`
`
`
`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`
`
`PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`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. 8,293,284
`
`
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313–1450
`
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`Table of Contents
`
`INTRODUCTION ........................................................................................... 1
`
`Page
`
`
`
`
`I.
`
`II.
`
`OVERVIEW .................................................................................................... 1
`
`A.
`
`B.
`
`Summary of the ‘284 Patent .................................................................. 1
`
`Summary of the Prosecution History of the ‘284 Patent ...................... 6
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ................................. 9
`
`IV. PAYMENT OF FEES (37 C.F.R. § 42.103) ................................................. 10
`
`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 ........................................ 21
`
`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 1-3, 5-9, 11, 13, 14, 16-18, 21, 23-27, and 29
`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
`
`i
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`3.
`
`4.
`
`5.
`
`Independent Claims 1 and 6 ...................................................... 32
`
`Independent Claims 13 and 23 .................................................. 41
`
`Dependent Claims 2-3, 5, 7-9, 11, 14, 16-18, 21, 24-27, and
`29 ............................................................................................... 45
`
`B.
`
`Ground 2: Claims 4, 10, 12, 15, 19, 20, 22, 28, and 30 are
`Unpatentable Under 35 U.S.C. § 103(a) as Obvious Over
`Greenough, Jaypee, and Widlitz .......................................................... 51
`
`X.
`
`CONCLUSION .............................................................................................. 53
`
`
`
`
`
`ii
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`List of Exhibits
`
`Ex. 1001: U.S. Patent No. 8,293,284 (“‘284 Patent”), filed June 22, 2010, issued
`
`October 23, 2012.
`
`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 of U.S. Patent No. 8,293,284.
`
`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: A. Widlitz et al, Pulmonary arterial hypertension in children,
`
`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
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`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
`
`disease, British Journal of Anaesthesia, 97(2): 208-14 (2006).
`
`(“Goyal”).
`
`Ex. 1015: Pozzoli, et al., Non-Invasive Estimation of Left Ventricular Filling
`
`Pressures by Doppler Echocardiography, 3 Eur J Echocardiogr.,
`
`3:75-79 (2002) (“Pozzoli”).
`
`Ex. 1016: Plaintiff’s Opposition to Defendants’ Motion for Judgment on the
`
`Pleadings for Counts I-V of Plaintiffs’ Complaint, Case No. 2015-cv-
`
`00170, Docket No. 54.
`
`Ex. 1017: December 4, 2013 Declaration of Dr. James S. Baldassarre Under 37
`
`C.F.R. § 1.132 Submitted during prosecution of U.S. Patent No.
`
`8,846,112.
`
`Ex. 1018: Prosecution History of U.S. Patent No. 8,282,966.
`
`iv
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`Ex. 1019: Deposition Transcript for January 5, 2016 Deposition of Dr. Geoffrey
`
`L. Rosenthal in IPR2015-00529.
`
`Ex. 1020: December 16, 2015 Notice of Abandonment in Application Serial No.
`
`14/451,057.
`
`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.
`
`14/482,704.
`
`Ex. 1023: Definition
`
`of
`
`“Contraindication”
`
`on Medicine.net.com;
`
`https://web.archive.org/web/20060812144659/http://www.medterms.c
`
`om/script/main/art.asp?articlekey=17824, (Aug. 12, 2006) 2 pages.
`
`v
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`I.
`
`INTRODUCTION
`
`Praxair Distribution, Inc. and NOxBOX Limited (collectively “Petitioner”)
`
`hereby request Inter Partes Review (“IPR”) of claims 1-30 of U.S. Patent No.
`
`8,293,284 (“‘284 Patent”) (Ex. 1001) under 35 U.S.C. §§ 311–319.
`
`Praxair Distribution, Inc. (“Praxair”) previously filed a petition seeking IPR
`
`of the ‘284 Patent. However, at the time of filing that petition, Petitioner 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 that patients with any
`
`type of left ventricular dysfunction (“LVD”) should not be treated with inhaled
`
`nitric oxide (iNO), the Board should institute trial in light of the discretion
`
`permitted by 35 U.S.C. § 325(d). See infra Section VI.
