W0 2007f104133
`
`PCTJ'C A2007fl)0(1295
`
`WE CLAIM:
`
`.A method of controlling an_823rfimRb elution system
`
`having a generator valve for proportioning a flow of
`
`saline solution between an_SZSr/”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:
`
`during 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 cencentration 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
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`

`

`W0 2007ll04133
`
`PCT/CAZImWUflOZEJS
`
`_ 25 i
`
`3.
`
`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.
`
`4.
`
`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.
`
`5.
`
`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.
`
`6.
`
`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.
`
`7.
`
`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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`

`

`W0 20071'104133
`
`PCTICA20071000295
`
`_26_
`
`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.
`
`A method as claimed in claim 1,
`
`further comprising a
`
`step of
`
`enforcing a predetermined delay between
`
`successive elution runs.
`
`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-
`
`10-
`
`11.
`
`12.
`
`A method
`
`as
`
`claimed
`
`in
`
`claim 11, 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
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`

`

`WO 20071104 133
`
`PCT!CA200 7}000295
`
`_ 2'7 _
`
`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 KEthDd 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.
`
`15.
`
`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 20071104 133
`
`PCT!CA200 7}000295
`
`-28_
`
`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.
`
`17.
`
`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
`
`82Sr breakthrough.
`
`18.
`
`A poaitron detector for detecting instantaneous 82Rb
`
`activity concentration of an active saline solution
`
`generated by an 32Sr/“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.
`
`19.
`
`A positron detector as claimed in claim 18, wherein a
`
`thickness of the radiation shield is on the order of
`
`% inch.
`
`1431 of 1754
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`
`

`

`W0 2(l07f104l33
`
`PCTICA200'U000295
`
`_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
`
`scintillatiOH fiber.
`
`1432 of 1754
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`
`

`

`W0 200 7l104133
`
`PC T!C A2007»r00 0295
`
`U7
`
`mémw
`
`gm2:5
`
`At<hozav
`
`mm9:9;
`
`:3En;
`
`E50
`
`Egan.AI
`
`223m
`
`:2ace293mm
`
`1433 of 1754
`1433 of 1754
`
`
`

`

`'WO 20(i7l104133
`
`PCT!C A2007f000295
`
`21'?
`
`mm
`
`ESQ
`
`Egan...
`
`or
`
`
`
`08:3532.5:95:00
`
`
`
`1434 of 1754
`
`.55.ho#9:.
`
`m23mm
`
`25mm
`
`2&5
`
`
`

`

`W0 2007;104133
`
`PCTICA200 71000295
`
`31"?
`
`
`
`wi1“-I‘vl‘llll-l‘lln¢v“*‘ltIIVIIII-llt.‘llllllélllllllllllllll
`
`Illnl-r.-rIIIIIIIIIIIIIII
`
`.T
`501m
`mOF<mmsz
`
`m-_._nu2__u_
`
`ONK‘
`
`MOHdmmsz
`
`OH
`
`ww<a>m
`
`mmAAOmhzoo
`
`201m
`
`w9:9;
`
`1435 of 1754
`14350f1754
`
`
`
`
`

`

`W0 20072104133
`
`PC TICAZOOWIJOOZQS
`
`4;”?
`
`Figure 6a
`
`
`
`
`
`10
`Patient
`Outlet
`
`
`1a
`1
`
`26
`
`Waste
`RES.
`
`Figure 6c
`
`28
`
`
`
`1436 of 1754
`1436 of 1754
`
`

`

`W0 2007f104133
`
`PCTICA2007J'000295
`
`Figure 6d
`
`Patient
`
`Outiet I
`
`18
`
`:
`
`2‘5
`
`Waste
`Res.
`
`1437 of 1754
`1437 of 1754
`
`

`

`W0 20071’104133
`
`PCT!CA 200 71000295
`
`617
`
`Figure 7a
`
`Compute
`
`S2
`
`
`CM
`Valve
`
` Open
`Generator
`
` Close
`
`Generator
`
`
`Valve
`
`
`No
`
`Figure 7b
`
`Cdet
`
`CM _______
`
`
`
`.
`Figure 7c
`
`Cdet
`
`C _.
`
`t0
`
`:t1
`I
`II
`I
`
`.'
`
`time
`
`
`
`time
`
`1438 of 1754
`1438 of 1754
`
`

