Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 1 of 15 PageID #: 2748
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`MALLINCKRODT HOSPITAL PRODUCTS IP
`LTD., INO THERAPEUTICS LLC and IKARIA,
`INC.
`
`
`
`
`
`
`
`Plaintiffs,
`
`v.
`
`
`PRAXAIR DISTRIBUTION, INC. and
`PRAXAIR, INC.,
`
`
`
`Defendants.
`
`
`
`
`
`C. A. No.: 15-170-GMS
`
`
`
`
`
`
`
` ))))))))))))
`
`PRAXAIR’S RESPONSIVE CLAIM
`CONSTRUCTION BRIEF REGARDING U.S. PATENT NO. 8,846,112
`
`MORGAN, LEWIS & BOCKIUS LLP
`Michael J. Abernathy
`Sanjay K. Murthy
`Maria E. Doukas
`Jennifer M. Dienes
`77 West Wacker Drive, Fifth Floor
`Chicago, IL 60601
`(312) 324-1000
`
`
`
`
`
`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: April 14, 2016
`
`Ex. 2035-0001
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 2 of 15 PageID #: 2749
`
`TABLE OF CONTENTS
`
`
`Page
`
`
`
`
`
`I. 
`II. 
`
`INTRODUCTION AND SUMMARY OF THE ARGUMENT ................................... 1 
`ARGUMENT .................................................................................................................... 2 
`1. 
`The Claims Were Not Amended to Distinguish Prior Art ............................... 2 
`2. 
`The Term “Pharmaceutically Acceptable Nitric Oxide Gas” Is Not the
`“Essence of the Invention” .................................................................................. 6 
`Plaintiffs’ Proposed Construction is Not the Plain and Ordinary
`Meaning of “Pharmaceutically Acceptable Nitric Oxide Gas” ....................... 9 
`Defendants Are Not Required to Provide any Alternative
`Construction ....................................................................................................... 10 
`III.  CONCLUSION .............................................................................................................. 11 
`
`
`3. 
`
`4. 
`
`i
`
`Ex. 2035-0002
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 3 of 15 PageID #: 2750
`
`
`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp.,
`320 F.3d 1339 (Fed. Cir. 2003)..........................................................................................6, 7, 8
`
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002)........................................................................................3, 6, 7, 8
`
`Fantasy Sports Props., Inc. v. Sportsline.com, Inc.,
`287 F.3d 1108 (Fed. Cir. 2002)..............................................................................................5, 6
`
`Finjan, Inc. v. Secure Computing Corp.
`626 F.3d 1197 (Fed. Cir. 2010)................................................................................................10
`
`Gilead Sciences, Inc. v. Abbott Laboratories, Inc.,
`Civil Action No. 13–2034, 2015 WL 7306206 (D. Del. Nov. 3, 2015) ..................................10
`
`Goldenberg v. Cytogen, Inc.,
`373 F.3d 1158 (Fed. Cir. 2004)................................................................................................10
`
`Helsinn Healthcare S.A. v. Dr. Reddy’s Labs.,
`Civil Action No. 11-3962 (MLC), 2015 WL 1817109 (D.N.J. Apr. 22, 2015) .........................6
`
`LG Electronics U.S.A., Inc. v. Whirlpool Corp.,
`798 F.Supp.2d 541 (D. Del. 2011) ...........................................................................................10
`
`Merck & Co., Inc. v. Ranbaxy Inc.,
`Civil Action No. 07–229, 2008 WL 5727540 (D. Del. Feb. 29, 2008) ...................................10
`
`Nuance Commc’ns, Inc. v. ABBYY USA Software House, Inc.,
`Nos. 14-1629, -1630, at 8 (Fed Cir. Feb. 22, 2016) .................................................................11
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)..........................................................................................10, 11
`
`Pfizer, Inc. v. Ranbaxy Labs. Ltd.,
`457 F.3d 1284 (Fed. Cir. 2006)..................................................................................................9
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)..................................................................................................9
`
`Symantec Corp. v. Computer Assocs. Int’l, Inc.,
`522 F.3d 1279 (Fed. Cir. 2008)..................................................................................................8
`
`ii
`
`Ex. 2035-0003
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 4 of 15 PageID #: 2751
`
`
`Tris Pharma, Inc. v. Actavis Laboratories FL, Inc.,
`Civil Action No. 14-1309, 2016 WL 125495 (D. Del. Jan. 8, 2016) .......................................10
`
`
`
`iii
`
`Ex. 2035-0004
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 5 of 15 PageID #: 2752
`
`
`I.
