WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`AUTHORITY (SEPARATE SHEET)
`
`International application No.
`
`PCT /US2009/04 7027
`
`The use of the shielding assembly in claim 34 permits to provide in an alternative way
`an access to the compartment.
`In conclusion, the groups of claims are not linked by common or corresponding special
`technical features and define 4 different inventions not linked by a single general
`inventive concept. Therefore the application claims4 inventions not so linked to form a
`single general inventive concept. The requirement of unity is not fulfilled, according to
`Rule 13 PCT.
`
`Re Item V
`Reasoned statement under Rule 66.2(a)(ii) with regard to novelty, inventive step
`or industrial applicability; citations and explanations supporting such statement
`1
`Reference is made to the following documents:
`WO 2005/002971 A1
`01
`
`02
`
`03
`
`04
`
`05
`
`06
`
`07
`
`US 2003/004463 A 1
`
`JP 2000 350783 A
`
`WO 2008/037939 A2
`
`WO 2008/082966 A2
`
`EP0102121A1
`
`JP 2006 325826 A
`
`2.1
`
`Novelty Article 33(2) PCT
`Invention 1 : Claims 1 - 15,37
`2
`The present application does not meet the criteria of Article 33 (1) PCT,
`because the subject-matter of claim 1 is not new in the sense of Article 33(2)
`PCT.
`The document 01 is regarded as being the closest prior art and discloses (the
`references in parentheses applying to this document) discloses a shielding
`assembly for an infusion system, the shielding assembly being mounted within
`a cabinet structure comprising (figure 1-4):
`- a
`first compartment (30) sized to contain one or more radioisotope
`generators (34) of the infusion system, the first compartment being enclosed
`by a first sidewall (sidewall 31) that forms a barrier to radioactive radiation, the
`first sidewall including an opening extending therethrough and a lid (32), the
`lid mating with the opening to alternately enclose the first compartment and
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 3) (EPO-April 2005)
`
`579 of 1573
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`AUTHORITY (SEPARATE SHEET)
`
`International application No.
`
`PCT/US2009/047027
`
`provide access to the first compartment, via the opening, and the opening
`being oriented upward and located at a first elevation, with respect to a
`lowermost portion of the cabinet structure;
`- a second compartment (2) sized to contain a portion of an infusion tubing
`circuit (tubing 57) of the infusion system that is downstream of the one or more
`generators, the second compartment being enclosed by a second sidewall
`that forms a barrier to radioactive radiation, the second sidewall including a
`base portion and a lid portion (9), the lid portion mating with the base portion
`to alternately enclose the second compartment and provide access to the
`second compartment; and
`- a third compartment (52) sized to contain a waste bottle (53) of the infusion
`system, the third compartment being enclosed by a third sidewall that forms a
`barrier to radioactive radiation, the third sidewall including an opening,
`extending through the third sidewall, and a lid (41 }, the lid of the third sidewall
`mating with the opening of the third sidewall to alternately enclose the third
`compartment and provide access to the third compartment, via the opening of
`the third sidewall, the opening of the third sidewall being oriented upward and
`located at a second elevation, with respect to the lowermost portion of the
`cabinet structure, and the second elevation being greater than the first
`elevation of the opening of the first sidewall.
`The subject matter of claim 1 is not novel document D1.
`The technical feature of claim 37 is also disclosed in Document D1.
`The technical feature of claims 1 and 37 is shown in Documents D2 and D3.
`
`2.2
`2.3
`
`3.1
`
`Invention 2: Claims 22-26
`3
`The present application does not meet the criteria of Article 33 (1) PCT,
`because the subject-matter of claim 22 is not new in the sense of Article 33(2)
`PCT.
`The document D4 is regarded as being the closest prior art and discloses (the
`references in parentheses applying to this document) discloses a shielding
`assembly for an infusion system (6) comprising (figure 1-2):
`- a plurality of compartments (2a,2b,2c) and providing a radioactive radiation
`barrier for the compartments, the assembly further comprising:
`- a first door (2b) to alternately enclose and provide access to a first
`compartment of the plurality of compartments, the first compartment sized to
`contain one or more radioisotope generators (11) of the infusion system; and
`- second door ( 41 ) to alternately enclose and provide access to a second
`compartment (2) of the plurality of compartments, the second compartment
`being separate from, and outside of, the first compartment, the second
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 4) (EPO-April 2005)
`
`580 of 1573
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`AUTHORITY (SEPARATE SHEET)
`
`International application No.
`
`PCT/US2009/047027
`
`4.1
`
`compartment being sized to contain a portion of an infusion tubing circuit (22)
`of the infusion system that is downstream of the one or more generators, and
`the second door, when enclosing the second compartment, preventing the first
`door from opening to provide access to the first compartment.
`The subject matter of claim 22 is not new over document 04.
`The technical feature of claim 1 is revealed in Document 03.
