WO 2007/104133
`
`PCT/CA2007/000295
`
`WE CLAIM:
`
`A method of controlling an °Sr/®*Rb elution system
`
`having a generator valve for proportioning a flow of
`saline solution between an **Sr/®**Rb generator and a
`
`bypass
`
`line coupled to an outlet of
`
`the generator
`
`such that saline solution traversing the bypass line
`
`will merge with eluted saline solution emerging from
`
`the generator to provide an active saline solution,
`
`the method comprising steps of:
`
`Guring each elution run:
`
`obtaining a plurality of successive concentration
`
`parameter values at predetermined intervals,
`
`each
`
`concentration parameter value
`
`being
`
`indicative of
`
`a
`
`respective
`
`instantaneous
`
`activity concentration of
`
`the active saline
`
`solution;
`
`computing respective error values between each
`
`concentration parameter value and a target
`
`activity concentration value of the elution
`
`run; and
`
`accumulating error data based on a plurality of
`
`the computed error values; and
`
`between successive elution runs, adjusting at
`
`least
`
`one performance parameter of
`
`the elution system
`
`based on the accumulated error data.
`
`A method as claimed in claim 1, wherein the step of
`
`adjusting at
`
`least one performance parameter of
`
`the
`
`elution
`
`system comprises
`
`a
`
`step
`
`of
`
`tuning
`
`a
`
`performance model of the generator valve.
`
`1427 of 1754
`1427 of 1754
`
`

`

`WO 2007/104133
`
`PCT/CA2007/000295
`
`- 25 =
`
`A method
`
`as
`
`claimed
`
`in
`
`claim 2, wherein
`
`the
`
`accumulated error data comprises the computed error
`
`values as a function of an estimated flow ratio.
`
`A method as claimed in claim 3, wherein the step of
`
`tuning a performance model of
`
`the generator valve
`
`comprises steps of:
`
`calculating a slope of the error data; and
`
`adjusting a response slope parameter of the generator
`
`valve model based on the calculated slope of the
`
`error data.
`
`A method as claimed in claim 2, wherein the error
`
`data comprises one or more error values accumulated
`
`during
`
`a
`
`period
`
`in which
`
`a
`
`target
`
`activity
`
`concentration of
`
`an elution exceeds
`
`the predicted
`
`activity concentration of that elution.
`
`A method as claimed in claim 5, wherein the step of
`
`tuning a performance model of
`
`the generator valve
`
`comprises steps of:
`
`calculating a slope of the error data; and
`
`adjusting an upper
`
`limit parameter of
`
`the generator
`
`valve based on the calculated slope of the error
`
`data.
`
`A method as claimed in claim 6, wherein the step of
`
`adjusting the upper
`
`limit parameter comprises steps
`
`of:
`
`if
`
`the calculated slope is zero,
`
`reducing the
`
`upper
`
`limit parameter by a predetermined
`
`increment; and
`
`1428 of 1754
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`
`

`

`WO 2007/104133
`
`PCT/CA2007/000295
`
`- PE -
`
`otherwise,
`
`calculating an adjusted upper
`
`limit
`
`parameter value using the calculated slope.
`
`A method as claimed in claim 2, wherein the error
`
`data
`
`comprises
`
`a difference
`
`between
`
`a predicted
`
`elution duration required to achieve a desired total
`
`activity dose and an actual elution duration.
`
`A method as claimed in claim 8, wherein the step of
`
`tuning a performance model of
`
`the generator valve
`
`comprises a step of adjusting a hysteresis factor H
`
`based on the difference between the predicted and
`
`actual elution durations.
`
`10.
`
`A method as claimed in claim 1,
`
`further comprising a
`
`step of
`
`enforcing a predetermined delay between
`
`successive elution runs.
`
`Hee,
`
`A method as claimed in claim 1,
`
`further comprising
`
`steps of:
`
`defining a plurality of operating modes
`
`of
`
`the
`
`elution system; and
`
`during each elution run, automatically transitioning
`
`between selected ones of the operating modes,
`
`in
`
`accordance with user-input
`
`parameters
`
`of
`
`the
`
`elution run.
`
`V2 3
`
`A method
`
`as
`
`claimed
`
`in
`
`claim il, wherein
`
`the
`
`plurality of operating modes comprise:
`
`a “Bypass-to-waste” mode
`
`in which the entire saline
`
`flow is directed through the bypass line and into
`
`a waste reservoir;
`
`1429 of 1754
`1429 of 1754
`
`

