IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`C. A. No.: 15-170-GMS
`
`
`
`
`
`
`
` ))))))))))))
`
`
`MALLINCKRODT HOSPITAL PRODUCTS IP
`LTD., INO THERAPEUTICS LLC and IKARIA,
`INC.
`
`
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`PRAXAIR DISTRIBUTION, INC. and
`PRAXAIR, INC.,
`
`
`
`Defendants.
`
`
`
`PRAXAIR’S OPENING CLAIM CONSTRUCTION BRIEF
`REGARDING U.S. PATENT NO. 8,846,112
`
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`Melanie K. Sharp (No. 2501)
`James L. Higgins (No. 5021)
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6681
`msharp@ycst.com
`jhiggins@ycst.com
`
`
`Attorneys for Praxair Distribution, Inc. and Praxair, Inc.
`
`Dated: March 17, 2016
`
`MORGAN, LEWIS & BOCKIUS LLP
`Michael J. Abernathy
`Sanjay K. Murthy
`Maria E. Doukas
`77 West Wacker Drive, Fifth Floor
`Chicago, IL 60601
`(312) 324-1000
`
`K&L GATES LLP
`Christopher E. Hanba
`Benjamin E. Weed
`Margaux L. Nair
`70 West Madison Street, Suite 3100
`Chicago, IL 60602
`(312) 372-1121
`
`Ex. 2034-0001
`
`

`
`
`
`
`
`I. 
`
`II. 
`
`III. 
`
`IV. 
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION AND SUMMARY OF THE ARGUMENT ....................................... 1 
`
`OVERVIEW OF THE ’112 PATENT ............................................................................... 2 
`
`LEGAL STANDARD ........................................................................................................ 3 
`
`ARGUMENT ..................................................................................................................... 5 
`
`1. 
`
`“pharmaceutically acceptable” ............................................................................... 5 
`
`a. 
`
`b. 
`
`c. 
`
`The Preamble Is Non-Limiting .................................................................. 6 
`
`The Term “Pharmaceutically Acceptable” Should Carry Its Plain
`And Ordinary Meaning .............................................................................. 7 
`
`Plaintiff’s Proposed Construction Improperly Imports Limitations
`Into The Claims And Is Ambiguous ........................................................ 10 
`
`V. 
`
`CONCLUSION ................................................................................................................ 11 
`
`
`
`i
`
`Ex. 2034-0002
`
`

`
`
`
`
`
`CASES
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Allen Eng'g Corp. v. Bartell Indus.,
`299 F.3d 1336 (Fed. Cir. 2002)..................................................................................................6
`
`ALM Holding Co. v. Akzo Nobel Surface Chem. LLC,
`C.A. No. 13-1069 (GMS) (D. Del. Nov. 4, 2014) ...............................................................8, 10
`
`Am. Bioscience, Inc. v. Baker Norton Pharm., Inc.,
`No. CV 00-09589MRP(AJWX), 2001 WL 36170997 (C.D. Cal. Aug. 31,
`2001) ..........................................................................................................................................7
`
`Bell Commc’ns Research, Inc. v. Vitalink Commc’ns Corp.,
`55 F.3d 615 (Fed. Cir. 1995)......................................................................................................6
`
`Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002)................................................................................................6, 7
`
`Chef Am., Inc. v. Lamb-Weston, Inc.,
`358 F.3d 1371 (Fed. Cir. 2004)................................................................................................10
`
`Evolutionary Intelligence, LLC v. Sprint Nextel Corp.,
`No. C-13-03587, 2014 WL 4802426 (N.D. Cal. Sept. 26, 2014) ..............................................5
`
`Gart v. Logitech,
`254 F.3d 1334 (Fed. Cir. 2001)..................................................................................................3
`
`Intirtool, Ltd. v. Texar Corp.,
`369 F.3d 1289 (Fed. Cir. 2004)..................................................................................................6
`
`LG Philips LCD Co. v. Tatung Co.,
`434 F. Supp. 2d 292 (D. Del. 2006) ...........................................................................................4
`
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995)..................................................................................................3, 5
`
`Merck Sharp & Dohme Corp. v. Xellia Pharm. ApS,
`No. CV 14-199-RGA, 2015 WL 82386 (D. Del. Jan. 6, 2015) ...............................................10
`
`Nystrom v. TREX Co., Inc.,
`424 F.3d 1136 (Fed. Cir. 2005)..................................................................................................4
`
`ii
`
`Ex. 2034-0003
`
`