`

`W0 2007;104133
`
`71"?
`
`PCTICA200W000295
`
`Figure 8a
`
`
`
`Compme
`0M0)
`
`52
`
`
`Pfedict
`Flow Ratio.
`
`
`
`S14
`
`Duty Cycle
`
`S16
`
`
`328
`
`S18
`
`
`Compute
`AC=CM(t)-Cdet
`
`
`
` S26
`
`
`Increase
`
`DutyCycle
`
`Decrease
`
`DutyCycle
`
`
`
`
`524
`
`¢ Yes
`
`No
`
`Figure 8b
`
`
`
`Figure 8G
`
`t0
`
`t1
`
`t2
`
`time
`
`Cdet
`
`CM — _ _ _ _ _
`
`46
`
`
`
`to
`
`t‘
`
`12
`
`time
`
`1439 of 1754
`1439 of 1754
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`

`

`International application No.
`INTERNATIONAL SEARCH REPORT
`PCT/CA2007/000'295
`
`A.
`
`CLASSDTTCATION 0F SUBJECT NIATTER
`
`1PC: .4611” 36/06 (2006.01) . A6111! 36/08 (20116.01) . GUITI/164(2l106.011 . GUI!" 1:20 (2006.011
`According [0 International Patent (Tlaasiiieation (113(3) or to both national classification and lPC
`
`B. FIT-11,138 SEARCHED
`
`Minimum documentation searched (classification system lollowed by classification symbols]
`IPCtS): AfilM All (21106.01 _1 4- Gt}l'l'All (20116.01)
`
`Documentation searched other than minimum documentation to the extent that such doc-Lunetits are included in the fields searched
`
`Electronic dataliaae(s) consulted during the international search (name ol'database(s) and. where practicable, search terms used)
`QPat, QWeh, Delphioa (Keywords 1.1.5ch positron emission tomography, “rye—card“ perfusion, radiation detector. scintillation fibre.
`generator. etc.)
`
`C. DOCUNEENTS CONSJDERED TO BE RELEVANT
`
`Citation o't'doctttmmt. with indication, where appropriate. of the relevant passages
`
`Relevant to claim No.
`
`JP 2000131443 A (cram. K. et a1.) 12 May 2001]
`‘ Figs 1-6; Abstract: Machine translation “
`
`(lE—US—ZUUU]
`
`JP 7231884 A (OKADA. H. et at.) 5 September 1995 (05-09-1995)
`‘ Figs. 1—7'. Abstract *
`
`US [1975583 A (SPUWAR'I‘. AR.) ,1 December 1990 ( 04—12—1990)
`‘ Fig. 2'. Abstract: Columns 2-3 “
`
`Us 6713765 F32 (TESTARDI. 1.,.R.} 30 March 21111-11. (30-03-3104)
`’3 Whole document ‘1‘
`
`ALVARI‘IZ—UIAZ, 'l'eresa M. et .31., Manufacture of strontiuni—SEJrubidiinn—82
`generators and quality control of rubidium—82 chloride for myocardial perfilsion
`imaging in patients using positron emission tomography, Applied Radiation and
`Isotopes. vol. EU. no. 6. 1999. pp. 1015—1023
`
`
`
`IX} Further doctunents are listed in the continuation of Box C.
`See patent family annex.
`Special categoriea ol'ciled documents
`later dmttmonl. publishedjltler the :n;em;:itiun-il lili‘l
`date and not In conflict With the op ilteatton but. cute
`:hxrurnent defining the general slan- nl' lh: nrl whr'h is tn: ennMdt-rad
`Ihe pn'irlple nr [hoary underlying I
`r:'
`l"!\'t‘?’t’t1l{ln
`to be of particular relevance
`_
`_
`emu-neat of particular relevance. the claimed invent-on came] be
`carller notification or patent 1:ut published on or after the Intermuonal
`concldcrt-d novel or cannot. be (:Jnxldcred to ll'|\'D.\“.‘ an 1n\'cflll‘.'\:
`filing clam:
`step was“ the document I15 taken alum:
`document which may throw doubts on priority clairm's) or winch i:-
`document L‘l'particular rclm'ance; the claimed invent-tin ccrL'tcl he
`cited to establlsl‘. the publication date of another citation or other
`considered to Involve an imentivc step when the document is
`spent-.1 rcaaon (as specified)
`combined With one or more other ouch doctm‘lnmts. ouch combination
`_
`_
`_
`_
`_
`lacing oh'ioua Lo .1 person skilled in the M1
`dcxmmcnt rel‘cmng roan -.-ralrt|15c1uuu1c. use. exillbrtrun or other means
`slnrurnunt member nE' the some patent Iiiml 13'
`dt‘cument published Friar tn the inlernaLit‘Vnnl tiling (late but letter than
`the priority data ctalmed
`
`{X ]
`" "
`
`"
`
`(1ch or priority
`to understand
`
