`PTO/SB/28 (07-09)
`Dec Description: Petition for 12-month Accelerated Exam
`Approved f°.’ use mmugh 07/31/2012 OMB 0651'0031
`U.S. Patent and Trademark Office; U. 8. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number,
`PETITION TO MAKE SPECIAL UNDER ACCELERATED EXAMINATION PROGRAM
`
`
`
`I.
`
`Attorney Docket
`Number
`
`IOO1—0002USC3
`
`Application Number (if Known)
`
`
`
`FIrSt Named
`Inventor
`
`James S. Baldassarre
`
`Methods of Treating Term and Near—Term Neonates Having Hypoxic Respiratory Failure Associated with Clinical or
`Title of
`
`Invention Echocardiographic Evidence of Pulmonary Hypertension
`APPLICANT HEREBY PETITIONS TO MAKE THE ABOVE—IDENTIFIED APPLICATION SPECIAL UNDER THE
`
`REVISED ACCELERATED EXAMINATION PROGRAM. See Instruction sheet on page 3.
`1.
`Claims of the application:
`a, The application must contain three (3) or fewer independent claims and twenty (20) or fewer total claims. The
`application may not contain any multiple dependent claims.
`
`b. Applicant hereby agrees not to separately argue the patentability of any dependent claim during any
`appeal in the application. Specifically, the applicant agrees that the dependent claims will be grouped together
`with and not argued separately from the independent claim from which they depend in any appeal brief filed in
`the application (37 CFR 41 .37(c)(1)(vii))l
`
`The claims must be directed to a single invention.
`c.
`Interviews:
`
`Applicant hereby agrees to have (if requested by examiner):
`a. An interview (including an interview before a first Office action) to discuss the prior art and any potential
`rejections or objections with the intention of clarifying and possibly resolving all issues with respect to
`patentability at that time, and
`
`
`
`
`
`A telephonic interview to make an election without traverse if the Office determines that the claims are not
`obviously directed to a single invention.
`
`
`Preexamination Search Statement and Accelerated Examination Support Document:
`With this petition, applicant is providing: a preexamination search statement, in compliance with the requirements
`set forth in item 8 of the instruction sheet, and an “accelerated examination support document” that includes:
`a. An information disclosure statement in compliance with 37 CFR 1.98 citing each reference deemed most
`closely related to the subject matter of each of the claims;
`
`b.
`
`b.
`
`c.
`
`d.
`
`For each reference cited, an identification of all the limitations of the claims that are disclosed by the
`reference specifying where the limitation is disclosed in the cited reference;
`
`A detailed explanation of how each of the claims are patentable over the references cited with the
`particularity required by 37 CFR 1.111(b) and (c);
`
`A concise statement of the utility of the invention as defined in each of the independent claims (unless the
`application is a design application);
`
`e. An identification of any cited references that may be disqualified as prior art under 35 U.S.C. 103(0) as
`amended by the CREATE act; and
`
`f. A showing of where each limitation of the claims tinds support under the first paragraph of 35 U.S.C.
`112 in the written description of the specification. If applicable, the showing must also identify: (1) each means-
`(or step-) plus-function claim element that invokes consideration under 35 U.S.C. 112, 116; and (2) the structure,
`material, or acts that correspond to any means- (or step-) plus-function claim element that invokes
`consideration under 35 U.S.C. 112,116. If the application claims the benefit of one or more applications under
`title 35, United St ates Code, the showing must also include where each limitation of the claims finds support
`under the first paragraph of 35 U.S.C. 112 in each such application in which such support exists.
`
`
`
`J
`The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an application Confidentiality is governed by
`35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This form is estimated to take 12 hours to complete, including gathering, preparing, and submitting the completed
`application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to complete this form and/or
`suggestions for reducrng this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, PO. Box
`1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. If you need assistance in completing the form, call
`1-800-PTO-9199 and select option 2.