`
`II. OVERVIEW
`A.
`Summary of the ‘284 Patent
`Nitric oxide (“NO”) is a gaseous chemical compound used to treat patients
`
`with severe breathing problems. Ex. 1002 at ¶ 13. In 1999, the U.S. Food and
`
`Drug Administration (“FDA”) approved iNO 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 1:20-24, 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 5:22-27. Nitric oxide is a selective pulmonary
`1
`
`
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`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 3:31-44; 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:
`
`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 3:34-55. 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 3:46-51;
`
`Ex. 1010 at 4.
`
`Nine years after the FDA approved INOmax for sale in the United States,
`
`INO Therapeutics, Inc. filed the application that ultimately lead to the ‘284 Patent.
`
`Ex. 1001 at cover; see also Ex. 1010.
`
`
`
`2
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`The ‘284 Patent does not purport to relate to any inventive method of
`
`treating a patient with iNO or using iNO. To the contrary, it discloses admittedly
`
`well-known diagnostic steps and analyses to determine whether a patient with
`
`LVD is at risk of a Serious Adverse Event (“SAE”), such as pulmonary edema, if
`
`treated with iNO, and excluding such patients from treatment based on the assessed
`
`risk.1 Ex. 1001 at Abstract, 1:49-62; Ex. 1002 ¶ 11.
`
`The purported invention of the ‘284 Patent is simply the allegedly new
`
`recognition that patients with non right-to-left shunting dependent LVD (“non-
`
`RTL LVD”) should be excluded from treatment with iNO. Ex. 1001 at 9:13-22,
`
`14:11-25, 14:44-59, 15:12-30, 16:8-29. Despite 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 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 earliest possible priority date
`
`(“EPD”) of the ‘284 Patent.
`
`After the allegedly novel aspect of the ‘284 Patent is stripped away, the
`
`claims of the ‘284 Patent describe nothing more than well-known methods and
`
`1 The ‘284 Patent describes a “Serious Adverse Event” or “SAE” as “a
`
`significant hazard or side effect, regardless of the investigator’s opinion on the
`
`relationship to the investigational product.” Ex. 1001 at 4:36-40.
`
`
`
`3
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`techniques (e.g., echocardiography, 2 measuring wedge pressure,3 measuring blood
`
`oxygen, etc.) for determining who can or cannot be safely treated with iNO. See,
`
`e.g., Ex. 1001 at 4:63-65 (“Patients having pre-existing LVD may be described in
`
`general as those with elevated pulmonary capillary wedge pressure”); id. at 5:7-11
`
`(“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 5:14-16 (“Identifying patients with pre-existing PCWP is known to those
`
`skilled in the medicinal arts”); id. at 6:27-31 (“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 ¶¶ 25-44. 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
`
`heart. Ex. 1002 at n. 2.
`
`3 “Wedge pressure” is also sometimes referred to as pulmonary capillary wedge
`
`pressure (“PCWP”), pulmonary artery occlusion pressure, or merely “wedge.”
`
`Ex. 1002 at ¶ 12. Wedge pressure may be determined via measurement through
`
`cardiac catheterization or by extrapolation through echocardiography. Ex. 1002
`
`at ¶ 19.
`
`
`
`4
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`prior art in accordance with MPEP §2129. See Intri–Plex Technologies, Inc. and
`
`Mmi Holdings, Ltd., v. Saint–Gobain Performance Plastics Rencol Limited, Case
`
`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
`
`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
`
`of choosing to exclude patients with non-RTL dependent 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 (“‘966 Patent”), as well as in the other patents
`
`in the same family (including the ‘284 Patent), “were well-known and practiced.”).
`
`These arguments thus confirm what the specification of the ‘284 Patent admits:
`
`the analytical techniques recited in the claims of the ‘284 Patent were well known
`
`methods and techniques. See, e.g, Ex. 1001 at 4:63-65; 5:7-19, 6:27-45. Thus the
`
`prior art references discussed in this Petition reinforce that concession, as the prior
`
`art discloses all of the limitations of the ‘284 Patent, including the allegedly novel
`
`exclusion step.
