PTO/SB/28 (07-09)
`Doc Code: PET.SPRE.ACX
`APP'°"e" f°' “Se ”"°”9“ 07/31/2011 OMB °‘55l'°°3l
`Dec Description‘ Petition for 12-month Accelerated Exam
`U.S. Patent and Trademark Office; U. 8. DEPARTMENT OF COMMERCE
`’
`Under the Papenivork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number,
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`I_
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`PETITION TO MAKE SPECIAL UNDER ACCELERATED EXAMINATION PROGRAM
`
`Atmmey D°°ket
`Number
`
`roo1—o0o2usc3
`
`Firsmamed
`Inventor
`
`James S.Baldassarre
`
`Application Number (if Known)
`
`Methods of Treating Term and Near-Term Neonates Having Hypoxic Respiratory Failure Associated with Clinical or
`Title of
`Echocardiographic Evidence of Pulmonary Hypertension
`Invention
`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.
`
`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)).
`
`The claims must be directed to a single invention.
`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.
`
`c.
`
`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);
`
`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 finds 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.
`
`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 reducing 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
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`PRAXAIR ET AL. 1018
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`001
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`

`
`PTO/SBl28 (U7-U9)
`Doc Code: PET.SPRE.ACX
`Approved for use through 07l31/2012. OMB 0651-0031
`Doc Description: Petition for 12-month Accelerated Exam
`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
`
`Attorney Docket
`Number
`
`I001-OOOZUSC3
`
`Attachments:
`
`(Continued)
`First Named
`Inventor
`
`James S. Baldassarre
`
`a- ><
`
`Accelerated Examination Support Document (see item 3 above).
`
`b
`
`'
`
`A statement, in compliance with the requirements set forth in item 8 of the instruction sheet, detailing the preexamination
`search which was conducted.
`
`0 ><
`
`D
`
`Information Disclosure Statement.
`
`Other (eg., a statement that the claimed subject matter is directed to environmental quality, energ)’. or
`countering terrorism (37 CFR 1.102(c)(2)).
`
`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.
`
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`
`Petition fee under 37 CFR 1.17(h) - unless the petition is filed with a showing under 37 CFR 1.102(c)(2).
`
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`Click Remove if you wish
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`/We
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`Christopher P. Rogers
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`Click Add if you wish to add additional signatory
`
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`Note: Signatures of all the inventors orassignees of record of the entire interest or their representatii/e(s) are required in accordance with 37 CFR 1.33 and 10.18. Please
`see 37 CFR 1.4(d) for the form of the signature.
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`EFS Web 2.2.20
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`002
`
`

`
`IN 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
`
`
`
`Pre-Examination Search Document
`
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`This pre—exa1nination search statement is provided in support of the Petition for
`
`Accelerated Examination filed herewith.
`
`A pre-examination search was conducted involving U.S. 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 dysfiinction.
`
`The patients have a pulmonary capillary wedge pressure greater than 20mm Hg.
`
`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.
`
`Arty Docket No.: 1()0l—0002 USC3
`
`Page 1 of 5
`
`Lee & Hayes PLLC
`
`003
`
`

`
`The patient’s population are children and adults.
`
`Adverse events are pulmonary edema, hypotension, cardiac arrest, ECG changes,
`
`hypoxemia, hypoxia and bradycardia.
`
`The patient in need of nitric oxide inhalation has PCWP<=l 5mg,
`
`PVRI>3micro.sq.meters.
`
`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 QA) Pre-examination Search
`
`Details of US Patent Classification Codes used
`
`http://www.uspto.;z,ov/go/glyassificatio11/
`
`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
`
`558- 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://www.wipo.int/classifications/ipc/ipc8/?la1g=en
`
`A61K — Preparations for Medical, Dental, or Toilet Purposes
`
`A61K 33/00 — Medicinal preparations containing inorganic active ingredients
`
`A61K 33/08 — Oxides; Hydroxides
`
`Atty Docket No.: 100140002 USC3
`
`Page 2 of 5
`
`Lee & Hayes PLLC
`
`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
`
`C0lB 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 No.: 1001-0002 USC3
`
`Page 3 of 5
`
`Lee & Hayes PLLC
`
`005
`
`