`EFS Web 2.2.20
`
`001
`
`PRAXAIR 1052
`
`001
`
`
`
`PTO/SBl28 (07.09)
`Doc Code: PET.SPRE.ACX
`Approved for use through 07/31/2012. OMB 0651-0031
`00 Des r'
`-
`1 Petition for 12_m n h Accelerated Exam
`us, Patent and Trademark Office; u. 3. DEPARTMENT OF COMMERCE
`C iption
`0 t
`Under the Paperwork Reduction Act of 1995. no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`D
`
`PETITION TO MAKE SPECIAL UNDER ACCELERATED EXAMINATION PROGRAM
` (Continued)
`
`Attorney DOCket
`Number
`
`lOO1-0002USC3
`
`FIrSt Named
`Inventor
`
`
`
`James S. Baldassarre
`
`Attachments:
`
`
`a- ><
`
`Accelerated Examination Support Document (see item 3 above).
`
`
`A statement, in compliance with the requirements set forth in item 8 of the instruction sheet, detailing the preexamination
`b
`search which was conducted.
`
`
`
`
`
`
`
`
`Information Disclosure Statement.
`
`C X
`
`Other (9.9., a statement that the claimed subject matter is directed to environmental quality, energy, or
`countering terrorism (37 CFR 1.102(c)(2)).
`
`rim
`
`Fees: The following fees must be filed electronically via EFS or EFS-Web:
`
`
`
`The basic filing fee, search fee, examination fee, and application size fee (if required) under 37 CFR 1.16.
`a.
`
`
`b.
`
`Petition fee under 37 CFR 1.17(h) - unless the petition is filed with a showing under 37 CFR 1.102(c)(2).
`
`l____—______
`
`Signature:
`
`Name
`(Print/Typed)
`
`
`
`.
`Christopher P. Rogers
`
`
`
`Registration
`Number
`
`36334
`
`
`move this si
`Click Remove if you wish
`atory
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`Signature
`/W Date
`,Z/Q’imie20/0
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`
`
`
`Click Add if you wish to add additional signatory
`
`Note: Signatures of all the inventors orassignees of record of the entire interest or their representative(s) are required in accordance with 37 CFR 133 and 10.18. Please
`see 37 CFR 1.4(d) for the form of the signature.
`
`EFS Web 2.2.20
`
`002
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`002
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`
`
`lN THE UNITED STATES PATENT AND TRADEMARK OFFICE (USPTO) v
`'
`,
`
`
`
`
`
`
`
`
`
`
`Title of Application
`
`Methods of Treating Term and Near—Term
`Neonates Having Hypoxic Respiratory
`Failure Associated with Clinical or
`
`Echocardiographic Evidence of Pulmonary
`Hypertension
`
`@—
`
`I001-0002USC3
`
`
`
`
`
`Pre-Examination Search Document
`
`Commissioner for Patents
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`This pre—examination search statement is provided in support of the Petition for
`
`Accelerated Examination filed herewith.
`
`A pre-examination search was conducted involving US. patents and patent application
`
`publications, foreign patent documents and non-patent literature as indicated below. The results
`
`of the search are provided on an Information Disclosure Statement filed concurrently herewith.
`
`The search primarily includes the following aspects:
`
`0 The method of reducing adverse events in patients in need of treating with nitric
`
`oxide — excluding patients with pre-existing lefi ventricular dysfunction.
`
`0 The patients have a pulmonary capillary wedge pressure greater than 20mm Hg.
`
`0
`
`Patients with left ventricular dysfunction have conditions like systolic or diastolic
`
`dysfunction, hypertensive, viral, iodopathic cardiomyopathy, autoimmune disease
`
`related cariomyopathy, structural heart disease, idiopathic pulmonary arterial
`
`hypertension, pulmonary hypertension cardiomyopathy.
`
`Atty Docket No. .- 100170002 USCJ
`
`Page 1 of 5
`
`Lee & Hayes PLLC
`
`003
`
`003
`
`
`
`o The patient’s population are children and adults.
`
`- Adverse events are pulmonary edema, hypotension, cardiac arrest, ECG changes,
`
`hypoxemia, hypoxia and bradycardia.
`
`o The patient in need of nitric oxide inhalation has PCWP<=15mg,
`
`PVRI>3micro.sq.meters.
`
`0 Left ventricular afierload is minimized by administering a pharmaceutical dosage
`
`form comprising nitroglycerin and calcium channel blocker to the patient, using an
`
`inter—aortic balloon pump.
