PTO/SB/08a (01-08)
`Approved tor use through 07/31/2012. OMB 0651-0031
`U.S. Patent and Trademark Ottice; U.S. DEPARTMENT OF COMMERCE
`Under the Paerwork Reduction Act of 1995, no ersons are re uired to resond to a collection of information unless it contains a valid OMB control number.
`Substitute for form 1449A/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Application Number
`Filing Date
`First Named Inventor
`
`Art Unit
`
`Examiner Name
`
`Complete if Known
`
`Not yet as signed
`Herewith
`Duncan P. Bathe
`
`Not Yet Assigned
`Unknown
`
`(Use as many sheets as necessary)
`
`Submitted: May 15, 2012
`
`Attorney Docket No:
`
`3000-US-OO26(lKAO011-OOUS)
`
`Document Number
`
`US PATENT DOCUME
`NTS
`Publication Date
`Name of Patentee or Applicant of Cited
`Document
`
`Pages. Columns, Lines,
`Where Relevant Passages
`Or RelevantFigures Appear
`
`2005/0172966
`2009/0266358
`
`Au 11, 2005
`Oct 29, 2009
`
`Blaise, Gilbert et al.
`Rock, Emilio S., et al.
`
`6125846
`
`Oct 3, 2000
`
`Bathe, Duncan P., et al.
`
`Examiner
`lnitialst
`
`Examiner
`
`Foreign Patent
`Document
`
`FOREIGN PATENT DOCUMENTS
`
`Publication Date
`
`Name 01 Patentee or Applicant o1 cited
`Document
`
`Pages, Columns,
`Lines, Where
`Relevant Passages
`or RelevantFigures
`Aear
`
`(book, magazine, iournal, serial, symposium, catalog,
`etc.), date, page(s), volume-issue number(s),
`publisher, city and/or country where published.
`“PCT International Search Report and Written Opinion for
`(98
`PCT/US2011/020319",Jan. 31, 2012, 19 a
`
`EXAMINER
`
`DATE CONSIDERED
`
`Substitute Disclosure Statement Form (PTO-1449)
`' EXAMlNER: Initial it relerence considered, whether or not citation Is in contormance with MPEP 609. Draw line through citation It not in contormance and not considered. Include copy oi this Iorm with next communication to
`applicant.I Applicant's unique citation designation number (optional) 2 Applicant is to place a check mark here it English language Translation is attached
`
`PRAXAIR 1016
`
`001
`
`