`
`Search Concept
`No.
`
`Keywords
`
`Search Logic
`
`J Nitric oxide
`
`Nitric oxide, nitrogen monoxide, nitrogen oxide, iNO, NO
`
`Inhale, breath, gasp
`Inhale
`Reduce, minimize, prevent, avoid, exclude, reject, except, omit
`Reduce
`Adverse event Adverse/undesirable/unfavorable/unfavorable
`
`l 2
`
`3
`4
`
`Identify
`
`Lefi
`ventricular
`dysfunction
`Pulmonary
`Capillary
`wedge pressure
`Respiratory
`failure
`
`event/effect/consequence/indication, side effect, toxicity, toxin
`Identify, select, choose, opt, pick, screen, find, segregate,
`separate, distinguish, take out
`Left ventricular dysfunction, LVD, diastolic/systolic
`dysfunction, cardiomyopathy, heart disease
`
`Pulmonary Capillary wedge pressure, PCWP
`
`Respiratory failure, Pulmonary edema, hypotension or cardiac
`arrest, heart failure, heart attack, electrocardiogram/ECG
`change, hypoxia, hypoxemia, bradycardia
`
`8§§[
`
`Search Directed to the Invention
`
`The pre-exarnination 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.
`
`812!
`
`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 No.: I001—()002USC3
`
`Page 4 of 5
`
`Lee & Hayes PLLC
`
`006
`
`

`
`Respectfully Submitted,
`
`Christop
`
`Date:
`
`P. R ers,,§eg. No. 36,334
`i07zL/
`jflflf //Q/0
`
`Lee & Hayes, PLLC
`601 W. Riverside Avenue, Suite 1400
`Spokane, WA 99201
`
`Atty Docket No: I00]-0002USC3
`
`Page 5 Of5
`
`Lee & Hayes PLLC
`
`007
`
`

`
`Australian Government
`
`~
`
`11: Australia
`
`Discovery House, Phillip AC?” 2605
`PO Box 200, Woden ACT 2606
`Australia
`Phone: 3300 651 010-
`lntematiocnal Callers: -1--5!-2 5283 2999
`racssmi:e:'+e1—2 6283 was
`Email: assist@ipau5tralia.gov.au
`Website: wwvv.ipaustralia.gov.au
`
`15 March 2010
`
`R-actives 1 7 an Zfllil
`
`PIZZEYS
`Level l4, ANZ Centre
`324 Queen Street
`Brisbane QLD 4000
`Australia
`
`Your Ref: 286861KA/AMM:Is
`
`'
`
`P
`
`Examiners first report on patent application no. 2009202685
`by Ikaria Holdings, Inc.
`
`Last proposed amendment no.
`
`Dear Madam/Sir,
`
`I" am replying to the request for normal examination. I have examined the application and I believe
`that there are lawfulgrounds of objection to the application. These grounds of objection are:
`
`1. The invention defined in claims i~30 does not involve an inventive step when compared to the
`disclosure of each of the following prior art docume-nts*:
`
`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 al. “Inhaled 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):j 816-824.
`D3: ROSALES, A et al. “Adverse I-Iemodynamic 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 al. “Inhaled Nitric Oxide Leading to Pulmonary Edema in Stable Severe
`Heart Failure”. THE AMERICAN JOURNAL OFICARDIOLOGY, 1994, vol.74: 70-7].
`D5: ARGENZIANO, M. et al. “inhaled Nitric Oxide is not a Myocardial Depressant in a
`Porcine Model of Heart Failure”. THE JOURNAL OF TI-IORACIC AND
`CARDIOVASCULAR SURGERY, 1998, vol.1 15: 700-704.
`
`The problem addressedlby the current application is reducing adverse events or serious adverse
`events associated with inhaled nitric oxide in patients who have preexisting 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 cardi'omyopathy.(see abstract and Methods: Study Population). Following
`
`giflfiustralia - Patents - Fade Marks. Designs «' P/ant Breeder’: Rights
`ABN 38 333 072 755
`
`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 E , left col. 1”‘ 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 pre~existing 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
`i
`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—diastoiic 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.
`A
`
`* 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
`
`