`
`
`O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)................................................................................................11
`
`Omega Eng’g, Inc. v. Raytek Corp.,
`334 F.3d 1314 (Fed. Cir. 2003)..................................................................................................5
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ....................................................................3, 4, 5, 11
`
`PSC Computer Products, Inc. v. Foxconn Int’l, Inc.,
`355 F.3d 1353 (Fed. Cir. 2004)................................................................................................11
`
`Purdue Pharma L.P. v. Endo Pharms. Inc.,
`438 F.3d 1123 (Fed. Cir. 2006)..................................................................................................5
`
`S. Snow Mfg. Co. v. SnoWizard Holdings, Inc.,
`567 FApp’x 945 (Fed. Cir. 2014) ..............................................................................................6
`
`Spectrum Pharm., Inc. v. Sandoz Inc.,
`No. 2:12-CV-000111-GMN, 2013 WL 6865692 (D. Nev. Dec. 31, 2013) .............................10
`
`Teleflex, Inc. v. Ficosa N Am. Corp.,
`299 F.3d 1313 (Fed. Cir. 2002)..............................................................................................4, 8
`
`Teva Pharm. USA, Inc. v. Sandoz, Inc.,
`135 S. Ct. 831 (2015) .................................................................................................................3
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996)....................................................................................................4
`
`OTHER AUTHORITIES
`
`Oxford English Dictionary ...............................................................................................................8
`
`iii
`
`Ex. 2034-0004
`
`

`
`
`I.
`
`INTRODUCTION AND SUMMARY OF THE ARGUMENT
`
`Although this case involves ten patents, the parties only dispute the meaning of one term:
`
`“pharmaceutically acceptable,” found in the preamble of claims 1-11 of U.S. Pat. No. 8,846,112
`
`(“the ’112 patent”). While Mallinckrodt Hospital Products IP Ltd., INO Therapeutics LLC and
`
`Ikaria Inc. (collectively “Plaintiffs”) request construction of this straightforward phrase,
`
`Defendants Praxair Distribution, Inc. and Praxair, Inc. (collectively, “Defendants”) submit that
`
`no construction is necessary.
`
`Not surprisingly, Plaintiff’s
`
`request
`
`for construction of a clear
`
`term
`
`like
`
`“pharmaceutically acceptable” is motivated by a desire to undercut an unfavorable ruling from
`
`the Patent Trial and Appeal Board (the “Board”).1 In instituting an Inter Partes Review
`
`proceeding, the Board found that several limitations of the claims of the ’112 patent contain
`
`printed matter, without a functional relationship to other claim elements. See Ex. A, Institution
`
`of Inter Partes Review, Paper No. 12 at 9 (July 29, 2015). Therefore, the Board did not give
`
`those limitations any patentable weight. Id. Plaintiffs now seek a ruling that 1) finds the
`
`preamble of claims 1-11 to be limiting; and 2) construes the term “pharmaceutically acceptable,”
`
`found in the preamble, to have an unnecessarily narrow meaning. As is apparent from Plaintiff’s
`
`briefing in front of the Board, Plaintiff seeks such a ruling in order to bolster its argument that
`
`the printed matter claim limitations are functionally related to the “pharmaceutically acceptable”
`
`preamble such that these limitations should be given patentable weight. See Ex. B, Patent
`
`Owner’s Response to Petition for Inter Partes Review, Paper No. 22 at 23-33 (Nov. 5, 2015).
`
`
`
`
`
`
`1 The ’112 patent is currently being reviewed in an Inter Partes Review proceeding. See Praxair
`Distribution, Inc. v. INO Therapeutics LLC, IPR2015-00529.
`
`
`
`Ex. 2034-0005
`
`