`
`INTRODUCTION AND SUMMARY OF THE ARGUMENT
`
`Mallinckrodt Hospital Products IP Ltd.’s, INO Therapeutics LLC’s and Ikaria Inc.’s
`
`(collectively “Plaintiffs’”) proposed construction of “pharmaceutically acceptable nitric oxide
`
`gas” in U.S. Patent No. 8,846,112 (“the ’112 Patent”) is flawed for multiple reasons.
`
`First, this term only appears in the preamble of the asserted claims and does not provide
`
`an antecedent basis for any limitation appearing in the body of the claims. Plaintiffs try to skirt
`
`this fact by arguing that the term is limiting because it was supposedly added “to overcome a
`
`prior art rejection during prosecution.” (D.I. 70 at 6.) Not so. As Defendants pointed out in their
`
`Opening Claim Construction Brief, the patentee added this term to address an issue of priority,
`
`not to distinguish the claimed invention from any prior art cited by the Examiner. (D.I. 71 at 7.)
`
`While Plaintiffs cite Federal Circuit authority that relying on the preamble during
`
`prosecution to distinguish the claimed invention from the prior art may transform the preamble
`
`into a claim limitation, they notably cite no Federal Circuit authority that addressing an issue of
`
`priority achieves that same result. (D.I. 70 at 6.)
`
`Second, Plaintiffs’ argument that the preamble is the “essence of the invention” ignores
`
`the file history. (D.I. 70 at 6.) A limitation cannot qualify as the “essence of the invention” if
`
`the patentee did not even deem it necessary to claim it in the first instance. Here the file history
`
`confirms that the patentee initially claimed a generic “pharmaceutical product.” (Ex. F, ‘112
`
`Patent File History, Office Action Response dated Dec. 23, 2013 at 11.)1 It only added the
`
`limitation “pharmaceutically acceptable nitric oxide gas” after the Examiner objected that the
`
`“priority documents” did not disclose the originally claimed “pharmaceutical product.” Rather
`
`than suggest that the former term had some special meaning (as Plaintiffs now propose), the
`
`
`1 Exhibits A through G were attached to Praxair’s Opening Claim Construction Brief
`Regarding U.S. Patent No. 8,846,112, D.I. 71. Exhibit H is attached hereto.
`
`
`
`Ex. 2035-0005
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 6 of 15 PageID #: 2753
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 6 of 15 Page|D #: 2753
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`patentee argued that “pharmaceutical product” and “pharmaceutically acceptable nitric oxide
`
`gas” were effectively the same.2
`
`Third, as a matter of law, a term in the preamble cannot be a limitation where the body of
`
`the claim defines a complete invention.
`
`As discussed below,
`
`removing the term
`
`“pharmaceutically acceptable nitric oxide gas” from the preamble in claim 1 of the ‘l 12 Patent
`
`has no impact on the claimed invention.
`
`Fourth, nothing supports Plaintiffs “suitably safe” construction.
`
`In fact, the words
`
`“suitably safe” appear nowhere in the ‘ 1 12 Patent or its file history. Moreover, Plaintiffs’ expert
`
`Dr. Rosenthal opines that What qualities as “suitably safe” supposedly varies over time.
`
`(Ex. G,
`
`Rosenthal Dep. Tr. at 68: 17-25.) No Federal Circuit decision supports the notion that claims can
`
`be construed in a manner that changes over time.
`
`For these reasons, as well as the reasons in Defendants’ Opening Claim Construction
`
`Brief, Defendants respectfully request this Court to find that no construction is necessary for the
`
`claim term “pharmaceutically acceptable nitric oxide gas.”
`
`H.
`
`ARGUMENT
`
`1.
`
`The Claims Were Not Amended to Distinguish Prior Art
`
`Claim Term
`
`Defendants’ Construction
`
`Plaintiffs’ Construction
`
`“pharmaceutically
`acceptable nitric
`oxide gas”
`’ 1 12 Patent, claims
`1-1 1
`
`Plain and ordinary meaning
`
`Nitric oxide gas that is
`suitably safe for
`pharmaceutical use
`
`Before the PTO, the patentee argued as follows: “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, ‘I12 Patent File History,
`Office Action Response dated Dec. 23, 2013 at 11.)