`
`You will need to pay a monthly fee for any response you file after 12 months from the date
`of the first report.
`
`You will 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 faithfully,
`
`5?//V9
`
`EDWINA VANDINE
`Patent Examination A
`
`A1 - PBR Plants & Biotechnology
`Phone: (02) 6225 61 13
`
`010
`
`

`
`26.May.
`
`2010 l6:4l
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`NO-4473
`European Patent Office
`80293 MUNIGH
`' WZHMANY
`Tel. +49 (0)39 2399 - 0
`Fax +49 (0)89 2399 ~ 4455
`
`-
`
`this communication:
`
`Te|.:+31 (0)70 340 45 00
`
`Duckwonhq Timothy ‘John
`J.A. Kemp Sr Co.
`14 South Square
`Gray's Inn
`London WG‘lFi 5.J-J
`(BF-lANDE BRETAGNE
`
`E i"EW-‘-E
`N.'I0856D—T.JD
`
`-‘ - p Icon ‘ riopnator
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`ll-(aria Holdings Inc.
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`‘ pp Icflt uh No..n’F"atent No.
`0925194-9.5 r 2123
`
`10.05.10
`
`'l neextnoed turopean search report is enclosed.
`
`Communication
`
`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 EPG) 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:
`
`E’
`
`Abstract
`
`Q’
`
`Title
`
`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:
`
`Ftefund of the search fee
`
`if applicable under Article 9 Flules relating to fees, a separate cornmunicalzion lrom the Receiving Section
`on the refund of the search fee will be sent later.
`
`fikfithes Patenmw
`*2‘
`
`E90 Fertn15O7N
`
`D4-.10
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`011
`
`

`
`26.May.
`
`2010 16:41
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`
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`EUROPEANSEAHCHREPORT
`
`Application Number
`
`DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Gate 0
`9 W
`
`Citation of document wlti-I indication, where appropriate,
`of relevani paeeaes
`
`Relevant
`to claim
`
`CLASSIFICATION OF THE
`APPLICATION (IPC)
`
`LOH EVAN ET AL:
`
`"CardioVascu1ar Effects
`
`of Inhaled Nitric Ox1de in patients w1th
`Left Ventricu1ar Dysfunction"
`CIRCULATION,
`Vo1. 90, no. 5, 1994, pages 2780-2785,
`XP002577161
`ISSN: 0009-7322
`* the who1e document *
`
`"Hemodynamic
`SEMIGRAN MARC J ET AL:
`effects of inha1ed nitric oxide in heart
`failure"
`JOURNAL OF THE AMERICAN COLLEGE OF
`CARDIOLDGY,
`V01. 24, no. 4, 1994, pages 982-988,
`XP009131903
`ISSN: 0735-1097
`* the who1e document *
`
`HAYWARD C S.FT AL:
`"Inhaled nitric oxide
`:,2n:::2;%:.f::4:::;Hm‘ii
`JOURNAL 0F_CARDIOVASCULAR PHARMACOLOGY,
`V01. 27, no. 1, 1996, pages 80—85,
`XF009131904
`ISSN: 0160-2446
`* the who1e document *
`
`"Nitric ox1de: C1inica1
`
`OVODOV ET AL:
`app1ications”
`SEMINARS IN ANESTHESIA, SAUNDERS, CD, NEW
`YORK, NY, US LNKD-
`DOI:10.1053/SA.2000.6785,
`V01. 19, no. 2,
`1 June 2000 (2000-06—01),
`pages 88-97, XP005426335
`ISSN: 0277~0326
`* page 90, column 1 *
`* Page 93, co1umn 2 « page 94 *
`
`,/__
`
`The present SEEITC-l'| report has been drawn up for all claims
`H359 Cl 39E"€h
`0-316 of completion al the saareh
`
`13 Aprii 2010
`
`A61K33/00
`A61P9/D8
`A61P9/12
`
`iéfiiiie
`A61K
`
`Examlnar
`
`‘
`
`A1brecht, SI'1Ke
`
`CATEGORY DF C1TED DOCUMENTS
`
`X: parilculany relevam If {alien alone
`‘I’: particularly relevant if combined wllh another
`document of me same category
`A r technological background
`O2 F\DI1PWFl1l8l‘1 dl5C|O5LliE
`P: inlerrriediate clooume nl
`
`'
`
`T: theory or principle underlying II-Ia Invention
`E : earlier patent document, but publmhecl an, or
`at-tarqha fill,-lg (jalg
`D: document cllecl In 1115 application
`L : document clted for other reas
`s
`
`51: member ofthe same palern *a'n'rly, corresponding
`do-:;urnent
`
`page 1 of 3
`
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`
`
`E90Fania15u3oa.e2[I:cuII:n1]
`
`012
`
`