`3.2
`Invention 3: Claims 27-33
`4
`The present application does not meet the criteria of Article 33 (1) PCT,
`because the subject-matter of claim 27 is not new in the sense of Article 33(2)
`PCT.
`The document 04 is regarded as being the closest prior art and discloses (the
`references in parentheses applying to this document) discloses an infusion
`system comprising (figure 1-2):
`- a cabinet structure (figure 2) including a shell defining an interior space
`thereof, the shell including a first opening (21 ), a second opening (2b) and an
`access panel (41 ), the access panel mating with the second opening and
`being removable therefrom;
`- a lock reversibly (it is implicit that the access panel has a lock) engaging the
`access panel to secure access to the interior space of the cabinet structure;
`- an eluant source (16);
`- a shielding assembly located within the interior space of the cabinet
`structure, the shielding assembly including a sidewall defining a plurality of
`compartments and providing a barrier to radioactive radiation
`for
`the
`compartments, the shielding assembly further including a corresponding
`plurality of doors (41,2b), each door, when open, providing access to the
`corresponding compartment via an opening in the sidewall, and, when closed,
`radioactive radiation for the corresponding
`providing
`further barrier to
`compartment;
`first
`- one or more radioisotope generators (11) contained within a
`compartment of the plurality of compartments (2c) of the shielding assembly
`and being accessible through the second opening (2b) of the shell of the
`cabinet structure, when the access panel (41) is unlocked, and when a first
`door (2b) of the plurality of doors, which corresponds to the first compartment,
`is open;
`- an eluant line (23) coupled to the eluant source and to the one or more
`generators; an eluate line coupled to the one or more generators; and a
`patient line (17) coupled to the eluate line and extending out from the interior
`space of the cabinet structure through the first opening of the shell.
`The subject matter of claim 27 is not new over Document 04.
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 5) (EPO-April 2005)
`
`581 of 1573
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`AUTHORITY (SEPARATE SHEET}
`
`International application No.
`
`PCT /US2009/047027
`
`5.1
`
`The technical feature of claim 27 is disclosed in Document 03.
`4.2
`Invention 4: Claims 34-36
`5
`The present application does not meet the criteria of Article 33 (1) PCT,
`because the subject-matter of claim 34 is not new in the sense of Article 33(2}
`PCT.
`The document 01 is regarded as being the closest prior art and discloses (the
`references in parentheses applying to this document) discloses a shielding
`assembly comprising (figure 1-4):
`- a plurality of compartments (2,30) having sidewalls providing barriers to
`radioactive radiation for the compartments;
`- a corresponding plurality of doors (9,32), each door, when open, providing
`access to the corresponding compartment via an opening in its sidewall, and,
`when closed, providing
`further barrier to
`radioactive radiation
`for the
`corresponding compartment;
`- a first compartment (2) of the plurality of compartments enclosed by a first
`sidewall of the sidewalls and sized to contain one or more radioisotope
`generators (62) of the infusion system, the first sidewall including a first
`sidewall opening oriented upward and aligned with a first upper opening
`through a shell of the cabinet structure;
`- wherein an upper surface of the shell is located at an elevation, with respect
`to a lowermost portion of the cabinet structure, such that the elevation of the
`upper surface is substantially greater than that of the first sidewall opening
`and the first upper opening (see figure 1)
`The subject matter of claim 34 is not new over Document D1.
`Furthermore the technical features of claims 34 are revealed by documents
`D2,D3 and 06.
`
`5.2
`
`Inventive step Article 33<3> PCT
`Invention 1: Claims 1 -15,37
`6
`The present application does not meet the criteria of Article 33 (1) PCT,
`because the subject- matter of claims 2 to 15 does not seem to involve an
`inventive step in the sense of Article 33(3) PCT. Document D1 is the closest
`prior art.
`In claims 2 to 15 a slight constructional change in the shielding assembly is
`defined which comes within the scope of the customary practice followed by
`persons skilled in the art, especially as the advantages thus achieved can
`readily be foreseen. Consequently, the subject- matter of these claims also
`lacks an inventive step.
`
`Form PCT/lSA/237 (Separate Sheet) (Sheet 6) (EPO-April 2005)
`
`582 of 1573
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`AUTHORITY (SEPARATE SHEET)
`
`International application No.
`
`PCT /US2009/047027
`
`Invention 2: Claims 22-26
`7
`The present application does not meet the criteria of Article 33 (1) PCT,
`because the subject- matter of claims 23 to 26 does not seem to involve an
`inventive step in the sense of Article 33(3) PCT. Document D4 is the closest
`prior art.
`In claims 23 to 26 a slight constructional change in the shielding assembly is
`defined which comes within the scope of the customary practice followed by
`persons skilled in the art, especially as the advantages thus achieved can
`readily be foreseen. Consequently, the subject- matter of these claims also
`lacks an inventive step.