`Date of the actual completion of the intemational search
`
`Date of mailing ot'flte intentationai search report
`
`1 3 April 2007 ( | 3-04—20117j
`
`Name and mailing address or the ISA/CA
`Canadian httcllectual Property Office
`Place du Portage 1. C l H — Isl Floor. Box PC‘l‘
`5t} Victoria SLreet
`
`13 Ma_\' It“)? ( I 84115—20071)
`
`Authorized otlicer
`
`Valerie Dubé 819- 934.4261
`
`Galineau. Quebec K] A 0C9
`Facsimile No: 001-819-95 3-2476
`
`Form PC'UISAIZ 10 (second sheet ) (April 2005)
`
`Page 3 of 5
`
`1440 of 1754
`1440 of 1754
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCTI’CAZOOWOOOZQS
`
`Box No. It
`
`Observations where certain claims were found unsearchablc (Continuation of item 2 of the first sheet)
`
`This international search report has not been established in respect of certain claims under Article l7(2)(a) for the following
`reasons :
`
`[
`
`] Claim Nos:
`because they relate to subject matter not required to be searched by this Authority= namely :
`
`2
`
`I
`
`] ClaiiuNos.:
`
`because they relate to parts of the international application that do not comply with the prescribed requirements to such an extent
`that no meaningful intemational search can be carried out. specifically :
`
`
`
`i
`
`] Claim Nos;
`because they an: dependant claims and are not drafted in accordance with the second and third sentences of Rule (3.481).
`
`Box No. 111
`
`Obscn'ntions “here unity ofinvention is lacking (Continuation of item 3 of first sheet)
`
`This International Searching Authority found multiple inventions in this international application, as follows :
`
`-
`
`Claims ]~] 7 pertain to a method ofcontrolling an SQSr/SLle elntion system, the system comprising a generator valve, an
`RZSrESZRb generator and a bypass line and providing an active saline solution. the method comprising: during each elation rim.
`obtaining concequation values, computing error values between the obtained values and a target value. acctunulating error data
`and adjusting a system mrameter accordingly.
`Claims 18-20 pertain to a positron detector [or detecting 82Rb activity concentration oi'an active saline solution generated by an
`SZSrI’SZRb elution s),-'stem= the detector comprising a scintillation fibre adjacent a Feed line, a photon cotmter and a radiation
`shield.
`The eonuuou feature between aforesaid groups ol‘ciairns is an XESrISZRb elntion system generating an active saline solution. However.
`such a system is already well known in the art and therefore cannot be regarded as constituting a single common inventive feature linking
`
`l
`
`.
`
`I
`
`] As all required additional search fees were timely paid by the applicant. this intematioual search report. covers all
`searchable claims.
`
`As all scarclnible claims could be searched without effort justifying additional fees. this Authority did not invite
`payment ot'additioual t'ees.
`
`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 additiomil search fees were timely paid by the applicant. Consequently, this intcmational searcl'l report is
`
`restricted to the invention first mentioned in the claims; it is covered by claim Nos. .-
`
`Remark an Protest
`
`{
`
`1
`
`] The additional‘sxcareh fees were accompanied by the applicant's protest and. Where applicable.
`the payment ol a protest fee.
`
`] The additional search fees were accompanied by the applicant's protest but the applicable protest
`'ec \ “as not paid within the time limit specified in the invitation.
`
`] No protest accompanied the payment of additional search tics.
`{
`
`l-‘orrn l’C'l‘IISAfz It} (continuation of first sheet (2)) {April 2005)
`’age 2 of 5
`
`1441 of 1754
`1441 of 1754
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`