`
`26.1/lay.
`
`2010 16:42
`
`1
`
`A KEMP & co (3)
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`European
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`AF|P|I¢31NI‘.m Number.
`EF 09 25 1949
`
`DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category
`
`Citation of document with indication, where appropriate,
`of relevant assa es
`
`Relevant
`to claim
`
`CLASSIFICATION OF THE
`APPLICATION (IPCJ
`
`1-9
`
`1-9
`
`X
`
`“Inhaied nitric oxide
`HENRICHSEN ET AL:
`can cause severe systemic hypotension"
`JOURNAL OF PEDIATRICS, MOSBY-YEAR BOOK,
`ST. LOUIS, MO, US LNKD—
`DOI:10.1016/SOO22—3476(96)7U230-5,
`voi. 129, no. 1,
`1 Juiy 1996 (1996-07-01),
`page 183, XP022199226
`ISSN: 0022-3476
`* the whole document *
`
`"Inhaied nitric oxide and
`ADATIA ET AL:
`hemodynamic evaluation of patients with
`pulmonary hypertension before
`transpiantetion"
`JOURNAL OF THE AMERICAN COLLEGE OF
`CARDIOLDGY, ELSEVIER, NEH YORK, NY, US
`LNKD- DOI:10.1016/0735-1097(9S)00O48-9,
`voi. 25, no. 7,
`1 June 1995 (1995-06-01),
`pages 1656-1664, XP005857183
`ISSN: 0735-1097
`* page 1663, column 1 *
`CUJEC BIBIANA ET AL:
`"Inhaled nitric
`oxide reduction in systoiic puimonary
`artery pressure is iess in patients with
`decreased ieft ventricuiar ejection
`fraction"
`
`CANADIAN JOURNAL OF CARDIOLDGY,
`vol. 13, no. 9, 1997, pages 816-824,
`XP002577162
`ISSN: 0828-282X
`* the whoie document v
`
`;Eg:gEE;rmcfl%)
`
`PU
`
`EP-OFGFIM1503-03.82[F|JI1C|31]
`
`The present Search report has been drawn up for an c|aim5;
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`Dale of ccmpielion oi the 56:5rI'J'\
`
`Examiner
`
`Munich
`CATEGORY OF CiTED DOCUMENTS
`X : particularly relevant ii taken alone
`‘V’
`I iiartloulariy relevant Ii combined with another
`oooumerni of lhe same category
`A: Iechrwioeical background
`O‘. non—wriuen disclosure
`F‘: Inlermediate cioourneni
`
`A1breCht, Siike
`13 Aprii 2010
`T I theory or principle underlying the Invention
`E: earlier palenr document, but published on. or
`afier the tiling date
`0 ; document cited in the application
`L : document ciied for other reasons
`
`5:
`
`: member of the same pai-eni iamuy, corresponding
`docurnem
`
`page 2 of 3
`
`013
`
`