`Invention 3: Claims 27-33
`8
`The present application does not meet the criteria of Article 33 (1) PCT,
`because the subject-matter of claims 28 to 33 does not seem to involve an
`inventive step in the sense of Article 33(3) PCT. Document D4 is the closest
`prior art.
`The features of claims 28 to 33 are merely one of several straightforward
`possibilities from which the skilled person would select, in accordance with
`circumstances, without the exercise of inventive skill, in order to solve the
`problem posed.
`(see Document D7
`for using a
`latch component)
`Consequently, the subject-matter of these claims also lacks an inventive step.
`Invention 4: Claims 34-36
`9
`The present application does not meet the criteria of Article 33 (1) PCT,
`because the subject-matter of claims 35 and 36 does not seem to involve an
`inventive step in the sense of Article 33(3) PCT. Document D1 is the closest
`prior art.
`In claims 35 and 36 a slight constructional change in the shielding assembly
`(elevation) is defined which comes within the scope of the customary practice
`followed by persons skilled in the art, especially as the advantages thus
`achieved can readily be foreseen. Consequently, the subject-matter of these
`claims also lacks an inventive step.
`
`Further comments
`Invention 1 : Claims 1 - 15,37
`Contrary to the requirements of Rule 5.1 (a)(ii) PCT, the relevant background
`1 O
`art disclosed in the documents 01 - D4 are not mentioned in the description,
`nor are these documents identified therein.
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 7) (EPO-April 2005)
`
`583 of 1573
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`AUTHORITY (SEPARATE SHEET)
`
`International application No.
`
`PCT/US2009/047027
`
`11
`
`12
`
`13
`
`Independent claim 1 is not in the two-part form in accordance with Rule 6.3
`(b) PCT, which in the present case would be appropriate, with those features
`known in combination from the prior art (document 01) being placed in the
`preamble (Rule 6.3(b)(I) PCT) and with the remaining features being included
`in the characterising part (Rule 6.3(b)(ii) PCT).
`The features of the claims are not provided with reference signs placed in
`parentheses (Rule 6.2(b) PCT).
`The unit employed in claims 4 and 5 and in description is not recognised in
`international practice, contrary to the requirements of Rule 10.1 (d) PCT.
`Invention 2: Claims 22-26
`Contrary to the requirements of Rule 5.1 (a)(ii) PCT, the relevant background
`14
`art disclosed in the documents 03,04 and 06 are not mentioned in the
`description, nor are these documents identified therein.
`Independent claim 22 is not in the two-part form in accordance with Rule 6.3
`(b) PCT, which in the present case would be appropriate, with those features
`known in combination from the prior art (document 04) being placed in the
`preamble (Rule 6.3(b)(I) PCT) and with the remaining features being included
`in the characterising part (Rule 6.3(b)(ii) PCT).
`The features of the claims are not provided with reference signs placed in
`parentheses (Rule 6.2(b) PCT).
`Invention 3: Claim 27-33
`Contrary to the requirements of Rule 5.1 (a)(ii) PCT, the relevant background
`17
`art disclosed in the documents 03,04 and 07 are not mentioned in the
`description, nor are these documents identified therein.
`Independent claim 27 is not in the two-part form in accordance with Rule 6.3
`(b) PCT, which in the present case would be appropriate, with those features
`known in combination from the prior art (document 04) being placed in the
`preamble (Rule 6.3(b)(I) PCT) and with the remaining features being included
`in the characterising part (Rule 6.3(b)(ii) PCT).
`The features of the claims are not provided with reference signs placed in
`parentheses (Rule 6.2(b) PCT).
`Invention 4: Claim 34-36
`Contrary to the requirements of Rule 5.1 (a)(ii) PCT, the relevant background
`20
`art disclosed in the documents 01 ,02,03 and 06 are not mentioned in the
`description, nor are these documents identified therein.
`
`15
`
`16
`
`18
`
`19
`
`Form PCT/ISA/237 (Separate Sheet) (Sheet 8) (EPO-April 2005)
`
`584 of 1573
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING
`AUTHORITY (SEPARATE SHEET)
`
`International application No.
`
`PCT/US2009/04 7027
`
`21
`
`22
`
`23
`
`Independent claim 34 is not in the two-part form in accordance with Rule 6.3
`(b) PCT, which in the present case would be appropriate, with those features
`known in combination from the prior art (document 01) being placed in the
`preamble (Rule 6.3(b)(I) PCT) and with the remaining features being included
`in the characterising part (Rule 6.3(b)(ii) PCT).
`The features of the claims are not provided with reference signs placed in
`parentheses (Rule 6.2(b) PCT).
`The unit employed in claims 35 and 36 and in description is not recognised in
`international practice, contrary to the requirements of Rule 10.1 (d) PCT.
`
`Re Item VI
`Certain documents cited
`Certain published documents
`rA~-~i·i~~~i-~~-·N·~·······r·P~bii·~~~i;~--d~~~····r·F·i·ii·~~--d~~~····················T·p;j;~i~~-·d·~~~--(~~;;d·-~;~1~;·--·:
`I Patent No
`I (day/month/year) I (day/month/year) l (day/month/year)
`l~?~~~~~~~~~~li?-~?-~~~~ -1~~-~;-~~o~- -1~~-1-~-~~~~ :
`
`]
`Document 05 discloses the technical feature of claims 1,22,27 and 34. This document
`will be considered during the European phase.
`
`'
`
`Form PCT/ISN237 (Separate Sheet) (Sheet 9) (EPO-April 2005)
`
`585 of 1573
`
`

