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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
`
`v.
`
`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. 8,846,112
`
`
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`Patent Owner Box 1450
`Alexandria, Virginia 22313–1450
`
`i
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`

`

`Table of Contents
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`OVERVIEW OF THE ‘112 Patent .................................................................. 1
`
`A.
`
`B.
`
`Summary of the ‘112 Patent .................................................................. 1
`
`Summary of the Prosecution History of the ‘112 Patent ...................... 5
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ................................. 7
`
`IV. PAYMENT OF FEES (37 C.F.R. § 42.103) ................................................... 8
`
`V. MANDATORY NOTICES (37 C.F.R. § 42.8) ............................................... 8
`
`A.
`
`B.
`
`C.
`
`Real Parties-In-Interest .......................................................................... 8
`
`Related Matters ...................................................................................... 8
`
`Lead and Backup Counsel (37 C.F.R. § 42.8(b)(3)) and Service
`Information (37 C.F.R. § 42.8(b)(4)) .................................................. 10
`
`VI. THE BOARD SHOULD INSTITUTE IPR UNDER 35 U.S.C. § 325(d) .... 11
`
`VII. PERSON OF SKILL IN THE ART AND STATE OF THE ART ............... 18
`
`VIII. CLAIM CONSTRUCTION .......................................................................... 18
`
`IX. STATEMENTS OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. § 42.22(a) and 42.104(b)) ................ 19
`
`A. Ground 1: Claims 1-19 Are Unpatentable Under 35 U.S.C. §
`103(a) As Obvious Over Greenough in View of INOmax Label,
`and Jaypee ........................................................................................... 22
`
`1.
`
`Overview of the Prior Art ......................................................... 22
`
`2. Motivation to Combine ............................................................. 25
`
`3.
`
`4.
`
`Independent Claims 1, 7, 12 and 14 .......................................... 30
`
`Dependent Claims 2-6, 8-11, 13, 15-19 .................................... 37
`
`i
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`

`

`
`
`List of Exhibits
`
`Ex. 1001: U.S. Patent No. 8,846,112 to Baldassarre et al. (“‘112 Patent), filed
`
`November 21, 2012, issued September 30, 2014.
`
`Ex. 1002: Declaration of Dr. Edward Lawson.
`
`Ex. 1003: Curriculum vitae of Dr. Edward Lawson.
`
`Ex. 1004: Waivers of Service of Summons in Case No. 2015-cv-00170.
`
`Ex. 1005: Prosecution History for U.S. Patent No. 8,846,112.
`
`Ex. 1006: A. Greenough & A. D. Miller, Neonatal Respiratory Disorders 149,
`
`183–87, 392 (2nd ed. 2003) (“Greenough”).
`
`Ex. 1007:
`
`Jaypee, Pediatric & Neonatal Mechanical Ventilation 148–58
`
`(Praveen Khilnani ed., 1st ed. 2006) (“Jaypee”).
`
`Ex. 1008: Reserved.
`
`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”).
`
`ii
`
`

`

`Ex. 1012: M. Hoeper, et al., Definitions and Diagnosis of Pulmonary
`M. Hoeper,
`et al., Definitions and Diagnosis of Pulmonary
`
`1012:
`
`EX.
`
`Hypertension 62:25 J. of the American College of Cardiology D44
`Hypertension 62:25 J. of the American College of Cardiology D44
`
`(2013) (“Hoeper”).
`(2013) (“Hoeper”).
`
`Ex. 1013: Royster, et al., Differences in Pulmonary Artery Wedge Pressures
`Royster, et al., Difierences in Pulmonary Artery Wedge Pressures
`
`1013:
`
`EX.
`
`Obtained by Balloon Inflation Versus Impaction Techniques, 61
`Obtained by Balloon Inflation Versus Impaction Techniques, 61
`
`Anesthesiology, 339 – 341 (1984) (“Royster”).
`Anesthesiology, 339 — 341 (1984) (“Royster”).
`
`Ex. 1014: Goyal et al., Efficacy of nitroglycerin inhalation in reducing
`Goyal et al., Efiicacy of nitroglycerin inhalation in reducing
`
`1014:
`
`EX.
`
`pulmonary arterial hypertension in children with congenital heart
`pulmonary arterial hypertension in children with congenital heart
`
`disease, British Journal of Anaesthesia, 97(2): 208-14 (2006).
`disease, British Journal of Anaesthesia, 97(2): 208-14 (2006).