`
`
`
`However, despite Plaintiff’s best efforts, this Court should find that the term
`
`“pharmaceutically acceptable” appears in the preamble and, per the Federal Circuit’s general
`
`rule, is non-limiting. Therefore, the Court need not proffer a claim construction. Even if the
`
`Court undertakes a claim construction analysis for “pharmaceutically acceptable,” it should find
`
`that no construction is necessary and the term should carry its plain and ordinary meaning. The
`
`term “pharmaceutically acceptable” is unambiguous, and neither the specification nor the
`
`prosecution history of the ’112 patent support deviating from the term’s plain and ordinary
`
`meaning. For these reasons, as well as the reasons articulated below, Defendants respectfully
`
`request this Court to find that no construction is necessary for the claim term “pharmaceutically
`
`acceptable.”
`
`II.
`
`OVERVIEW OF THE ’112 PATENT
`
`Newborns with a certain form of respiratory failure called persistent pulmonary
`
`hypertension (“PPHN”) are unable to breathe on their own and have high blood pressure in the
`
`blood vessels of their lungs. ’112 patent, 6:34-40. INOmax® is an FDA-approved blend of
`
`nitric oxide and nitrogen which can be administrated as an inhaled drug to treat newborns greater
`
`than 34 weeks gestational age with PPHN that are not getting enough oxygen into their blood.
`
`Id. at 1:20-25, 3:34-36, 3:57–62.
`
`During clinical trials of INOmax® the named inventors of the ’112 patent allegedly
`
`discovered that patients with pre-existing left ventricular dysfunction experienced an increased
`
`rate of serious adverse events after receiving INOmax®. See, e.g., id. at 9:47–51, 14:17–25.
`
`Therefore, the ’112 patent proposes amending the INOmax® prescribing information to include
`
`a precaution for patients with left ventricular dysfunction. Id. at 9:51–53. Independent claim 1,
`
`which is representative for purposes of claim construction, is reproduced below:
`
`
`
`
`
`2
`
`Ex. 2034-0006
`
`

`
`
`
`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.
`
`’112 patent, claim 1 (emphasis added).
`
`III. LEGAL STANDARD
`
` Claim construction is a question of law. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.
`
`Ct. 831, 835 (2015) (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 387-91
`
`(1996)). The goal of claim construction is to explain the words in a claim without changing the
`
`scope of the claim. Gart v. Logitech, 254 F.3d 1334, 1339 (Fed. Cir. 2001).2 However, “[i]t is
`
`
`2 The appropriate perspective for analyzing the meaning of a claim term is of a person having
`ordinary skill in the art at the time the patent application was filed. Phillips v. AWH Corp., 415
`
`3
`
`Ex. 2034-0007
`
`