`

`PATENT COOPERATION TREATY
`
`PCT
`
`INTERNATIONAL SEARCH REPORT
`
`(PCT Article 18 and Rules 43 and 44)
`
`Applicanfs or agenfs file reference
`
`56782.1.6.1
`International application No.
`
`PCT/US2009/047030
`Applicant
`
`BRACCO DIAGNOSTICS INC.
`
`FOR FURTHER
`ACTION
`International filing date {day/month/year)
`
`see Form PCT/ISA/220
`as well as, where applicable, item 5 below.
`
`(Earliest) Priority Date (day/month/year)
`
`11/06/2009
`
`11/06/2008
`
`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.
`
`It is also accompanied by a copy of each prior art document cited in this report.
`
`IKl
`
`1 . Basis of the report
`a. With regard to the language, the international search was carried out on the basis of:
`[il
`the international application in the language in which it was filed
`D
`, which is the language
`a translation 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
`c. 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 43.6bis(a)).
`
`With regard to any nucleotide and/or amino acid sequence disclosed in the international application, see Box No. I.
`
`2.
`
`3.
`
`Certain claims were found unsearchable (See Box No. II)
`
`Unity of invention is lacking (see Box No Ill)
`
`4. With regard to the title,
`
`IKl
`D
`
`the text is approved as submitted by the applicant
`the text has been established by this Authority to read as follows:
`
`5. With regard to the abstract,
`
`IKl
`D
`
`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,
`the figure of the drawings to be published with the abstract is Figure No. ~l'""d,,__ ___ _
`D
`as suggested by the applicant
`[Kl
`D
`
`a.
`
`b. D
`
`as selected by this Authority, because the applicant tailed to suggest a figure
`as selected by this Authority, because this figure better characterizes the invention
`none of the figures is to be published with the abstract
`
`Form PCT/ISA/210 (first sheet) (April 2007)
`
`586 of 1573
`
`