`

`WO 2007/104133
`
`PCT/CA2007/000295
`
`= 27 =
`
`a “patient
`
`line flush” mode in which the saline flow
`
`is directed through the bypass
`
`line and out
`
`through a patient outlet;
`
`a “waiting for threshold” mode
`
`in which the saline
`
`flow is directed through the generator,
`
`and the
`
`active saline solution directed into the waste
`
`reservoir; and
`
`an
`
`“elution” mode
`
`in which
`
`the
`
`saline
`
`flow is
`
`proportioned between the generator and the bypass
`
`line, and the active saline solution directed out
`
`through the patient outlet.
`
`13.
`
`A method as claimed in claim 11, wherein the user-
`
`input parameters comprise:
`
`at
`
`least one of
`
`a desired duration of
`
`the elution,
`
`and a desired saline flow rate; and
`
`at
`
`least
`
`one of
`
`a
`
`target activity concentration
`
`profile, and a total eluted activity dose.
`
`14.
`
`A method as claimed in claim 1,
`
`further comprising
`
`steps of:
`
`defining a set of one or more predetermined elution
`
`runs, each having respective set of predetermined
`
`parameters; and
`
`executing the set of predetermined elution runs
`
`in
`
`accordance with a predetermined schedule.
`
`1s.
`
`16.
`
`A method
`
`as
`
`claimed
`
`in
`
`claim 14, wherein
`
`the
`
`predetermined schedule defines a daily protocol.
`
`A method as claimed in claim 14, wherein the set of
`
`one or more predetermined elution runs comprises a
`
`1430 of 1754
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`
`

`

`WO 2007/104133
`
`PCT/CA2007/000295
`
`- 2S —-
`
`calibration elution for calibrating any one or more
`
`of:
`
`a performance of the generator;
`
`a proportionality constant between the concentration
`
`parameter value and the instantaneous activity
`
`concentration of the active saline solution.
`
`Lis
`
`A method
`
`as
`
`claimed
`
`in
`
`claim 16, wherein
`
`the
`
`calibrated performance of
`
`the generator
`
`comprises
`
`either one or both of:
`
`82Rb activity concentration vs. eluted volume; and
`
`®*sr breakthrough.
`
`18.
`
`A positron detector for detecting instantaneous **Rb
`
`activity concentration of an active saline solution
`generated by an **Sr/**Rb elution system,
`the positron
`
`detector comprising:
`
`a scintillation fiber disposed adjacent a feed line
`
`for conveying the active saline solution;
`
`a
`
`photon
`
`counter
`
`operatively
`
`coupled
`
`to
`
`the
`
`scintillation
`
`fiber
`
`for
`
`detecting
`
`photons
`
`generated by positron annihilation within the
`
`scintillation fiber; and
`
`a
`
`radiation shield surrounding
`
`the
`
`scintillation
`
`fiber and at
`
`least a portion of
`
`the feed line,
`
`for shielding at
`
`least
`
`the scintillation fiber
`
`from spurious radiation.
`
`L9'.
`
`A positron detector as claimed in claim 18, wherein a
`
`thickness of the radiation shield is on the order of
`
`¥% inch.
`
`1431 of 1754
`1431 of 1754
`
`

`

`WO 2007/104133
`
`PCT/CA2007/000295
`
`- 29 =
`
`20).
`
`A positron detector as claimed in claim 18, wherein
`
`the radiation shield surrounds a length of
`
`the feed
`
`line corresponding to at
`
`least
`
`five times an outer
`
`diameter or the feed line,
`
`in each direction from the
`
`scintillation fiber.
`
`1432 of 1754
`1432 of 1754
`
`

`

`WO 2007/104133
`
`PCT/CA2007/000295
`
`1/7
`
`yenno
`
`juaneg—-
`
`Gd/4Sz¢e
`
`ua
`
` (LyJO)(Hy10d)
`
`
`
`qzaunbi4ezaunbi4
`
`e|oinbi4
`
`(HyJOld)
`
`1433 of 1754
`1433 of 1754
`
`
`
`

`

`WO 2007/104133
`
`PCT/CA2007/000295
`
`2/7
`
`9¢
`
`yenno
`
`yuayeqS—
`
`+3Gu/4Sze
`
`
`
`
`
`aoeHaIU]4887)J91[0..U0D
`
`
`
`ua
`
`SLI4°VErL
`
`1434 of 1754
`
`¢aunbi4
`
`
`