`
`
`both unjust to the public and an evasion of the law to construe an invention in a manner different
`
`from the plain import of its terms.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir.
`
`2005) (en banc). Therefore, it is well established that “claim terms take on their ordinary and
`
`accustomed meanings unless the patentee demonstrated an intent to deviate from the ordinary
`
`and accustomed meaning of a claim term by redefining the term or by characterizing the
`
`invention in the intrinsic record using words or expressions of manifest exclusion or restriction,
`
`representing a clear disavowal of claim scope.” Teleflex, Inc. v. Ficosa N Am. Corp., 299 F.3d
`
`1313, 1327 (Fed. Cir. 2002).
`
`If a claim term requires construction, the Federal Circuit has instructed courts to focus on
`
`the “intrinsic evidence” while construing claims—namely, the patent claims and specification
`
`along with the prosecution history. Phillips, 415 F.3d at 1317. The most important inquiry is to
`
`look at the language of the claims themselves. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
`
`1576, 1582 (Fed. Cir. 1996). But claims always “must be read in view of the specification, of
`
`which they are a part [because it is] the single best guide to the meaning of a disputed term.”
`
`Phillips, 415 F.3d at 1315-16 (citation omitted). For example, the specification may indicate
`
`whether the patentee expressly defined any of the claim terms. See Vitronics, 90 F.3d at 1582.
`
`“In such cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316. Also, the
`
`consistent use of a claim term by the inventor in the specification may serve to limit the scope of
`
`a claim. Nystrom v. TREX Co., Inc., 424 F.3d 1136, 1145 (Fed. Cir. 2005); see also LG Philips
`
`F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). In this case, Plaintiffs argue a person of skill in the
`art would be “a physician with experience treating and/or studying pediatric heart and lung
`disease.” Ex. C, Praxair Distribution, Inc. v. INO Therapeutics LLC, IPR2015-00529,
`Preliminary Response by Patent Owner, Paper No. 8 at 20 (May 6, 2015). Defendants maintain
`that a person of skill in the art would be a “pediatric cardiologist with experience prescribing
`iNO.” Ex. D, Petition for Inter Partes Review, Paper No. 1 at 7-8 (Jan. 5, 2015). While the
`parties disagree over the appropriate level of skill of a person of ordinary skill in the art, this
`should not affect the court’s interpretation of the claim term “pharmaceutically acceptable.”
`
`4
`
`Ex. 2034-0008
`
`

`
`LCD Co. v. Tatung Co., 434 F. Supp. 2d 292, 296 (D. Del. 2006) (construing claim tenn to be
`
`consistent with use in specification’s embodiments).
`
`A court “should also consider the patent’s prosecution history.”
`
`See Markman v.
`
`Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995). The file history not only provides
`
`further context for the meaning of the terms; it also highlights disavowals of claim scope during
`
`prosecution. Phillips, 415 F.3d at 1314; Purdue Pharma L.P. v. Endo Plmrms. Inc., 438 F.3d
`
`1123, 1136 (Fed. Cir. 2006). Thus, when the patentee unambiguously disavows a certain
`
`meaning to obtain a patent, the doctrine of prosecution history disclaimer narrows the meaning
`
`of the claim consistent with the scope of the claim surrendered. Omega Eng ’g, Inc. v. Raytek
`
`Corp, 334 F.3d 1314, 1323, 1324 (Fed. Cir. 2003). The record of an Inter Partes Review of a
`
`patent becomes part of its prosecution history and, therefore, part of the intrinsic record. See,
`
`e.g., Ev0lutiouar_v Intelligence, LLC v. Sprint Nextel Corp., No. C-13-03587, 2014 WL 4802426
`
`(N.D. Cal. Sept. 26, 2014).
`
`IV.
`
`ARGUMENT
`
`1.
`
`“pharmaceutically acceptable”
`
`Claim Term
`
`Defendants’ Construction
`
`Plaintiffs’ Construction
`
`“pharmaceutically
`acceptable”
`’ 1 12 patent, claims
`1-1 1
`
`Plain and ordinary meaning
`
`oxide
`
`gas
`Nitric
`safe
`suitably
`pharmaceutical use
`
`that
`
`is
`for
`
`The parties disagree Whether the tenn “pharmaceutically acceptable,” found in the
`
`preamble of claims 1-11 of the ’l 12 patent, needs to be construed. See, e.g., ’l 12 patent, claims
`
`1 and 7 (“A method of providing pharmaceutically acceptable nitric oxide gas, the method
`
`comprising .
`
`.
`
`. .”) (emphasis added). Defendants maintain no construction is necessary, so this
`
`term can carry its plain and ordinary meaning, while Plaintiffs propose a construction that
`
`improperly imports the requirement that the gas be “suitably safe” for pharmaceutical use.
`
`Ex. 2034-0009
`
`