`
`PATENT COOPERATION TREATY
`
`From the INTERNATIONAL SEARCHING AUTHORITY
`
`Patel, Payal A.
`D,EHL SEFMLLA LLC
`33 Wood Ave South suite 2, 0
`‘Selim NJ 08830
`I
`ETATS—UNlS D'AMEFl|QUE
`
`-
`
`*
`
`NOTIFICATION OF TRANSMITTAL OF
`THE INTERNATIONAL sEARoH REPORT AND
`THE WFll'l‘l'EN OPINION OF THE INTERNATIONAL
`SEARCHING AUTHORITY, OR THE DECLARATION
`
`Applicant's or agent's file reference
`
`"(A001 1'00“/O
`
`International application No.
`
`PCVUSZOI W203‘ 9
`Applicant
`
`IKARIA, INC.
`
`Date of mailing
`(day/month/year)
`
`(PCT Rule 44.1)
`
`31 January 2012 (31-01-2012)
`
`FOR FURTHER ACTION
`
`See paragraphs 1 and 4 below
`
`International filing date
`
`(day/mom/year)
`
`5 January 201 1 (06-01 -201 1)
`
`The applicant is hereby notified that the international search report and the written opinion of the International Searching
`Authority have been established and are transmitted herewith.
`Filing of amendments and statement under Article 19:
`The applicant is entitled, if he so wishes, to amend the claims of the International Application (see Fiule 46):
`When’? The time limit for filing such amendments is normally two months from the date of transmittal of the
`International Search Report.
`Where? Directly to the International Bureau of WI PO, 34 chemin des Colombettes
`1211 Geneva 20, Switzerland, Fascimile No.1 (41 -22) 338.82.70
`For more detailed instructions, see PCTAppIicant's Guide, International Phase, paragraphs 9.004 - 9.011 .
`
`2. D The applicant is hereby notified that no international search report will be established and that the declaration under
`Article 17(2)(a) to that effect and the written opinion of the International Searching Authority are transmitted herewith.
`
`3. D with regard to any protest against payment of (an) additional fee(s) under Rule 40.2, the applicant is notified that:
`
`D the protest together with the decision thereon has been transmitted to the lntemational Bureau together with the
`applicant's request to forward the texts of both the protest and the decision thereon to the designated Offices.
`
`C] no decision has been made yet on the protest; the applicant will be notified as soon as a decision is made.
`4. Reminders
`
`The applicant may submit comments on an informal basis on the written opinion of the International Searching Authority to the
`International Bureau. The International Bureau will send a copy of such comments to all designated Offices unless an
`international preliminary examination report has been or is to be established. Following the expiration of 30 months from the
`priority date, these comments will also be made available to the public.
`
`Shortly after the expiration of 18 months from the priority date, the international application will be published by the
`International Bureau. It the applicant wishes to avoid or postpone publication, a notice of withdrawal of the international
`application, or of the priority claim, must reach the lntemational Bureau before completion ofthe technical preparations for
`international publication (Rules 90bis.1 and 90bis.3).
`
`Within 19 months from the priority date, but only in respect of some designated Offices, a demand for international preliminary
`examination must be filed it the applicant wishes to postpone the entry into the national phase until 30 months from the priority
`date (in some Offices even later); otherwise, the applicant must, within 20 months from the priority date, perform theprescribed
`acts for entry into the national phase before those designated Offices.
`In respect of other designated Offices, the time limit of 30 months (or later) will apply even if no demand is filed within 19
`months.
`
`For details about the applicable time limits, Office by Office, see www.wipo.int/pct/enltexts/timejimits.html and the
`POTAppIicanf's Guide, National Chapters.
`
`Name and mailing address of the International Searching Authority
`European Patent Office, P.B. 5818 Patentlaan 2
`NL-2280 HV Rijswijk
`‘ g TEL (+3170) 340-2040
`Fax: (+31-70) 340-3016
`
`Authorized officer
`FLAN-I-ER Gerda
`Tel: +49 (0)89 2399-7024
`
`Form PCT/ISA/220 (July 2010)
`
`002
`
`

`
`PATENT COOPERATION TREATY
`
`INTERNATIONAL SEARCH REPORT
`
`(PCT Article 18 and Rules 43 and 44)
`
`Applicant s or agents file reference
`IKAO 0 ll _ OOWO
`International.application No.
`
`see Form PCT/ISA/220
`FOR FURTHER
`as well as, where applicable, item 5 below.
`Ac'|'|oN
`international filing date (day/month/year)
`(Earliest) Priority Date (day/month/year)
`
`PCT/US2011/020319
`Applicant
`
`IKARIA ,
`
`INC .
`
`O6/Ol/2011
`
`This international search report has been prepared by this international Searching Authority and is transmitted to the applicant
`according to Article 18. A copy is being transmitted to the international Bureau,
`
`This international search report consists of a total of
`
`6
`
`sheets.
`
`[3
`
`it is also accompanied by a copy of each prior art document cited in this report.
`
`_
`1. Basis of the report
`a. With regard to the language, the international search was carried out on the basis of:
`
`the international application in the language in which it was filed
`, which is the language
`m atranslation of the international application into
`of a translation furnished for the purposes of international search (Rules 12.3(a) and 23.1 (b))
`
`b. D This international search report has been established taking into account the rectification of an obvious mistake
`authorized by or notified to this Authority under Rule 91 (Rule 43.8bis(a)).
`
`with regard to any nucleotide and/or amino acid sequence disclosed in the international application, see Box No. I.
`
`Certain claims were found unsearchable (See Box No. II)
`
`Unity of invention is lacking (see Box No ill)
`
`4. With regard to the title,
`
`the text is approved as submitted by the applicant
`D the text has been established by this Authority to read as follows:
`
`5. With regard to the abstract,
`
`'3 the text is approved as submitted by the applicant
`the text has been established, according to Rule 38.2(b), by this Authority as it appears in Box No. IV. The applicant
`may, within one month from the date of mailing of this international search report, submit comments to this Authority
`
`6. With regard to the drawings,
`
`a.
`
`the figure of the drawings to be published with the abstract is Figure No.
`
`1
`
`as suggested by the applicant
`as selected by this Authority, because the applicant failed to suggest a figure
`E]
`D as selected by this Authority, because this figure better characterizes the invention
`b. D none of the figures is to be published with the abstract
`
`Form PCTIISA/210 (first sheet) (July 2009)
`
`003
`
`

