IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C. A. No.: 15—l70—GMS
`
`) ) ) ) ) ) ) ) ) )
`
`IN0 TIIERAPEUTICS LLC and IKARIA, INC.
`
`Plaintiffs,
`
`V.
`
`PRAXAIR DISTRIBUTION, INC. and
`PRAXAIR, INC.,
`
`Defendants.
`
`DEFENDANTS’ INITIAL INVALIDITY CONTENTIONS
`
`Defendants Praxair Distribution, Inc. and Praxair, Inc. (“Praxair” or “Defendants”) serve
`
`their Initial Invalidity Contentions (“Invalidity Contentions”) and accompanying document
`
`production on Plaintiffs INO Therapeutics LLC and Ikaria,
`
`Inc.
`
`(“Ikaria” or “P1aintiffs”).
`
`Defendants contend that cach of the asserted claims of U.S. Patent Nos. 8,282,966 (the “966
`
`Patent”); 8,293,284 (the ‘“284 Patent”); 8,431,163 (the ‘"163 Patent”); 8,795,741 (the “‘741
`
`Patent”); 8,846,112 (the “‘112 Patent”) (collectively, “Label Patents”) and US. Patent No.
`
`8,291,904 (the “‘904 Patent”); 8,573,209 (the “‘209 Patent”); 8,573,210 (the “‘210 Patent”);
`
`8,776,794 (the “‘794 Patent”); and 8,776,795 (the ‘“ 795 Patent”) (collectively, “Device Patents”)
`
`(Label Patents and Device Patents collectively referred to as the “Patents—in—Suit”) is invalid under at
`
`least pre—America Invents Act (AIA) 35 U.S.C. §§ 101, 102, 103, and/or 112.
`
`INTRODUCTION
`
`Ikaria filedthis action seeking a judgment that the claims ofthe Patents—in—Suit are infringed
`
`Defendants separately counterclaimed seeking judgments that the claims of the Patents—in—S uit are
`
`invalid and not infringed. As indicated in its Disclosure of Asserted Claims and Infringement
`
`Contentions (“Infringement Contentions”), Ikaria asserts the following claims against Praxair:
`
`01:18076737.1
`
`Mallinckrodt Hosp. Prods. IP Ltd.
`Exhibit 2021
`Praxair Distrib., Inc. et al., v. Mallinckrodt Hosp. Prods. IP Ltd.
`Case IPR2o16-00779
`
`Ex. 2021-0001
`
`

`
`‘904 Patent Claims 1, 3, 5, 7.
`
`‘209 Patent Claims 1-3, 6, 7.
`
`‘2l0 Patent Claims 1-4, 6, 8, 12-16.
`
`‘794 Patent Claims 1-4, 6-20.
`
`‘795 Patent Claims 1-4, 6-20.
`
`‘966 Patent Claims 1-29.
`
`‘284 Patent Claims 1-30.
`
`‘163 Patent Claims 1-25.
`
`‘74l Patent Claims 1-44.
`
`‘1 12 Patent Claims 1-1 1.
`
`These Invalidity Contentions are based in Whole or in part on Defendants‘ present
`
`understanding of the asserted claims and ll<aria’s apparent construction of the asserted claims in its
`
`Infringement Contentions. Accordingly, the Invalidity Contentions, including the attached invalidity
`
`claim charts, may reflect alternative positions as to claim construction and scope. Further, by
`
`including prior art that would anticipate or render obvious those claims based on Ikaria’s apparent
`
`claim construction or on any other particular claim construction, Defendants are not adopting
`
`Ikaria’s claim construction, nor admitting to the accuracy of any particular claim construction.
`
`Ikaria’s Infringement Contentions, which were only recently received, lack proper and
`
`complete disclosure as to each accused product, and thus do not provide adequate information to
`
`permit Defendants to prepare their Invalidity Contentions. Accordingly, Defendants reserve the
`
`right to further supplement or modify these contentions, including the prior art disclosed and the
`
`stated grounds of invalidity.
`
`011180767371
`
`Ex. 2021-0002
`
`