`
`(“Goyal”).
`(“Goyal”).
`
`Ex. 1015: Pozzoli, et al., Non-Invasive Estimation of Left Ventricular Filling
`Pozzoli, et al., Non—Invasive Estimation of Left Ventricular Filling
`
`1015:
`
`EX.
`
`Pressures by Doppler Echocardiography, 3 Eur J Echocardiogr.,
`Pressures by Doppler Echocardiography, 3 Eur J Echocardiogr.,
`
`3:75-79 (2002) (“Pozzoli”).
`3:75-79 (2002) (“Pozzoli”).
`
`Ex. 1016: Plaintiff’s Opposition to Defendants’ Motion for Judgment on the
`Plaintiff’s Opposition to Defendants’ Motion for Judgment on the
`
`1016:
`
`EX.
`
`Pleadings for Counts I-V of Plaintiffs’ Complaint, Docket No. 54.
`Pleadings for Counts I—V of Plaintiffs’ Complaint, Docket No. 54.
`
`Ex. 1017: December 4, 2013 Declaration of Dr. James S. Baldassarre Under 37
`December 4, 2013 Declaration of Dr. James S. Baldassarre Under 37
`
`1017:
`
`EX.
`
`C.F.R. § 1.132 Submitted during prosecution of U.S. Patent No.
`C.F.R. § 1.132 Submitted during prosecution of U.S. Patent No.
`
`8,846,112.
`8,846,112.
`
`Ex. 1018: Prosecution History of U.S. Patent No. 8,282,966.
`Prosecution History of U.S. Patent No. 8,282,966.
`
`1018:
`
`EX.
`
`Ex. 1019: Deposition Transcript for January 5, 2016 Deposition of Dr. Geoffrey
`Deposition Transcript for January 5, 2016 Deposition of Dr. Geoffrey
`
`1019:
`
`EX.
`
`
`
`iii
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`iii
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`

`

`L. Rosenthal in IPR2015-00529.
`
`L. Rosenthal in IPR2015—00529.
`
`Ex. 1020: December 16, 2015 Notice of Abandonment in Application Serial No.
`December 16, 2015 Notice of Abandonment in Application Serial No.
`
`. 1020:
`
`Ex
`
`14/451,057.
`14/451,057.
`
`Ex. 1021: December 1, 2015 Notice of Abandonment in Application Serial No.
`December 1, 2015 Notice of Abandonment in Application Serial No.
`
`. 1021:
`
`Ex
`
`14/454,373.
`14/454,373.
`
`Ex. 1022: March 14, 2016 Notice of Abandonment in Application Serial No.
`March 14, 2016 Notice of Abandonment in Application Serial No.
`
`. 1022:
`
`Ex
`
`14/482,704.
`14/482,704.
`
`Ex. 1023: Definition
`Definition
`
`. 1023:
`
`Ex
`
`of
`of
`
`“Contraindication”
`“Contraindication”
`
`on Medicine.net.com;
`on
`Medicine.net.com;
`
`https://web.archive.org/web/20060812144659/http://www.medterms.c
`https://web.archiVe.org/web/20060812144659/http://www.medterms.c
`
`om/script/main/art.asp?articlekey=17824, (Aug. 12, 2006), 2 pages.
`om/script/main/art.asp?articlekey=17824, (Aug. 12, 2006), 2 pages.
`
`
`
`
`
`iv
`
`iv
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`I.
`
`INTRODUCTION
`
`Praxair Distribution, Inc. and NOxBOX Limited (collectively “Petitioner”)
`
`hereby request Inter Partes Review (“IPR”) of claims 1-19 of U.S. Patent No.
`
`8,846,112 (“the ‘112 Patent”) (Ex. 1001) under 35 U.S.C. §§ 311–319.
`
`Praxair Distribution, Inc. (“Praxair”) previously filed a petition seeking IPR
`
`of the ‘112 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
`
`entirely new art and arguments, including specific recitations of information that
`
`may be provided along with canisters of inhaled nitric oxide (“iNO”) disclosing
`
`that patients with any type of left ventricular dysfunction (“LVD”) should not be
`
`treated with iNO, the Board should institute trial in light of the discretion permitted
`
`by 35 U.S.C. § 325(d). See infra Section VI.1
`
`II. OVERVIEW OF THE ‘112 Patent
`A.