`
`8 1A) Pre-examination Search
`
`Details of US Patent Classification Codes used
`
`http://www.usptogov/go/glassificatio11/
`
`128-Surgery
`
`128/200.14 — Liquid Medicament Atomizer or Sprayer
`
`128/200-24 — Respiratory Method or Device
`
`128/203. 15 — Particular treating agent carried by breathes gas
`
`128/203.12 — Means for mixing treating agent with respiratory gas
`
`55 8— Organic Compounds
`
`558/486 — Glyceryl trinitrate per se (i.e., trinitro glycerin)
`
`423 — Chemistry or Inorganic Compounds
`
`423/405 — Nitric Oxide (NO)
`
`600 — Surgery
`
`600/481 — Cardiovascular
`
`600/513 — Detecting heartbeat electric signal and diverse cardiovascular characteristic
`
`
`Details of IPC-8 Codes used
`
`http://wwwxnwipoint/ c1355ifications/ipc/ipc8/Hang,er
`
`A61K — Preparations for Medical, Dental, or Toilet Purposes
`
`A61K 33/00 — Medicinal preparations containing inorganic active ingredients
`
`A61K 33/08 — Oxides; Hydroxides
`
`Atty Docket Na: 100170002 USC3
`
`Page 2 of 5
`
`Lee & Hayes PLLC
`
`004
`
`004
`
`
`
`A61P — Specific Therapeutic Activity of Chemical Compounds or Medicinal Preparations
`
`A61P 9/00 —- Drugs for disorders of the cardiovascular system
`
`A61P 9/04 — Inotropic agents, i.e. stimulants of cardiac contraction; drugs for heart failure
`
`A61P 9/08 ~ Vasodilators for multiple indications
`
`A61P 43/00 — Drugs for specific purposes
`
`C01B — Non—Metallic Elements; Compounds Thereof
`
`C01B 21/24 — Nitric oxide (NO)
`
`Dates Conducted:
`
`May 10, 2010 and May 17, 2010
`
`Database Searches
`
`Database Service: Legal Advantage
`
`Data Searched: All patents and Non-patent literature
`
`Database Used: MicroPatent, USPTO, European Patent Office/Espacenet, WIPRO, JPO,
`
`Google, Springerlink, Wiley Interscience, ScienceDirect, Scirus, Journal of Medicinal
`
`Chemistry, ACS Publications, and, Journal of American Academy of Pediatrics.
`
`Atty Docket Na: 1001—0002 USC3
`
`Page 3 of 5
`
`Lee & Hayes PLLC
`
`005
`
`005
`
`
`
`Search Logic
`
`
`
`
`
`
`
`
`
`
`
`
`Search Concept
`Keywords
`No.
`
`
`1
`Nitric oxide
`Nitric oxide, nitrogen monoxide, nitrogen oxide, iNO, NO
`
`2
`Inhale
`Inhale, breath, gasp
`
`3
`Reduce
`Reduce, minimize, prevent, avoid, exclude, reject, except, omit
`4
`Adverse event Adverse/undesirable/unfavorable/unfavorable
`
`
`event/effect/consequence/indication, side effect, toxicity, toxin
`
`5
`Identify
`Identify, select, choose, opt, pick, screen, find, segregate,
`
`
`separate, distinguish, take out
`
`Left ventricular dysfunction, LVD, diastolic/systolic
`Lefi
`ventricular
`dysfunction, cardiomyopathy, heart disease
`
`dysfunction
`Pulmonary
`Capillary
`
`wedge pressure
`Respiratory
`failure
`
`Pulmonary Capillary wedge pressure, PCWP
`
`Respiratory failure, Pulmonary edema, hypotension or cardiac
`arrest, heart failure, heart attack, electrocardiogram/ECG
`
`change, hypoxia, hypoxemia, bradycardia
`
`81m Search Directed to the Invention
`
`The pre-examination search was directed to the claimed invention, encompassing all the
`
`features of the claims and giving the claims their broadest reasonable interpretation.
`
`8 C
`
`Search Directed to the Disclosure
`
`No disclosed features that are unclaimed at this time are currently seen as features that
`
`may be claimed later.
`
`81!)!
`
`Search Report from a Foreign Patent Office
`
`Search reports from Australia, Japan, and the EPO are attached herewith.
`
`8
`
`Statement of Good Faith
`
`All statements above in support of the petition to make special are based on a good faith
`
`belief that the search was conducted in compliance with the requirements of this rule.
