.C. § 325(d). See infra Section VI.
`
`II. OVERVIEW
`A.
`Summary of the ‘741 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 1:20-24, 3:34-36; 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 5:29-34. Nitric oxide is a selective pulmonary
`1
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`
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`vasodilator that increases the partial pressure of arterial oxygen by dilating
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`pulmonary vessels in ventilated areas of the lung, and directing blood flow away
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`from areas with low ventilation/perfusion ratios toward regions with normal ratios.
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`Ex. 1001 at 3:36-42.
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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,
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`which it sells under the brand INOmax®. Ex. 1001 at 3:34-52; see also Ex. 1010.
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`The originally approved labeling for INOmax in the U.S. (as approved by the FDA
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`in 1999), attached hereto as Exhibit 1010, recites:
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`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 3:34-52. The FDA’s original prescribing
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`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 ‘741 Patent.
`
`Ex. 1001 at cover; see also Ex. 1010.
`
`2
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`The ‘741 Patent does not purport to relate to any inventive method of
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`treating a patient with iNO or using iNO. To the contrary, it discloses admittedly
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`well-known diagnostic steps and analyses to determine whether a patient with
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`LVD is at risk of a Serious Adverse Event (“SAE”), such as pulmonary edema, if
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`treated with iNO, and excluding such patients from treatment based on the assessed
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`risk.1 Ex. 1001 at Abstract, 1:49-60; Ex. 1002 at ¶ 11.
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`The purported invention of the ‘741 Patent is simply the allegedly new
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`recognition that patients with LVD should be excluded from treatment with iNO.
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`Ex. 1001 at 9:25-34, 14:37-49, 15:21-35, 16:39-53, 17:29-41, 18:4-19. Despite
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`Patent Owner’s assertion that this discovery is new and non-obvious, the prior art
`
`cited in this Petition shows that LVD in all forms was described in the literature as
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`a contraindication (indeed, it is described in one of the cited references as an
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`“absolute contraindication”) for treatment with iNO before June 30, 2009, the
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`earliest possible priority date (“EPD”) of the ‘741 Patent.
`
`After the allegedly novel aspect of the ‘741 Patent is stripped away, the
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`claims of the ‘741 Patent describe nothing more than well-known methods and
`
`
`1 The ‘741 Patent describes a “Serious Adverse Event” or “SAE” as “a
`
`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 4:43-47.
`
`3
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
`
`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,
`
`e.g., Ex. 1001 at 5:4-6 (“Patients having pre-existing LVD may be described in
`
`general as those with elevated pulmonary capillary wedge pressure”); id. at 5:15-
`
`19 (“Identifying patients with pre-existing LVD is known to those skilled in the
`
`medicinal arts, and such techniques for example may include assessment of clinical
`
`signs and symptoms of heart failure, or echocardiography diagnostic screening”);
`
`id. at 5:22-23 (“Identifying patients with pre-existing PCWP is known to those
`
`skilled in the medicinal arts”); id. at 6:34-52 (“In general, patients approved for
`
`treatment of iNO are term and near-term (>34 weeks gestation) neonates having
`
`hypoxic respiratory failure associated with clinical or echocardiographic evidence
`
`of pulmonary hypertension”. . . .); Ex. 1002 at ¶¶ 25-45. Such methods and
`
`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. 5.
`
`3 “Wedge pressure” is also sometimes referred to as pulmonary capillary wedge
`
`pressure (“PCWP”), pulmonary artery occlusion pressure, or merely “wedge.”
`
`Ex. 1002 at ¶ 19. Wedge pressure may be determined via measurement through
`
`cardiac catheterization or by extrapolation through echocardiography. Ex. 1002
`
`at ¶¶ 12, 19.
`
`4
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`prior art in accordance with MPEP § 2129. See Intri–Plex Technologies, Inc. and
`
`Mmi Holdings, Ltd., v. Saint–Gobain Performance Plastics Rencol Limited, Case
`
`Nos. IPR2014–00309, Paper 83 at 20-22 (PTAB March 23, 2015) (confirming that
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`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
`
`in the same family (including the ‘741 Patent), “were well-known and practiced.”).
`
`These arguments thus confirm what the specification of the ‘741 Patent admits:
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`the analytical techniques recited in the claims of the ‘741 Patent were well known
`
`methods and techniques. See, e.g, Ex. 1001 at 5:4-6; 5:15-19, 5:22-23. The prior
`
`art references discussed in this Petition reinforce that concession, as the prior art
`
`discloses all of the limitations of the ‘741 Patent, including the allegedly novel
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`exclusion step.