`Summary of the ‘112 Patent
`Nitric oxide (“NO”) is a gaseous chemical compound used to treat patients
`
`with severe breathing problems. Ex. 1002 at ¶ 14. In 1999, the U.S. Food and
`
`
`1 As described further below, to the extent that the Board finds all the claims of
`
`the ‘112 Patent invalid in IPR2015-00529 (“‘529 IPR”), there is no need for the
`
`Board to consider the instant petition other than the possibility that the Federal
`
`Circuit eventually reverses the Board’s conclusions.
`
`1
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`Drug Administration (“FDA”) approved inhaled nitric oxide to treat term and near-
`
`term infants (born after the 34th week of gestation) with hypoxic respiratory failure
`
`associated with clinical or echocardiographic evidence of pulmonary hypertension.
`
`Ex. 1001 at 1:20-25; 3:34-36; see also Ex. 1010. Pulmonary hypertension is
`
`characterized by an increased pulmonary artery pressure and increased pulmonary
`
`vascular resistance. See, e.g. Ex. 1001 at 5:29-34. Nitric oxide is a selective
`
`pulmonary vasodilator that increases the partial pressure of arterial oxygen by
`
`dilating pulmonary vessels in ventilated areas of the lung, and directing blood flow
`
`away from areas with low ventilation/perfusion ratios toward regions with normal
`
`ratios. Ex. 1001 at 3:36-42.
`
`Mallinckrodt Hospital Products IP Ltd., through its subsidiary iNO
`
`Therapeutics, Inc. (“Patent Owner”), is the exclusive supplier in the U.S. for iNO,
`
`which it sells under the brand INOmax®. Ex. 1001 at 3:34-46; 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:
`
`INOmax, in conjunction with ventilatory support and other 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 3:34-56.
`
`2
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`The FDA’s original prescribing information for INOmax also includes a
`
`“CONTRAINDICATIONS section” that describes situations in which INOmax
`
`“should not be used.” Ex. 1001 at 3:53-56; Ex. 1010 at 4. The Label also includes
`
`descriptions of situations in which nitric oxide should be used with caution in the
`
`“PRECAUTIONS” and “ADVERSE REACTIONS” sections. Ex. 1010 at 4-5.
`
`Nine years after the FDA approved INOmax for sale in the United States,
`
`iNO Therapeutics, Inc. filed the application that ultimately lead to the ‘112 Patent.
`
`Ex. 1001 at cover; see also Ex. 1010.
`
`The ‘112 Patent does not purport to relate to any inventive method of
`
`treating a patient with iNO or using iNO. To the contrary, it instead claims
`
`methods of providing information about potential contraindications2 for iNO
`
`2 The March 14, 2011 definition for “contraindication” from Medicine.Net is
`
`listed in a reference on the face of the ‘112 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 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
`
`3
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`therapy and instructions for the potential exclusion of patients from therapy based
`
`thereon. See, e.g., Ex. 1001 at 14:28-52 and 14:57-15:7; 15:8-33; Ex. 1002 at ¶ 11.
`
`The purported invention of the ‘112 Patent is simply the recognition that
`
`cylinders of nitric oxide should be provided to doctors with instructions that
`
`patients with LVD should not necessarily be treated with iNO. Despite Patent
`
`Owner’s claim that this is new and non-obvious as of the filing of the ‘112 Patent,
`
`the prior art cited in this Petition shows that LVD was described in the literature as
`
`a contraindication for treatment with iNO before June 30, 2009, the earliest
`
`possible priority date (“EPD”) of the ‘112 Patent.
`
`Given that the allegedly novel aspect of the ‘112 Patent is disclosed in the
`
`written prior art, it is unsurprising that the claims of the ‘112 Patent merely
`
`combine providing cylinders containing compressed nitric oxide gas for
`
`determining who can or cannot be safely treated with iNO and excluding those
`
`who cannot be safely treated with iNO. See, e.g., Ex. 1001 at 1:50-63; 3:34-62;
`
`Ex. 1010.
`____________________
`particular treatment or procedure absolutely inadvisable.” Id. As described in
`
`the ‘112 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).
`
`4
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`In fact, Patent Owner has admitted in filings made to the United States
`
`District Court for the District of Delaware that, other than the step of choosing to
`
`exclude patients with LVD from treatment with iNO, all the steps of the patent
`
`claims “were well-known and practiced.” Ex. 1016, Dkt. No. 54 at 16 (“the
`
`individual analytical techniques” recited in the claims of U.S. Patent No.