`
`Ex. 2035-0006
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 7 of 15 PageID #: 2754
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`
`
`Defendants agree that a preamble can be (but is not always) limiting when there is “clear
`
`reliance on the preamble during prosecution to distinguish the claimed invention from the prior
`
`art.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
`
`Plaintiffs’ evidence here, however, fails to meet this standard. Indeed, Plaintiffs’ discussion of
`
`the prosecution history is both incomplete and misleading.
`
`In their opening brief, Plaintiffs argue that:
`
`On February 5, 2014, the Examiner rejected pending claims directed to methods
`of “providing a pharmaceutical product” because they were allegedly invalid as
`obvious over the prior art. (Ex. __, ’112 Patent Prosecution History, Feb. 5, 2014
`Office Action, at 3-4.) In response, the patentees amended the subject claims to
`recite the current preamble of “providing pharmaceutically acceptable nitric oxide
`gas.” (Ex. __, ’112 Patent Prosecution History, May 1, 2014 Resp. to Office
`Action at 2, 12-13.) In view of this amendment, the Examiner withdrew the
`rejection. (Ex. __, ’112 Patent Prosecution History, July 16, 2014 Office Action,
`at 2.)
`
`(D.I. 70 at 6.) Plaintiffs wrongly suggest that the patentee used the preamble to distinguish the
`
`prior art. The file history proves otherwise.
`
`The patentee added “pharmaceutically acceptable nitric oxide gas” language 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 and claimed
`
`methods of “providing pharmaceutically acceptable nitric oxide gas.” The Examiner objected as
`
`follows:
`
`3
`
`Ex. 2035-0007
`
`

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`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 8 of 15 PageID #: 2755
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 8 of 15 Page|D #: 2755
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`Priority
`
`Applicant has amended the independent claims 1, 21 , 33 and 35 to include the
`
`recitations of "providing a pharmaceutical product" and in claims 1 and 21 "generating a
`
`cylinder containing compressed nitric oxide gas...".
`
`
`
`—Furthermore, 12494598 teaches with respect to the gas
`
`(Ex. H, ‘I12 Patent File History, Office Action dated Feb. 5, 2014 at 3 (emphasis added).)
`
`The patentee responded by amending the claims to specify that the “pharmaceutical
`
`product” was “pharmaceutically acceptable nitric oxide gas,” as originally claimed in the priority
`
`document.
`
`(See Ex. E, ‘112 Patent File History, Office Action Response dated May 1, 2014 at
`
`13.) Even then, the patentee disagreed with the Examiner and argued that it amended the claims
`
`only to “secure rapid allowance,” not to distinguish any prior art reference:
`
`Lt“!
`
`The present Office Action at pages 3-4 raises three concerns regarding claim language
`
`that, according to the Office Action, is not disclosed in the applications to which the present
`
`application claims priority. According to the Office Action, this means that the claims are not
`
`entitled to claim priority to a date earlier than the present application‘s filing date, i.e.,
`
`November 21, 201
`
` the claims
`
`are newly amended consistent with the Examiner's advice during the Interview, in an effort to
`
`resolve the issues and thereb—
`
`(Id. at 13 (emphasis added).)
`
`Ex. 2035-0008
`
`

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`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 9 of 15 PageID #: 2756
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 9 of 15 Page|D #: 2756
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`After the patentee amended their claims to comply with their priority document, they
`
`removed the VasoKlNOX reference as prior art because they were able to “swear behin ” it3 :
`
`Rejections under 35 USC § 1031a)
`
`The Office action rcjcclcd all ofthc pending claims (i.c., claims 1, 6-10, 21, 25, 26, and
`
`31-36) as obvious over a combination of references of which the VasoKlNOX prescribing
`
`information is the primary rctcrcncc.
`
` _
`
`
`
` In the Reply mod
`
`December 23, 2013. applicant submitted evidence including a Declaration under 37 C .F.R.
`
`§ 1.131 establishing that VasoKlNOX also does not qualify as prior art under 35 USC § l02(a).