`
`
`
`a.
`
`The Preamble Is Non-Limiting
`
`As an initial matter, the term “pharmaceutically acceptable” appears only in the preamble
`
`of the claims and is non-limiting. Under Federal Circuit law, generally the preamble does not
`
`limit the claims. See, e.g., S. Snow Mfg. Co. v. SnoWizard Holdings, Inc., 567 FApp’x 945, 953
`
`(Fed. Cir. 2014) (stating that “[g]enerally, the preamble does not limit the claims,” and noting
`
`that the patentee “has not provided any persuasive reason why this general proscription should
`
`not apply.”) (quoting Allen Eng'g Corp. v. Bartell Indus., 299 F.3d 1336, 1346 (Fed. Cir. 2002)).
`
`However, the preamble may be limiting “when the claim drafter chooses to use both the
`
`preamble and the body to define the subject matter of the claimed invention.” Bell Commc’ns
`
`Research, Inc. v. Vitalink Commc’ns Corp., 55 F.3d 615, 620 (Fed. Cir. 1995). A claim
`
`preamble is limiting if “it recites essential structure or steps, or if it is necessary to give ‘life,
`
`meaning, and vitality’ to the claim.” Intirtool, Ltd. v. Texar Corp., 369 F.3d 1289, 1295 (Fed.
`
`Cir. 2004) (citation omitted). However, if the body of the claim “describes a structurally
`
`complete invention such that deletion of the preamble phrase does not affect the structure or
`
`steps of the claimed invention,” the preamble is generally not limiting unless there is “clear
`
`reliance on the preamble during prosecution to distinguish the claimed invention from the prior
`
`art.” Id. (internal citations omitted) (emphasis added).
`
`Here, the preamble does not recite any “additional structure or steps underscored as
`
`important by the specification.” Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d
`
`801, 808 (Fed. Cir. 2002). Nor does the preamble provide any “antecedent basis” for any term
`
`found in the body of the claim.
`
`For example, claim 1 requires within the body of the claim “providing to the medical
`
`provider (i) information that a recommended dose of inhaled nitric oxide gas for treatment . . . .”
`
`Such a recommended dose would be “pharmaceutically acceptable,” so the language in the
`
`6
`
`Ex. 2034-0010
`
`

`
`
`preamble is superfluous and adds nothing additional. There is also no evidence in the
`
`prosecution history of clear reliance specifically on the preamble to distinguish the claims from
`
`the prior art, which if present might provide a basis for transforming the preamble into a claim
`
`limitation. See id. (“[C]lear reliance on the preamble during prosecution to distinguish the
`
`claimed invention from the prior art transforms the preamble into a claim limitation.”).
`
`The prosecution history demonstrates that the “pharmaceutically acceptable” language
`
`was added in order to claim priority to an earlier application. Specifically, the claims initially
`
`recited “providing a pharmaceutical product” in the preamble, but the priority documents
`
`disclosed methods “providing pharmaceutically acceptable nitric oxide gas.” The patentee
`
`explained, “to address this issue [of priority], the present amendment deletes the phrase
`
`‘providing a pharmaceutical product’ . . . [and] the preambles . . . now recite “A method of
`
`providing pharmaceutically acceptable nitric oxide gas . . . .” Ex. E, ’112 Patent File History,
`
`Office Action Response dated May 1, 2014 at p. 13 (emphasis in original). Amending claims “to
`
`address this issue [of priority]” is not a “clear reliance on the preamble during prosecution to
`
`distinguish the claimed invention from the prior art” and, therefore, does not “transform [] the
`
`preamble into a claim limitation.” Since the preamble is non-limiting, the Court need not
`
`construe the term “pharmaceutically acceptable.”
`
`b.
`
`The Term “Pharmaceutically Acceptable” Should Carry Its Plain
`And Ordinary Meaning
`
`Even if this Court disagrees and concludes that the preamble is limiting, the plain English
`
`reading of “pharmaceutically acceptable” is readily apparent to lay persons, as the phrase is
`
`composed of two commonly understood terms. See Am. Bioscience, Inc. v. Baker Norton
`
`Pharm., Inc., No. CV 00-09589MRP(AJWX), 2001 WL 36170997, at *2 (C.D. Cal. Aug. 31,
`
`2001) (finding the term “pharmaceutically acceptable” to be “neither ambiguous nor a special
`
`7
`
`Ex. 2034-0011
`
`