`
`INTERNATIONAL SEARCH REPORT
`
`international application No.
`PCT/“S2911/020319
`
`Box No. II
`
`Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet)
`
`This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:
`
`1.
`
`Claims Nos;
`because they relate to subject matter not required to be searched by this Authority, namely:
`
`Rule 39.1(iv)
`therapy
`
`PCT — Method for treatment of the human or animal body by
`'
`
`2. El Claims Nos.:
`because they relate to parts of the international application that do not comply with the prescribed requirements to such
`an extent that no meaningful international search can be carried out, specifically:
`
`3. El Claims Nos;
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
`
`Box No. Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet)
`
`This International Searching Authority found multiple inventions in this international application, as follows:
`
`see additional sheet
`
`1. E] As all required additional search fees were timely paid by the applicant, this international search report covers all searchable
`claims.
`
`2. B As all searchable claims could be searched without effort justifying an additional fees, this Authority did not invite payment of
`additional fees.
`
`3. E‘ As only some of the required additional search fees were timely paid by the applicant, this international search report covers
`only those claims for which fees were paid, specifically claims Nos.:
`
`4. E No required additional search fees were timely paid by the applicant. Consequently, this international search report is
`restricted to the invention first mentioned in the claims; it is covered by claims Nos;
`
`1-10
`
`Remark on Protest
`
`E] The additional search fees were accompanied by the applicant's protest and, where applicable, the
`payment of a protest tee.
`
`B The additional search fees were accompanied by the applicant's protest but the applicable protest
`fee was not paid within the time limit specified in the invitation.
`
`E No protest accompanied the payment of additional search fees.
`
`Form PCT/ISA/210 (continuation of first sheet (2)) (April 2005)
`
`004
`
`

`
`INTERNAHONALSEARCHREPORT
`
`A. CLASSlFlCATl0N OF SUBJECT MATTER
`
`INV. A61M16/10
`ADD.
`
`A61M16/20
`
`International application No
`
`‘PCT/US201l/020319
`
`According to International Patent Classification (lPC) or to both national classification and lPC
`B. FIELDS SEARCHED
`"
`A
`
`'
`
`Minimum documentation searched (classification system followed by classification symbols)
`
`»
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`Electronic data base consulted during the international search (name of data base and, where practical, search terms used)
`
`EPO-Internal
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category‘
`
`Citation of document, with indication, where approptiate, of the relevant passages
`
`Relevant to claim No.
`
`X
`
`A
`
`A
`
`US 2009/266358 A1 (SACRISTAN ROCK EMILIO
`[MX] ET AL) 29 October 2009 (2009-10-29)
`paragraphs [0131],
`[@132],
`[0142]
`-
`[0148]; figures 3,4
`
`US 2005/172966 A1 (BLAISE GILBERT [CA] ET
`AL) 11 August 2005 (2005-08-11)
`paragraphs [0049]
`—
`[0061]; figure 5
`
`B Further documents are listed in the continuation of Box 0.
`' Special categories of cited documents :
`
`'A" document defining the general state of the art which is not
`considered to be of particular relevance
`
`'E' earlier document but published on or after the international
`fi“"9 date
`'L' document which may throw doubts on priority claim(s) or
`which is cited to establish the publication date of another
`°itafi°" °r “her special '°as°" (as spedfied)
`'0' document referring to an oral disclosure, use, exhibition or
`other means
`'P' document published priorto the international filing date but
`laterthan the priority date claimed
`
`See patent family annex.
`
`'T' later document published after the international filing date
`giiggghgniitggmfiQgéigrffggigtgtiglggfy flag
`invention
`y
`
`.X. document of particular relevance. the claimed invention
`cannot be considered novel or cannot be considered to
`involve an inventive step when the document is taken alone
`.Y. document of pamcmar relevance; the claimed invention
`cannot be considered to involve an inventive step when the
`document is combined with one or more other such docu-
`ments, such combination being obvious to a person skilled
`in the an‘
`'&" document meniaer of the same patent family
`
`Date of the actual completion of the international search
`
`Date of mailing of the international search report
`
`17 October 2011
`Name and mailing address of the lSA/
`European Patent Office, P.B. 5818 Patentlaan 2
`NL — 2280 HV Flijswijk
`T I.
`31-70 340-2040,
`§x%amnhMcams
`Foam PCT/lSAI21O (second sheet) (April 2005)
`
`31/01/2012
`Authorized oificer
`
`-
`--
`B0ttCheVs Stephanie
`
`005
`
`