`
`8,282,966, as well as in the other patents in the same family (including the ‘112
`
`Patent), “were well-known and practiced.”) The prior art references discussed in
`
`this Petition reinforce that concession, as the prior art discloses all of the
`
`limitations of the ‘112 Patent, including the allegedly novel step of providing
`
`information regarding the risks of treating patients with LVD with iNO.
`
`These references all relate to providing information regarding risks and
`
`contraindications associated with treating patients with iNO, and particularly
`
`associated with treating neonatal patients. This Petition identifies where printed
`
`publication-type prior art shows the provision of nitric oxide in conjunction with
`
`information regarding avoidance of treatment of patients with LVD. Accordingly,
`
`this Petition should be granted and trial instituted on all of the challenged claims.
`
`Summary of the Prosecution History of the ‘112 Patent
`
`B.
`The application leading to the ‘112 Patent was filed on November 21, 2012.
`
`Ex. 1005 at cover. On January 3, 2013, the Examiner rejected the claims under 35
`
`U.S.C. § 101, stating that the claims were “directed to mental processes which are
`
`5
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`non-statutory subject matter.” Ex. 1005 at 222-27. The Examiner stated that
`
`“[t]he Examiner cannot see how a method of: ‘Here, take this nitric oxide gas
`
`source, but do not do anything with it’ is patent eligible.” Ex. 1005 at 225. Patent
`
`Owner amended the claims on April 2, 2013, and argued that its claims required
`
`active steps and thus were patent eligible. Ex. 1005 at 285-307. Not satisfied, the
`
`Examiner issued a final rejection on April 24, 2013, finding that the parent
`
`applications did not disclose a “method of distributing a pharmaceutical product,”
`
`and thus finding that Patent Owner would be afforded a filing date of November
`
`21, 2012. Ex. 1005 at 325. The Examiner also maintained the previous rejection
`
`under 35 U.S.C. § 101. Ex. 1005 at 326-29. Finally, the Examiner rejected the
`
`claims as obvious. Ex. 1005 at 329-38. In response, Patent Owner filed for a
`
`correction of inventorship (Ex. 1005 at 354) and filed a response with three
`
`affidavits from two different employees/partial owners of INO Therapeutics in
`
`support of the alleged patentability of the claims. Ex. 1005 at 378-686. The
`
`affidavits allegedly supported arguments for non-obviousness (based on the
`
`findings from the INOT22 study)3 and that a prior art reference that pre-dated the
`
`3 Patent Owner has argued to this Board the INOT22 study renders the claims of
`
`the ‘112 Patent novel. See, e.g., ‘529 IPR, Patent Owner Response, Paper No.
`
`22 at 59 (“…the repeated failure of experts in the field to recognize the need to
`
`exclude pediatric patients with non-RTL-Dependent LVD from being treated
`
`6
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`EPD by more than 11 months should not be prior art because the sole inventor
`
`conceived and reduced to practice 11 months before filing the patent application.
`
`See id. The Examiner issued another rejection, again asserting that the priority
`
`claim was improper and that the claims were invalid as obvious. Ex. 1005 at 690-
`
`721. Patent Owner again amended the claims and argued that its priority claim
`
`supported the pending claims, and therefore that the primary reference involved in
`
`the rejection under 35 U.S.C. § 103 should be disqualified as prior art. Ex. 1005 at
`
`735-51. After a final rejection containing non-statutory obviousness-type double
`
`patenting rejections, Patent Owner filed the necessary terminal disclaimers and the
`
`‘112 Patent issued on September 30, 2014.
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`Petitioner certifies that (1) the ‘112 Patent, issued on September 30, 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
`
`____________________
`with iNO and the unexpected results stemming from the INOT22 study
`
`represent such evidence [supporting patentability].”) However, this Petition
`
`explicitly shows that Patent Owner’s statements regarding the INOT22 study
`
`are incorrect: at least Greenough and Jaypee teach that all neonates with LVD
`
`generally should be excluded from treatment.
`
`
`
`7
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`relating to the ‘112 Patent and (4) Petitioner is filing this petition within one year
`
`of being served with a complaint for infringement. 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
`
`Drug Application (“ANDA”) infringes the ‘112 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
`
`8
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`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 ‘112 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 ‘112 Patent in
`
`the ‘529 IPR. The Patent Trial and Appeal Board (“Board”) granted that petition.