`
`
`term of art. According to the Oxford English Dictionary (Second Edition), the plain meaning of
`
`‘pharmaceutically’ is ‘related to pharmacy’; the plain meaning of ‘pharmacy’ is ‘the use or
`
`administration of drugs or medicine.’ Thus, a ‘pharmaceutically acceptable’ formulation is one
`
`‘acceptable for administration.’ While experts may debate what would make a particular
`
`formulation ideal for administration, their observations have no place in the interpretation of this
`
`unambiguous term.”). And this Court need not construe claim terms that are readily apparent.3
`
`Even Plaintiffs stated in their Response to Defendants’ Petition for Inter Partes Review of the
`
`’112 patent that the Board erred in instituting the proceeding because it failed to construe the
`
`term “pharmaceutically acceptable nitric oxide” “consistent with its plain and ordinary
`
`meaning.” See Praxair Distribution, IKnc. v. INO Therapeutics LLC, IPR2015-00529, Patent
`
`Owner’s Response to Petition for Inter Partes Review, Paper No. 22 at 18 (Nov. 5, 2015)
`
`(emphasis added).
`
`Further, neither the specification nor the prosecution history of the ’112 patent support
`
`deviating from the plain and ordinary meaning of “pharmaceutically acceptable.” See Teleflex,
`
`299 F.3d at 1327 (“claim terms take on their ordinary and accustomed meanings unless the
`
`patentee demonstrated an intent to deviate from the ordinary and accustomed meaning of a claim
`
`term by redefining the term or by characterizing the invention in the intrinsic record using words
`
`or expressions of manifest exclusion or restriction, representing a clear disavowal of claim
`
`scope.”).
`
`Here, the term “pharmaceutically acceptable” does not appear anywhere in the
`
`3 See ALM Holding Co. v. Akzo Nobel Surface Chem. LLC, C.A. No. 13-1069 (GMS) (D. Del.
`Nov. 4, 2014) (“The court agrees with the plaintiffs that these terms should be given their plain
`and ordinary meanings. ‘In some cases, the ordinary meaning of claim language as understood
`by a person of skill in the art may be readily apparent even to lay judges, and claim construction
`in such cases involves little more than the application of the widely accepted meaning of
`commonly understood words.’” (quoting Phillips, 415 F .3d at 1314).
`
`8
`
`Ex. 2034-0012
`
`