`

`PCT/CA2007/000295
`
`|ssvane
`
`WOuSd
`
`YOLVYANSD
`
`WO 2007/104133
`
`3/7
`
`YATIOWLNOS
`
`OL
`
`YOLVYANAD
`
`OL
`
`SSVdAd
`
`YSTIONLNOO
`
`WOU
`
`7ainbi
`
`1435 of 1754
`1435 of 1754
`
`
`
`

`

`WO 2007/104133
`
`PCT/CA2007/000295
`
`4/7
`
`Figure 6a
`
`
`Saline
`
`Supply
`22
`8 —
`40
`10
`sana Joe Patient
`
`Se ®2Sr/Rb
`Gen
`
`ee;
`
`Outlet
`
`Figure 6b
`
`22
`
`10
`cS Patient
`Outlet
`
`
`
`
`
`
`
`8
`+
`
`26
`
`Waste
`Res.
`
`14
`
`x
`
`24
`
`40
`
`J
`
`10
`Patient
`Outlet
`
`pe
`
` 8 1
`
`Figure 6c
`
`ée
`
`1436 of 1754
`1436 of 1754
`
`

`

`WO 2007/104133
`
`s/7
`
`PCT/CA2007/000295
`
`Figure 6d
`
`28
`
`
`
`
`10
`Patient
`Outlet
`
`
`*
`
`18
`
`-26
`
`Waste
`Res.
`
`1437 of 1754
`1437 of 1754
`
`

`

`WO 2007/104133
`
`6/7
`
`PCT/CA2007/000295
`
`No
`change
`
`No
`
`Figure 7b
`
`Generator
`Valve
`
`Close
`Generator
`Valve
`
`.
`Figure 7c
`
`t
`
`Caoet
`
`Figure 7a Open
`
`Cc. =
`
`t,
`
`time
`
`t!
`
`{
`
`;
`
`|| |
`
`|
`
`ty
`
`t
`
`t
`
`time
`
`1438 of 1754
`1438 of 1754
`
`

`

`WO 2007/104133
`
`WT
`
`PCT/CA2007/000295
`
`Figure 8a
`
`$2
`
`Predict
`Flow Ratio,
`Duty Cycle
`
`S14
`
`Si6
`
`
`
`
`AC=C,,(t)-Cge
`
`
`$24<> Yes
`
`
`S28
`
`Compute
`
`
`
`S18
`
`No
`
`Figure 8b
`
`Increase
`DutyCycle
`
`
`Decrease
`
`DutyCycle
`
`Figure 8c
`
`ty
`
`t
`
`t,
`
`time
`
`Coser
`
`Cy, -}---------
`
`46
`
`
`
`%
`
`Ot
`
`i
`
`time
`
`1439 of 1754
`1439 of 1754
`
`