`

`INTERNATIONAL SEARCH REPORT
`
`
`
`
`C“ (Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT
` C ilation ot'doetu‘nent, with indication. where appropriate, ol‘ the relevant passages
`
`Category"
`
`
`international application No.
`PCTICA2007K00029S
`
`
`
`Relevant lo claim No.
`
`
`
`YANO. Y. et al.. A Precision Flow-Controlled lib-82 Generator for Bolus
`or Constant-Infusion Studies of the Heart and Brain. The Journal of
`
`Nuclear Medicine. vol. 22. no. ll. 1981. pp. 1006-1010
`
`YANG. Y. Essentials of a Rubidium-SZ Generator for Nuclear Medicine.
`International journal of radiation applications and instrumentation. Part
`A. Applied radiation and isotopes. vol. 38, no. 3- Great Britain. 1937, pp.
`205-21]
`
`KENSETT. M. .I. et 31.. Experience with a SZSn’SZRb Generator for
`Clinical Use. International journal of radiation applications and
`instrumentation. Part A- Applied radiation and isotopes. vol. 38- no. 3.
`Great Britain. 1987, pp. 227-23]
`
`SAHA. G. et al.. Use of the 828r{82Rb Generator in Clinical PF.T Studies.
`International journal of radiation applications and instnunentation. Part
`B. Nuclear medicine and biology. vol, 17. no. 8. Great Britain. 1990. pp.
`2763-7168
`
`
`
`Form PCTHSAJE It} (continuation of second sheet) {April 2005}
`
`
`1442 of 1754
`1442 of 1754
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`

`

`INTERNATIONAL SEARCH REPORT
`Information on paleni family members
`
`lnlcmalional application No.
`
`PCTICA2007HOOOZ9S
`
`Patent Document
`Cited in Search Report
`
`Publication
`Date
`
`Patent Family
`Memherfi)
`
`Publication
`Date
`
`JP 200(113l443 A
`
`[2-05-2000
`
`JP 7231884 A
`
`05-09-1995
`
`L'S 4975583 A
`
`04-12-1990
`
`NONE
`
`NONE
`
`AU1299288 A
`EP0346369 A]
`GB8704(J7-| DO
`JP25022 I"! T
`W08806297 AI
`
`14419-1988
`20-[2-198‘)
`25-03-1987
`l9—i'J7—1990
`25-08-1988
`
`LS 6713765 82
`
`30-03-2004
`
`NONE
`
`
`
`1301111 [‘C'l'flSA/Z l [i (patent family annex ) {April leilj)
`
`Page 5 01’5
`
`1443 of 1754
`1443 of 1754
`
`

`

`Electronic Acknowledgement Receipt
`
`
`
`Application Number: 12137356
`
`International Application Number:
`
`Confirmation N um ber:
`
`Title of Invention:
`
`SHIELDING ASSEMBLIES FOR INFUSION SYSTEMS
`
`
`
`First Named InventoriApplicant 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 111(a]
`
`Payment information:
`
`
`Submitted with Payment
`
`no
`
`File Listing:
`
`Document
`.
`.
`.
`File SizeiBytesh‘
`
`
`
`
`Number Part hzip (ifappl.) Document Description “a Name Message Digest
`
`_
`_
`Information Disclosure Statement (IDS)
`56782_1_5_|DS3.pdf
`Filed (SB/08]
`~l .i'B-dflfil IiIJtI IbL’u HILL-553 itl ubmbsslm
`and!
`
`
`396240
`
`Warnings:
`
`Info rmation:
`
`1444 of 1754
`of‘17‘54
`
`