`
`
`
` t thcrcforc appears I0
`
`(Ex. E, ‘ 1 12 File History, Office Action Response dated May 1, 2014 at 17.)
`
`The file history thus confirms that:
`
`(1) the patentee did not agree with or rely upon the
`
`Examiner’s priority objection; (2) the amendment was not, and indeed could not have been,
`
`made to “distinguish the prior art;’’ (3) the amendment was not substantive in nature; and (4) the
`
`patentee did not ascribe any special meaning to its amendment.4 Accordingly, there was no
`
`3
`
`Indeed, the amendment could not distinguish the claim language from the prior art because
`the reference applied by the Examiner (VasoKINOX), like Plaintiffs’ invention, undisputedly
`relates to “pharmaceutically acceptable nitric oxide gas.” According to the Examiner,
`VasoKlNOX disclosed: “methods of providing the pharmaceutical product VasoKlNOX
`(pages 19-21 of 37) by supplying a cylinder of mixed nitrogen/nitric oxide under a pressure
`of 200 bar (pages 21, 23, 33 and 36 of 37) and other devices such as ventilators (page 24 of
`37) and treating pulmonary hypertension .
`.
`.
`.”
`(Ex. H, ‘112 File History, Oflice Action
`dated February 5, 2014 at 6.) Plaintiffs did not contest this characterization.
`
`To the extent Plaintiffs cite Fantasy Sports Props., Inc. v. Sportslinecom, Inc., 287 F.3d
`1108, 1118 36 n.3 (Fed. Cir. 2002), in their Reply Brief to generally argue that addressing
`
`In
`§ 112 issues can make a term in a preamble limiting, that case is not relevant here.
`Fantas_v Sports, the preamble was found to be “necessary to give life, meaning and vitality to
`the claims” and “[t]he prosecution history demonstrate[d] that the examiner treated all of the
`
`Ex. 2035-0009
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 10 of 15 PageID #: 2757
`
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`“clear reliance on the preamble during prosecution to distinguish the claimed invention from the
`
`prior art.” Catalina, 289 F.3d at 808.
`
`Plaintiffs, moreover, cite Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Civil Action No.
`
`11-3962 (MLC), 2015 WL 1817109 (D.N.J. Apr. 22, 2015), to argue that a “preamble [can be]
`
`limiting where patentees amended it to overcome rejection for lack of enablement.” (D.I. 70 at
`
`6.) An issue of priority under 35 U.S.C. § 119, however, is not the same as a substantive issue
`
`under 35 U.S.C. § 112. In any event, Plaintiffs’ characterization of the holding in Helsinn is
`
`inaccurate. Helsinn actually held that the preamble was a limitation because: “(1) the applicants
`
`for the ‘219 patent considered the preamble language ‘reducing the likelihood of CINV’ to be a
`
`limitation of the claim; and (2) the examiner relied on the applicants’ arguments about that
`
`preamble language, and their arguments distinguishing the prior art Tang reference, in allowing
`
`the patent to be approved.” Helsinn, 2015 WL 1817109, at *14 (emphasis added). As the file
`
`history above demonstrates, no similar facts exist.
`
`2.
`
`The Term “Pharmaceutically Acceptable Nitric Oxide Gas” Is Not the
`“Essence of the Invention”
`
`Plaintiffs’ argument that “pharmaceutically acceptable nitric oxide gas” is the “essence of
`
`the invention” is equally meritless.
`
`Plaintiffs cite Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d
`
`1339, 1345 (Fed. Cir. 2003), for the proposition that the preamble can be a limitation where it is
`
`“not merely a context in which the invention may be used, but the essence of the invention
`
`without which performance of the recited steps is nothing but an academic exercise.” (D.I. 70 at
`
`claims in Fantasy’s application as containing the “computer” limitation in order to comply
`with the written description requirement of 35 U.S.C. § 112, and Fantasy acquiesced in that
`treatment.” Id. (emphasis added). Here, the claim term is not “necessary to give life,
`meaning and vitality to the claims,” there was no “written description issue,” and there was
`never any reliance by the Examiner or acquiescence by the patentee on this language.
`
`6
`
`Ex. 2035-0010
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 11 of 15 PageID #: 2758
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 11 of 15 PagelD #: 2758
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`6-7.) The tenn “ harmaceutically acceptable nitric oxide gas,” however, fails to meet this rare
`
`exception to the general rule that preamble language is non-limiting.