`
`26.May.
`
`2010 16:42
`
`I
`
`A KEMP & CO (9
`
`Eurupiiulilrx
`Mlenlsmt
`European
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`
`EUROPEAN EEARCH REPORT
`
`Appilcsllon Number
`EP 09 25 1949
`
`DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category
`
`Citation of document with Indication. where appropriate,
`of relevant passa as
`
`Relevant
`to claim
`
`cLAosIFIoATIoN OF THE
`APPLICATION (IPC)
`
`X
`
`"ParadoxicaI haemodynamic
`FINDLAY G F:
`response to inhaled nitric oxide"
`INTERNATIONAL JOURNAL OF INTENSIVE CARE
`1993 GB,
`voi. 5, no. 4, 1998, pages 134-139,
`XP001536771
`ISSN: 1350-2794
`* the whole document *
`
`1-9
`
`"Inha1ed nitric oxide
`BOCCHI E A ET AL:
`leading to puimonary edema in stabie
`severe heart faiIure”
`
`AMERICAN JOURNAL OF CARDIOLOGY, CAHNERS
`PUBLISHING CD., NENTON, MA, Us LNKD—
`D01:10.1015/0002—9149(94)90496—O,
`voi. 74, no. 1,
`1 July 1994 (1994-07-01),
`pages 70-72, XPO2327B686
`ISSN: 0002-9149
`
`[retrieved on 1994~D7—01J
`e the whole document *
`
`TECHNICAL FIELDS
`SEARCHED
`(IPC)
`
`l'\J
`
`EFC-FICIFll.«115EI'_'.II.‘G,a2[l3'fl-IJZIZII]
`
`E""|Bt=6 0' Search
`
`Date of completion at the saarcll
`
`Examlnar
`
`Munich
`CATEGORY OF CWTED DOCUMENTS
`
`X: particularly relevant if taken alone
`Y : particularly relevant ifoornolned with another
`document oi the same category
`A: technological oackgrotrnd
`C‘: f‘lOl’I—Wl‘1llen disclosure
`P: intermediate document
`
`Albrecht, SIIRE
`13 ADPII 2010
`T: theory or principle underlying the invention
`E 2 eariler patent document, b-U1 published on, or
`aflarlha filing gale
`D ; document cited in the application
`L ; document cited for other reasons
`
`:3 : lnemljler 01 the same patent family, corresponding
`documen;
`
`page 3 O‘F 3
`
`014
`
`

`
`l6.|Vlar. 2010 ll:32
`
`KYOWA PATENT & LAW OFFlCE
`
`Nc_ 5593
`
`P
`
`4
`
`(Translation of Official Action)
`NQTIFICATIQN OF REAQON FOR REJECTION
`
`Mailed: February 23, 2010
`
`Japanese Patent Application No. 2009-157623
`
`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 %
`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, I. at al., Journal of the American College of Cardiology, 2004, Vol.
`
`44, No. 4, pp, 793-793
`
`Citation 2: Loh, E. e1.‘al., Circulation, 1994, 90, pp. 2780-2785
`Citation 3: Steinhorn, R.H. at al., Pulmonary Hypertension, Persistent-Newbom,
`
`emedicine, updated Apr. 19, 2007
`
`[http://emedicinernedscape.com/article/898437-overview]
`Citation 4: BOCCI-II, EA. et al., The American Journal of Cardiology, 199-4, Vol. 74, pp.
`
`70-72
`
`Page 1/3
`NOTIFICATION OF REASON FOR REJECTION
`Japanese Patent Appln. No. 2009-157623
`
`015
`
`

`
`l6.|Vlar. 2010 ll:32
`
`KYOWA PATENT & LAW OFFlCE
`
`Nc_ 5593
`
`P
`
`5
`
`A.
`
`Reasons 1 and gg Claims 1 to 14/ glitation I
`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 [D0l3]), the patients of Citation
`1 having a POW]? of less than 20 rnmI-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 functions/effects.)
`
`B.
`
`Reason 2/ Cla.i1,r_I,s 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
`
`

`
`i6.|Vlar.Q010 11:32
`
`KYOWA PATENT & LAW OFFICE
`
`NC. 5593
`
`P.
`
`5
`
`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 pre-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 should be rejected on the grounds that the recitation of the
`claim(s) fails to meet the requirement of Article 36, paragraph 6, sub-paragraph 2 of the
`Japanese Patent Law in the following respect(s).
`
`NOTES:
`
`(1) The abbreviations “PAPm,” “PCWP” and “PVRI” are unclear in meaning.
`
`(2) The term “near” renders the scope of the claimed invention unclear, and
`
`thus is inappropriate as an expression for use in the claims.
`
`Baclgground Art InformaI:ion*
`
`Field of Search:
`
`IPC
`
`A6lI<33/00
`
`"'The information provided herein constitutes no reason for rejection.
`
`Page 3/3
`NOTIFICATION OF REASON FOR REJECTION
`Japanese Patent Appln. No. 2009-157623
`
`017
`
`

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