Filed on behalf of: Mallinckrodt Hosp. Prods. IP Ltd.
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`Entered: September 16, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
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`v.
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`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner.
`_______________________
`
`Case IPR2015-00529
`U.S. Patent No. 8,846,112 B2
`_______________________
`
`Before LORA M. GREEN, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`PATENT OWNER’S
`NOTICE OF CROSS-APPEAL
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`Entered: September 16, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
`
`v.
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`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner.
`_______________________
`
`Case IPR2015-00529
`U.S. Patent No. 8,846,112 B2
`_______________________
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`Before LORA M. GREEN, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`PATENT OWNER’S
`NOTICE OF CROSS-APPEAL
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`Case IPR2015-00529
`U.S. Patent No. 8,846,112
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`Notice is hereby given, pursuant to 37 C.F.R. § 90.2(a), Federal Rule of
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`Appellate Procedure 4(a)(3) and Federal Circuit Rule 15, that Patent Owner
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`Mallinckrodt Hospital Products IP Ltd., (“Patent Owner”) hereby cross-appeals to
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`the United States Court of Appeals for the Federal Circuit from the Final Written
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`Decision entered by the Patent Trial and Appeal Board (the “Board”) on July 7,
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`2016 (Paper 53) (the “Final Written Decision,” a copy of which is attached hereto)
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`and from all underlying orders, decisions, rulings, and opinions.
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`This notice is timely because Petitioner Praxair Distribution, Inc. filed a
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`notice of appeal on September 6, 2016. That appeal was assigned Case No.
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`16-2616.
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`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Patent Owner further indicates
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`that the expected issues on appeal include the Board’s decision that claims 1, 7, 12,
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`and 14 of the patent-at-issue are anticipated and obvious, that claims 1-8 and 10-19
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`of the patent-at-issue are obvious, and any underlying or related orders, decisions,
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`rulings, and opinions.
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`Simultaneous with this submission, a copy of this Notice of Cross-Appeal is
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`being filed with the Board, as well as with the Clerk of the United States Court of
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`Appeals for the Federal Circuit.
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`Case IPR2015-00529
`U.S. Patent No. 8,846,112
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`Dated: September 16, 2016
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`Respectfully submitted,
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`By: /s/ Robert Steinberg
`Robert Steinberg (Reg. No. 33,144)
`bob.steinberg@lw.com
`Latham & Watkins LLP
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`213.485.1234; 213.891.8763 (Fax)
`
`Counsel for Patent Owner
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`2
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`Case IPR2015-00529
`U.S. Patent No. 8,846,112
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`CERTIFICATE OF SERVICE
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`I hereby certify that, on this 16th day of September, 2016, in addition to
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`being filed electronically through the Patent Trial and Appeal Board’s Patent
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`Review Processing System (PRPS), the foregoing Patent Owner’s Notice of Cross-
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`Appeal was delivered by hand to the Director of the United States Patent and
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`Trademark Office, at the following address pursuant to 37 C.F.R. § 104.2:
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`Office of the General Counsel
`United States Patent and Trademark Office
`Madison Building East, 10B20
`600 Dulany Street
`Alexandria, VA 22314-5793
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`I further certify that, on this 16th day of September, 2016, a copy of the
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`foregoing Patent Owner’s Notice of Cross-Appeal, along with the required
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`docketing fee, was submitted electronically through the United States Court of
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`Appeals for the Federal Circuit’s CM/ECF system.
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 16th day of
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`September, 2016, a true and correct copy of the foregoing Patent Owner’s Notice
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`of Cross-Appeal was served by electronic mail on Petitioner’s lead and backup
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`counsel at the following email addresses:
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`sanjay.murthy@morganlewis.com
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`mike.abernathy@morganlewis.com
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`maria.doukas@morganlewis.com
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`Case IPR2015-00529
`U.S. Patent No. 8,846,112
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`By: /s/ Robert Steinberg
`Robert Steinberg (Reg. No. 33,144)
`bob.steinberg@lw.com
`Latham & Watkins LLP
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`213.485.1234; 213.891.8763 (Fax)
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`2
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`Trials@uspto.gov
`Tel: 571-272-7822
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`Paper 53
`Entered: July 7, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
`
`v.