`
`For instance, the claims in Boehringer were rendered meaningless without the language
`
`in the preamble.5 Here, in contrast, the body of the claims in the ‘I12 Patent defines a complete
`
`invention and the preamble adds nothing. Deleting the “pharmaceutically acceptable nitric oxide
`
`gas” language from the preamble of claim 1 of the ‘I12 Patent proves the point:
`
`1- A 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.
`
`A preamble is not a limitation, where, as here, “deletion of the preamble phrase does not
`
`affect the structure or steps of the claimed invention.” Catalina, 289 F.3d at 809.
`
`Other limitations in the claim confirm the fact that “pharmaceutically acceptable nitric
`
`oxide gas” in the preamble adds nothing to the claim. The body of claim 1 requires that the
`
`5
`
`Specifically, claim 1 in Boehringer recited: “1. A method of growing and isolating swine
`infertility and respiratory syndrome virus, ATCCVR2332, which comprises inoculating the
`virus on a f11ll or partial sheet of simian cells in the presence of serum in a suitable grown
`medium and incubating the inoculated cell sheet at about 34° C. to 37 ° C. until CPE is
`observed.” Unlike here, removing the language in the preamble in Boehringer rendered the
`claim inoperative.
`
`Ex. 2035-0011
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 12 of 15 PageID #: 2759
`
`
`compressed nitric oxide gas be supplied to a “medical provider responsible for treating neonates
`
`who have hypoxic respiratory failure.” (‘112 Patent at Cl. 1.) Therefore, unlike in Boehringer,
`
`the term “pharmaceutically acceptable nitric oxide gas” provides no necessary context to the
`
`claim nor does failing to give it weight reduce the claim to an “academic exercise.” Rather, the
`
`preamble language is “merely duplicative of the limitations in the body of the claim.” Symantec
`
`Corp. v. Computer Assocs. Int’l, Inc., 522 F.3d 1279, 1288-89 (Fed. Cir. 2008).
`
`Plaintiffs’ citation to language from the specification to argue that the preamble is
`
`limiting and is a “crucial aspect of the claimed inventions” is likewise unavailing. (D.I. 70 at 7.)
`
`As the specification citations confirm, only “one aspect of the invention”—not the sole or even
`
`an important aspect—is providing a method, one step of which includes the provision of
`
`“pharmaceutically acceptable nitric oxide gas.” (‘112 Patent at 1:64-2:6 (emphases added).)
`
`Providing “pharmaceutically acceptable nitric oxide gas,” however adds no additional structure
`
`or steps in the claims and these citations to the specification fail to demonstrate its importance.
`
`In sum, Plaintiffs do not overcome the general rule that language in a preamble is non-limiting.
`
`See Catalina, 289 F.3d at 808.
`
`Finally, it defies common sense that “pharmaceutically acceptable nitric oxide gas” is the
`
`“essence of the invention” (as Plaintiffs argue now) when the patentee did not even originally
`
`claim it. As the file history shows, the patentee preferred the generic term (“pharmaceutical
`
`product”), believed that “pharmaceutical product” was in fact supported by its priority document,
`
`and only amended its claims to include this language to “secure rapid allowance,” placing no
`
`importance on the term it now argues is the “essence of the invention.” (Ex. E, ‘112 File
`
`History, Office Action Response dated May 1, 2014 at 13.) All of this confirms that Plaintiffs’
`
`argument here that “pharmaceutically acceptable nitric oxide gas” is the “raison d’être of the
`
`8
`
`Ex. 2035-0012
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 13 of 15 PageID #: 2760
`
`
`claimed method itself” is a litigation-inspired construct to negate an unfavorable ruling from the
`
`Patent Trial and Appeal Board.
`
`3.
`
`Plaintiffs’ Proposed Construction is Not the Plain and Ordinary Meaning of
`“Pharmaceutically Acceptable Nitric Oxide Gas”
`
`Plaintiffs seek to import the language “suitably safe” into the claim. However, the
`
`language “suitably safe” is found nowhere in the ‘112 Patent or its prosecution history.
`
`Plaintiffs’ citation regarding the purpose of the INOT22 study is immaterial. (D.I. 70 at 8-9.)