`

`A US. Patent Number Citation or a US. Publication Number Citation is required in the Information Disclosure Statement (IDS) form for
`autoloading of data into USPTO systems. You may remove the form to add the required data in order to correct the Informational Message if
`you are citing U.S. References. If you chose not to include US. References, the image of the form will be processed and be made available
`within the Image File Wrapper (IFW) system. However. no data will be extracted from this form. Any additional data such as Foreign Patent
`Documents or Non Patent Literature will be manually reviewed and keyed into USPTO systems.
`
`Foreign Reference
`
`56782_‘I_W007071022A‘l.pdf
`
`4 .i'LIdL lbbbxm‘JLIch'S 36';me ml chbbh. I
`7mm
`
`Warnings:
`
`Info rmation:
`
`Info rmation:
`
`Foreign Reference
`
`56782_‘I_W007104133A‘l.pdf
`
`1590246
`
`81 l sz-IEIIJWLIGU‘J‘Jc-col N I tlcd‘hfi‘i‘fl {13 2.
`“ii" I Ra
`
`Warnings:
`
`
`
`Total Files Size (in bytes) 3381448
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`Ifa new application is being filed and the application includes the necessary components for a filing date [see 37 CFR
`1.53lb)-(d} and MPEP 506}, a Filing Receipt (37 CFR 1.54] will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date ofthe application.
`
`National Stage of an International Application under 35 U.S.C. 371
`Ifa timely submission to enter the national stage ofan international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT!DO!EO!903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO asa Receiving Office
`Ifa new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP1810], a Notification of the International Application Number
`and ofthe International Filing Date (Form PCTI'ROI'105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`
`1445 of 1754
`1445 of 1754
`
`

`

`05/04/2009 15:22 FAX
`
`612 492 7077
`
`FREDRIKSON 8: BYRON
`
`@oozmoe
`
`The following is an example at an acceptable property rights statement. Statements at this type are. of course.
`only sultabie tor simations in which NO Agency lunde or other considerations were involved in the making or
`conception or the Invention. While this example is in theiorm of a declaration. a sworn dowment 3 equally
`acceptable.
`
`1
`
`‘
`W650?)
`
`a
`
`IIWB) Charles R. Qulrico
`citizens oi
`
`residing at
`
`declare:
`
`Li
`
`That ttwe) made and perceived the invention described and claimed in patent applimtion:
`
`Serial NuntberiLLEJiL—liled In the United Statesol America on am 11- 2006
`
`titledWmmzwm
`
`(mwmmmmrorumm
`
`(attack ill Wont! bolowes smog-rate)
`
`B I. (For inventors Employed by an Omar-linden} That
`I[We) made and conceived this
`Invention while
`employed byWWW...—
`That the invention in related to the work I am {we are)
`employedto perionnendwae madewithlnthe scope
`of my (our) emptoyment duties; That the invention was
`rrIade during working hours and with the use oi
`
`The: to the best of my (our) lmowledpe and belief:
`ill. The invention was not made or comeived in the '
`course or. or In connection with. or under the terms ol‘
`any contract. subcontract or arrangement entered into
`with or for the benefit or the United States Atomic
`Energy Coan or
`its
`successors: Energy
`Research and Development Administration or the
`
`facilities. equipmenl. materials. funds. information and DepartmentalEnergy
`
`services of Bremen Diagneatice. Inc.
`0mm (“mm are eggccg wrecgfl with won-e11. Inc. in the design of the invention.
`tor which Harrell asetfid all rights to Braechr-ANDIOH"
`-
`That to the best or my (our) knowledge and belief
`tender) based upon
`iniorrnetion
`provided
`by
`
`
`
`at Brecco unwritten: Inc.
`
`—OH—-
`
`III II. (For M-wqmrnwnm; That I (we) male and
`conceived this Invention on my (our) own time using.
`only my (our) own facilities, ermipment, materials.
`funds. infonnetlon and services. Other relevant factors
`are
`
`CI iv. The Invention was not made (conceived or first
`actually reduced to pracfice) under nor is there any
`relationship of the invention to the periormance oi any
`work under any contract of the National Aeronautics
`and Space Administration.
`
`The undersigned Inventorsts) declare iurther that all statements made herein or his or her {their} own imowledge
`are true and that all statements made on inlormetion and belief are believed to be true and further that these
`statements are matte with the lmowiedge that Mlltul false statements and the like so made are punishable by
`line or Imprisonment. or both. under Section 1001 at Tine 18 or the United States CodeIend that such willful lelse
`statements may leoonrdiz
`-:
`.
`.:
`Inventor's Signature:
`'.-
`._
`'
`'PostOtliceAddress:'y'
`Dete:__‘1,&ifl2?__——_—_—___
`Inveninl’s Signature:
`
`
`
`PoetOtiiceAddrees:
`
`Date:
`
`mmmmmm
`
`”932“:
`
`1446 of 1754
`1446 of 1754
`
`I.
`
`i
`
`.-
`
`.
`
`