`
`Defendants reserve the right to revise their Invalidity Contentions, which may change
`
`depending upon the Court’s construction of the claims, additional information obtained during
`
`discovery, any findings as to the priority date of the asserted claims, and/or positions that Ikaria or
`
`expert witness(es) may take concerning claim construction, infringement, and/or invalidity issues.
`
`The Invalidity Contentions pertain only to the asserted claims as identified by Ikaria’s Infringement
`
`Contentions. Defendants reserve the right to modify, amend, or supplement the Invalidity
`
`Contentions to show the invalidity of any additional claims that the Court may later allow Ikaria to
`
`assert. Defendants further reserve the right to supplement their accompanying document production
`
`should it later find additional relevant documents, software and/or source code.
`
`Defendants further may rely on inventor admissions concerning the scope or state ofthe prior
`
`art relevant to the asserted claims; the patent prosecution history for the asserted patents, and related
`
`patents and/or patent applications; any deposition or trial testimony of the named inventors on the
`
`asserted patents; and the papers filed and any evidence produced or submitted by Ikaria in
`
`connection with this or related litigation. In particular, Defendants reserve the right to contend that
`
`the asserted claims are invalid under pre—AIA 35 U.S.C. § lO2(f) in the event Defendants obtain
`
`evidence that the named inventors did not invent the subject matter in the asserted claims.
`
`Defendants also reserve the right to contend that the asserted claims are invalid under pre—AIA 35
`
`U.S.C. § 1 O2(g)(2) if the Defendants obtain evidence that the invention was made in this country by
`
`another inventor who had not abandoned, suppressed, or concealed it.
`
`Prior art not included in these contentions, whether known or not known to Defendants, may
`
`become relevant.
`
`In particular, Defendants are currently unaware of the extent, if any, to which
`
`Ikaria will contend that limitations of the asserted claims are not disclosed in the prior art identified
`
`in the Invalidity Contentions. Accordingly, Defendants reserve the right to identify other references
`
`that would render obvious the allegedly missing limitation(s) of the disclosed device or method.
`01:18076737.1
`
`- 3 _
`
`Ex. 2021-0003
`
`

`
`Discovery has recently begun and Defendants anticipate that additional prior art may be
`
`found. Thus, Defendants reserve the right to revise, amend, and/or supplement the information
`
`provided herein, including identifying, charting, and relying on additional references, should such art
`
`be found.
`
`Additionally, because third—party discovery is ongoing, Defendants reserve the right to
`
`present additional items of prior art under pre—Al/\ 35 U.S.C. §§ l02(a), (b), (e), and/or (g), and/or
`
`§ 103 located during discovery or further investigation, and to assert contentions of invalidity under
`
`35 U.S.C. §§ 102(c), (d), or (t). For example, Defendants expect to issue subpoenas to third parties
`
`believed to have knowledge, documentation and/or corroborating evidence concerning the validity of
`
`the asserted claims.
`
`In addition to the prior art identified below and the accompanying invalidity claim charts,
`
`Defendants also incorporate by reference any additional invalidity contentions, such as supplemental
`
`contentions, identified prior art, or invalidity claim charts disclosed at any time by parties in the
`
`present litigation or by any party to any other litigation or U.S. Patent and Trademark Office
`
`proceeding involving the ‘904, ‘209, ‘Z10, ‘794, ‘795, ‘966, ‘284, ‘I63, ‘741, or ‘I12 Patents.
`
`Defendants reserve the right to supplement or otherwise amend these Invalidity Contentions
`
`in response to any original or rebuttal expert report, or in response to the Court’s claim construction
`
`order. Defendants also reserve the right to supplement or otherwise amend these Invalidity
`
`Contentions in response to any rebuttal evidence by lkaria or as otherwise may be necessary or
`
`appropriate under the circumstances.
`
`I.
`
`THE LABEL PATENTS
`
`A.
`
`Prior Art
`
`Defendants list below prior art that anticipates or renders obvious the asserted claims of the
`
`Label Patents under 35 U.S.C. § 102 and/or § 103. A complete listing of these references is also
`
`0l:18076737.l
`
`_ 4 _
`
`Ex. 2021-0004
`
`