`
`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner.
`_______________
`
`Case IPR2015-00529
`Patent 8,846,112 B2
`_______________
`
`
`Before LORA M. GREEN, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`POLLOCK, Administrative Patent Judge.
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`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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`IPR2015-00529
`Patent 8,846,112 B2
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`I. INTRODUCTION
`Petitioner, Praxair Distribution, Inc., filed a Petition requesting inter
`partes review of claims 1–19 of U.S. Patent No. 8,846,112 B2 (Ex. 1001;
`“the ’112 patent”). Paper 1 (“Pet.”). Patent Owner, Mallinckrodt Hospital
`Products IP Ltd. (“Patent Owner”), filed a Patent Owner Preliminary
`Response. Paper 8 (“Prelim. Resp.”).1 We determined that there was a
`reasonable likelihood that Petitioner would prevail in challenging those
`claims as unpatentable. Pursuant to 35 U.S.C. § 314, therefore, on July 29,
`2015, we authorized an inter partes review to be instituted. Paper 12
`(“Dec.”).
`After institution, Patent Owner filed a Patent Owner Response (Paper
`22, “PO Resp.”) and Petitioner filed a Reply (Paper 35, “Pet. Reply”). With
`permission from this Panel, Patent Owner further filed a Sur Reply. Paper
`39 (“PO Sur Reply”). Petitioner also filed objections to Patent Owner’s
`Exhibit 2029, and to selected pages of Exhibit 2024. Paper 31.
`An oral hearing was held on March 29, 2016. A transcript of the
`hearing was subsequently entered into the record of the proceeding as Paper
`50 (“Tr.”). Both parties have filed objections to demonstratives presented at
`trial. Papers 46 and 47.
`We have jurisdiction under 35 U.S.C. § 6(b). This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`
`
`1 In accord with the Petition and Preliminary Response, this matter was
`originally captioned as Praxair Distribution Inc, v. INO Therapeutics Inc.
`After institution, Patent Owner Mallinckrodt identified itself as the Patent
`Owner, and listed INO Therapeutics LLC, Mallinckrodt Hospital Products,
`Inc., and Mallinckrodt PLC as real parties-in-interest. Paper 37; Paper 51.
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` 2
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`IPR2015-00529
`Patent 8,846,112 B2
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`For the reasons that follow, we determine that Petitioner has shown by
`a preponderance of the evidence that claims 1–8 and 10–19 of the ’112
`patent are unpatentable. Such a showing has not been made with regard to
`claim 9.
`
`A. Related Proceedings
`Patent Owner states that the ’112 patent is asserted in a case
`captioned: Mallinckrodt Hospital Products IP Ltd. et al. v. Praxair
`Distribution, Inc. et al., Case No. 1:15-cv-170 (D. Del.). Paper 37; see
`Paper 7.
`In addition to the case before us, Petitioner requested, and the Board
`denied, institution of inter partes review in the following matters involving
`patents with substantially the same specification as the ’112 patent at issue
`here:
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`Case No. IPR2015-00522 (U.S. Patent No. 8,282,966);
`Case No. IPR2015-00524 (U.S. Patent No. 8,293,284);
`Case No. IPR2015-00525 (U.S. Patent No. 8,431,163); and
`Case No. IPR2015-00526 (U.S. Patent No. 8,795,741).
`Petitioner also requested, and the Board instituted, inter partes review
`in the following matters involving Mallinckrodt’s patents generally directed
`to methods of administering inhaled nitric oxide to neonates:
`Case No. IPR2015-00884 (U.S. Patent No. 8,291,904);
`Case No. IPR2015-00888 (U.S. Patent No. 8,776,794);
`Case No. IPR2015-00889 (U.S. Patent No. 8,573,209);
`Case No. IPR2015-00891 (U.S. Patent No. 8,573,210); and
`Case No. IPR2015-00893 (U.S. Patent No. 8,776,795).