`
`Atty Docket Na: 100170002USC3
`
`Page 4 0f 5
`
`Lee & Hayes PLLC
`
`006
`
`006
`
`
`
`Respectfiilly Submitted,
`
`
`
`Christop P. R ers,,,§eg. N0 36,334
`my
`Date: Z( 34 '41: ./Q/[)
`
`Lee & Hayes, PLLC
`601 W. Riverside Avenue, Suite 1400
`Spokane, WA 99201
`
`Atty Docket No: 1001-0002USC3
`
`Page 5 Of5
`
`Lee & Hayes PLLC
`
`007
`
`007
`
`
`
`
`
`Australian Government
`
`IPAustralia
`
`Discovery House, Phillip AC?” 2605
`PO Box 200, Woden ACT 2606
`Australia
`Phone: 1300 651 010-
`lntematicmal Callers: Mil-2 5283 2999
`Facsimisef-ieiuz 6283 7999
`Email: assist@ipau5tralia.gov.au
`Website: wwwipaustraliagoaau
`
`15 March 2010
`
`RECEIVED ’l 7 are are
`
`PIZZEYS
`
`Level 14, ANZ Centre
`324 Queen Street
`Brisbane QLD 4000 '
`Australia
`
`Your Ref: 28686IKA/AMles
`
`Examiner's first report on patent application no. 2009202685
`by Ikaria Holdings, Inc.
`
`Last propOSed amendment no.
`
`Dear Madam/Sir,
`
`lam replying to the request for normal examination. I have examined the application and I believe
`that there are lawful grounds of objection to the application. These grounds of objection are:
`
`i.
`
`The invention defined in claims l~30 does not involve an inventive step when compared to the
`disclosure of each of the following prior art doeuments*:
`
`D1: LOH, E. er al. “Cardiovascular Effects of Inhaled Nitric Oxide in Patients with Left
`Ventricular Dysfunction”. CIRCULATION, 1994, vol.90: 2780—2785.
`.
`D2: CUJEC, B. et all. f‘lnhaled Nitric Oxide Reduction in Systolic Pulmonary Artery Pressure is
`Less in Patients with Decreased Left Ventricular Ejection Fraction". CANADIAN
`'
`JOURNAL OF CARDIOLOGY, 1997, vol.13(9)17 816—824.
`D3: ROSALES, A et of. “Adverse Hemodynamic Effects Observed with Inhaled Nitric Oxide
`After Surgical Repair of Total Anomalous Pulmonary Venous Return”. PEDIATRIC
`'
`CARDIOLOGY, 1999, vol.20: 224—226.
`.
`D4: BOCCHI, E. er a1. “Inhaled Nitric Oxide Leading to Pulmonary Edema in Stable Severe
`Heart Failure”. THE AMERICAN JOURNAL OF‘CARDIOLOGY, 1994, vol.74: 70-7].
`D5: ARGENZIANO, M. et a]. “inhaled Nitric Oxide is not a Myocardial Depressant in a
`Porcine Model of Heart Failure”, THE JOURNAL OF TI-IORACIC AND
`CARDIOVASCULAR SURGERY, l998, vol.1 l5: 700—704.
`
`The problem addressed by the current application is reducing adverse events or serious adverse
`events associated with inhaled nitric oxide in patients who have pre-existing left ventricular
`dysfunction.
`
`The cited art is directed to a problem similar to the applicant’s problem, and in searching the
`' problem a person skilled in the art could reasonably be expected to have found, and to have
`ascertained, understood, and regarded, this prior art as relevant.
`
`D1 investigated the use of inhalation of the pulmonary vasodilator, nitric oxide (NO), in
`patients with heart failure due to left ventricular dysfunction (LVD). The cause of heart failure
`in half the patients was ischemic cardiomyopathy and in the other half it was caused by
`idiopathic dilated cardibmyopathy.(see abstract and Methods: Study Population). Following
`
`
`Wfiustralia - Patents - Fade Marks. Designs 6 Plant Breeder’s Rights
`ABN 38 ll?! 072 755
`
`008
`
`008
`
`
`
`administration ofNO via a face masks patients showed an increase in the mean pulmonary
`artery wedge pressure associated with decreases in cardiac index and stroke volume index (see
`Results). It is suggested that selective pulmonary vasodilation is not desirable in patients with
`left ventricular failure (see page 2784, last paragraph).