`

`International application No.
`INTERNATIONAL SEARCH REPORT
`PCT/CA2007/000295
`
`A,
`
`CLASSIFICATION OF SUBJECT MATTER
`
`IPC: A61M 36/06 (2006.01) , A61M 36/08 (2006.01), GOTT 1/164 (2006.01) , GOIT 1/20 (2006.01)
`According to International Patent Classification (IPC) or to beth national classification and IPC
`
`B. FIELDS SEARCHED
`
`Minimumdocumentation searched (classification system followed byclassification symbols)
`IPC(S): AGIM All (2006.01) + GOT All (2006.01)
`
`Documentation searched other than nunimum documentation to the extent that such documents are included in the fields searched
`
`Electronic database(s) consulted during the international search (name ofdatabase(s) and, where practicable, scarch terms used)
`QPat, OQWeb, Delphion (Keywords used: positron emission tomography, myocard* perfusion, radiation detector, scintillation fibre,
`generator, etc.)
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`
`|Category*|Citation ofdocument, with indication, where appropriate, ofthe relevant passages Relevant to claim No.
`
`JP 2000131443 A (CHIBA,K.et al.) 12 May 2000 (12-05-2000)
`* Figs 1-6: Abstract. Machine translation *
`
`JP 7231884 A (OKADA. H. et al.) 5 September 1995 (05-09-1995)
`* bigs. 1-7, Abstract *
`
`US 4975583 A (SPOWART, A.R.) 4 December 1990 (04-12-1990)
`* Fig. 2, Abstract: Columns 2-3 *
`
`US 6713765 B2 (TESTARDI, L.R.) 30 March 2004 (30-03-2004)
`* Whole document *
`
`ALVAREZ-DLAZ, ‘Teresa M. et al., Manufacture of strontium-$2/rubidium-$2
`generators and quality control of rubidium-82 chloride for myocardial perfusion
`imaging in patients using positron emission tomography, Applied Radiation and
`Isotopes, vol. 50, no. 6. 1999, pp. 1015-1023
`
`“Te
`
`="
`
`Facsimile No.: 001-819-953-2476
`
`[X} Further documents are listed in the continuation of Box C.
`See patent family annex.
`Special categories ofcited documents
`later document publishedatter the internatianal filimg date or priority
`date and not in cenflict with the epplicsion but cited
`to understand
`document defining the general state of the art which 1s not considered
`the principle or theory underlying the mvention
`to be ofparticular relevance
`.
`.
`document of particular relevance, the claimed invention cannot be
`earlier apalication or patent but published cn orafier the intemmatianal
`considered novel or cannot be considered ta involve an inventive
`filing date
`step waen the documentis taken alone
`decument which may throwdoubts on priority clainys) or which is
`document ofparticular relevance; the claimed invention cannot be
`cited to establish the publication date of another citation or other
`considered to involve an inventive step when the document is
`special reason (as specified)
`combined with one or more other such documents, such combination
`;
`;
`oo
`being obvious to a person skilled in the art
`document referring toan orl disclosure. use. exhibivien or other means
`.
`decument member of the same patent family
`decument published prior to the international filing date but later than
`the priority date claimed
`Date of the actual completion ofthe international search
`Date of mailing of the international search report
`
`13 April 2007 (13-04-2007)
`
`Name and mailing address of the ISA/CA
`Canadian Intellectual Property Office
`Place du Portage I, C114 - Ist Floor, Box PCT
`50 Victoria Street
`
`Gatineau. Quebec KIA 0C9
`
`18 May 2007 (18-05-2007)
`
`Authorized officer
`
`Valérie Dubé 819- 934-4261
`
`Form PCT/ISA/210 (second sheet ) (April 2005)
`
`Page 3 of 5
`
`1440 of 1754
`1440 of 1754
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/CA2007/000295
`
`Box No. II
`
`Observations where certain claims were found unsearchable (Continuation of item 2 of the first sheet)
`
`This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following
`reasons:
`
`[
`
`|] Claim Nos. :
`because theyrelate to subject matter not required to be searched by this Authority, namely:
`
`2
`
`[
`
`| Clan Nos.:
`
`because thevrelate 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:
`
`restricted to the inventionfirst mentioned in the claims; it is covered by claim Nos. :
`
`{
`
`| Claim Nos. :
`because they are dependant claims and are not drafted in accordance with the second andthird sentences of Rule 6.4fa).
`
`Box No, Uf
`
`Observations where unity of invention is lacking (Continuation of item 3 offirst sheet)
`
`This International Searching Authority found multiple inventions in this international application, as follows:
`
`.
`
`Claims 1-17 pertain to a method of controlling an $2S1r/82Rb elution system, the system comprising a generator valve, an
`82S81r/82Rb generator and a bypass line and providing an active saline solution, the method comprising: during each elution run,
`obtaining concentration values, computing error values between the obtained values and a target value. accumulating error data
`and adjusting a system parameter accordingly.
`Claims 18-20 pertain to a positron detector for detecting 82]Rb activity concentration ofan active saline solution generated by an
`82S8r/82Rb elution system, the detector comprising a scintillation fibre adjacent a feed Line, a photon counterand a radiation
`shield.
`The common feature between aforesaid groups of claims 1s an 82Sr/S$2Rb elution system generating an active saline solution. However,
`such a systemis already well knowninthe art and therefore cannot be regarded as constituting a single commoninventive feature linking
`
`1.
`
`[|
`
`| Asall required additional search fees were timely paid bythe applicant, this international search report coversall
`searchable claims.
`
`As all searchable claims could be searched without effort justifying additional fees, this Authority did not invite
`paymentofadditional 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 claim Nos.
`:
`
`No required additional search fees were timely paid bythe applicant. Consequently, this international search report is
`
`Remark on Protest
`
`{
`
`{
`
`| The additional search fees were accompanied bythe applicant's protest and, where applicable.
`the payment of a protest fee.
`
`| The additional search fees were accompanted bythe applicant's protest but the applicable protest
`ee Was not paid within the time limit specified in the invitation.
`
`{ | No protest accompanied the payment of additional searchfees,
`
`Form PCT/ISA/2 10 (continuation of first sheet (2)) (April 2005)
`age 2 of 5
`
`1441 of 1754
`1441 of 1754
`
`