`
`provided in Appendix A. Invalidity claim charts for these references with respect to the asserted
`
`claims ofthe Patents—in—Suit are attached in Appendix B.
`
`Defendants have identified relevant portions and/or features of the prior art. However, the
`
`identified prior art may contain additional descriptions of or alternative support for the claim
`
`limitations. Defendants may rely on uncited portions or features of the identified prior art, other
`
`documents, and expert testimony, to provide context or to aid in understanding the identified prior
`
`art and the state of the art. Citations to a particular figure in a reference include the caption and
`
`description of the figure and any text relating to the figure. Similarly, citations to particular text
`
`referring to a figure include the figure and caption as well.
`
`B.
`
`Anticipation
`
`In Tables lA— l B, Defendants identify prior art that anticipates certain asserted claims of the
`
`Label Patents under at least 35 U.S.C. §§ ]02(a), (b), (e), (t) and/or (g), either expressly or
`
`inherently, as understood by a person having ordinary skill in the art at the time of the invention. In
`
`some instances, Defendants have treated certain prior art as anticipatory where certain elements are
`
`inherently prcscnt based on Ikaria’s apparent claim construction in its Infringement Contentions. To
`
`the extent that any of the prior art identified below in Tables 1A—lB is found not to anticipate
`
`particular claims of the Label Patents, that prior art may render those claims obvious, either alone or
`
`in combination with other prior art disclosed herein, including with those patents, publications, or
`
`systems referenced in Tables 1A—lB.
`
`01 : l8076737.l
`
`Ex. 2021-0005
`
`

`
`3.
`
`Prior Art Publications
`
`The following publications are anticipatory prior art to at least one asserted claim of the
`
`Label Patents under at least one of35 U.S.C. §§ 102(3), (b) and/or (g):1
`
`rAuth6§/Rererrcncce
`
`Bernasconi
`
`9
`
`Goyal
`
`Greeno ugh
`
`Ichinose
`
`INO1nax Label
`
`Loh
`
`' ;j.fMTabi_le,1A“ - N
`V
`V.
`ff ~ EXéinplary;l’,rio'r A:r_t,Publicationsr I‘
`4 v_:v‘Ri,f€ien9e
`A
` ,Date(s,)
`A 920962”
`i
`
`A 1
`
`,
`
`K ; .:Bates
`
`.[
`
`if
`
`iPRiAiXA1Rl_170D]300Oi9io3l3i-9 ’
`PRAXAlR_170DE0009662
`
`if
`
`1
`
`.
`
`K
`Inhaleldiiiitricioxideii
`applications for paediatric
`practice
`
`Efficacy of nitroglycerin
`inhalation in reducing
`pulmonary arterial
`hypertension in children
`with congenital heart
`disease
`
`Anne Greenough, et al.,
`Neonatal Respiratory
`Disorders, (Anne
`Greenough & Anthony D.
`Milner eds., 2nd ed. 2003).
`Dean R. Hess, Adverse
`
`Effects and Toxicity of
`Inhaled Nitric Oxide, 44
`Respiratory Care 315-330
`(Mar. 1999).
`
`llnhaled Nitric Oxide: A
`Selective Pulmonary
`Vasodilator: Current Uses
`
`and Therapeutic Potential
`NDA 20845 — Final
`
`F Printed Labeling
`Cardiovascular effects of
`inhaled nitric oxide in
`
`patients with left
`ventricular dysfunction
`
`May 2006
`
`7 PRAXAIRM1’/'0DE0039071 —
`PRAXAIR_170DE0039077
`
`PRAXAIR__170DF,O041797 -7
`PR/\XAIR_170DE00423 64
`
`PRAXAIR_170DE0039250 —
`PRAXAIR~_170DE00393 83
`
`PRAXAIR_170DE0039422 - 1
`PRAXAIR_170DEOO39428
`
`PRAXAIR_l70DE0034851 —l
`PRAXAIR 170DE0034858
`PRAXAIR;170DE00395 68 —
`PRAXAIR_170DE0039573
`
`1 Additionally, all documents referenced in Office Actions, Search Reports, or in lnformation
`Disclosure Statements as relevant art during the prosecution of the patent applications in the Label
`Patent family are identified as prior art invalidating at least one asserted claim of the Label Patents.
`These applications include, but are not limited to application numbers 14/482,704, 14/454,373 and
`14/451,057.
`
`011180767371
`
`Ex. 2021-0006
`
`