`
`The fact that the INOT22 study, like most clinical trials, was designed to assess safety generally
`
`says nothing about any special definition for the term “pharmaceutically acceptable nitric oxide
`
`gas” in the ‘112 Patent. Moreover, the fact that the method steps supposedly are designed to
`
`provide for safer administration of the drug does not somehow change the ordinary meaning of
`
`“pharmaceutically acceptable nitric oxide gas” found only in the preamble of the claim. Indeed,
`
`Plaintiffs’ drug was first approved by the Food and Drug Administration in 1999 (and was
`
`therefore “pharmaceutically acceptable nitric oxide gas”) and has not changed since then.
`
`Additionally, Plaintiffs cite to decisions from other districts construing the term
`
`“pharmaceutically acceptable” in other patents to support their “suitably safe” language. (D.I. 70
`
`at 8.) These decisions involving different patents, with different specifications and file histories
`
`are irrelevant. Indeed, under Phillips v. AWH Corp., 415 F.3d 1303, 1314-15 (Fed. Cir. 2005)
`
`(en banc) and Pfizer, Inc. v. Ranbaxy Labs. Ltd., 457 F.3d 1284, 1290 (Fed. Cir. 2006), extrinsic
`
`evidence like unrelated patents cannot be used to interpret the claims of the ‘112 Patent.6
`
`
`6 The Federal Circuit “takes a narrow view on when a related patent or its prosecution history
`is available to construe the claims of a patent at issue and draws a distinct line between
`patents that have a familial relationship and those that do not.” Goldenberg v. Cytogen, Inc.,
`373 F.3d 1158, 1167 (Fed. Cir. 2004). Plaintiffs do not argue that any of the decisions
`interpreting the term “pharmaceutically acceptable” in these other miscellaneous patents are
`“related” by family to the ‘112 Patent.
`
`9
`
`Ex. 2035-0013
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 14 of 15 PageID #: 2761
`
`
`
`
`
`4.
`
`Defendants Are Not Required to Provide any Alternative Construction
`
`Plaintiffs reliance on O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351,
`
`1361 (Fed. Cir. 2008) is misplaced on two fronts. (D.I. 70 at 9.)
`
`
`
`First, O2 Micro merely requires that the Court resolve the parties’ dispute regarding
`
`construction for a term; it does not require that the Court actually construe the term. The Court
`
`has multiple mechanisms to resolve the parties’ dispute here. For example, it can correctly find
`
`that the preamble is not limiting. And even if the Court were to agree with Plaintiffs’ argument
`
`that the preamble is limiting (which it should not), the Court can resolve the parties’ dispute by
`
`rejecting Plaintiffs’ “suitably safe” construction. Either result satisfies the Federal Circuit’s
`
`holding in O2 Micro.
`
`
`
`Second, the Federal Circuit has held that plain and ordinary meaning (with no further
`
`clarification) is an acceptable construction under O2 Micro.7 For example, in Finjan, Inc. v.
`
`Secure Computing Corp., the parties offered competing constructions for the term “addressed to
`
`a client” with the plaintiffs arguing plain and ordinary meaning. 626 F.3d 1197, 1206 (Fed. Cir.
`
`2010). This Court construed the term as having its plain and ordinary meaning, and the
`
`Defendants appealed, arguing “the district court shirked its responsibility to construe a disputed
`
`claim term by adopting ‘plain and ordinary meaning’ violating the principles of O2 Micro . . . .”
`
`
`7 Plaintiffs disregard the fact that this Court has adopted “plain and ordinary meaning” as a
`construction in many cases. See, e.g., Tris Pharma, Inc. v. Actavis Laboratories FL, Inc.,
`Civil Action No. 14-1309, 2016 WL 125495, at *1 (D. Del. Jan. 8, 2016) (“The term ‘single
`mean average plasma concentration peak’ is construed to have its plain and ordinary
`meaning”); Gilead Sciences, Inc. v. Abbott Laboratories, Inc., Civil Action No. 13–2034,
`2015 WL 7306206, at *1 (D. Del. Nov. 3, 2015) (“The term ‘treatment for HCV’ is
`construed to have its plain and ordinary meaning”); LG Electronics U.S.A., Inc. v. Whirlpool
`Corp., 798 F.Supp.2d 541, 554 (D. Del. 2011) (“The court previously determined as a matter
`of law that the term ‘outer surface’ should be given its plain and ordinary meaning…”)
`Merck & Co., Inc. v. Ranbaxy Inc., Civil Action No. 07–229, 2008 WL 5727540, at *1 (D.