`
`
`specification other than in the claims and in passages which recite “said method comprising the
`
`steps or acts of (a) providing pharmaceutically acceptable nitric oxide gas to a medical provider.”
`
`’112 patent, 2:2-3, 2:12-13. Therefore, the patentee has not redefined the term in the
`
`specification. Further, as stated previously, the prosecution history demonstrates that the
`
`“pharmaceutically acceptable” language was added in order to claim priority to an earlier
`
`application. See Ex. E, ’112 Patent File History, Office Action Response dated May 1, 2014 at
`
`p. 13. Prior to making that amendment, the patentee also stated during prosecution that
`
`“Applicant maintains that the disclosure present in each of the related applications to which this
`
`application claims priority . . . generally disclosed the concept of distributing a source of
`
`pharmaceutically acceptable nitric oxide gas, which is certainly a pharmaceutical product.” Ex.
`
`F, Office Action Response dated Dec. 23, 2013 at p. 11. If anything, this language represents an
`
`attempt to broaden the meaning of “pharmaceutically acceptable,” not narrow—much less
`
`disavow—the scope of the term.
`
`Courts throughout the country have also applied the plain and ordinary meaning to
`
`“pharmaceutically acceptable.” For example, in AstraZeneca AB v. Dr. Reddy’s Labs., Ltd., the
`
`District of New Jersey explained: “Because its ordinary and customary meaning would be clear
`
`to one skilled in the art, the Court declines to construe ‘pharmaceutically acceptable salt.’ The
`
`ordinary meaning of the term as understood by those of ordinary skill in the art shall apply.” No.
`
`CIV.A.05-5553 JAP, 2010 WL 1981790, at *21 (D.N.J. May 18, 2010) adhered to sub nom.
`
`AstraZeneca AB v. Dr. Reddy’s Labs., Inc., No. CIV.A. 11-2317 JAP, 2013 WL 1847639 (D.N.J.
`
`May 1, 2013). And the District of Nevada found “after looking first to the words of the claim
`
`and then the remaining parts of the intrinsic record, . . . that a person of ordinary skill in the art of
`
`organic chemistry would understand the phrase ‘pharmaceutically acceptable,’ as used in the
`
`9
`
`Ex. 2034-0013
`
`

`
`
`’829 Patent, to have its plain and ordinary meaning,” noting “[t]he language of this disputed
`
`claim term is certainly clear on its face.”4 In view of the claims, the specification, and the
`
`prosecution history, this Court should likewise find that the claim term “pharmaceutically
`
`acceptable” is sufficiently clear and need not be construed.
`
`c.
`
`Plaintiff’s Proposed Construction Improperly Imports Limitations
`Into The Claims And Is Ambiguous
`
`Plaintiff’s propose construing “pharmaceutically acceptable” as “nitric oxide gas that is
`
`suitably safe for pharmaceutical use” (emphasis added). However, this construction improperly
`
`imports the requirement that something that is pharmaceutically acceptable be suitably safe. See
`
`ALM Holding (“The plaintiffs attempt to insert the word ‘conventional’ into the claim language
`
`. . . . The court must interpret the patent ‘as written, not as the patentees wish they had written
`
`it.’”) (citing Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004)).
`
`The intrinsic record provides no support for importing “suitably safe” into the
`
`construction. As mentioned previously, the term “pharmaceutically acceptable” is not redefined
`
`in the specification. See ’112 patent, 2:2-3, 2:12-13. The specification does not even associate
`
`the term “pharmaceutically acceptable” with the idea of being “suitably safe.” Further, although
`
`the INOT22 study that is described in the specification “was conducted both to assess the safety
`
`and effectiveness of IMOmax,” ’112 patent, 9:35-46, the purpose of the study that may have led
`
`the patentees to the alleged invention is not indicative of the meaning of the claim term
`
`“pharmaceutically acceptable.”
`
`Plaintiff’s construction should also not be adopted because it will lead to unnecessary
`
`4 Spectrum Pharm., Inc. v. Sandoz Inc., No. 2:12-CV-000111-GMN, 2013 WL 6865692, at *16
`(D. Nev. Dec. 31, 2013); see also Merck Sharp & Dohme Corp. v. Xellia Pharm. ApS, No. CV
`14-199-RGA, 2015 WL 82386, at *3 (D. Del. Jan. 6, 2015) (construing “a pharmaceutically
`acceptable amount of an acetate buffer effective to provide a pharmaceutically acceptable pH” to
`carry its plain and ordinary meaning).
`
`10
`
`Ex. 2034-0014
`
`