`

`1 ·;~;;~;;;~~~~0;;~30
`
`A. CLASSIFICATION OF SUBJECT MATTER
`INV. A61M5/00
`ADD. A61M5/14
`
`According to International Patent Classification (IPC) orto both national classification and IPC
`
`B. FIELDS SEARCHED
`Minimum documentation searched (classification system followed by classification symbols)
`A61M
`
`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 praclical, search terms used)
`EPO-Internal, WPI Data, INSPEC
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category*
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`x
`
`x
`
`x
`
`FR 2 867 084 Al (GEN ELECTRIC [US])
`9 September 2005 (2005-09-09)
`figures 1-12
`page 6, line 16 - page 30, line 11
`-----
`EP 0 102 121 Al (BYK MALLINCKRODT CIL BV
`[NL]) 7 March 1984 (1984-03-07)
`
`figures 1-4
`page 9, 1 i ne 15 - page 12, line 11
`-----
`WO 99/56117 Al (GEN HOSPITAL CORP [US];
`LAYFIELD DOMINICK [US]; VENEGAS JOSE [US])
`4 November 1999 (1999-11-04)
`page 4, 1 i ne 20 - page 16, line 13;
`figures 1-6
`-----
`
`-/--
`
`1-2,5-9
`
`1,5-9,
`17-25,
`27-32,
`36-38
`
`1-3,
`15-17,
`31-38
`
`[II Further documents are listed in the continuation of Box C.
`
`• 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 priority claim(s) or
`which is cited to establish the publication date of another
`citation or other special reason (as specified)
`•o• document referring to an oral disclosure, use, exhibition or
`other means
`•p• document published prior to the international filing date but
`later than the priority date claimed
`
`El See patent family annex.
`
`·r 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 the actual completion of the international search
`
`Date of mailing of the international search report
`
`10 February 2010
`
`Name and mailing address of the ISA!
`European Patent Office, P.B. 5818 Patentlaan 2
`NL - 2280 HV Rijswijk
`Tel. (+31-70) 340-2040,
`Fax: (+31-70) 340-3016
`
`2
`
`Form PCT/ISA/210 (seoorld sheet) (April 2005)
`
`17/02/2010
`
`Authorized officer
`
`Reinbold, Sylvie
`
`page 1 of 2
`
`587 of 1573
`
`

`

`C(Contlnuation). DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category* Citation of document, with indication, where appropriate, of the relevant passages
`
`X
`
`x
`
`x
`
`x
`
`x
`
`EP 0 160 303 A2 (SQUIBB & SONS INC [US])
`6 November 1985 (1985-11-06)
`figures 1-12
`page 7, line 28 -
`
`line 15
`
`JP 2000 350783 A (SUMITOMO HEAVY
`INDUSTRIES) 19 December 2000 (2000-12-19)
`paragraph [0014] - paragraph [0032];
`figures 1-5
`
`US 2008/093564 Al (TARTAGLIA DANIEL [CA]
`ET AL) 24 April 2008 (2008-04-24)
`figures 1-7
`paragraph [0023] - paragraph [0035]
`
`WO 2007/149108 A2 (MALLINCKRODT INC [US];
`POLLARD RALPH E JR [US])
`27 December 2007 (2007-12-27)
`figures 1-18
`paragraph [0031] - paragraph [0053]
`
`US 2003/004463 Al (REILLY DAVID M [US] ET
`AL) 2 January 2003 (2003-01-02)
`paragraph [0049] - paragraph [0072];
`figures 1-4
`
`Relevant to claim No.
`
`1-2
`
`18-25,
`27-30
`
`18-30
`
`18-30
`
`31-38
`
`2
`
`Form PCT/ISN210 (continuation of second sheet) (April 2005)
`
`page 2 of 2
`
`588 of 1573
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/US2009/047030
`
`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. D
`
`Claims Nos.:
`because they relate to subject matter not required to be searched by this Authority, namely:
`
`2.D 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. D
`
`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 . [XJ As all required additional search fees were timely paid by the applicant, this international search report covers all searchable
`claims.
`
`2. D
`
`As all searchable claims could be searched without effort justifying an additional fees, this Authority did not invite payment of
`additional fees.
`
`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.o
`
`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.:
`
`Remark on Protest
`
`DThe additional search fees were accompanied by the applicanfs protest and, where applicable, the
`payment of a protest fee.
`The additional search fees were accompanied by the applicanfs protest but the applicable protest
`fee was not paid within the time limit specified in the invitation.
`
`D
`
`~No protest accompanied the payment of additional search fees.
`
`Form PCT/ISA/210 (continuation of first sheet (2)) (April 2005)
`
`589 of 1573
`
`