`

`C (Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`
`
`|Relevant to claim No.
`
`
`International application No.
`
`PCT/CA2007/000295
`
` INTERNATIONAL SEARCH REPORT
`
`YANO.Y. et al., A Precision Flow-Controlled Rb-82 Generator for Bolus
`or Constant-Infusion Studies of the Heart and Brain. The Journal of
`
`Nuclear Medicine, vol. 22, no. 11, 1981, pp. 1006-1010
`
`YANO,Y. Essentials of a Rubidium-82 Gencrator for Nuclear Medicine.
`International journal of radiation applications and instrumentation. Part
`A, Applied radiation and isotopes, vol. 38, no. 3, Great Britain, 1987, pp.
`205-211
`
`KENSETT, M. J. et al.. Experience with a 82Sr/82Rb Generatorfor
`Clinical Use, International journal of radiation applications and
`instrumentation. Part A. Applied radiation and isotopes, vol. 38. no. 3,
`Great Britain, 1987, pp. 227-231
`
`SAHA.G. et al., Use of the 82Sr/82Rb Generator in Clinical PET Studies,
`International journal of radiation applications and instrumentation. Part
`B. Nuclear medicine and biology, vol, 17. no. 8. Great Britain, 1990, pp.
`763-768
`
`Porm PCT/ISA/210 (continuation of second sheet) (April 2005)
`
`1442 of 1754
`1442 of 1754
`
`
`
`

`

`INTERNATIONAL SEARCH REPORT
`Information on patent family members
`
`International application No.
`
`PCT/CA2007/000295
`
`Patent Document
`Cited in Search Report
`
`Publication
`Date
`
`Patent Family
`Member(s)
`
`Publication
`Date
`
`JP 2000131443 A
`
`12-05-2000
`
`JP 7231884 A
`
`05-09-1995
`
`US 4975583 A
`
`04-12-1990
`
`NONE
`
`NONE
`
`AU1299288 A
`EP0346369 Al
`GB8704074 DO
`JP2502217 T
`WO08806297 Al
`
`14-09-1988
`20-12-1989
`25-03-1987
`19-07-1990
`25-08-1988
`
`LS 6713765 B2
`
`30-03-2004
`
`NONE
`
`
`
`Form PCT/ISA/210 (patent family annex ) (April 2005)
`
`Page 5 of 5
`
`1443 of 1754
`1443 of 1754
`
`

`

`Electronic AcknowledgementReceipt
`
`
`
`Application Number: 12137356
`
`International Application Number:
`
`Confirmation Number:
`
`Title of Invention:
`
`SHIELDING ASSEMBLIES FOR INFUSION SYSTEMS
`
`
`
`First Named Inventor/Applicant Name:
`
`Charles R. Quirico
`
`22859
`Customer Number:
`
`
`
`
`Filer: Elisabeth Lacy Belden
`
`Filer Authorized By:
`
`
`
`Receipt Date: 20-MAY-2009
`
`
`
`Filing Date: 11-JUN-2008
`
`Time Stamp:
`
`13:54:24
`
`Application Type:
`
`Utility under 35 USC 11 1{a)
`
`Paymentinformation:
`
`
`File Listing:
`
`Submitted with Payment
`
`no
`
`Warnings:
`
`Document
`5
`ge
`-
`File Size(Bytes)/
`
`
`
`
`Number Message Digest|Part/.zip| (ifappl.) Becumant Mescnpnon FileName
`.
`:
`796240
`Information Disclosure Statement (IDS)
`56782_1_5_|IDS3.pdf
`Filed (SB/08)
`4780261 1d $d 16c5 tdcesSo fd 27beibSShi
`
`
`Information:
`
`1444 of 1754
`4-of t754
`
`

`

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`Documents or Non PatentLiterature will be manually reviewed and keyed into USPTO systems.
`
`Foreign Reference
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`56782_1_W0O07071022A1.pdf
`
`4iddcfobhabtdde?5 265b828 360bch7c 1
`
`Information:
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`Warnings:
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`Information:
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`Foreign Reference
`
`56782_1_W007104133A1.pdf
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`1590246
`
`Bd 23dsO9aBOMeced 791 dedaS491652,
`57 lsa
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`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar toa
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`If a new applicationis being filed and the application includes the necessary componentsfora filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shownonthis
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`
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`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
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`national stage submission under35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
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`If a new international application is being filed and the international application includes the necessary componentsfor
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105)will be issued in due course, subject to prescriptions concerning
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`the application.
`
`
`1445 of 1754
`1445 of 1754
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`