`

`05/04/2009 15:22 FAX
`
`812 492 7077
`
`FREDRIKSON 8i BYRON
`
`I003/009
`
`The following is an example of an acceptable property rights statement. Statements of this type are. of course.
`only suitable [motivations in which NO Agency tunds er other considerations were involved In the making or
`conception oi the Invention. While this example is in the form of a declaration. a sworn document ls equaily
`acceptable.
`
`I(WB) Dani e1 beret
`
`citizens of i...
`
`declare:
`
`That liwe} made and conceived the invention described and claimed In patent application:
`
`Serial NumberMMIM in the United States of America on'
`
`Jun” 11' 2"”
`
`fined seismnvo ass memes Poe Imsmn sve‘rane
`
`{ohedt and mmpiele either i' or ii below)
`
`(check iii andfor iv below as appropriate)
`
`i. (For inventors Employed by an Organization) That
`uWe) made and conceived this
`invention while
`employed byW.
`That the invention is Isleted to the work I am {we are)
`employed to perform and was made within the scope
`of my {our} employment duties: That the invention was
`made during working hours and with the use oi
`tacitities. equipment. materials. funds. iniormation and
`services of miagnosticsl Inc.
`Inc.
`Other relevant facts are eracco concussed with warren.
`for which Worrell assigned an rights to BracoorANDlORn
`That to the best of my (our) knowledge and belie!
`(addict)
`based
`upon
`information
`provided
`by
`
`That to the best of my {our} knowledge and hotel:
`13 III. The invention was not made or conceived in the
`course of. or in connection with. or under the terms of
`any contract. subcontract or arrangement entered into
`with or tor the benefit of the United States Atomic
`Energy Commission
`or
`its
`successors: Energy
`Flesearch and Development Administration or
`the
`Department of Energy.
`
`in the design as the invention.
`
`
`
`0! Bracca tilfteggoeiti.i::sg Inc.
`
`-03-.
`
`CI ii. (For Sell-Emplonid inventors) That i (we) made and
`conceived this invenfidn on my (our) own time using
`only my {our} own lacllities. equipment, materials,
`funds, information and services. Other relevant factors
`are
`
`El IV. The invention was not made (conceived or iirst
`actually teduced to practice} under not is there any
`relationship oi the [mention to
`perionnance of any
`work under any contract of t
`‘onal Aeronautics
`and Space Administration.
`
`The undersigned invontorsis} declare further that all statements made herein at his or her (their) own knowledge
`are two and that all statements made on information and belief are believed to be this and tumor that these
`statements are made with the knowledge that willlui taise statements and the like so made are punishable by
`line or Imprisonment. or both. under Section 1001 of Title 18 ot the United States Code and that such willful [also
`statements may jeopardize t
`elidity of_
`up
`'cn or any patent issuing thereon.
`,
`Inventors Signature:
`Dan in
`atrial:
`Post omgg Addisss: 25540 96th Street. NW Zimmerman MN 55393
`
`22. 0
`
`Date:
`
`inventors Signature:
`Post Office Address;
`
`Date:
`
`3
`
`son» not—4e: ma. air-oat
`
`Page 2 ol 2
`
`1447 of 1754
`1447 of 1754
`
`