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` 3
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`IPR2015-00529
`Patent 8,846,112 B2
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`B. The ’112 Patent and Related Information
`The ’112 patent issued on September 30, 2014, from a series of
`continuation and divisional applications beginning with application No.
`12/494,598 filed on June 30, 2009. Ex. 1001. The ’112 patent is broadly
`directed to “methods of distributing a pharmaceutical product comprising
`nitric oxide gas.” Id. Abstract.
`Nitric oxide is a lung-specific vasodialator that significantly improves
`blood oxygenation and reduces the need for extracorporeal oxygenation. Id.
`at 3:36–45, 7:1–29. INOmax® is an FDA-approved blend of nitric oxide and
`nitrogen, which may be administered in conjunction with ventilary support
`for iNO (inhaled nitric oxide) therapy. Id. at 1:20–25, 3:34–36, 3:57–62.
`The product is approved “for the treatment of . . . term and near-term (>34
`weeks gestation) neonates having hypoxic respiratory failure associated with
`clinical or echocardiographic evidence of pulmonary hypertension, a
`condition also known as persistent pulmonary hypertension in the newborn
`(PPHN).” Id. at 6:34–40. iNO has also been used for a variety of other
`conditions, where it generally “acts by preventing or treating reversible
`pulmonary vasoconstriction, reducing pulmonary arterial pressure and
`improving pulmonary gas exchange.” Id. at 6:40–52.
`Example 1 of the Specification discusses the conduct and results of
`the INOT22 Study, in which children undergoing cardiac catheterization
`were administered oxygen, oxygen in conjunction with iNO, or iNO alone.
`Id. at 9:35–10:27. The Specification states that “[i]dentifying patients with
`pre-existing LVD [left ventricular dysfunction] 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 electrocardiography
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`IPR2015-00529
`Patent 8,846,112 B2
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`diagnostic screening.” Id. at 5:15–19. During the INOT22 study, patients
`with pre-existing LVD experienced an increased rate of serious adverse
`events (SAEs) including pulmonary edema. See, e.g., id. at 9:47–51, 14:17–
`25. In an effort to minimize the risk of adverse events, the INOT22 protocol
`was amended to exclude patients with an elevated pulmonary capillary
`wedge pressure (PCWP). See id. at 14:17–25. PCWP is a measure of left
`atrial pressure that may be used to diagnose LVD. Id. at 5:20–28. The
`Specification states, for example:
`The upper limit of normal PCWP in children is 10-12 mm
`Hg and 15 mm Hg in adults. In INOT22, a baseline PCWP value
`was not included as exclusion criteria. However, after the
`surprising and unexpected identification of SAEs in the early
`tested patients, it was determined that patients with pre-existing
`LVD had an increased risk of experiencing an AE or SAE upon
`administration (e.g., worsening of left ventricular function due to
`the increased flow of blood through the lungs). Accordingly, the
`protocol for INOT22 was thereafter amended to exclude patients
`with a baseline PCWP greater than 20 mm Hg after one patient
`experienced acute circulatory collapse and died during the study.
`The value “20 mm Hg” was selected to avoid enrollment of a
`pediatric population with LVD such that they would be most
`likely at-risk for these SAEs.
`Id. at 12:47–61. In light of the above results indicating that iNO therapy
`may be detrimental to patients with pre-existing LVD, the Specification
`proposes amending the INOmax® prescribing information to include a
`precaution for patients with LVD. Id. at 9:51–53.
`
`During prosecution of the ’112 patent, the inventor, Dr. James S.