`
`The prior art references relied on here all relate
`
`to risks and
`
`contraindications associated with treating patients with iNO, and particularly
`
`5
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
`
`associated with treating neonatal patients. This petition identifies printed
`
`publications that teach the use of well-known practices to determine whether
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`neonatal patients have LVD, and if so, that those patients should be excluded from
`
`treatment with iNO. Accordingly, this petition should be granted and trial
`
`instituted on claims 1-44 of the ‘741 Patent.
`
`Summary of the Prosecution History of the ‘741 Patent
`
`B.
`The application leading to the ‘741 Patent was filed on November 21, 2012.
`
`Ex. 1001 at cover. Patent Owner submitted a declaration during prosecution to
`
`overcome various claim rejections by arguing that the INOT22 study results
`
`rendered the claims novel and nonobvious, because that study was allegedly the
`
`first time anyone had seen a patient with LVD or significantly elevated PCWP
`
`harmed by treatment with iNO. See, e.g. Ex. 1005 at 415-420. The factual
`
`premise of tehse declarations is is demonstrably untrue. As shown below, prior art
`
`publications disclosed that LVD was a contraindication to iNO treatment.4
`
`
`4 Patent Owner has argued to this Board that the INOT22 study renders the
`
`claims of the ‘741 Patent novel. See, e.g., IPR2015-00526, Patent Owner
`
`Preliminary Response, Paper No. 8 at 2 (“…the evidence submitted during
`
`prosecution demonstrating that those of extraordinary skill in the art were
`
`unaware that all children or neonates with LVD should be excluded from iNO
`
`therapy.”). However, this Petition explicitly shows that Patent Owner’s
`
`6
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
`
`The substantive examination of the ‘741 Patent involved the Examiner
`
`issuing a double patenting rejection over (i) the ‘966 Patent; (ii) U.S. Patent No.
`
`8,293,284; and (iii) co-pending U.S. Patent Application Serial No. 13/651,660
`
`(now U.S. Patent No. 8,431,163). Ex. 1005 at 216-222. The Examiner did not
`
`reject any of the claims over the prior art because, as discussed below, the claims
`
`of the application leading to the ‘741 Patent already included elements (namely, 20
`
`parts per million (“ppm”) iNO and determining the wedge pressure was greater
`
`than or equal to 20 mm Hg) that the Examiner believed distinguished the claims
`
`over the prior art, as he had found in prosecutions for (i) the ‘966 Patent5 and (ii)
`
`U.S. Patent No. 8,293,284. Patent Owner filed terminal disclaimers to overcome
`
`the double patenting rejections.
`
`On June 23, 2014, the Examiner issued a notice of allowance reasoning that
`
`in view of the art an “artisan is directed to administering less than 10 ppm NO for
`
`statements regarding the INOT22 study are incorrect: at least Greenough and
`
`Jaypee teach that children and neonates with LVD should be excluded from
`
`treatment.
`
`5 The Examiner noted, in an August 14, 2012 interview conducted during the
`
`prosecution of the ‘966 Patent, that the independent claims needed to be further
`
`amended to define the wedge pressure as “greater than or equal to 20 mm Hg”
`
`in order to “put the case in condition for allowance.” Ex. 1018 at 907.
`
`7
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
`
`treatment which is less than the instantly claimed 20 ppm NO. See also the
`
`reasons provided in US Patent No’s: 8282966 and 8293284.” Ex. 1005 at 645.6
`
`On June 27, 2014, Patent Owner indicated that it did not concede that “the
`
`Examiner’s stated reasons for allowance are the only reasons for which the claims
`
`are allowable.” Ex. 1005 at 674.
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`Petitioner certifies that (1) the ‘741 Patent, issued on August 5, 2014, 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 ‘741 Patent; and (4) Petitioner is filing this petition within one year
`
`
`6 On August 31, 2012, the Examiner issued a notice of allowance for the ‘966
`
`Patent including the following reasons for allowance:
`
`[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 992 (emphasis added). The same day, Patent Owner filed
`
`comments asserting that “the Examiner’s statement of reasons for allowance
`
`. . . are just some of many reasons that the present claims are allowable over
`
`the cited art of record.” Ex. 1018 at 1001
`
`8
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
`
`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.
`
`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
`
`McCandless Ave., Pittsburgh, PA 15201; NOxBOX Limited, a company
`
`incorporated and registered in the United Kingdom with company number
`
`09563860 whose registered office is at 139-141 Watling Street, Gillingham, Kent,
`
`ME7 2YY; and Praxair, Inc., with its worldwide headquarters at 39 Old Ridgebury
`
`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
`
`9
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
`
`Drug Application (“ANDA”) infringes the ‘741 Patent under 35 U.S.C. §
`
`271(e)(2). Praxair waived service on March 26, 2015. See Ex. 1004. The lawsuit
`
`is 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
`
`Praxair, Inc. filed a Motion for Judgement on the Pleadings seeking a ruling that all
`
`the claims of the ‘741 Patent (as well as the other patents in the same family) were
`
`directed to non-patentable subject matter under 35 U.S.C. § 101. Exhibit 1016 is
`
`Patent Owner’s opposition to that Motion, which was filed on January 27, 2016.