`Del. Feb. 29, 2008) (same).
`
`10
`
`Ex. 2035-0014
`
`

`
`Case 1:15-cv-00170-GMS Document 83 Filed 04/14/16 Page 15 of 15 PageID #: 2762
`
`
`Id. at 1208. The Federal Circuit affirmed this Court’s “plain and ordinary meaning” construction
`
`and distinguished O2 Micro on the basis that the district court there failed to resolve the parties’
`
`dispute. Id.; see also Nuance Commc’ns, Inc. v. ABBYY USA Software House, Inc., Nos. 14-
`
`1629, -1630, at 8 (Fed Cir. Feb. 22, 2016) (“At the Markman hearing, the district court found in
`
`Nuance’s favor by adopting the plain and ordinary meaning of the term ‘identifying.’ The fact
`
`that shortly before trial Nuance became dissatisfied with its own proposed construction and
`
`sought a new one does not give rise to an O2 Micro violation.”) In sum, Plaintiffs’ demand that
`
`Defendants are obligated to further construe their construction contradicts Federal Circuit
`
`precedent.
`
`III. CONCLUSION
`
`For the foregoing reasons, this Court should conclude that “pharmaceutically acceptable
`
`nitric oxide gas” is not a limitation and has its plain and ordinary meaning.
`
`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
`Jennifer M. Dienes
`77 West Wacker Drive, Fifth Floor
`Chicago, IL 60601
`(312) 324-1000
`
`Attorneys for Praxair Distribution, Inc. and Praxair, Inc.
`
`11
`
`
`
`Dated: April 14, 2016
`01:18565576.1
`
`Ex. 2035-0015
`
`

`
`Case 1:15-cv-00170-GMS Document 83-1 Filed 04/14/16 Page 1 of 33 PageID #: 2763
`Case 1:15—cv—00170—GMS Document 83-1 Filed 04/14/16 Page 1 of 33 Page|D #: 2763
`
`EXHIBIT H
`
`EXHIBIT H
`
`Ex. 2035-0016
`
`Ex. 2035-0016
`
`

`
`Case 1:15-cv-00170-GMS Document 83-1 Filed 04/14/16 Page 2 of 33 PageID #: 2764
`Page 2 of 33 Page|D #: 2764
`
`UNITED STATES DEPARTMENT OF CONIMERCE
`United States Patent and Trademark Ofiice
`Address: COIVIIVIISSIONER FOR PATENTS
`P.O Box 1450
`Alexandria, Virginia 22313- 1450
`www.uspLo.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/683,236
`
`11/21/2012
`
`James S. Baldassarre
`
`26047—0003006
`
`5655
`
`7590
`94169
`.
`.
`Fish & Richardson PC
`P_0_]30x 1022
`
`minneapolis, MN 55440
`
`02/05/2014
`
`EXAMINER
`
`ARNOLD, ERNST V
`ART UNIT
`PAPER N UMBER
`
`161%
`
`MAIL DATE
`
`02/05/2014
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`Ex. 2035-0017
`
`

`
`Case 1:15-cv-00170-GMS Document 83-1 Filed 04/14/16 Page 3 of 33 PageID #: 2765
`Case 121:5-cv-99119-GMS Document
`pplfii(j§fil)n
`°J_:4=/I6 Page 3 gtplgfian
`: 2165
`13/683,236
`BALDASSARRE. JAMES s.
`
`Office Action Summary
`
`AIA (First lnventorto File)
`Art unit
`Examiner
`§‘;‘”S
`1613
`ERNST ARNOLD
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE Q MONTHS FROM THE MAILING DATE OF
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`— Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date ot this communication, even it timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`In no event, however, may a reply be timely tiled
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`Status
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`1)IZ Responsive to communication(s) filed on 12/23/13.
`I:I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b) This action is non-final.
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`4)I:l Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5) Claim(s) 1 6-10 21 25 26 and31—36 is/are pending in the application.
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`j is/are allowed.
`1 6-10 21 25 26 and 31-36 is/are rejected.
`)
`) j is/are objected to.
`)j are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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