`
`International appflcafion No
`1
`
`Publication
`d_ate_
`
`04-05-2011
`29-12-2010
`19-05-2011 1
`29-10-2009
`01-10-2009
`
`INTERNATIONAL SEARCH REPORT
`Information on patent lamily members
`Publication
`date
`
`Patent family
`member(s)
`
`Patent document
`cited in search report
`
`US 2009266358
`’
`'
`‘
`
`Al
`
`29-10-2009
`‘
`
`102046234 A
`CN
`2266653 A1
`EP.
`2011515184 A
`JP ’
`US . 2009266358 A1
`W0 »
`2009120057 A1
`
`Form PCT/|SAI210 (patent family annex) (April 2005)
`
`006
`
`

`
`lntemational Application No. PC-I7 US2011/020319
`
`FURTHER INFORMATION CONTINUED FROM PCTIISAI 210
`
`This International Searching Authority found multiple (groups of)
`inventions in this international application, as follows:
`
`1. claims: 1-10
`
`A gas delivery device comprising a valve, a memory to store
`gas data and a processor and a transceiver to send wireless
`signals to a control module.
`Problem to be solved: Simplifying the set-up procedure when
`new gas sources are loaded onto a cart.
`
`2. claims: 11-13
`
`A memory comprising instructions that cause a processor to
`receive gas data, compare the gas data with user inputted
`patient information, coordinate, select and control a
`therapy to the patient.
`Problem to be solved: Enhancing accuracy and safety of the
`therapy
`
`007
`
`

`
`NTERNAHONALSEARCHREPORT
`
`International application No.
`
`PCT/US20ll/020319
`
`Box No. IV
`
`Text of the abstract (Continuation of item 5 of the first sheet)
`
`A gas delivery system including a gas delivery device (100), a control module
`(200) and a gas delivery mechanism is described. An exemplary gas delivery
`device includes a valve (107) assembly with a valve and circuit including a
`memory (134), a processor (122) and a transceiver (l20)in communication with the
`memory. The memory may include gas data such as gas identification, gas
`expiration and gas concentration. The transceiver on the circuit of the valve
`
`assembly may send wireless optical line-of-sight signals to communicate the gas
`data to a control module. Exemplary gas delivery mechanisms include a ventilator
`(400) and a breathing circuit
`(410). Methods of administering gas are also
`described.
`
`Form PCT/ISA/210 (continuation of first sheet (3)) (July 2009)
`
`008
`
`