`
`In January 2015, Praxair filed a petition requesting IPR of the ‘741 Patent in
`
`IPR2015-00526 (“the ‘526 IPR”). On July 29, 2015, the Patent Trial and Appeal
`
`Board (“Board”) denied that petition. IPR2015-00526, Paper 12. Praxair also filed
`
`three other petitions directed to patents in the same family as the ‘741 Patent that
`
`were denied on July 29, 2015 in the same decision that denied the ‘526 IPR. See
`
`IPR2015-00524, Paper 12; IPR2015-00525, Paper 12; IPR2015-00522, 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 ‘741 Patent, in IPR2015-00529. The
`
`Board instituted review of that patent on July 29, 2015. IPR2015-00529, Paper
`
`10
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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`No. 12. That proceeding is currently pending, with a final written decision
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`expected in the July/August 2016 timeframe.
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`Petitioner is concurrently requesting IPR of U.S- Patent Nos. 8,282,966;
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`8,293,284; 8,431,163; and 8,846,112, which are in the same family as the ‘741
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`Patent.
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`One pending U.S. patent application claims priority to the ultimate parent
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`application of the ‘741 Patent: U.S. Application Serial No. 13/683,444 filed on
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`November 21, 2012, which has been on appeal from a final rejection in the Patent
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`Office since August 12, 2013. Three other applications claim priority to the
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`ultimate parent application of the ‘741 Patent (U.S. Application Serial Nos.
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`14/451,057, 14/454,373, and 14/482,704), but all are abandoned by Virtue of Patent
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`Owner not filing responses to office actions based on, among other references,
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`Greenough and Jaypee. See Ex. 1020, Ex. 1021, Ex. 1022.
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`C.
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`Counsel Information
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`Lead Counsel
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`Backu Counsel
`
`Margaux Nair
`Benjamin E. Weed
`Reg. No. 68,897
`Reg. No. 65,939
`benjamin.weed.PTAB@klgates.com margaux.nair.PTAB@klgates.com
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`K&L Gates LLP
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`K&L Gates LLP
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`70 W. Madison St., Suite 3100
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`70 W. Madison St., Suite 3100
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`F: 312 827-8057
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`Chicago, IL 60602
`T: (312) 781-7166
`F: 312 345-1843
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`Chicago, IL 60602
`T: (312) 807-4280
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`11
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`Backu n Counsel
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`Backu o Counsel
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`
`
`Michael J. Abernathy
`Sanj ay K. Murthy
`Pro
`Hac
`Vice
`Reg. No. 45,976
`Admission
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`To Be Requested
`sanjay.murthy_@morganlewis.com
`mike.abemathy@morganlewis.com
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`Morgan, Lewis & Bockius LLP
`Morgan, Lewis & Bockius LLP
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`77 West Wacker Dr., Fifth Floor
`77 West Wacker Dr., Fifth Floor
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`Chicago, IL 60601
`Chicago, IL 60601
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`T: (312) 324-1448
`T: (312) 324-1447
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`F: 312 324-1001
`F: (312)324-1001
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`
`
`
`
`
`Reg. No. 67,084
`maria.doukas@morganlewis.com
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`
`
`
`Morgan, Lewis & Bockius LLP
`77 West Wacker Dr., Fifth Floor
`Chicago, IL 60601
`T: (312) 324-1454
`F: (312)324-1001
`
`Maria E. Doukas
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`
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`
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`Petitioner consents to service by email.
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`VI. THE BOARD SHOULD INSTITUTE IPR UNDER 35 U.S.C. § 325(d)
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`Praxair previously filed a Petition for IPR of the ‘741 Patent on January 5,
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`2015. ‘526 IPR, Paper 1.
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`In that proceeding, Patent Owner filed a Preliminary
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`Response on May 4, 2015.
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`‘526 IPR, Paper 8. The Board issued a Decision
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`declining to institute trial on July 29, 2015.
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`‘526 IPR, Paper 12. Notwithstanding
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`the ‘526 IPR, this Petition demonstrates a reasonable likelihood that at least one of
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`the challenged claims is unpatentable (37 C .F.R. § 42. 108(0)). and the Board
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`should institute trial in View of the discretion permitted by 35 U.S.C. § 325(d).
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`35 U.S.C. § 325(d) is titled “MULTIPLE PROCEEDINGS” and provides:
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`12
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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`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.