`
`PRAX/\IR«17l0l)iE0039835 —
`PRAXAIR_170DE0039850
`
`PRAXAIR_1 70DE003901 8 -
`PRAXAlR_l70DE0039030
`
`""P1‘iAxArR_i70DE0039719 —
`PRAXAIR_l 70DE0039726
`
`PRAXAlR_l70DE00395 93 —
`PRAXAlR_l70DE003960l
`
`May 8, 2008
`
`PRAXAIR_l 70DE00423 65 —
`PRAXAlR_l 70DE0042403
`
`May 8, 2008
`
`PRAXAIR_l 70DE004l 788 —
`PRAXAIR_l 70DE004l796
`
`PRAXAIR_17ODE0042404 —
`PRAXAIR~_170DE0042601
`
`PRAXAIR_l 70DE002 l 865 —
`PRAXAIR_l 70DE002 1 868
`
`Pilbeam
`
`Gerrnann
`
`I Neonatal Group
`i
`
`VasoKINOX
`Authorization
`
`VasoKlNOX
`Leaflet
`
`Jaypee
`
`Juliana
`
`Pilbeam, Mechanical
`
`Ventilation, Special
`Techniques in Mechanical
`Ventilation, § 4: Nitric
`Oxide, (4th ed. 2006).
`Inhaled nitric oxide therapy
`in adults: European expert
`recommendations
`Inhaled Nitric Oxide in
`
`Full—Term and Nearly Full-
`Terrn Infants With
`
`Hypoxic Respiratory
`Failure
`Inhaled nitric oxide therapy
`in neonates and children:
`
`reaching a European
`consensus
`
`Directorate of the Spanish
`Drug and Healtheare
`Products Agency,
`Resolution Authorizing the
`Commercialization of the
`
`Drug VasoKINOX 450
`ppm/mol/mol inhalation
`gas in cylinder, no. 69773,
`May 2008, available at
`http://Wwwairliquidemedic
`inal.es/file/otherelement/pj/
`Vasokinox4906l .pdf.
`WIAir Liquide Medicinal,
`VasoKINOX, May 2008,
`availableat
`http://Wwwairliquidem edic
`inal.es/file/otherelement/pj/
`Vasokinox46604.pd£
`Jaypee, Pediatric &
`Neonatal Mechanical
`
`Ventilation, (Praveen
`Khilnani ed., 1st ed. 2006)
`Juliana, et al., Severe
`Persistent Pulmonary
`Hypertension of the
`Newborn in a Setting
`Where Limited Resources
`Exclude the use of Inhaled
`Nitric Oxide: Successful
`
`Treatment with Sildenafil,
`
`0l:l8076737.l
`
`-7-
`
`Ex. 2021-0007
`
`

`
`164 Eur. J. Pediatr. 626-
`
`629 (2005).
`
`_‘
`
`E
`
`Prior Art Knowledge, Uses, Sales, Offers for Sale, and Inventions by
`Others
`
`The following items of prior art are anticipatory for at least one asserted claim of the Label
`
`Patents under at least one of35 U .S.C. §§ l02(a), (b) and/or (g):
`
`Table ,1B — Exemplary Systems Currently Under Investigation
`
`j
`T
`.
`i
`3
`INOMAX System as described
`Air ljquide VasoKlNOX System
`
`Reference Name
`at least NDA 020845
`
`For each of the prior art systems identified above in Table 1B, Defendants have listed one or
`
`more references as evidence of features and functionality ofthe indicated system. The systems listed
`
`in Table 1B remain under investigation and Praxair expressly reserves the right to supplement the
`
`invalidity contentions with any additional information subsequently discovered or rely on additional
`
`documents describing the systems listed in Table 1B. Defendants are investigating several prior art
`
`systems and third parties believed to have knowledge, documentation and/or corroborating evidence
`
`concerning the validity of the asserted claims, and expect to issue subpoenas to at least some of such
`
`third parties. Defendants reserve the right to present additional products and systems of prior art
`
`under 3 5 U.S.C. §§ l02(a), (b), (e), and/or (g), and/or 53 103 located during discovery or upon further
`
`investigation, and to assert or revise their Invalidity Contentions, including based on prior art
`
`products and systems identified below and on additional prior art that may be found. Defendants
`
`will revise, am end, and/or supplement the information and Invalidity Contentions after information
`
`becomes available.
`
`To the extent that multiple references describe aspects of the same underlying system, that
`
`system is a single system under 35 U.S.C. § 102. Some or all of the indicated references may also
`0l:l8076737.l
`
`- g _
`
`Ex. 2021-0008
`
`