`
`IPR2015-00529, Paper 12. That proceeding is currently pending, with a final
`
`written decision expected in the July/August 2016 timeframe. The primary issue in
`
`that case is whether all the claim terms should be given patentable weight. Id. To
`
`the extent that the Board finds that all the claim elements should be given
`
`patentable weight, Petitioner avers that the art in the present petition discloses each
`
`and every claim element. Accordingly, the instant Petition is crafted under the
`
`assumption that all of the claim elements in the ‘112 Patent should be given
`
`patentable weight.
`
`Praxair also filed four other petitions directed to patents in the same family
`
`as the ‘112 Patent. Those petitions were denied on July 29, 2015. See IPR2015-
`
`00522, Paper No. 12; IPR2015-00524, Paper 12; IPR2015-00525, Paper 12;
`
`IPR2015-00526, Paper 12.
`
`9
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
`
`Petitioner is concurrently requesting IPR of U.S. Patent Nos. 8,282,966;
`
`8,293,284; 8,431,163; and 8,795,741, which are in the same family as the ‘112
`
`Patent.
`
`One pending U.S. patent application claims priority to the ultimate parent
`
`application of the ‘I12 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
`
`ultimate parent application of the ‘112 Patent (U.S. Application Serial Nos.
`
`14/451,057, 14/454,373, and 14/482,704), but all are currently 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
`
`70 W. Madison St., Suite 3100
`
`F: 312 827-8057
`
`Chicago, IL 60602
`T: (312) 781-7166
`F: 312 345-1843
`
`Chicago, IL 60602
`T: (312) 807-4280
`
`10
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`Petition for Inter Partes Review of U.S_ Patent No. 8,846,112
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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 Admission
`Reg. No. 45,976
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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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`
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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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`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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`Petitioner previously filed a Petition for IPR of the ‘ 1 12 Patent on January 5,
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`2015. ‘529 IPR, Paper 1.
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`In that proceeding, Patent Owner filed a Preliminary
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`Response on May 6, 2015.
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`‘529 IPR, Paper 8. The Board issued a Decision
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`instituting trial on July 29, 2015.
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`‘529 IPR, Paper 12.
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`In the Institution Decision,
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`the Board found that certain claim elements, such as the step in the independent
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`claims of providing information or recommendations to a medical provider
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`regarding treatment of patients with iNO, specifically that patients with LVD may
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`be at risk of pulmonary edema upon treatment (the “providing infonnation”
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`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
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`limitations), should not be given patentable weight. ‘529 IPR, Paper 12 at 8-13.
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`The Panel is likely to reach a Final Written Decision in that case by July or August
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`of 2016. If that decision confirms the Institution Decision and does not give the
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`“providing information” limitations patentable weight, then it is Petitioner’s
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`position that the Board need not consider the present petition except in the
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`eventuality of Federal Circuit reversal. Should the Panel find that the “providing
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`information” limitations are to be given patentable weight, the present Petition
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`provides references that explicitly disclose the “providing information” limitations.
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`Notwithstanding the ‘529 IPR, this Petition demonstrates a reasonable likelihood
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`that at least one of the challenged claims is unpatentable (37 C.F.R. § 42.108(c)),
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`and the Board should institute trial despite the discretion permitted by 35 U.S.C. §
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`325(d).
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`35 U.S.C. § 325(d) is titled “MULTIPLE PROCEEDINGS” and provides:
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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
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`exercise its Congressionally-granted discretion to institute a second petition
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`directed to a previously-challenged patent. See, e.g., Ericsson Inc. et al. v.
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`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
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`Intellectual Ventures I LLC, Case IPR2015-01367, Paper 6 at 5-6 (PTAB Dec. 9,
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`2015). Here, the Board should decline to exercise its discretion, and should
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`institute trial.