`Baldassarre, submitted a declaration under 37 C.F.R. § 1.132 stating that,
`“subsequent to excluding patients with pre-existing LVD (i.e., baseline
`PCWP >20 mmHg) [from the INOT22 study], the rate of SAEs (including
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`IPR2015-00529
`Patent 8,846,112 B2
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`SAEs associated with heart failure) was significantly reduced.” Ex. 1056,
`667 ¶ 17. Dr. Baldassarre further testified that:
`18. Based upon this unexpected finding, INOT submitted
`a labeling supplement to FDA on February 25, 2009, seeking to
`amend the prescribing information for INOMAX® to include a
`warning statement for physicians indicating that the use of
`inhaled NO in patients with pre-existing LVD could cause SAEs,
`such as pulmonary edema. No such warning regarding
`preexisting LVD was previously required to appear in the
`prescribing information for inhaled NO in the U.S. Following
`INOT's submission of the labeling supplement to FDA, FDA
`agreed that a warning regarding pre-existing LVD was required.
`On August 28, 2009, FDA approved the INOMAX® label
`supplement that included the following new information:
`WARNINGS AND PRECAUTIONS
`Heart Failure: In patients with pre-existing left ventricular
`dysfanction, inhaled nitric oxide may increase pulmonary
`capillary wedge pressure leading to pulmonary edmema
`(5.4).
`5
` WARNINGS AND PRECAUTIONS
`5.4 Heart Failure: Patients who had pre-existing ventricular
`dysfunction treated with inhaled nitric oxide, even for short
`durations, experienced serious adverse events
`(e.g.,
`pulmonary edema).
`
`Id. at 667–668 ¶ 18; see also Ex. 2023,2 3 (“5.4 Worsening Heart Failure
`Patients with left ventricular dysfunction treated with INOmax may
`experience pulmonary edema, increased pulmonary capillary wedge
`pressure, worsening of left ventricular dysfunction, systemic hypotension,
`bradycardia and cardiac arrest. Discontinue INOmax while providing
`symptomatic care.”).
`
`2 Full Prescribing Information for INOmax (nitric oxide) gas for inhalation
`(revised 10/2015).
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` 6
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`IPR2015-00529
`Patent 8,846,112 B2
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`C. Representative Claim
`The independent claims at issue, claims 1, 7, 12, and 14 of the ’112
`patent, involve “supplying [a] cylinder containing compressed nitric oxide
`gas to a medical provider” in conjunction with “information that, in patients
`with pre-existing left ventricular dysfunction, inhaled nitric oxide may
`increase pulmonary capillary wedge pressure (PCWP) leading to pulmonary
`edema.” Claim 1, reproduced below and formatted for clarity, is illustrative:
`1. A method of providing pharmaceutically acceptable nitric
`oxide gas the method comprising:
`obtaining a cylinder containing compressed nitric oxide gas in
`the form of a gaseous blend of nitric oxide and nitrogen:
`supplying the cylinder containing compressed nitric oxide gas to
`a medical provider responsible for treating neonates who have
`hypoxic respiratory failure, including some who do not have
`left ventricular dysfunction;
`providing to the medical provider
`(i) information that a recommended dose of inhaled nitric
`oxide gas for treatment of neonates with hypoxic
`respiratory failure is 20 ppm nitric oxide and
`(ii) information that, in patients with pre-existing left
`ventricular dysfunction, inhaled nitric oxide may
`increase pulmonary capillary wedge pressure (PCWP),
`leading to pulmonary edema,
`the information of (ii) being sufficient to cause a medical
`provider considering inhaled nitric oxide treatment for
`a plurality of neonatal patients who (a) are suffering
`from a condition for which inhaled nitric oxide is
`indicated, and (b) have pre-existing left ventricular
`dysfunction, to elect to avoid treating one or more of
`the plurality of patients with inhaled nitric oxide in
`order to avoid putting the one or more patients at risk
`of pulmonary edema.
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`IPR2015-00529
`Patent 8,846,112 B2
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`D. Instituted Grounds of Unpatentability
`We instituted the instant trial based on the following grounds of
`unpatentability (Dec. 25–26):
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`References
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`Basis
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`Claims Challenged
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`INOmax label3
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`INOmax label
`INOmax label, Bernasconi,4 Loh,5
`and Goyal6
`
`§ 102(a)
`
`1, 7, 12, and 14
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`§ 103(a)
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`1, 7, 12, and 14
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`§ 103(a)
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`1–19
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`II. CLAIM CONSTRUCTION
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to their broadest reasonable construction in light
`of the specification of the patent in which they appear. 37 C.F.R.