`

`05/04/2009 15:22 FAX
`.
`
`612 492 7077
`
`FREDRIKSON & BYRON
`
`002/009
`
`2
`
`The following is an example of an acceptable property rights statement. Statements of this type are, of course,
`only sultable for situations In which NO Agency funds or other considerations were involved in the making or
`conception of the invention, While this example Is in the form of a declaration, a swom document Is equally
`acceptable.
`
`pois)
`loi
`
`\(We) Charles R. Quirico
`citizens of
`
`
`
`That i(we) made andconcelved the invention described and claimed In patent application:
`Serial Number _12/237,356____filed in the United States of Amarica on
`_June 212. 2008
`
`
`
`titledSHIELDINGASSEMBLIESFORINFUSION.SYSTEMS|
`
`(check III and/or IV below as appropriate)
`(check and complete either I or II befow)
`@ |. (For Inventors Employed by an Organization) That
`That to the best of my (our) knowledge andbelief:
`Ill, The invention was not made or conceived in the-|
`\(We) made and conceived this
`invention while
`
`employed byBraccoDiagnostics,Inc,
`course of, or in connection with, or under the terms of
`That the invention is ralated to the work | am (we are)
`any contract, subcontract or arrangement entered into
`with or for the benefit of the United States Atomic
`employed to perform and was made within the scope
`of my (our) employment duties; That the invention was
`Energy Commission or
`its
`successors: Energy
`made during working hours and with the use of
`Research and Development Administration, or the
`facilities, equipment, materials, funds, Information and
`Depastment of Energy.
`services of Bracco Diagnostics, Inc.
`
`Other relevant facts areBraccocontractedwithWorrell, Inc. in the design of the invention,
`for which Worrell assigned all rights to BraccorAND/OR--
`-
`That to the best cf my (our) knowledge and belief
`(and/or) based upon
`information
`provided
`by
`
`Oe
`
`of Bracco Diagnostica, Inc.
`
`~OR--
`
`OU. (For Self-Employed Inventors) That | (we) made and
`conceived this invention on my (our) own time using.
`only my (our) ownfacilities, equipment, materials,
`funds, information and services. Other relevant factors
`are
`
`Q IV. The Invention was not made (conceived orfirst
`actually reduced to practice) under nor Is there any
`relationship of the invention to the performance of any
`work under any contract of the National Aeronautics
`
`andSpace Administration. XeC&Ay “&
`
`4,
`
`Sg.» M9
`*ygy
`
`The undersigned inventors(s) declare further that all statements made herein of his or her (their) own knowledge
`ar6é true and that all statements made on Information and belief are believed to be true and further that these
`statements are made with the knowledge that willful false statements and the like so made are punishable by
`fine or Imprisonment, or both, under Section 1001 of Title 18 of the United States Code and that such willful false
`statements mayleopardlZa) o
`F
`any
`patentIssuing thereon.
`‘Inventor's Signature:
`és
`,
`Post Office Address: £7 /
`LLG
`ecm
`Je
`ses
`pate:S/2b/OF
`Inventor's Signature:
`
`Post Office Address:
`
`Date:
`
`FORM PTOL-454 (Rev, 07-08)
`
`Page 2 of 2
`
`1446 of 1754
`1446 of 1754
`
`