`

`International Application No. PCT/US2009 /047030
`
`FURTHER INFORMATION CONTINUED FROM PCTJISAI 210
`
`This International Searching Authority found multiple (groups of)
`inventions in this international application, as follows:
`
`1. claims: 1-17
`
`These claims essentially define an infusion system
`comprising an eluant source, a shielding assembly having a
`plurality of compartments and plurality of doors, a
`radioisotope generator, a eluate line and a patient line.
`(technical effect: to provide an infusion system to infuse
`an radioactive eluate)
`
`2. claims: 18-30
`
`These claims essentially define a shielding assembly
`comprising a sidewall defining a plurality of compartments,
`a first passageway formed in an upper surface of a first
`portion of the sidewall and defining a first compartment
`sized to contain a radioisotope and a second passageway with
`a second compartment.
`(technical effect: to provide a shielding assembly to permit
`a more effective operation)
`
`3. claims: 31-38
`
`These claims essentially define a disposable infusion
`circuit subassembly comprising: an eluate line, a patient
`line, a waste line, a valve member and a support frame.
`(technical effect: to facilitate the positioning of the
`components of a portion of infusion circuit in an infusion
`system)
`
`590 of 1573
`
`

`

`Information on patent family members
`
`Patent document
`cited in search report
`
`FR 2867084
`
`I
`
`Al
`
`Publication
`date
`
`09-09-2005
`
`I
`
`Patent family
`member(s)
`
`DE 102005010152 Al
`DE 102005010154 Al
`FR
`2867294 Al
`JP
`2005326398 A
`JP
`2005324007 A
`US
`2008242915 Al
`
`I Publication
`
`date
`
`15-09-2005
`15-09-2005
`09-09-2005
`24-11-2005
`24-11-2005
`02-10-2008
`
`EP 0102121
`
`WO 9956117
`
`EP 0160303
`
`Al
`
`Al
`
`A2
`
`07-03-1984
`
`NONE
`
`04-11-1999
`
`06-11-1985
`
`EP
`us
`
`AU
`CA
`CA
`DE
`JP
`JP
`us
`
`1075654 Al
`6773673 Bl
`
`581218 B2
`1250504 Al
`1233274 A2
`3581653 DI
`2568169 B2
`60241454 A
`4562829 A
`
`JP 2000350783 A
`
`19-12-2000
`
`NONE
`
`US 2008093564 Al
`
`24-04-2008
`
`WO 2007149108
`
`A2
`
`27-12-2007
`
`US 2003004463 Al
`
`02-01-2003
`
`WO
`
`CA
`CN
`EP
`JP
`us
`
`US
`US
`
`2009003290 Al
`
`2627429 Al
`101253577 A
`1938339 A2
`2009506343 T
`2008224065 Al
`
`2005238576 Al
`2003216609 Al
`
`14-02-2001
`10-08-2004
`
`16-02-1989
`28-02-1989
`23-02-1988
`14-03-1991
`25-12-1996
`30-11-1985
`07-01-1986
`
`08-01-2009
`
`27-12-2007
`27-08-2008
`02-07-2008
`12-02-2009
`18-09-2008
`
`27-10-2005
`20-11-2003
`
`Form PCT/ISA/210 (patent family annex) (April 2005)
`
`591 of 1573
`
`