`
`
`ambiguity and, potentially, invalidity issues. See Phillips, 415 F.3d at 1327 (“claims should be
`
`construed to preserve their validity”). The term “suitably safe” is ambiguous, and itself, would
`
`require interpretation. Indeed, in the underlying Inter Partes Review Plaintiff’s expert took the
`
`position that “pharmaceutically acceptable” is supposedly a “time-sensitive construct” and can
`
`change over time. Ex. G, Rosenthal Dep. at 65:23-66:2 (“Well, what I would say is that the
`
`determination of pharmaceutical acceptability is a time-sensitive construct.”) Adopting
`
`Plaintiff’s approach would, therefore, mean that the scope of the claims could change over time,
`
`eviscerating the public notice function of the claims. See PSC Computer Products, Inc. v.
`
`Foxconn Int’l, Inc., 355 F.3d 1353, 1360 (Fed. Cir. 2004) (“The ability to discern both what has
`
`been disclosed and what has been claimed is the essence of public notice. It tells the public
`
`which products or processes would infringe the patent and which would not.”).
`
`While it is true that “[a] determination that a claim term ‘needs no construction’ or has
`
`the ‘plain and ordinary meaning’ may be inadequate when a term has more than one ‘ordinary’
`
`meaning or when reliance on a term’s ‘ordinary’ meaning does not resolve the parties’ dispute,”
`
`O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008), this is
`
`not the case here. “Pharmaceutically acceptable” does not have more than one “ordinary
`
`meaning,” and reliance on the term’s ordinary meaning will resolve the parties’ dispute, i.e., it
`
`will make clear that it is improper to import the unnecessary and unsupported “suitably safe”
`
`requirement into the claims. Therefore, this Court should adopt Defendants’ proposed plain and
`
`ordinary meaning construction.
`
`V.
`
`CONCLUSION
`
`For the foregoing reasons, this Court should conclude that “pharmaceutically acceptable”
`
`carries its plain and ordinary meaning.
`
`11
`
`Ex. 2034-0015
`
`

`
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`
`/s/ James L. Higgins
`____________________________________________
`Melanie K. Sharp (No. 2501)
`James L. Higgins (No. 5021)
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6681
`msharp@ycst.com
`jhiggins@ycst.com
`
`MORGAN, LEWIS & BOCKIUS LLP
`Michael J. Abernathy
`Sanjay K. Murthy
`Maria E. Doukas
`77 West Wacker Drive, Fifth Floor
`Chicago, IL 60601
`(312) 324-1000
`
`K&L GATES LLP
`Christopher E. Hanba
`Benjamin E. Weed
`Margaux L. Nair
`70 West Madison Street, Suite 3100
`Chicago, IL 60602
`(312) 372-1121
`
`Attorneys for Praxair Distribution, Inc. and Praxair, Inc.
`
`
`
`
`
`Dated: March 17, 2016
`
`
`01:18439154.1
`
`12
`
`Ex. 2034-0016
`
`

`
`EXHIBIT A
`
`EXHIBIT A
`
`Ex. 2034-0017
`
`Ex. 2034-0017
`
`

`
`Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 12
`Entered: July 29, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`PRAXAIR DISTRIBUTION, INC.,
`Petitioner,
`v.
`INO THERAPEUTICS LLC,
`Patent Owner.
`_______________
`
`Case IPR2015-00529
`Patent 8,846,112 B2
`_______________
`
`
`Before LORA M. GREEN, TINA E. HULSE,
`and ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`Ex. 2034-0018
`
`

`
`IPR2015-00529
`Patent 8,846,112 B2
`
`Petitioner asserts that all claim terms should be accorded their plain and
`ordinary meanings. 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. We provide express constructions for the following terms.
`
`1. “Near Term Neontates,” “Full Term Infant,” and “Neonate”
`Patent Owner contends that “near term neonates” are defined in the
`Specification as “those having achieved ‘>34 weeks gestation.’” Id. (citing
`Ex. 1001, 6:34–36) see also Ex. 1014, 4 (“near-term (>34 weeks) neonates”).
`Patent Owner further contends that Stedman’s Medical Dictionary2 evidences the
`common and ordinary meaning of “full term infant” as one with a “gestational age
`between 37 completed weeks (259 completed days) and 42 completed weeks (294
`completed days),” and “neonate” as “an infant aged 1 month or younger;
`newborn.” Prelim. Resp. 21