`
`D2 discloses that there have been reports that a decrease in pulmonary vascular resistance
`following iNO inhalation occurs in patients with LVD as a result of an increase in pulmonary
`capillary wedge pressure. D2 further investigated the effects of iNO in a group of patients with
`a broad range of left ventricular function in a randomized manner (see page 817, left col.)
`Some of the patients received oxygen in addition to NO (see page 818, Study protocol). Three
`patients with depressed left ventricular ejection fraction (LVEF) presented with pulmonary
`oedema after administration of nitric oxide (see page 82 i , left col. lfit paragraph and page 822,
`right col., lines 4—6). Other adverse events to occur in patiens with depressed LVEF were an
`increase in pulmonary wedge pressure and decreased pulmonary vascular resistance (the latter
`patientswere also cardiomyopathy patients) (see page 821, right col). There is a clear
`suggestion that the use of nitric oxide is limited in patients with preexisting LVD (see
`CONCLUSIONS).
`
`D3 discloses a case report of a one month old patient who underwent corrective surgery with
`pulmonary vein confluence to left atrial anastornosis (see abstract). The patient was treated with
`NO therapy following development of sudden onset systemic-level pulmonary pressure with
`concomitant systemic hypotension. However, favourable changes were followed by "rebound"
`pulmonary hypertension that occurred with concomitant systemic hypotension and central
`venous pressure. Therapy with NO was discontinued based on the rationale that this episode of
`pulmonary hypertension may have been caused by left atrial hypertension secondary to a
`sudden increase in pulmonary blood flow into a noncompliant left atrium and ventricle (see
`page 225, 4‘“ and 5“ paragraphs). As a result, D3 states that NO therapy can be detrimental in
`patients with LVD and/or cardiomyopathy as these patients may develop pulmonary oedema
`(see abstract and page 226, left col., last paragraph).
`
`D4 pertains to a study in which patients with refractory heart failure and severe pulmonary
`hypertension having impaired LVEF and severe and diffuse systolic dysfunction were
`‘
`administered NO via inhalation. Following NO therapy patients presented with an increase in
`pulmonary wedge pressure and developed pulmonary oedema (see whole document).
`
`D5 discloses that there have been reports of increases in left ventricular end—diastolic pressure
`and episodes of pulmonary oedema during the clinical use of inhaled nitric oxide (iNO) in
`patients with pre—existin g LVD (see abstract and the introduction).
`
`Each of D1—D5 differs from the instant specification in that they do not specifically disclose
`excluding patients with LVD from iNO treatment nor the steps of informing a medical provider
`that excluding patients with LVD from iNO treatment reduces adverse events. However, eachof.
`D1 —D5 discloses that adverse events occur in patients with preexisting LVD following
`administration of iNO and they clearly suggest that precautions should be taken when
`administering iNO.
`
`Therefore the person skilled in the art would directly and without difficulty, by routine steps,
`arrive at a solution which is the same as the claimed solution, and therefore the claimed
`invention lacks an inventive step.
`‘
`
`* As found during a national phase search
`
`NOTE: There is a current postponement of acceptance in place. If you overcome all other objections
`before the expiration of that postponement, the Commissioner will only accept the application at that
`time if you have filed a clear and unambiguous statement requesting the withdrawal of that
`postponement. Otherwise, a further adverse report will be issued.
`
`You have 21 months from the date of this report to overcome all my objection(s) otherwise
`your application will lapse.
`
`009
`
`009
`
`
`
`You will need to pay a monthly fee for any response you file after 12 months from the date
`of the first report.
`
`You wi 11 also need to pay any annual continuation fees that apply, These will normally be
`first due five years from the-filing date Please note however that earlier commencement
`dates apply for divisional applications. -
`,
`
`Information about fees may be obtained by phoning 1300 651 010.
`
`Yours faith fully,
`
`5/214»
`
`EDWINA VANDINE
`Patent Examination A
`
`A1 - PBR Plants & Biotechnology
`Phone: (02) 6225 6113
`
`010
`
`010
`
`
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`J
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`A KEMP & CO (3)
`
`26. May.
`2010 i6:4i
`
`Europiisrhes
`
`
`firtentamt
`
`Eur-mm”. _
`_.