`

`05/04/2009 15:22 FAX
`
`612 492 7077
`
`FREDRIKSON & BYRON
`
`003/009
`
`Thefollowing is an example of an acceptable property rights statement. Statements of this type are, of course,
`only suitable for situations in which NO Agency funds or other considerations were invoWed in the making or
`conception of the Invention. While this example is in the form of a declaration, a sworn documentIs equally
`acceptable.
`
`{(We) Daniel Darst
`
`citizens of
`
`__
`
`declare:
`
`ThatI(we) made and conceived the invention described and claimed in patent application:
`Serial Number —12/137,356filed in the United States of America on _June_21,_ 2006
`
`tiled SHIELDING ASEEMBLIES FOR INFUSION SYSTEMS
`
`(check {Il and/or lV below as appropriate)
`(check and complete elther t or I! below)
`|. (For tnventors Employed by an Organization) That
`That to the best of my (our) knowledge andbelief:
`B lll. The Invention was not made or conceived In the
`(We) made and conceived this
`invention while
`course of, or in connection with, or under the terms of
`
`employed byBracceDiagnostics,Inc.
`any contract, subcontract or arrangement entered into
`That the invention is related to the work | am (we are)
`with or for the benefit of the United States Atomic
`employed to perform and was made within the scope
`Energy Commission
`or
`its
`successors: Energy
`of my (our) employment duties; That the invention was
`made during working hours and with the use of
`Research and Development Administration or
`the
`facilities, equipment, materials, funds, information and
`Departmentof Enargy.
`sarvices of Bracco Tiagnostics,
`Inc.
`Other relevant facts ere Braccocontractedwith Worrell, TOR
`for which Worrell assigned allrightsto Bracco-AND/O
`That to the bast of my (our) knowledge and belief
`(andor)
`based
`upon
`information
`provided
`by
`
`in the design of the invention,
`
`of Bracco Disgnostics,
`
`Inc.
`
`—~OR--
`
`Q Il. (For Seif-Employud inventors) That | (we) made and
`conceived this invention on my (our) own time using
`only my (our) own facllitias, equipment, materials,
`funds, Information and services. Other relevant factors
`are
`
`Q IV. The invention was not made (conceived orfirst
`actually reduced to practice) under nor is there any
`relationship of the invention to
`performance of any
`work under any contract of t
`jonal Aeronautics
`and Space Administration.
`Y
`
`“en
`Ly iy .
`sy 42
`C&2 Np
`Vey
`
`i
`
`The undersigned Inventors(s) declare further that all statements made herein of his or her(their) own knowledge
`are tue and that all statements made on information and bellef are believed to be true and further that these
`statements are made¢with the knowledgethat willful false statements and the like so made are punishable by
`fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and that such willful false
`statements may jeopardizet!
`alidity of the
`ap
`jon or any patentissuing thereon.
`L
`Inventor's Signature:
`Danie
`arat
`Post Office Address: 25540 96th Street NW,
`
`Zimmerman, MN_55398
`
`Sez
`
`Date:
`
`Inventors Signature:
`Post Office Address:
`
`Date:
`
`FORM PTOL-456 (Rev. 07-08)
`
`Page 2 of 2
`
`1447 of 1754
`1447 of 1754
`
`

`

`05/04/2009 15:23 FAX
`
`612 492 7077
`
`FREDRIKSON & BYRON
`
`004/009
`
`04/29/2009 WED 15:50
`
`PFA 3125403710
`
`Moo1/o01
`
`The following is an exampte of an acceptable property rights statement. Statements of this type are, of course,
`only suitable for situations In which NO Agency funds or other considerations were Involved In the making or
`conceptionof the Invention, While this example Is In the form of a declaration, a sworn documentis equally
`
`acceptable
`
`Daniel V. Clements
`
`(We)
`
`That ((we) made and conceived the Invention described and claimed in patent application:
`Serial Number __12/137.356____filed in the United States of America on
`June 11, 2008
`
`tiled SHIELDING ASSEMBLIES POR INFUSION SYSTEMS
`
`ceeSSNSiSe
`
`(cheak and complete either | or Ii below)
`{check iil and/or IV below a9 appropriate)
`|. (For Inventors Employed by an Organization) That
`That to the best of my (our) knowledge and belief:
`il]. The Invention was not made or conceivedin the
`(We) made and conceived this
`invention while
`course of, or in connection with, or under the terms of
`
`employed byBraccoDiganosticg,Ing.
`That the invention Is related to the work | am (we are)
`any contract, subcontract or arrangement entered into
`with or for the benefit of the United States Atomic
`employed to perform and was made within the scope
`of my (our) employment duties; That the invention was
`Energy Commission or
`its
`successors: Energy
`made during working hours and with the use of
`Research and Development Administration or
`the
`Department of Energy.
`facilities, equipment, materials, funds, information and
`servicas of Bracco Diagnostics, Inc.
`Other relevant tacts are Bracco contracted with Worrell, Inc.
`for which Worrell assigned all rights to BraccorAND/OR--
`That to the best of my (our) knowledges and belief
`(and/or)
`based
`upon
`information
`provided
`by
`V——_—_—————————
`of Bracco Diagnostics, Inc.
`
`in the design of the invention,
`
`~OR-
`
`CII. (For Sei-Employed Inventars) That | (we) made and
`conceived this invantion on my (our) own time using
`only my (our) own facllities, equipment, materials,
`funds, Information ind services. Other relavant factors
`are
`
`
`1 {V. The Invention was not made (conceived or first
`actually reduced to practice) under nor ts there any
`relationship of the Invention to
`ormance of any
`work under any contract of
`jal Aeronautics
`and Space Administration.
`&
`Nyy
`Ve
`log, AY x
`O
`ey,
`
`The undersigned inventora(s) declare furtherthat all statements made herein of his or her (thelr) own knowledge
`are true and that all statements made on Information and bellef are belleved to be tue and further that these
`statements are made with the knowledge that willful false statements and the like so made are punishable by
`
`fine or imprisonment, or both, under. S agiion 1001 ot Tile 18 oftheUnited States Cade and that such wilfulfatse
`
`Date:iyfr i a eeaa
`
`Post Office Address:
`
`Inventor's Signature:
`
`
`
`Post Office Address:
`
`
`
`
`Date:
`
`FORM PTOL-~4S6 (tev, 07-08)
`
`Page 2 of 2
`
`oe
`
`1448 of 1754
`1448 of 1754
`
`