`

`r-R I Cl~ I vVVl""CnA I IUN I ncA I J
`
`From the
`INTERNATIONAL SEARCHING AUTHORITY
`
`To:
`
`see form PCTAS.At220
`
`PCT
`
`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`(PCT Rule 43bis.1)
`
`Date of mailing
`(day/month/year) see form PCTASA,210 (second sheet)
`
`Applicant's or agent's file reference
`see form PCT/ISA/.220
`
`International application No.
`PCT AJS2009!04 7030
`
`FOR FURTHER ACTION
`See paragraph 2 below
`I
`International filing date (dayAnonth!jtear)
`11.06.2009
`
`Priority date (dayAnonthlyear)
`11.06.2008
`
`International Patent Classification (IPC) or both national classification and IPC
`INV. A61M5!00
`ADD. A61M5/14
`Applicant
`BRACCO DIAGNOSTICS INC.
`
`\ 1.
`
`This opinion contains indications relating to the following items:
`
`0 Box No. I
`D Box No. II
`D Box No. Ill
`0 Box No. IV
`0 Box No. V
`
`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 or industrial
`applicability; citations and explanations supporting such statement
`D Box No. VI
`Certain documents cited
`D Box No. VII Certain defects in the international application
`0 Box No. VIII Certain observations on the international application
`
`2.
`
`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 ("IPEA") except that this does not apply where
`the applicant chooses an Authority other than this one to be the IPEA and the chosen IPEA has notifed the
`International Bureau under Rule 66.1 bis(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 IPEA, the applicant is invited to
`submit to the IPEA a written reply together, where appropriate, with amendments, before the expiration of 3 months
`from the date of mailing of Form PCTASAi220 or before the expiration of 22 months from the priority date,
`whichever expires later.
`
`For further options, see Form PCTASAi220.
`
`3.
`
`For further details, see notes to Form PCTASAi220.
`
`Name and mailing address of the ISA:
`
`European Patent Office
`
`D-80298 Munich
`Tel. +49 89 2399 - 0
`Fax: +49 89 2399 - 4465
`
`Form PCTASA.1237 (Cover Sheet) (April 2005)
`
`Date of completion of
`this opinion
`
`Authorized Officer
`
`see form
`PCTllSAi210
`
`Reinbold, Sylvie
`
`Telephone No. +49 89 2399-7918
`
`592 of 1573
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCTAJS2009i047030
`
`Box No. I Basis of the opinion
`
`1 . With regard to the language, this opinion has been established on the basis of:
`
`[gJ
`
`D
`
`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 (Huie 43bis.1 (a))
`
`3. With regard to any nucleotide and/or amino acid sequence disclosed in the international application and
`necessary to the claimed invention, this opinion has been established on the basis of:
`
`a. type of material:
`
`D
`
`D
`
`a sequence listing
`
`table(s) related to the sequence listing
`
`b. format of material:
`
`D
`
`D
`
`on paper
`
`in electronic form
`
`c. time of filingifurnishing:
`
`D
`
`D
`
`D
`
`contained in the international application as filed.
`
`filed together with the international application in electronic form.
`
`furnished subsequently to this Authority for the purposes of search.
`
`4. D
`
`In addition, in the case that more than one version or copy of a sequence listing and/or table relating thereto
`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 PCTASA/ 237 (April 2007)
`
`593 of 1573
`
`

`

`WRITTEN OPINION OF THE
`INTERNATIONAL SEARCHING AUTHORITY
`
`International application No.
`PCT AJS2009,04 7030
`
`Box No. IV Lack of unity of invention
`
`1. l8l
`
`In response to the invitation (Form PCTl1SM06) to pay additional fees, the applicant has, within the
`applicable time limit:
`
`l8l paid additional fees
`
`D
`
`D
`
`D
`
`paid additional fees under protest and, where applicable, the protest fee
`
`paid additional fees under protest but the applicable protest fee was not paid
`
`not paid additional fees
`
`2. D This Authority 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