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`The instant Petition is based on an entirely new theory as compared to the
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`‘529 IPR. That theory involves using the teachings of the Greenough and Jaypee
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`references previously unknown to Praxair and previously unconsidered by the
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`Examiner or the Board, which teach that LVD is an absolute contraindication from
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`treatment with iNO. Contrary to the ‘529 IPR, in the present petition, it is assumed
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`that all claim elements are given patentable weight. To the extent that the Board
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`finds that the claim elements are to be given patentable weight, this Petition
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`explains how all the elements are nonetheless shown in printed publications in the
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`art not previously considered by the Board. Specifically, Greenough, Jaypee, and
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`the theory of combination have never been considered with regard to the claims of
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`the ‘112 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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`‘529 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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`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
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`treatment. The art and arguments relied on herein also are substantially different
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`from those previously considered by the Office because all of the references
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`unquestionably relate to neonates; by contrast, some of the references previously
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`relied on arguably related to other categories of patients. The arguments presented
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`here are of a different character and advance a different theory and thus are
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`substantially different from arguments and prior art previously presented. See
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`International Bus. Machines Corp. v. Intellectual Ventures II LLC, Case IPR2015-
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`01323, Paper 12 at 5-7 (PTAB Dec. 8, 2015). 4
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`4 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 North America,
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`Inc. et al. v. Magna Elec., Inc., Case IPR2014-01203, Paper 13 at 10-11 (PTAB
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`Jan. 28, 2015); Oxford Nanopore Techs. Ltd. v. Univ. of Wash. Et al., Case
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`IPR2015-00057, Paper 10 at 20-21 (PTAB April 27, 2015); Atlas Copco
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`Airpower N.V. v. Kaeser Kompressoren SE, Case IPR2015-01421, Paper 8 at 6-
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`8 (PTAB Dec. 28, 2015); Valeo North Amer., Inc. et al. v. Magna Elec. Inc.,
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`Case Nos. IPR2015-01410 and IPR2015-01414, Paper 7 at 11-13 (PTAB Dec.
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`28, 2015).
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`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
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`These references were also not available to Praxair at the time of filing of
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`the ‘522 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 PTO during
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`examination, it was not until after the IPRs were filed that these references were
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`located. Tellingly, when faced with rejections based on Greenough and/or Jaypee
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`that occurred because those references were located only after the ‘529 IPR
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`Petition was submitted to the examiner of three pending applications in the family
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`of the ‘741 Patent, Patent Owner chose to abandon each of those three applications.
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`See, e.g. Ex. 1020, 14/451,057, Notice of Abandonment dated Dec. 16, 2015 for
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`Non Response to Office Action dated May 7, 2015; Ex. 1021, 14/454,373, Notice
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`of Abandonment dated Dec. 16, 2015 for Non Response to Office Action dated
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`May 7, 2015; Ex. 1022, 14/482,704, Notice of Abandonment dated March 14,
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`2016 for Non Response to Office Action dated July 30, 2015.
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`Here, Praxair filed a first round of IPR petitions before it was sued for patent
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`infringement. Despite conducting diligent searches, Praxair did not find the
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`Greenough or Jaypee references prior to filing the first set of IPRs. See, e.g. Ex.
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`1009, Exemplary List of Search Results from Cardinal Intellectual Property, Inc.5
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`5 As shown in the exemplary search attached as Exhibit 1009, Praxair’s searching
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`prior to filing the first set of IPRs, which includes specific searches for art
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`disclosing exclusion of patients with LVD from treatment with iNO, should be
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`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
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`It was thereafter sued, and correspondingly its efforts to generate prior art for use
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`in the district court litigation continued and intensified. Through the course of
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`these additional efforts Praxair was able to uncover the art relied on herein.
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`Praxair is not simply harassing Patent Owner – instead, it is presenting invalidity
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`arguments developed after filing of the district court lawsuit that could not have
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`been raised in the initial IPR petitions. The Board recently held that just such a
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`scenario, where a previously un-located prior art reference that squarely addressed
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`the purportedly patentable limitations of the claims following denial of a prior
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`petition for IPR, warranted institution of the second IPR. World Bottling Cap,
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`considered to be more than reasonable and Praxair should not be prejudiced by
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`the fact that its pre-litigation prior art searches did not reveal the Greenough
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`and Jaypee references. As described by Senator Kyl in the legislative history of
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`the America Invents Act, Petitioners should not be estopped from raising art
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`and arguments that were not uncovered through reasonably diligent searching:
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`The present bill also softens the could-have-raised estoppel that is
`applied by inter partes review against subsequent civil litigation by
`adding the modifier “reasonably.”
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`.
`. Adding the modifier
`“reasonably” ensures that could-have-raised estoppel extends only to
`that prior art which a skilled searcher conducting a diligent search
`reasonably could have been expected to discover.
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`157 Cong. Rec. S1375 (daily ed. Mar. 8, 2011).
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`Petition for Inter Partes Review of U.S. Patent No. 8,846,112
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`LLC v. Crown Packaging Tech., Inc., Case IPR2015-01651, Pa