`
`
`3 Center for Drug Evaluation and Research, Application Number: NDA
`20845, INOmaxTM, Final Printed Labeling, available at
`http://www.accessdata.fda.gov/
`drugsatfda_docs/nda/99/20845_INOmax_prntlbl.pdf (August 9, 2000).
`Ex. 1014 (“INOmax label”).
`4 A. Bernasconi & M. Beghetti, Inhaled Nitric Oxide Applications in
`Paediatric Practice, 4 IMAGES IN PAEDIATRIC CARDIOLOGY 4 (2002).
`Ex. 1004 (“Bernasconi”).
`5 Evan Loh et al., Cardiovascular Effects of Inhaled Nitric Oxide in Patients
`with Left Ventricular Dysfunction, 90 CIRCULATION 2780 (1994). Ex. 1006
`(“Loh”).
`6 P. Goyal, et al., Efficacy of Nitroglycerin Inhalation in Reducing
`Pulmonary Arterial Hypertension in Children with Congenital Heart
`Disease, 97 BRITISH JOURNAL OF ANAESTHESIA 208 (2006). Ex. 1007
`(“Goyal”).
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`IPR2015-00529
`Patent 8,846,112 B2
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`§ 42.100(b); see Cuozzo Speed Techs., LLC v. Lee, No. 15–446, 2016 WL
`3369425, at *12 (U.S. June 20, 2016) (upholding the use of the broadest
`reasonable interpretation standard). Under this standard, claim terms are
`given their ordinary and customary meaning, as would be understood by one
`of ordinary skill in the art in the context of the entire disclosure. In re
`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Nevertheless,
`a “claim term will not receive its ordinary meaning if the patentee acted as
`his own lexicographer and clearly set forth a definition of the disputed claim
`term in either the specification or prosecution history.” CCS Fitness, Inc. v.
`Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). Such definitions
`must be set forth with reasonable clarity, deliberateness, and precision. In re
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Petitioner contends that a person of ordinary skill in the art is “a
`pediatric cardiologist with experience prescribing iNO . . . . [having]
`knowledge of diagnostic techniques and scientific literature related to
`pediatric cardiology, and . . . how to search the literature for relevant
`publications.” Pet. 7–8 (citing Ex. 1002 ¶¶ 54–55). Patent Owner similarly
`contends that a person of ordinary skill in the art “is a physician with
`experience treating pediatric heart and lung disease and/or experience
`studying pediatric heart and lung disease[; and further has] . . . experience
`prescribing and administering vasodilators and additional supportive
`therapies and/or experience designing clinical trials related to pediatric heart
`and lung disease.” PO Resp. 17–18 (citing Ex. 2020 ¶ 27). Neither party
`has raised objections to the other’s proposed definition. We find that both
`proposed definitions are reasonable in light of the Specification and art of
`record, and that the overall level of skill in the art is high.
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`IPR2015-00529
`Patent 8,846,112 B2
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`Petitioner asserts that a person of ordinary skill in the art “would have
`understood each term of each claim to have its plain and ordinary meaning.”
`Pet. 8. Patent Owner “agrees that the plain and ordinary meaning should
`apply where the patentee has not acted as his own lexicographer” (Prelim.
`Resp. 21) but does not point to any term in which it acted as its own
`lexicographer, and, thus, should not be accorded its ordinary meaning.
`We provide express constructions for the following terms.
`
`A. “pharmaceutically acceptable nitric oxide gas”
`Independent claims 1 and 7 are directed to “method[s] of providing
`pharmaceutically acceptable nitric oxide gas.” Patent Owner argues that
`although the term “pharmaceutically acceptable nitric oxide gas” appears in
`the preamble, it should be given weight as a claim limitation. PO Resp. 18–
`21. Petitioner, in contrast, “asserts the preamble is not limiting, and, to the
`extent it is considered to be limiting, is disclosed by the cited art.” Pet.