`
`The prior art references relied on here all relate
`
`to risks and
`
`contraindications associated with treating patients with iNO, and particularly
`
`
`
`5
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`associated with treating neonatal patients. This petition identifies where printed
`
`publication-type prior art teaches the use of well-known practices to determine
`
`whether neonatal patients have non-RTL dependent 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 1-30 of the ‘284 Patent.
`
`Summary of the Prosecution History of the ‘284 Patent
`
`B.
`The application leading to the ‘284 Patent was filed on June 22, 2010. Ex.
`
`1001 at cover. Patent Owner submitted several declarations 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 who was not dependent on right-to-
`
`left shunting of blood harmed by treatment with iNO. See, e.g. Ex. 1005 at 74-77.
`
`The factual premise of these declarations 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 ‘284 Patent novel. See, e.g., IPR2015-00524, Patent Owner
`
`Preliminary Response, Paper 8 at 2 (“…the evidence submitted during
`
`prosecution demonstrating that those of extraordinary skill in the art were
`
`unaware that all neonates with LVD should be excluded from iNO therapy.”).
`
`
`
`6
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`The prosecution history is also contrary to Patent Owner’s arguments, as the
`
`Examiner did not find that the exclusion step was novel. The Examiner even stated
`
`that “What did Applicant actually do? The instant specification teaches that
`
`children with pulonary [sic] hypertension where [sic] treated with 80 ppm NO
`
`inhalation gas therapy [0066] and two patients developed signs of pulmonary
`
`edema which has been previously reported in 1994 and 1996, over ten years before
`
`the present application was filed, with the use of iNO in patents [sic] with LVD
`
`due to decreasing PVRI and overfilling of the left atrium [0062].” Ex. 1005 at
`
`801-837 (internal citations omitted). Relying on this conclusion, the Examiner
`
`noted, in the August 14, 2012 interview that even in view of the previously-
`
`submitted declarations, in the prosecution of the related ‘966 Patent, 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 51. Additionally, the Examiner suggested that the Patent
`
`Owner “do a similar amendment in the present application [that eventually issued
`
`as the ‘284 patent] as well.” Ex. 1005 at 871.
`
`
`However, this Petition explicitly shows that Patent Owner’s statements
`
`regarding the INOT22 study are incorrect: at least Greenough and Jaypee teach
`
`that neonates with LVD should be excluded from treatment.
`
`
`
`7
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`Thus, on August 15, 2012, Patent Owner amended all four independent
`
`claims to specify that the dosage of iNO should be 20 parts per million (“ppm”),
`
`and that a patient identified as needing treatment has a pulmonary capillary wedge
`
`pressure greater than or equal to 20 mm Hg and thus has LVD. Ex. 1005 at 864-
`
`870 (additions via amendment underlined). Representative application Claim 38
`
`(which issued as Claim 1 of the ‘284 Patent) reproduced below illustrates these
`
`amendments:
`
`
`Patent Owner did not provide any substantive arguments regarding the cited prior
`
`art, nor did it make any arguments based on the declarations they submitted with
`
`the prior response to the Office Action. Instead, Patent Owner merely amended the
`
`claims as shown and stated: “Applicants do not agree that the claims as they stood
`
`prior to the present amendment were obvious. Nonetheless, in the interest of
`
`
`
`8
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`advancing prosecution, Applicants have amended the claims in a manner consistent
`
`with the above-described communications with the Examiner.” Ex. 1005 at 872.
`
`On September 4, 2012, the Examiner issued a notice of allowance 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 of a term or near term neonate 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. 1005 at 971 (emphasis added). The same day, Patent Owner filed
`
`comments asserting that “the Examiner’s statement of reasons for allowance . . .
`
`describes just some of many reasons that the present claims are allowable over
`
`the cited art of record.” Ex. 1005 at 991.