`
`qualify as prior art publications under 35 U.S.C. § 102 and may be used as invalidating references
`
`under 35 U.S.C. §§ 102 and 103.
`
`In addition, Defendants continue to investigate each of these
`
`systems and reserve the right to supplement the contentions and accompanying claim charts after
`
`further investigation.
`
`C.
`
`Obviousness
`
`In Appendix A, Defendants identify additional prior art references that either alone or in
`
`combination with other prior art (including any ofthe above—identified anticipatory prior art listed in
`
`Tables lA— l B) render certain of the asserted claims ofthe Label Patents invalid as obvious under 3 5
`
`U.S,C. § 103. Appendix A also includes references that provide evidence of the background
`
`knowledge of one of ordinary skill in the art and the state of the art. The presentation of these
`
`references is not to be construed to suggest that any reference included below is not by itself
`
`anticipatory or does not by itself render the asserted claim obvious.
`
`D.
`
`Combinations of Prior Art
`
`Each prior art reference disclosed in the preceding Anticipation section (Tables lA~lB) and
`
`in Appendix A, either alone or in combination with other prior art disclosed herein, also renders
`
`certain of the asserted claims of the Label Patents invalid as obvious.
`
`In addition, to render the
`
`claims invalid as obvious, each anticipatory prior art reference and/or each obviousness prior art
`
`reference may be combined with (1) information known to persons skilled in the art at the time of
`
`the alleged invention, including admissions describing the state ofthe art described below, (2) any of
`
`the anticipatory prior art references in Tables lA—lB, and/or (3) any of the prior art references
`
`identified in Appendix A.
`
`Although the applicable law does not require evidence ofmotivation to combine, motivation
`
`exists to combine one or more of the references disclosed herein with each other. Beyond specific
`
`motivations identified in the present charts, motivation to modify a particular reference or to
`
`011180767311
`
`_ 9 -
`
`Ex. 2021-0009
`
`

`
`combine any two or more of the identified references comes from (1) the nature ofthe problem being
`
`solved; (2) the teachings of the prior art; (3) the knowledge of persons of ordinary skill in the art; (4)
`
`the fact that all of the references teach systems, apparatuses, and methods related to the subject
`
`matter and address the same technical issues of the Label Patents; and (5) one would be motivated by
`
`considerations of efficiency, effectiveness, convenience, cost—savings, and accessibility, to combine
`
`the various teachings. Additionally, one would be motivated to address the alleged problems or
`
`achieve the purported objectives identified in the Background of the Label Patents.
`
`If, and to the extent, Ikaria challenges the correspondence of any of these references with
`
`respect to particular elements of the asserted claims of the Label Patents, Defendants reserve the
`
`right to supplement these Invalidity Contentions to identify motivation to combine particular
`
`references with additional particularity.
`
`Generally, it would have been obvious to one of ordinary skill in the art to modify a
`
`particular reference or to combine any of these references to arrive at the claimed invention.
`
`Specifically, KSR Int’! Co. v. Teleflex, Ina, held that, among other things, “[t]he combination of
`
`familiar elements according to known methods is likely to be obvious when it does no more than
`
`yield predictable results.” 127 S.Ct. at 1727, 1739 (2007); see also id. at 1740 (“[A] court must ask
`
`whether the inrprovernent is nrore than the predictable use of prior art elements according to its
`
`established functions .
`
`.
`
`. .” ). In particular, a patent is obvious where “the content of the prior art,
`
`the scope of the patent claim, and the level of ordinary skill in the art are not in material dispute, and
`
`the obviousness of the claim is apparent in light of these factors.” KSR, 127 S.Ct. at 1745-46.
`
`Indeed, the KSR court found that “if a technique has been used to improve one device, and a person
`
`of ordinary skill in the art would recognize that it would improve similar devices in the same way,
`
`using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 1740.
`
`Each combination of familiar elements according to known methods is obvious here because it
`0l:18076737.1
`
`- 10 ..
`
`Ex. 2021-0010
`
`

`
`yielded predictable results. And, in combination, each element merely performs the same function
`
`as it does separately. The rationale to combine or modify prior art references is significantly
`
`stronger when references seek to solve similar problems, come from the same field, and correspond
`
`well. In re Inland Steel Ca, 265 F.3d 1354, 1362 (Fed. Cir. 2001).
`
`In addition, when a work is
`
`available in one field of endeavor, design incentives and other market forces can prompt variations
`
`of it, either in the same field or a different one. If a person of ordinary skill can implement a
`
`predictable variation, Section 103 likely bars its patentability.
`
`As is apparent, numerous combinations ofthe references in Tables 1A—1B and in Appendix A
`
`would have been naturally considered as part of the exercise of ordinary skill by one skilled in the
`
`art. For example, a person of ordinary skill in the art at the time of the invention would have sought
`
`to combine or modify one or more of the references listed in Tables lA—lB with the knowledge of
`
`persons of ordinary skill in the art and/or would have sought to combine or modify one or more of
`
`the references listed in Tables 1A—lB with one or more other references in Tables 1A—1B, or with
`
`one or more of the references listed in Appendix A.
`
`E.
`
`State of the Art
`
`Defendants may rely on the state of the art known to a person of skill in the art to
`
`demonstrate that a claim limitation is inherent or would have been obvious to a person of skill in the
`
`art at the time of the filing of the application for the Label Patents. The references identified above
`
`and in the Appendices may be relied upon to show the state of the art. Defendants may also rely on
`
`testimony from the inventors or other fact or expert witnesses to demonstrate the state of the art.
`
`Additionally, Defendants may rely on admissions by the inventors as to the state of the art. These
`
`admissions include those made during prosecution of the Label Patents and admissions in the
`
`specification of the Label Patents, including any references cited therein.
`
`012180767371
`
`Ex. 2021-0011
`
`