`
`INTERNATIONAL SEARCH REPORT
`
`international application No.
`PCT/“S2011/030319
`
`Box No. II
`
`Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet)
`
`This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:
`
`1.
`
`Claims Nos.:
`because they relate to subject matter not required to be searched by this Authority, namely:
`
`Rule 39.1(iv)
`therapy
`
`PCT - Method for treatment of the human or animal body by
`
`2. El Claims Nos.:
`because they relate to parts of the international application that do not comply with the prescribed requirements to such
`an extent that no meaningful international search can be carried out, specifically:
`
`Claims Nos.:
`
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a)_
`
`Box No. lll Observations where unity of invention is lacking (Continuation of item 3 of first sheet)
`
`This International Searching Authority found multiple inventions in this international application, as follows:
`
`see additional sheet
`
`1. I: As all required additional search fees were timely paid by the applicant, this international search report covers all searchable
`clai ms.
`
`2. El As all searchable claims could be searched without effort justifying an additional fees, this Authority did not invite payment of
`additional fees.
`
`3. E] As only some of the required additional search fees were timely paid by the applicant, this international search report covers
`only those claims for which fees were paid, specifically claims‘ Nos.:
`
`4. Ex] No required additional search fees were timely paid by the applicant. Consequently, this international search report is
`restricted to the invention first mentioned in the claims; it is covered by claims Nos.:
`
`1-10
`
`Remark on Protest
`
`The additional search fees were accompanied by the applicant's protest and, where applicable, the
`payment of a protest fee.
`
`The additional search fees were accompanied by the applicant's protest but the applicable protest
`fee was not paid within the time limit specified in the invitation.
`
`E] No protest accompanied the payment of additional search fees.
`
`Form PCT/ISA/210 (continuation of first sheet (2)) (April 2005)
`
`009
`
`

`
`INTERNATIONAL SEARCH REPORT
`
`A. CLASSIFICATION OF SUBJECT MATTER
`
`INV. A6lM16/10
`ADD.
`-
`
`A6lMl6/20
`
`According to International Patent Classification (IPC) or to both national classification and IPC
`B. FIELDS SEARCH ED
`
`Minimum documentation searched (classification system followed by classification symbols)
`A61M
`
`International application No
`
`PCT/US2011/020319
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`1‘
`
`Electronic data base consulted during the international search (name of data base and, where practical, search terms used)
`
`EPO-Internal
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category‘
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`I
`
`Relevant to claim No.
`
`X
`
`A
`
`A
`
`US 2009/266358 A1 (SACRISTAN ROCK EMILIO
`[MX] ET AL) 29 October 2009 (2009-10-29)
`paragraphs [@131],
`[0132],
`[0142]
`-
`[0148]; figures 3,4
`
`US 2005/172966 A1 (BLAISE GILBERT [CA] ET
`AL) 11 August 2005 (2005-08-11)
`paragraphs [0049]
`-
`[0061]; figure 5
`
`E Further documents are listed in the continuation of Box 0.
`‘ Special categories of cited documents :
`
`'A' document defining the general state of the art which is not
`considered to be of particular relevance
`'E' earlier document but published on or after the international
`filing date
`'L' document which may throw doubts on prioriw claim(s) or
`which is cited to establish the publication date of another
`citation or other special reason (as specified)
`'0‘ document referring to an oral disclosure, use, exhibition or
`other means
`'P' document published prior to the international filing date but
`laterthan the priority date claimed
`
`Date of the actual completion of the international search
`
`17 October 2011
`
`Name and mailing address of the ISN
`European Patent Office, PB. 5818 Patentlaan 2
`NL - 2280 HV Rijswijk
`Tel. (+31-70) 340-2040,
`Fax: (+31-70) 340-3016
`
`Form PCT/ISA/210 (second sheet) (April 2005)
`
`See patentfamily annex,
`
`'"I‘' later document published after the international filing date
`or priority date and not in conflict with the application but
`cited to understand the principle or theory underlying the
`invention
`'X" document of particular relevance; the claimed invention
`cannot be considered novel or cannot be considered to
`involve an inventive step when the document is taken alone
`'Y' document of particular relevance; the claimed invention
`cannot be considered to involve an inventive step when the
`document is combined with one or more other such docu-
`ments, such combination being obvious to a person skilled
`in the art.
`'&' document member of the same patent family
`
`Date of mailing of the international search report
`
`31/01/2012
`Authorized officer
`
`Bcttcher, Stephanie
`
`010
`
`