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`Petitioner certifies that (1) the ‘284 Patent, issued on October 23, 2012, 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 ‘284 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 Corp. v. A&J Mfg., LLC,
`
`Case IPR2015-00056, Paper 10 at 6-7 (PTAB Mar. 23, 2015); Motorola Mobility
`
`
`
`9
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`LLC v. Arnouse, Case IPR2013-00010, Paper 20 at 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
`
`Drug Application (“ANDA”) infringes the ‘284 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
`10
`
`
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`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 ‘284 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 ‘284 Patent in
`
`IPR2015-00524 (“the ‘524 IPR”). The Patent Trial and Appeal Board (“Board”)
`
`denied that petition. ‘524 IPR, Paper 12. Praxair also filed three other petitions
`
`directed to patents in the same family as the ‘284 Patent that were also denied on
`
`July 29, 2015 in the same decision that denied the ‘524 IPR. See IPR2015-00522,
`
`Paper 12; IPR2015-00525, 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 ‘284 Patent, in IPR2015-00529. The
`
`Board instituted review of that patent on July 29, 2015. IPR2015-00529, Paper 12.
`
`That proceeding is currently pending, with a final written decision expected in the
`
`July/August 2016 timeframe.
`
`
`
`11
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`Petitioner is concurrently requesting IPR of U.S. Patent Nos. 8,282,966;
`
`8,431,163; 8,795,741; and 8,846,112, which are in the same family as the ‘284
`
`Patent.
`
`One pending U.S. patent application claims priority to the ultimate parent
`
`application of the ‘284 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 ‘284 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
`
`12
`
`
`
`Petition for Inter Partes Review of U.S_ Patent No. 8,293,284
`
`Backu n Counsel
`
`Backu o Counsel
`
`
`
`Michael J. Abernathy
`Sanj ay K. Murthy
`Pro
`Hac
`Vice
`Reg. No. 45,976
`Admission
`
`To Be Requested
`sanjay.murthy_@morganlewis.com
`mike.abemathy@morganlewis.com
`
`Morgan, Lewis & Bockius LLP
`Morgan, Lewis & Bockius LLP
`
`77 West Wacker Dr., Fifth Floor
`77 West Wacker Dr., Fifth Floor
`
`Chicago, IL 60601
`Chicago, IL 60601
`
`T: (312) 324-1448
`T: (312) 324-1447
`
`F: 312 324-1001
`F: (312)324-1001
`
`
`
`
`
`
`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
`
`Maria E. Doukas
`
`
`
`
`
`
`
`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 ‘284 Patent on January 5,
`
`2015.
`
`‘524 IPR, Paper 1.
`
`In that proceeding, Patent Owner filed a Preliminary
`
`Response on May 4, 2015.
`
`‘524 IPR, Paper 8. The Board issued a Decision
`
`declining to institute trial on July 29, 2015.
`
`‘524 IPR, Paper 12. Notwithstanding
`
`the ‘524 IPR, this Petition demonstrates a reasonable likelihood that at least one of
`
`the challenged claims is unpatentable (37 C.F.R. § 42.l08(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:
`
`13
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`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.
`
`The instant Petition is based on an entirely new theory with regard to the
`
`allegedly patentable exclusion claimed in the ‘284 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 contraindication5 from treatment with iNO.
`
`5 The March 14, 2011 definition for “contraindication” from Medicine.Net is
`
`listed in a reference on the face of the ‘284 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;
`
`
`
`14
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`Greenough, Jaypee and additional secondary reference Widlitz have never been
`
`considered with regard to the claims of the ‘284 Patent, and the theory of
`
`combination presented here, has never been considered with regard to the claims of
`
`the ‘284 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
`
`‘524 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
`
`
`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 ‘284 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).
`
`
`
`15
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`iNO treatment.6 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 ‘524 IPR was deficient with regard to the explicit teaching of
`
`excluding neonatal patients with LVD from iNO treatment, the reliance on
`
`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).7 The substantial difference between the prior art and
`
`6 Therefore, these references squarely address the primary deficiency identified
`
`by the PTAB in the Denial of Institution in the ‘524 IPR. ‘524 IPR, Paper 12.
`
`7 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.
`
`
`
`16
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,293,284
`
`arguments here is further emphasized by Praxair’s decision not to request rehearing
`
`in the ‘524 IPR; the theories and art presented here were not included in the ‘524
`
`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, 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 ‘524 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 those references were located only after the ‘524 IPR
`
`Petition was submitted to the examiner of three pending applications in the family
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