`
`Defendants also may rely on admissions that certain prior art references describe the state of
`
`the art, such as “Kieler-Jensen M et al., 1994, Inhaled Nitric Oxide in the Evaluation of Heart
`
`Transplant Candidates with Elevated Pulmonary Vascular Resistance, J Heart Lung Transplantation
`
`13:366-375; Pearl R G et al., 1983, Acute Hemodynamic Effects of Nitroglycerin in Pulmonary
`
`Hypertension, American College of Physicians 99:9-13; Ajami G H et al., 2007, Comparison of the
`
`Effectiveness of Oral Sildenafil Versus Oxygen Administration as a Test for Feasibility ol‘Operation
`
`for Patients with Secondary Pulmonary Arterial Hypertension, Pediatr Cardiol; Schulze-Neick I et
`
`al., 2003, Intravenous Sildenafil Is a Potent Pulmonary Vasodilator in Children With Congenital
`
`Heart Disease, Circulation 108 (Suppl lI):II-167-II-173; Lepore J J et al., 2002, Effect of Sildenafil
`
`on the Acute Pulmonary Vasodilator Response to Inhaled Nitric Oxide in Adults with Primary
`
`Pulmonary Hypertension, The American Journal of Cardiology 902677-680; and Ziegler J W ct al.,
`
`1998, Effects of Dipyridamole and Inhaled Nitric Oxide in Pediatric Patients with Pulmonary
`
`Hypertension, American Journal of Respiratory and Critical Care Medicine 158:1388-95.” ‘966
`
`Patent at 1:24-44; see also ‘ 1 12 Patent at 1:20-46; ‘284 Patent at 1:25-45; ‘163 Patent at 1:24-44;
`
`‘741 Patent at 1:25-45.
`
`Defendants reserve the right to rely on any and all admissions as to the state of the art in the
`
`specification of the Label Patents or made during prosecution of applications in the Label Patent
`
`family.
`
`F.
`
`Invalidity Under 35 U.S.C. § 112
`
`The asserted claims of the Label Patents are also invalid under pre-AIA 35 U.S.C. § 112.
`
`The presentation ofthese theories is also not to be construed to suggest that any cl aim term included
`
`below should be construed in any particular way. Defendants reserve the right to amend or
`
`supplement these positions in light of developments in discovery, claim construction exchanges and
`
`briefing, expert discovery, or otherwise as the case progresses.
`
`01:18076737.1
`
`_ 12 _
`
`Ex. 2021-0012
`
`

`
`Section 112 includes a definiteness requirement.
`
`See 35 U.S.C.
`
`§
`
`1 12(2)
`
`(“[T]11e
`
`specification shall conclude with one or more claims particularly pointing out and distinctly claiming
`
`the subject matter which the applicant regards as his invention”). The definiteness requirement is
`
`satisfied when a person skilled in the art “would understand the bounds of the claim when read in
`
`light of the specification” and “[i]f the claims read in light of the specification reasonably appraise
`
`those skilled in the art of the scope of the invention.” Solomon v. Kz'mberly—Clark Ca, 216 F.3d
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`1372, 1378 (Fed. Cir. 2000) (quoting Personalized Media Commc ’ns, LLC v. Int’! Trade Comm ’n,
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`161 F.3d 696, 705 (Fed. Cir. 1998)). Thus, when claims are “not amenable to construction” or
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`“insolubly ambiguous,” they are indefinite. Young v. Lumenis, Inc, 497 F.3d 1336, 1346 (Fed. Cir.
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`2007)
`
`35 U.S.C. § 1 12 includes an enablement requirement.
`
`See 35 U.S.C. § 112 (“The
`
`specification shall contain a written description .
`
`.
`
`. of the manner and process of making and using
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`[the invention] in such full, clear, concise and exact terms as to enable any person skilled in the artto
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`which it pertains, or with which it is mo st nearly connected, to make and use the same”). To satisfy
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`the enablement requirement of 35 U.S.C. § 112, the disclosure “must teach those skilled in the art
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`how to make and use the full scope of the claimed invention Without ‘undue experimentation?”
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`Sizrick v. Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008). Moreover, “[i]t is the
`
`specification, not the knowledge of one skilled in the art that must supply the novel aspects of the
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`invention in order to constitute adequate enablement.” Genentech, Inc. v. Novo Nordz'skA/S, 108
`
`F.3d 1361, 1366 (Fed. Cir. 1997). The Federal Circuit has explained “undue experimentation” as
`
`follows: “The test is not merely quantitative, since a considerable amount of experimentation is
`
`permissible, ifit is merely routine, or if the specification in question provides a reasonable amount of
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`guidance with respect to the direction in which the experimentation should proceed to enable the
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`determination of how to practice a desired embodiment of the invention claimed.” PPG Indus. Inc.
`O1:l.8076737.1
`
`Ex. 2021-0013
`
`