`Flinn! Office
`
`
`Office europécn
`dc; brevetj
`
`
`
`Ii |||i| l||i| ii||i||i|
`
`
`I III” lllil III" [III II“
`Duckworth, Timothy Y:John
`JA. Kemp Sr Co.
`14 South Square
`Gray's Inn
`London W01 R 5JJ
`GRANDE BRETAGNE
`
`
`
`J. K“! KNEW .539 GO '
`
`
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`9mm)
`.10 MAY 2010
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`092519495 r 2123
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`5
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`No.4473
`European Patent Office
`BQ29$MUNIGH
`' (thMANY
`
`Tel. +49 (0)99 2399 - 0
`Fax +49 (0)99 2399 . 4495
`
`this communication:
`
`For any qUEStiDn-a abOUt
`Tel.:+31 (0)70 34c 45 cc
`
`late
`
`10.05.10
`
`
`
`'e vence
`N.108560—TJD
`
`4 - p Icon ‘ roprrotor
`
`lkaria Holdings, Inc.
`
`
`
`
`
`'l ne'extln‘ded turopean search report is enclosed.
`
`Cammunication
`
`The extended European search report includes, pursuant to Rule 62 EPC, the European search report
`(Fl. 61 EPC) orthe partial European search report/ declaration of no search (Fl. 63 EPO) and the
`European search opinion.
`
`Copies of documents cited in the European search report are attached.
`
`B 1 additional set(s) of copies of such documents is (are) enclosed as well,
`
`The following have been approved:
`
`3 Abstract
`
`3 Titie
`
`1:]
`
`The Abstract was modified and the definitive text is attached to this communication,
`
`The following figure(s) will be published together with the abstract:
`
`Refund of the search fee
`
`if applicable under Article 9 Rules relating to fees, a separate communication lrom the Receiving Section
`on the refund of the search fee will be sent later.
`
`fiat-hes Patent?”
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`A KEMP & CO (3)
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`No.4473
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`P.
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`6
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`Eurogilsches
`Patent-amt
`Him-wean
`
`
`
`’“"““
`Eti‘trttpi‘"
`
`EUROPEANSEAHCHREPORT
`
`Appltcntloh Number
`
`EP 09 25 1949
`
` DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Cate ory
`Citation of document wltit indication, where appropriate.
`Relevant
`
`
`
`9
`of relevant passe-es
`to claim
`
` A61K33/00
`
`
`
`
`X
`
`
`
`CLASSIFICATION OF THE
`APPLICATION (IPC)
`
`1—9
`
`A61P9/08
`A61P9/12
`
`"Cardiovascular Effects
`LOH EVAN ET AL:
`of Inhaled Nitric Oxide in patients With
`Left Ventricular Dysfunction"
`
`CIRCULATION,
`
`vol. 90, no. 6, 1994, pages 2780—2785,
`
`
`XF002577161
`
`
`ISSN: 0009-7322
`* the whole document *
`
`
`
`
`"Hemodynamic
`SEMIGRAN MARC J ET AL:
`effects of inhaled nitric oxide in heart
`
`
`failure"
`JOURNAL OF THE AMERICAN COLLEGE OF
`CARDIOLOGY,
`
`
`vol. 24, not 4, 1994, pages 982—988,
`
`
`XP009131903
`
`ISSN: 0735—1097
`
`
`* the whole document *
`
`
`
`"Inhaled nitric oxide
`HAYWARD C S.FT AL:
`TECHNICAL FIELDS
`
`in cardiac failure: Vascular versus
`
`SEARCHED
`(IPC)
`
`ventricular effects"
`A61K
`
`JOURNAL OF CARDIOVASCULAR PHARMACOLOGY,
`vol. 27, no. 1, 1996, pages 80—85,
`
`XP009131904
`
`ISSN: 0160—2446
`
`e the whole document *
`
`ovooov ET AL:
`"Nitric oxide: Clinical
` ‘x
`
`applications"
`
`SEMINARS IN ANESTHESIA, SAUNDERS, CD, NEW
`
`YORK, NY, US LNKD-
`DOI:10.IOEB/SA.2000.6785,
`
`vol. 19, no. 2,
`1 June 2000 (2000-06n01),
`
`pages 88—97, XP005426335
`
`ISSN: 0277u0326
`
`* page 90, column 1 c
`
`* page 93, column 2 w page 94 *
`
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`
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`
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`
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`APPLICATION (ch)
`
`1-9
`