`Reply 6, n.3.7
`During the prosecution of the ’112 patent the Examiner rejected then-
`pending claims directed to methods of “providing a pharmaceutical product”
`as not entitled to the claimed priority date and, therefore, invalid over certain
`prior art. Ex. 1056, 693–694 (“The priority documents disclose methods of
`‘providing pharmaceutically acceptable nitric oxide gas’ . . . but do not
`disclose providing any pharmaceutical product but only nitric oxide gas.”).
`
`
`7 Petitioner notes that in the related district court litigation, Mallinckrodt
`Hospital Products IP Ltd. v. Praxair Distribution, Inc., Case No. 1:15-cv-
`170 (D. Del.), Judge Sleet recently issued a Markman order including a
`determination that “[t]he term ‘pharmaceutically acceptable nitric oxide gas’
`is non-limiting, so no construction is necessary.” Paper 52.
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`IPR2015-00529
`Patent 8,846,112 B2
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`The Applicant amended the preamble of the rejected independent claims to
`recite “[a] method of providing pharmaceutically acceptable nitric oxide
`gas,” as presently set forth in claims 1 and 7. Id. at 746–747. Subsequent to
`the amendment, the Examiner withdrew the objection. Id. at 765; see id. at
`733 (“If all the priority issues are resolved then it appears that the primary
`reference in the 103 rejection will no longer be prior art.” (italics omitted)).
`On pages 19 and 20 of its Response, Patent Owner argues that the preamble
`is, therefore, limiting in light of Catalina Mktg. International, Inc. v.
`Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), which holds that
`“clear reliance on the preamble during prosecution to distinguish the claimed
`invention from the prior art transforms the preamble into a claim limitation
`because such reliance indicates the use of the preamble to define, in part, the
`claimed invention.”
`Although the prosecution history shows that amendment of the
`preamble only indirectly distinguished the claims over the prior art by
`establishing an earlier priority date, we conclude that both the Applicant and
`the Examiner treated the preamble as a claim limitation. Accordingly, we
`agree with Patent Owner that the preamble language “pharmaceutically
`acceptable nitric oxide gas” is limiting.
`Patent Owner further argues that, in contrast to medical applications,
`some nitric oxide gas is “used for industrial purposes,” and “can be used for
`fertilizer.” Tr. 44:20–45:2. Accordingly, in the context of the present
`invention, Patent Owner urges that we focus on “[t]he ordinary meaning of
`‘pharmaceutically acceptable’ nitric oxide gas [as] . . . suitably safe for
`
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`11
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`IPR2015-00529
`Patent 8,846,112 B2
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`pharmaceutical use.” PO Resp. 21.8 In support, Patent Owner points to the
`Specification’s disclosure that the INOT22 study was conducted, in part, to
`assess the safety and effectiveness of inhaled nitric oxide. PO Resp. 22; see
`Ex. 1001, 9:35–45 (“The INOT22 study . . . was conducted both to assess
`the safely and effectiveness of INOmax® as a diagnostic agent in patients
`undergoing assessment of pulmonary hypertension (primary endpoint), and
`to confirm the hypothesis that iNO is selective for the pulmonary vasculature
`(secondary endpoint).”). Also consistent with the idea that nitric oxide gas
`prepared for medical use may be qualitatively different from that prepared
`for industrial or agricultural applications, Patent Owner further argues that
`the parties’ experts agree that the claims do not require “just any nitric oxide
`gas” but one that is pharmaceutically acceptable. See PO Resp. 22–23
`(citing Ex. 2022, 73:14–74:22; Ex. 2020 ¶ 82).
`Patent Owner also points to instances where other courts have
`associated the claim language “pharmaceutically acceptable” with the
`concept of safety or acceptably low toxicity, particular,
`“pharmaceutically-acceptable moisturizer” has been construed
`as “material that has the effect of adding moisture to or keeping
`moisture in human skin that is also safe and effective for use on
`human skin.” LP Matthews, L.L.C. v. Bath & Body Works, Inc.,
`2006 WL 3020095, at *2 (D. Del. Oct. 19, 2006); see also Abbott
`Labs. v. Sandoz, Inc., 544 F.3d 1341, 1359 (Fed. Cir. 2008)
`(affirming injunction based on district court’s construction of
`“Pharmaceutically acceptable polymer”: “any polymer, which
`
`
`8 Petitioner offers no an alternative construction but argues that “[e]ven if
`Patent Owner were right that this preamble phrase is limiting, and even if it
`has the meaning Patent Owner ascribes to it, the preamble would still have
`no impact on the Board’s printed matter analysis.” Pet. Reply 1–2; see id. at
`6, n.3.