`
`v. Guardian Indus. Corp, 75 F.3d 1558, 1564 (Fed. Cir. 1996) (internal quotations omitted). The
`
`Federal Circuit has also enumerated several factors to consider in determining Whether a disclosure
`
`would require “undue experimentation”:
`
`(1) the quantity of experimentation necessary; (2) the
`
`amount of direction or guidance presented; (3) the presence or absence of working examples; (4) the
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`nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the
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`predictability or unpredictability ofthe art; and (8) the breadth of the claims. In re Wands, 858 F.2d
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`731, 737 (Fed. Cir. 1988).
`
`35 U.S.C. § 112 further includes a written description requirement. See 35 U.S.C. § 112(1)
`
`(“The specification shall contain a written description of the invention .
`
`.
`
`. .”). To satisfy the Written
`
`description requirement, a patent specification must describe the claimed invention in sufficient
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`detail that one skilled in the art can reasonably conclude that the inventor had possession of the
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`claimed invention. Ariad Pharms, Inc. v. Eli Lilly and C0,, 598 F.3d 1336, 1351 (Fed. Cir. 2010)
`
`(en banc).
`
`As Defendants best understand Il<aria’s Infringement Contentions at this time, the asserted
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`claims of the Label Patents fail to meet the requirements of 35 U.S.C. § 1 12 for at least the following
`
`reasons.
`
`For example, claims 12, 23, and 24 ofthe ‘966 Patent have no antecedent basis for the phrase
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`“the first and second children.” Claim 22(b) of the ‘966 Patent and claims 23-29 that depend
`
`therefrom lack antecedent basis for the phrases “the first child of the plurality,” “the second child of
`
`the plurality,” the “second child” and the “first child.”
`
`The claim term “serious” contained in at least claims 5, 11, 20, 28, and 29 ofthe ‘966 patent
`
`(and all related dependent claims) is indefinite and/or lacks enablement or written description
`
`support.
`
`0l:18076737.l
`
`Ex. 2021-0014
`
`

`
`The claim term “particular risk” contained in at least claims l, 6, 13, and 22 of the ‘966
`
`Patent (and all related dependent claims) is indefinite and/or lacks enablement or Written description
`
`support.
`
`Claim 6 of the ‘966 Patent, and claims 7—l 2 that depend therefrom, claim “determine
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`determining,” which is indefinite and/or lacks cnablement or written description support.
`
`Claims 1, 6, 13, 22 (and all related dependent claim s) of the ‘966 patent claim “a pulmonary
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`capillary wedge pressure greater than or equal to 20 mm Hg and thus has left ventricular
`
`dysfunction” which is indefinite and/or lacks enablement or written description support.
`
`Additionally, claims 4, 6, and l0 of the ‘ l 12 Patent are indefinite because the phrases “the
`
`first patient,” and “the second warning,” lack antecedent basis.
`
`Claim 1 of the’ l 12 Patent, and the claims that depend therefrom, are indefinite because the
`
`phrase “the information of (ii) being sufficient to cause a medical provider. .
`
`. to elect to avoid
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`treating” is indefinite and/or lacks enablement or written description support.
`
`The phrase “evaluating the potential benefit .
`
`.
`
`. vs. the potential risk” included in at least
`
`claims 3 and 5 of the ‘l l2 Patent is indefinite and/or lacks enablement or written description support.
`
`Similarly, claim 4 (and all related dependent claims) of the ‘l l2 Patent claim “evaluating on
`
`a case—by—case basis the potential benefit. .
`
`. vs. the potential risk” which is indefinite and/or lacks
`
`cnablement or written description support.
`
`Further, dependent claim 2 of the ‘74l Patent lacks antecedent basis. Claims 9(d), 24(c),
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`34(d), 37(d) (and all related dependent claims) of the ‘74l Patent are indefinite because the phrase
`
`“the first patien ” lacks antecedent basis. Claims 9(e), 24(e), 34(e), 37(e) (and all related dependent
`
`claims) claim “the second patient,” which lacks antecedent basis. Claims 9, l0, l7, 19, 37, 38, 42,
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`44 (and all related dependent claims) claim “the discontinuation,” which also lacks antecedent basis
`
`0l:l8076737.l
`
`Ex. 2021-0015
`
`