`

`05/04/2009 15:23 FAX
`
`612 492 7077
`
`FREDRIKSON & BYRON
`
`005/009
`
`The following Is an example of an acceptable property rights statement. Statements ofthis type are, of course,
`only suitable for situetions in which NO Agency funds or other considerations were involved in ths making or
`counnabie of the invention. While this example Is in the form of a declaration, a sworn document ts equally
`
`acca,
`
`2
`
`(We) Bric J. Kraze
`citizens of
`
`residing at 3360 Lake Ridge Drive, Big Lake, MN 55309
`declare:
`
`That Itwe) made and oncesived the Invention described and claimed In patent application:
`Serial Number _12/:.37,356filed in the United States of America on
`_June_t1+ 2008
`INFUSION SYSTEMS
`
`titled
`
`ELDING
`
`EMBLIES |
`
`(check and ec mplete either | ar tl below)
`(check Ill and/or IV below as appropriate)
`9 |, (For Inventors Employed by an Organization) That
`That to the best of my (our) knowledge and belief:
`tl, The invention was not made or concelved In the
`(We) made and conceived this
`invention while
`course of, or in connection with, or under the terms of
`
`employed by BraccoDiagnostics,Inc,
`any contract, subcontract or arrangement entered Into
`That the Invention ([s ‘elated to the work | am (we are)
`with or for the benefit of the United States Atomic
`employed to perform and was made within the scope
`Energy Commission
`or
`its
`successors: Energy |
`of my (our) employment duties; That the Invention was
`Reasearch and Development Administration or
`the
`mada during working hours and with the use of
`facilities, equipment, materials, funds, information and
`Departmentof Energy.
`services of Bracco Diagnostics, Inc.
`Other relevant facts are Bracco contracted with Worrell, Inc. in the design of the invention,
`for which Worrell assigned all rights to BraccorAND/OR-:-
`That to the best of my (our) knowledge and belief
`(and/or)
`based
`upon
`information
`provided
`by
`
`|1It |
`
`of Bracco Diagnostics, Inc.
`
`~OR--
`
`Q Il. (For Self-Employedinventars) That | (we) made and
`concelved this invention on my (our) own time using
`only my {our) own facilities, equipment, materials,
`funds,information and services. Otherrelevantfactors
`
`are
`
`IV. The invention was not made (conceived orfirst
`actually reduced to practice) under nor is there any
`telationship of the invention'to the performance of any
`work under any contract of the National Aeronautics
`and Space Administration.
`°
`
`i
`|
`
`O
`Ny
`Ve.
`Log. My
`Oo
`Cys ~g2
`Ng,
`“Ng
`Reky
`
`The undersigned inventors(s) declare further that all statements made herein of his or her(their) own knowledge
`are true and thatall statements made on information and belief are believed to be true and further that these
`statements are made with the knowledgethat willful false statements and the like so made are punishable by
`fine or imprisonment, or
`j
`Spctipn 1001of Title 18 of the United States Code and that suchwillful false
`
`statements may jaopardi
`ie valigi
`Inventor's Signature:.2
`| /
`
`
`
`Post Office Address: .
`
`
`Date:
`
`Inventor's Signature:
`
`
`
`Post Office Address:
`
`
`
`
`Date:
`
`Page 2 of 2
`
`1449 of 1754
`1449 of 1754
`
`

`

`05/04/2009 15:23 FAX
`
`612 492 7077
`
`FREDRIKSON & BYRON
`
`006/009
`
`That (we) made and conceived the invention described and claimed in patent application:
`
`Serial Number_12/:137,356___filed in the United States of America on _June_11, 2008
`BA eee
`oP
`G29 Mag Ce Eyl
`+
`POR
`NE
`Lon
`
`
`
`
`
`The following is an example of an acceptable property rights statement. Statements ofthis type are, of