`
`
`
`12
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`
`within the scope of sound medical judgment is suitable for use
`… without undue toxicity….”); Roche Palo Alto LLC v.
`Ranbaxy Labs. Ltd., 2009 WL 3261252, at *30 n.42 (D.N.J. Sept.
`30, 2009) (“‘Pharmaceutically acceptable’ means generally safe
`and non-toxic and ... acceptable for ... human pharmaceutical
`use”) (quotations and citations omitted).
`Id. at 22.9
`In contrast to these broad constructions of similar terms, Patent Owner
`also appears to argue that for “pharmaceutically acceptable” nitric oxide gas
`to be “suitably safe” for pharmaceutical use, the term must incorporate up-
`to-date FDA labeling information for iNO gas and, thus, it should be
`construed as encompassing the information set forth in elements (i) and (ii)
`of claim 1. See, e.g., PO Resp. 21–22, 28–33; Tr. 42:10–46:6. To illustrate,
`when asked how the limitation “pharmaceutically acceptable” differentiates
`one canister of nitric oxide gas from another, counsel for Patent Owner
`responded: “It’s the information that goes with it.” Tr. 44:20–25; see also
`id. at 31:13–16 (agreeing that the content of the cylinder never changes.).
`As noted above, Patent Owner’s proposed construction harnesses the
`claim term “pharmaceutically acceptable” to the words “suitably safe.” We
`do not agree with Patent Owner’s attempt to bootstrap information contained
`in current, FDA-approved labeling, into the term “pharmaceutically
`acceptable nitric oxide gas” by narrowly defining the meaning of “suitably
`safe.” “Although . . . FDA regulations require a label containing
`
`9 Patent Owner further relies on Apotex Inc. v. Alcon Pharmaceuticals, Ltd.,
`No. IPR2013-00012, 2013 WL 5970130, at *4 (PTAB Mar. 19, 2013), in
`which the Board construed the term “pharmaceutically acceptable vehicle”
`as “a vehicle that is acceptable for use as a topical ophthalmic
`pharmaceutical composition, i.e., any excipient(s) that can be safely used in
`the eye, such as saline.” PO Sur Reply 2, n.3.
`
`
`13
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`IPR2015-00529
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`
`information needed for the safe and effective use of any drug, this is a
`requirement for FDA approval, not patentability. . . . [T]he instructions do
`nothing more than explain how to use the known drug.” AstraZeneca LP v.
`Apotex, Inc., 633 F.3d 1042, 1065 (Fed. Cir. 2010). Patent Owner has not
`pointed to any example where courts have imported FDA-mandated labeling
`into the definition of “pharmaceutically acceptable.” Nor are we persuaded
`on this record that the claimed “method[s] of providing pharmaceutically
`acceptable nitric oxide gas” should be contrued as requiring that
`information.
`Patent Owner also argues that the meaning of “suitably safe,” as
`reflected in the contents of the labeling associated with the claimed
`“pharmaceutically acceptable nitric oxide gas,” would not vary over time.