`
`The claim term “particular risk,” contained in at least claims 1, 4, 9, 17, 24, 34, 35, 37, 42
`
`(and all related dependent claims) ofthe ‘741 Patent is indefinite and/or lacks enablement or written
`
`description support.
`
`The claim term “serious” contained in at least claims 4, 17, 18, 19, 35, 42-44 and claims 5,
`
`20, and 21of the ‘741 Patent is indefinite and/or lacks enablement or written description support.
`
`The claim terms “adverse event” and “serious adverse event” contained in at least claims 10-
`
`12, 19, 20, 38-40, 44 of the ‘741 Patent are indefinite and/or lack enablement or written description
`
`support.
`
`Claims 6(e), 8, 9, 10, 20(e), 22, 23 24 (and all related dependent claims) of the ‘163 Patent
`
`include the phrase “the first patient,” which has no antecedent basis. Further, claims 6(d), 7, 20(d),
`
`21 (and all related dependent claims) of the ‘163 Patent include the phrase “the second patient,”
`
`which has no antecedent basis. Claims 12(0), 15, 18, 20(e), 23, (and all related dependent claims) of
`
`the ‘163 Patent include the phrase “the exclusion,” which has no antecedent basis. Claims 12, 15,
`
`18, 20(e), 23 (and all related dependent claims) of the ‘ 1 63 Patent claim “the discontinuation,” which
`
`has no antecedent basis. Also, claims 1(c), 2, 3, 6(e), 9, l2(c), 13, 15, 18, 20(e), 23 (and all related
`
`dependent claims) of the ‘ 163 Patent include the phrase “the determination” which has no antecedent
`
`basis.
`
`The claim tenn “particular risk,” contained in at least claims 1(b), 1(c), 4, 6(b), 6(e), 9, 12(b),
`
`l2(c), 15, 18, 20(b), 20(e), 23 (and all related dependent claims) of the ‘163 Patent is indefinite
`
`and/or lacks enablement or written description support.
`
`The claim term “serious” contained in at least claims 4, 9, 15, 18, 23 (and all related
`
`dependent claims) of the ‘ 163 Patent, is indefinite and/or lacks enablement or Written description
`
`support.
`
`01 1181176737.]
`
`Ex. 2021-0016
`
`

`
`Claims 13(d), 16, 23(d), 26 (and all related dependent claims) of the ‘284 Patent use the
`
`phrase “the second patient, which lacks antecedent basis. Claims 13(e), 17, 20-22, 23 (e), 27, 29, and
`
`30 (and all related dependent claims) of the ‘284 Patent, use the term “the first patient,” which has
`
`no antecedent basis. Claims 14, 18, 24, 25 (and all related dependent claims) of the ‘284 Patent
`
`claim “the first and second patients,” which has no antecedent basis. Claims 1 (c), 5, 6(c), 1 1, 13(e),
`
`21, 23(e), 29, (and all related dependent claims) of the ‘284 Patent claim “the determination,” which
`
`has no antecedent basis.
`
`The claim term “particular risk,” contained in at least claims 1(b), 1(c), 5, 6(b), 6(c), 11,
`
`13(b), 13(e), 21, 23(b), 23(e), 29 (and all related dependent claims) of the ‘284 Patent is indefinite
`
`and/or lacks enablement or written description support.
`
`The claim tcrm “serious” contained in at least claims 5, 1 1, 21, 29 (and all related dependent
`
`claims) of the ‘284 Patent is indefinite and/or lacks enablement or written description support.
`
`The term “neonatc[s]” found in at least claims 2 and 8 of the