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`The Board frequently addresses this section when deciding whether to exercise its
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`Congressionally-granted discretion and institute a second petition directed to a
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`previously-challenged patent. See, e.g., Ericsson Inc. et al. v. Intellectual Ventures
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`I LLC, Case IPR2015-01367, Paper 6 at 5-6 (PTAB Dec. 9, 2015). Here, the
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`Board should institute trial.
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`
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`The instant Petition is based on an entirely new theory with regard to the
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`allegedly patentable exclusion claimed in the ‘741 Patent. That theory involves
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`using the teachings of the Greenough and Jaypee references previously unknown
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`to Petitioner and previously unconsidered by the Examiner or the Board, which
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`teach that LVD is an absolute contraindication7 from treatment with iNO.
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`7 The March 14, 2011 definition for “contraindication” from Medicine.Net is
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`listed in a reference on the face of the ‘741 Patent and found in the file history.
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`The definition provided from the same source in 2006, 3 years before the EPD,
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`is: “Contraindication: A condition which makes a particular treatment or
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`procedure potentially inadvisable. A contraindication may be absolute or
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`relative . . .” Ex. 1023, Definition of “Contraindication” on Medicine.net.com;
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`13
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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`Greenough, Jaypee and additional secondary reference Widlitz have never been
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`considered with regard to the claims of the ‘741 Patent and the theory of
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`combination presented here has never been considered with regard to the claims of
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`the ‘741 Patent. Accordingly, this Petition unquestionably does not raise the
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`“same” “prior art or arguments.” 35 U.S.C. § 325(d).
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`The prior art and arguments relied on herein also are not substantially the
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`same as those previously considered by the Office. 35 U.S.C. § 325(d). The
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`theory described herein is completely different than the theory presented in the
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`‘522 IPR, as the reference(s) relied on to exclude patients with LVD from
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`treatment with iNO explicitly contraindicate patients with LVD from iNO
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`treatment and do not merely suggest that patients with LVD may want to avoid
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`https://web.archive.org/web/20060812144659/http://www.medterms.com/script
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`/main/art.asp?articlekey=17824, (Aug. 12, 2006), 2 pages. The same definition
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`goes on to describe “absolute contraindication,” as “a situation which makes a
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`particular treatment or procedure absolutely inadvisable.” Id. As described in
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`the ‘741 Patent, the contraindications listed on the label for the INOmax drug
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`product appear to be a general or relative contraindications, as it states that
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`“INOmax® should not be used. . .” instead of saying “must not” or “cannot”.
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`Ex. 1001 at 3:53-56 (emphasis added).
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`14
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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`iNO treatment.8 The art and arguments relied on herein also are substantially
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`different from those previously considered by the Office because all of the
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`references unquestionably relate to neonates; by contrast, some of the references
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`previously relied on arguably related to other categories of patients.
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`Greenough explicitly teaches that children with LVD are contraindicated
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`from receiving iNO treatment. Ex. 1006 at 187. Given the Board’s prior finding
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`that the art in the ‘526 IPR was deficient with regard to the explicit teaching of
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`excluding children with LVD from iNO treatment, the reliance on Greenough here
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`renders the instant Grounds substantially different than those previously considered
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`by the Board. The arguments presented here are of a different character and
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`advance a different theory and thus are substantially different from arguments and
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`prior art previously presented. See International Bus. Machines Corp. v.
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`Intellectual Ventures II LLC, Case IPR2015-01323, Paper 12 at 5-7 (PTAB Dec. 8,
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`2015).9 The substantial difference between the prior art and arguments here is
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`8 Therefore, these references squarely address the primary deficiency identified
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`by the PTAB in the Denial of Institution in the ‘526 IPR. ‘526 IPR, Paper 12.
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`9 The Board has declined to exercise its § 325(d) discretion where different
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`disclosures were relied upon in previously presented prior art for which review
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`was denied. See, e.g., Samsung Elecs. Am., Inc. v. LED Tech Devel., LLC, Case
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`IPR2014-00590, Paper 23 at 8 (PTAB Sept. 3, 2014); Valeo N. Am., Inc. et al.
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`15
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`Petition for Inter Partes Review of U.S. Patent No. 8,795,741
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`further emphasized by Praxair’s decision not to request rehearing in the ‘526 IPR;
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`the theories and art presented here were not included in the ‘526 IPR Petition and
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`thus could not have been raised in a rehearing request. 37 C.F.R. § 42.72(c)-(d).
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`Medtronic, Inc. v. Mark A. Barry, Case IPR2015-00780, Paper 7 at 9, n. 4 (PTAB
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`Sept. 9, 2015) (declining to exercise discretion where Petitioner filed second
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`petition with art and arguments that could not have been raised in rehearing).
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`These references were also not available to Praxair at the time of filing of
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`the ‘526 IPR. Greenough and Jaypee were only recently discovered; in fact,
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`despite the dozens of references Patent Owner found and cited to the P