`
`INTERNATIONAL SEARCH REPORT
`Information on patent family members
`
`lmemafionai application No
`U
`1
`
`cited in search report
`
`date
`
`member(s)
`
`date
`
`US 2009266358
`
`A1
`
`29-10-2009
`v
`
`102046234 A
`CN
`2266653 A1
`- EP
`JP ' 2011515184 A
`US
`2009266358 A-1
`— WO
`2009120057 A1
`
`‘
`
`‘ 04-05-2011
`29-12-2010
`19-05-2011
`29-10-2009
`01-10-2009
`
`Form PCT/ISA/210 (patent iamxly annex) (April 2005)
`
`011
`
`

`
`International Application No.
`
`US2011/ 020319
`
`FURTHER INFORMATION CONTINUED FROM PCTIISAI 210
`
`This International Searching Authority found multiple (groups of)
`inventions in this international application, as follows:
`
`1. claims: 1-10
`
`A gas delivery device comprising a valve, a memory to store
`gas data and a processor and a transceiver to send wireless
`signals to a control module.
`Problem to be solved: Simplifying the set-up procedure when
`new gas sources are loaded onto a cart.
`
`2. claims: 11-13
`
`A memory comprising instructions that cause a processor to
`receive gas data, compare the gas data with user inputted
`patient information, coordinate, select and control a
`therapy to the patient.
`Problem to be solved: Enhancing accuracy and safety of the
`therapy
`
`012
`
`

`
`PATENT COOPERATION TREATY
`
`From the
`INTERNATIONAL SEARCHING AUTHORITY
`
`PCT
`
`399 f°'"‘ P°T"SA’22°
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`(PCT Rule 43bis.1)
`
`Date of mailing
`(day/month/year)
`
`see form PCT/ISA/210 (second sheet)
`
`Applicant's or agents file reference
`see form PCT/lSA/220
`
`FOR FURTHER Ac-“ON
`See paragraph 2 below
`
`International application No.
`PCT/US2011/020319
`
`international filing date {day/month/year)
`06.01.2011
`
`Priority date (day/month/year)
`
`international Patent Classification (IPC) or both national classification and IPC
`lNV. A61M16/1 0 A61 M18/20
`
`Applicant
`IKARIA, INC.
`
`This opinion contains indications relating to the following items:
`
`
`
`EIEJEJEIEEEIE
`
`Box No.
`Box No.
`
`Box No.
`Box No.
`
`Box No.
`
`Box No. Vl
`
`Basis of the opinion
`Priority
`
`Non—establishment of opinion with regard to novelty, inventive step and industrial applicability
`Lack of unity of invention
`
`Reasoned statement under Rule 43bis.1(a)(i) with regard to novelty, inventive step and industrial
`applicability; citations and explanations supporting such statement
`Certain documents cited
`
`Box No. Vll Certain defects in the international application
`Box No. Vlll Certain observations on the international application
`
`FURTHER ACTION
`
`if a demand for international preliminary examination is made, this opinion will usually be considered to be a
`written opinion of the International Preliminary Examining Authority ("lPEA") except that this does not apply where
`the applicant chooses an Authority other than this one to be the lPEA and the chosen lPEA has notifed the
`International Bureau under Rule 66.1bis(b) that written opinions of this International Searching Authority
`will not be so considered.
`
`If this opinion is, as provided above, considered to be a written opinion of the lPEA, the applicant is invited to
`submit to the lPEA a written reply together, where appropriate, with amendments, before the expiration of 3 months
`from the date of mailing of Form PCT/lSA22O or before the expiration of 22 months from the priority date,
`whichever expires later.
`
`For further options, see Form PCT/ISA/220.
`
`3.
`
`For further details, see notes to Form PCT/lSA/220.
`
`Name and mailing address of the ISA:
`__._.__
`
`Date of completion of
`this opinion
`
`Authorized Officer
`
`:0)
`
`European Patent Office
`
`‘—“': D-80293 Munich
`Tel, +49 39 2399 , 0
`Fax: +49 89 2399 — 4465
`
`g g‘§;*,,‘g'§,m
`
`1
`
`,_
`
`Bottcher, Stephanie
`
`_
`
`Telephone No. +49 89 2399-2875
`
`013
`
`