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`“Inhaled nitric oxide
`HENRICHSEN ET AL:
`can cause severe systemic hypotension"
`JOURNAL OF PEDIATRICS, MOSBYAYEAR BOOK,
`ST. LOUIs, MO, us LNKD—
`DOI:10.1016/50022—3476(96)70230-5,
`vol. 129, no. 1,
`1 July 1996 (1996—07—01),
`page 183, XP022199226
`ISSN: 0022~3476
`* the whole document *
`
`"Inhaled nitric oxide and
`ADATIA ET AL:
`hemodynamic eValuation of patients with
`pulmOnary hypertension before
`transplantation"
`JOURNAL OF THE AMERICAN COLLEGE OF
`CARDIOLDGY, ELSEVIER, NEH YORK, NY, US
`LNKD~ DOI:10.1016/0735—1097(95)00048—9,
`vol. 25, no. 7,
`1 June 1995 (1995-06—01),
`pages 1656-1664, XP005857183
`ISSN: 0735—1097
`* page 1563, column 1
`
`=i=
`
`"Inhaled nitric
`CUJEC BIBIANA ET AL:
`oxide reduction in systoiio pulmonary
`artery pressure is less in patients with
`decreased left ventricular ejection
`fraction"
`
`1—9
`
`CANADIAN JOURNAL OF CARDIOLOGY,
`vol. 13, no. 9, 1997, pages 816—824,
`XP002577162
`ISSN: 0828~282X
`* the whole document v
`
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`
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`Albrecht, Silko
`Munich
`13 April 2010
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`
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`26.May.
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`FINDLAY G P:
`response to inhaled nitric oxide"
`INTERNATIONAL JOURNAL OF INTENSIVE CARE
`1998 GB,
`vol. 5, no. 4, 1998, pages 134—139,
`XP001536771
`ISSN: 1350-2794
`e the whole document *
`
`X,D
`
`"Inhaled nitric oxide
`BOCCHI E A ET AL:
`leading to pulmonary edema in stable
`severe heart failure”
`
`AMERICAN JOURNAL OF CARDIOLOGY, CAHNERS
`PUBLISHING CD., NEwTON, MA, US LNKD—
`D01:10.1015/0002—9149(94)90496—0,
`vol. 74, no. I,
`1 July 1994 (1994—07—01),
`pages 70—72, XP023278686
`ISSN: 0002-9149
`
`[retrieved on 1994~07—011
`* the whole document *
`_____
`
`
`
`1—9
`
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`
`
`
`2
`
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`Albrecht, Siike
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`13 April 2010
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`
`014
`
`page 3 O‘F 3
`
`014
`
`
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`l6.Mar. 2010 llz32
`
`KYOWA PATENT 81 LAW OFFICE
`
`NC. 6593
`
`P.
`
`4
`
`(Translation of Official Action)
`NQTIFICATIQN OF REAQON FOR REJECTION
`
`Mailed: February 23, 2010
`
`Japanese Patent Application No. 2009-1571523
`
`Applicant: IKARIA HOLDINGS, INC.
`
`Ifthe
`The present application should be rejected for the following reason(s).
`applicant has any argument against the reason(s), an Argument must be filed win
`three months of the mailing date of this Official Action.
`
`REASON 1
`The present invention as claimed in the following claim(s) is unpatentable under Article
`29, paragraph 1, sub-paragraph 3 of the Japanese Patent Law as being anticipated by the
`following publication(s) distributed in Japan or elsewhere or as being identical with an
`invention made available to the public through electric telecommunications prior to the
`filing of the present application.
`
`REASON 2
`The present invention as claimed in the following claim(s) is unpatentable under Article
`29, paragraph 2 of the Japanese Patent Law since the invention could have been easily
`made by those skilled in the art to which it pertains on the basis of the invention(s)
`described in the following publication(s) distributed in Japan or elsewhere or an
`invention/inventions made available to the public through electric telecommunications
`prior to the filing of the present application.
`
`NOTE:
`
`Citation 1: Inglessis, 1. at 611., Journal of the American College of Cardiology, 2004, Vol.