`See Tr. 42:10–43:9, 44:20–25; PO Sur Reply 2, n.3. But reading the
`contents of the labeling into the term “pharmaceutically acceptable nitric
`oxide gas” (via the meaning Petitioner ascribes to “suitably safe”) would
`alter the meaning of the claim term every time the FDA approved revised or
`updated labeling. This would be contrary to the requirement that “the
`ordinary and customary meaning of a claim term is the meaning that the
`term would have to a person of ordinary skill in the art in question at the
`time of the invention, i.e., as of the effective filing date of the patent
`application.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005)
`(en banc) (citations omitted). Thus, even if the ordinary meaning of
`“pharmaceutically acceptable nitric oxide gas” were limited to cylinders of
`nitric oxide gas accompanied by the FDA-approved labeling information,
`because the information of claim elements (i) and (ii) was not reflected in a
`revised FDA label until after the earliest filing date of the ’112 patent (see
`
`
`
`14
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`section I(B), above), such information cannot limit “pharmaceutically
`acceptable nitric oxide gas” as used in claim 1.
`In accord with the above, and in light of the arguments and evidence
`of record, we construe “pharmaceutically acceptable nitric oxide gas” as
`“nitric oxide gas that is suitable for pharmaceutical use.” We expressly
`reject a construction of the term that encompasses the information supplied
`in an FDA-approved label of any vintage.
`
`B. “Providing . . . Information”
`Independent claim 1 includes the step of providing to a medical
`provider
`
`(i) information that a recommended dose of inhaled nitric
`oxide gas for treatment of neonates with hypoxic
`respiratory failure is 20 ppm nitric oxide and
`(ii) information that, in patients with pre-existing left
`ventricular dysfunction, inhaled nitric oxide may
`increase pulmonary capillary wedge pressure (PCWP),
`leading to pulmonary edema
`the information of (ii) being sufficient to cause a medical
`provider considering inhaled nitric oxide treatment for
`a plurality of neonatal patients who (a) are suffering
`from a condition for which inhaled nitric oxide is
`indicated, and (b) have pre-existing left ventricular
`dysfunction, to elect to avoid treating one or more of
`the plurality of patients with inhaled nitric oxide in
`order to avoid putting the one or more patients at risk
`of pulmonary edema.
`Claim 5, depending from claim 1, expressly provides that the
`information “appear[s] in prescribing information supplied to the medical
`provider with the cylinder containing compressed nitric oxide gas,” e.g., a
`version of the FDA-approved labling for INOmax®, Ex. 1004. Independent
`claims 12 and 14 also recite a “providing” step with respect to similarly-
`
`
`
`15
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`worded information (i) and (ii). Reading the claims as a whole, we view the
`information described in (i) and (ii) as printed matter, and, thus, not entitled
`to patentable weight. In re Distefano, 808 F.3d 845, 848 (Fed. Cir. 2015)
`(“[A] limitation is printed matter only if it claims the content of
`information.”).
`Specifically, in analyzing such claims, the Federal Circuit instructs us
`
`to:
`
`read the claim as a whole, considering each and every claim
`limitation. However, . . . if a limitation claims (a) printed matter
`that (b) is not functionally or structurally related to the physical
`substrate holding the printed matter, it does not lend any
`patentable weight to the patentability analysis. In performing
`this analysis we do not strike out the printed matter and analyze
`a “new” claim, but simply do not give the printed matter any
`patentable weight: it may not be a basis for distinguishing prior
`art.
`Id. (internal citations omitted).
`Because printed matter itself is non-statutory subject matter, it must
`have a functional relationship to other claim elements to be accorded
`patentable weight. See In re Miller, 418 F.2d 1392, 1396 (CCPA 1969); see
`also In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004) (“If we were to adopt
`Ngai’s position, anyone could continue patenting a product indefinitely
`provided that they add a new instruction sheet to the product.”). Expressly
`extending the printed matter doctrine to method claims, the Federal Circuit
`in King Pharmaceuticals found that an otherwise anticipated method claim
`did not become patentable because it included “a step of ‘informing’
`someone about the existence of an inherent property of that method.” King
`Pharms., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1278 (Fed. Cir. 2010); see
`id. at 1277 (claim 21 reciting “informing the patient that administration of a
`
`
`
`16
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`therapeutically effective amount of metaxalone in a pharmaceutical
`composition with food results in an increase in the maximal plasma
`concentration (Cmax) and extent of absorption (AUC(last)) of metaxalone
`compared to administration without food”). The court expressly rejected the
`argument that a functional relationship ex
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