`
`International application No.
`WRITTEN OPINION OF THE
`PCT/US20‘l 1/020319
`INTERNATIONAL SEARCHING AUTHORITY
`
`
`
`
`* Box No. l Basis of the opinion
`
`1. With regard to the language, this opinion has been established on the basis of:
`
`K4
`
`El
`
`the international application in the language in which it was filed
`
`a translation of the international application into ,which is the language of a translation furnished for the
`purposes of international search (Rules 12.3(a) and 23.1 (b)).
`
`2. D This opinion has been established taking into account the rectification of an obvious mistake authorized
`by or notified to this Authority under Rule 91 (Rule 43bis.1(a))
`
`3. With regard to any nucleotide and/or amino acid sequence disclosed in the international application, this
`opinion has been established on the basis of a sequence listing filed or furnished:
`
`a. (means)
`
`El
`
`CI
`
`on paper
`
`in electronic form
`
`b. (time)
`
`[1
`
`El
`
`C}
`
`in the international application as filed
`
`together with the international application in electronic form
`
`subsequently to this Authority for the purposes of search
`
`4. E]
`
`In addition, in the case that more than one version or copy of a sequence listing has been filed or furnished,
`the required statements that the information in the subsequent or additional copies is identical to that in the
`application as filed or does not go beyond the application as filed, as appropriate, were furnished.
`
`5. Additional comments:
`
`Form PCT/1SA/ 237 (April 2007)
`
`014
`
`

`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT/US2011/020319
`
`Box No. lll
`applicability
`
`Non-establishment of opinion with regard to novelty, inventive step and industrial
`
`The questions whether the claimed invention appears to be novel, to involve an inventive step (to be non
`obvious), or to be industrially applicable have not been examined in respect of
`
`El
`
`IZI
`
`the entire international application
`
`claims Nos. 11-18
`
`because:
`
`El
`
`El
`
`the said international application, or the said claims Nos.
`not require an international search (specify):
`
`relate to the following subject matter which does
`
`the description, claims or drawings (indicate particular elements below) or said claims Nos.
`that no meaningful opinion could be formed (specify):
`
`are so unclear
`
`the claims, or said claims Nos. are so inadequately supported by the description that no meaningful opinion
`could be formed (specify):
`
`no international search report has been established for the whole application or for said claims Nos. 11-18
`
`a meaningful opinion could not be formed without the sequence listing; the applicant did not, within the
`prescribed time limit:
`
`El furnish a sequence listing on paper complying with the standard provided for in Annex C of the
`Administrative instructions, and such listing was not available to the International Searching
`Authority in a form and manner acceptable to it.
`
`El furnish a sequence listing in electronic form complying with the standard provided for in Annex C
`of the Administrative Instructions, and such listing was not available to the International Searching
`Authority in a form and manner acceptable to it.
`
`El pay the required late furnishing fee for the furnishing of a sequence listing in response to an
`invitation under Rules 13ter.1 (a) or (b).
`
`See Supplemental Box for further details
`
`Form PCT/ISA/237 A '
`
`015
`
`

`
`WRITTEN OPINION OF THE A
`INTERNATIONAL SEARCHING AUTHORITY
`
`International ‘application No.
`PCT/US201 1/020319
`
`Box No. IV Lack of unity of invention
`
`1. I in response to the invitation (Form PCT/ISA/206) to pay additional fees, the applicant has, within the
`applicable time limit:
`
`El
`
`El
`
`paid additional fees
`
`paid additional fees under protest and, where applicable, the protest fee
`
`El
`
`paid additional fees under protest but the applicable protest fee was not paid
`
`not paid additional fees
`
`2. El
`
`. ThislAuthority found that the requirement of unity of invention is not complied with and chose not to invite
`the applicant to pay additional fees.
`
`3. This Authority considers that the requirement of unity of invention in accordance with Rule 13.1, 13.2 and 13.3 is
`
`El complied with
`
`not complied with for the following reasons:
`
`see separate sheet
`
`4. Consequently, this report has been established in respect of the following parts of the international application:
`
`El all parts.
`
`IXI
`
`the parts relating to claims Nos. 1-10
`
`Box No. V Reasoned statement under Rule 43bis.1(a)(i) with regard to novelty, inventive step or
`industrial applicability; citations and explanations supporting such statement
`
`1 . Statement
`
`Novelty (N)
`
`Inventive step (IS)
`
`Industrial applicability (IA)
`
`2. Citations and explanations
`
`see separate sheet
`
`Form PCT/ISA/237 Ari|2007
`
`016
`
`