`
`44, No. 4, pp. 793-798
`
`Citation 2: Loh, E. at at, Circulation, 1994, 90, pp. 2780-2785
`Citation 3: Steinhorn, RH. at 511., Pulmonary Hypertension, Persistent-Newborn,
`
`emedicine, updated Apr. 19, 2007
`
`[http:l/emedicinemedscape.com/article/898437-overview]
`Citation 4: BOCCHI, EA. at art, The American Journal of Cardiology, 199-4, Vol. 74, pp.
`
`70-72
`
`Page 1/3
`NOTIFICATION OF REASON FOR REJECTION
`Japanese Patent Appln. No. 2009-15762?)
`
`015
`
`015
`
`
`
`lat/lat. 2010 llz32
`
`KYOWA PATENT & LAW OFFlCE
`
`NC. 6593
`
`P.
`
`5
`
`A.
`
`Reasong l and at Claims 1 to 14/ Citation !
`Citation 1 discloses that inhaled nitric oxide is known as a selective pulmonary
`vasodilator (Abstract), and that inhaled nitric oxide, when administered to patients with
`right ventricular myocardial infarction and cardiogenic shock, reduced the pulmonary
`arterial pressure (Abstract). Citation 1 also discloses that the inhalation of nitric oxide
`is known to decrease pulmonary vascular tone in adults and children with pulmonary
`hypertension (page 793, right column, lines 11 to 6 from the bottom), and that nitric
`oxide is delivered by means of a ventilator or is mixed with oxygen (page 795, left
`column, “NO administration”). Especially, Table 2 presents hemodynamic parameters
`of target patients at the time of study enrollment, indicating that most of the patients
`have a pulmonary capillary wedge pressure (PCWP) of less than 20 mmHg.
`In light of the present specification (paragraph [0013]), the patients of Citation
`1 having a POW]? of less than 20 mmI-Ig are not deemed to have pre-existing left
`
`ventricular dysfunction (LVD).
`Thus, the present invention as claimed in claims 1 to 14 is indistinguishable
`
`from the invention disclosed in Citation 1.
`(The present invention and the invention disclosed in Citation l are identical in
`active ingredient and target patients, and thus are deemed to necessarily provide the
`
`same fitnctions/effects.)
`
`B.
`
`Reason 2/ Claims 1 to [41 Citations 1 to 51
`
`Inhaled nitric oxide is well known as a selective pulmonary vasodilator, as
`
`disclosed in Citation 1.
`
`On the other hand, Citation 2 (for example, Abstract) discloses that inhaled
`
`nitric oxide, when administered to patients with left ventricular dysfunction, may cause
`a decrease in pulmonary vascular resistance associated with an increase in left
`ventricular filling pressure, leading to the risk of the occurrence of adverse events.
`Citation 3 (for example, see Abstract and “Treatment with iNO”) discloses that,
`although inhaled nitric oxide is used for the treatment of pulmonary hypertension of
`newborns, patients suffering from congenital cardiac disease characterized by left
`Page 2/3
`NOTIFICATION OF REASON FOR REIECTION
`Japanese Patent Appln. No. 2009-157623
`
`016
`
`016
`
`
`
`lei/lat. 2010 H3?
`
`KYOWA PATENT ii LAW OFFICE
`
`NC. 6593
`
`P.
`
`6
`
`ventricular outflow tract obstruction and severe left ventricular dysfunction have a
`
`contraindication to the treatment with inhaled nitric oxide.
`
`Citation 4 (page 71, left column, lines 13 to 15) discloses that inhaled nitric
`
`oxide, when administered to patients with severe heart disease, may cause pulmonary
`
`edema.
`
`In View of the above, it would have been obvious to those skilled in the art to
`
`exclude patients with lure-existing left ventricular dysfunction from patients to be treated
`
`with a selective pulmonary vasodilator, in order to avoid the occurrence of adverse
`
`events, based on Citations 1 to 4.
`
`Further, the present invention as claimed in claims 1 to 14 is not deemed to
`
`provide particularly remarkable advantages, in view of Citations 1 to 4.
`
`REASON 3
`The present application sh0u1d be rejected on the grounds that the recitation of the
`c1aim(s) fails to meet the requirement of Article 36, paragraph 6, sub-paragraph 2 of the
`Japa