`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`
`AUTHORITY (SEPARATE SHEET)
`
`International application No.
`
`PCT/US201 1/020319
`
`' Re Item Ill
`
`Non-establishment of opinion with regard to novelty, inventive step and indus-
`trial applicability
`
`Rule 39.1 (iv) PCT — Claims 14-18 relate to a method for treatment of the human or
`animal body by therapy.
`
`Re item IV
`
`Lack of unity of invention
`
`This Authority considers that the application does not meet the requirements of unity
`
`of invention and that there are two inventions covered by the claims indicated as fol-
`lows:
`
`claims: 1-10
`
`A gas delivery device comprising a valve, a memory to store gas data and
`
`a processor and a transceiver to send wireless signals to a control mod-
`ule.
`
`Problem to be solved: Simplifying the set-up procedure when new gas
`sources are loaded onto a cart.
`
`claims: 11-13
`
`A memory comprising instructions that cause a processor to receive gas
`
`data, compare the gas data with user inputted patient information and co-
`
`ordinate, select and control a therapy to the patient.
`
`Problem to be solved: Enhancing accuracy and safety of the therapy
`
`The reasons for which the inventions are not so linked as to form a single general in-
`
`ventive concept, as required by Rule 13.1 PCT, are as follows:
`
`Form PCT/lSA/237 (Separate Sheet) (Sheet 1) (EPO-April 2005)
`
`017
`
`

`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`
`‘
`
`international application No.
`
`AUTHORITY (SEPARATE SHEET)
`
`' PCT/US-2011/020319
`
`The above-mentioned groups of claims relate to different devices and the technical
`problems which they pretend to solve are different (see above). Thus, they are not
`linked by common or corresponding special technical features and define two different
`inventions not linked by asingle general inventive concept.
`
`The application, hence does not meet the requirements of unity of invention as de-
`fined in Rules 13.1 and 13.2 PCT.
`
`Re Item V
`
`Reasoned statement with regard to novelty, inventive step or industrial applica-
`bility; citations and explanationssupporting -such statement
`
`Reference is made to the following documents:
`
`D1
`
`D2
`
`US 2009/266358 A1 (SACRISTAN ROCK EMILIO) 29 October
`2009
`
`us 2005/172966 A1 (BLAISE GILBERT [CA] ET AL) 11 August
`2005
`
`The present application does not meet the criteria of Article 33(2) PCT, be-
`
`cause the subject—matter of claim 1 is not new.
`
`Document D1 discloses (see paragraphs [O131], [O132], [0142] - [0148];
`
`figures 3,4) a gas delivery device (400) to administer therapy gas from a gas
`
`source, the gas delivery device comprising:
`
`a valve (518) attachable to the gas source, the valve including an inlet and an
`
`outlet in fluid communication and a valve actuator to open or close the valve
`
`to allow the gas through the valve to a control module; and
`
`a circuit including:
`
`memory (812) to store gas data comprising one or more of gas identification,
`
`gas expiration date and gas concentration and
`
`a processor and a transceiver in communication with the memory to send
`
`wireless optical line-of-sight signals to communicate the gas data to the con-
`
`trol module that controls gas delivery to a subject.
`
`Form PCT/lSA/237 (Separate Sheet) (Sheet 2) (EPO-April 2005)
`
`018
`
`

`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`
`international application No.
`
`AUTHORITY (SEPARATE SHEET)
`
`PCT/US2011/020319
`
`Dependent claims 6 and 8 do not contain any features which, in combination
`
`with the features of any claim to which they refer, meet the requirements of
`
`the PCT in respect of novelty (see D1, paragraphs [0131], [O132], [0142] —
`[O148]; figures 3,4).
`
`The combination of the features of dependent claims 2-5, 7 and 9-10 is nei-
`
`ther known from nor rendered obvious by the available prior art.
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 3) (EPO—Ap