`

`05/04/2009 15123 FAX
`
`612 492 7077
`
`FREDRIKSDN & BYRON
`
`04/29/2009 WED 15:50 VA! 31254-03710
`
`@004f009
`
`WOOL/001
`
`The following Is an attempts of an acceptable property rights statemant. Statements or this type are. of course.
`only suitable for situations In which no Agency lands or other considerations were Involved In the makingor
`conception of the Imrention. While this example In In the form of e declarations sworn document Is equally
`acceptable.
`
`
`[(we) Daniel V. Clemente
`GIIJZGDBOIL—mum“
`
`residing at
`declare:
`
`0
`
`2-
`
`°
`
`‘3
`
`‘30
`
`That [{we) made and conceived the Invention described and claimed In patent application:
`
`_
`
`Serial NumrJLLflL—Jed In the Unrted States or America on322%
`
`titled gflgnmgg ASSEMBHfi PO‘R mglgfl £23355
`
`fdiedr and annotate either tor It below)
`
`(shed: m and/or IV below as appropriate]
`
`I. (For Inventors Embyeo' by an Organization) That
`ItWe) made and concetved this
`invention while
`employed bymedium“
`That the Invention Is related to the work I am {we are)
`employed to pericrm and was made within the scope
`ct my (our) empicyme nt duties: That the Invention was
`made during wortdng hours and with the use of
`facilities. equipment. materials. tunes. Informaoon and
`SONIGBS ct Brando Diagnostics; Inc.
`Other [entrant [acts are Bgmo contrgcggd with Harrell, Inn.
`to: which Harrell. assigned all. rights to exaccOrANDi'OFl-~
`That to the best of my (our) knowledge and ballet
`
`uponbasedIandr'or) byWintormetton provided
`
`
`
`
`or Beacon Diagnouucer Inc.
`
`' That to the best of my (our) knowledge and belief:
`Iii. The [mention was not made or conceived In the
`ocurse cl. or In connection with. or under the terms or
`any contract. smocntraot or arrangement entered Into
`with or for the benefit of the United States Atomic
`Energy Commission or
`Its
`successors: Energy
`Research and Development Administration or
`the
`Depertmentof Energy.
`
`in the design 0:
`
`the inVontLou,
`
`0 IV. The Invention was not nude (conceived or first
`acute")! reduced to practice) under nor to there any
`relationship at the Invention to
`orrnenoe of any
`work under any contract or
`at Aeronaulice
`and Space Adrnhtlsuation.
`
`433—
`
`D II. [For Seii‘wtred inventors) That i {we} made all!
`conceived mic Invnntton on my {nun own time using
`only my {our} own racnitiee. settlement. materials.
`tends. Information and services. Other relevant Iaotors
`are
`
`
`The undersigned Inventorste} declare thither that all statements made herein or his or her (thelr) own knowledge
`are true and that all statements made on information and ballet are believed to be true and further that these
`statements are made with the knowledge that wililui letse statements and the like so made are punishable by
`
`
`
`Inventor's Signature:
`
`
`
`Post Olflce Address:
`
`
`
`
`Date:
`
`Panama-moms;
`
`2
`
`P
`
`no?
`
`03,2
`
`1448 of 1754
`1448 of 1754
`
`
`
`-“—___v..F-‘WH”_Wwfl-i-u.mmmm
`
`..--.._
`
`

`

`05/04/2009 15:23 FAX
`
`612 492 7077
`
`FREDRIKSON 8: BYRON
`
`IONS/009
`
`The following Is an example of an acceptable property rights statement. Statements of this type are‘ of course,
`only suitable tor sima'tions in which N0 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 sworn document is equally
`acceptable-
`
`ltwelmwflfi
`
`"3
`
`dtlzens of
`
`residing at ease Lake Ridge ogtvg. Big Lake‘ MN 55309
`declare:
`
`That ltwe} made and mnceived the Invention described and claimed In patent application:
`
`June 11 . 2'3”“
`
`Serial NumberWind in the United States of America on
`IN S NS‘ISTENLS
`
`[Med
`
`am: we
`
`a use '
`
`(check and or. mpiele either i or If below)
`
`(elm ill and/or it! below as appropriate)
`
`That to the best of my (our) knowledge and belief:
`[33} Ill. The invention was not made or conceived in the
`course of. or in connection wIlh, or under the terms cl
`any contract. subcontract or arrangement entered into
`with 0! for the benefit of the United States Atomic
`Energy Commission
`or
`its
`successors: Energy '
`Research and Development Administration or
`the
`Departmental Energy.
`
`IE I. (For inventors Eelpleyee by an Organization) That
`ItWa) made and conceived this
`invention while
`eranOyed byMW...
`That the Invention ls 'elated to the work I am {we are}
`employed to podium and was made within the scope
`of my (our) employment duties: That the Invention was
`made during working hours and with the use of
`facilities. equipment. materials. funds. InformatiOn and
`services of Bronco Diagnostic-3‘ Inc.
`Other relevant facts areWWI-2211, Inc. in the deaign or the inventton,
`for which Warren aeeifled all rights to BraccOvANDJOFl"
`That to the best of my (our) knowledge and ballet
`Wm" ”as“ upon
`'”°"“a"°" ”mm“ by D N. The invention was not made (conceived or first
`
`01 Bracoo engage [cs
`Inc,
`actualty reduced to practice) under nor is there any
`relationship at the invention’to the pertonnance of any
`work under any contract of the National Aeronautics
`arvt Space Administration.
`‘
`’96‘
`o
`” st
`4/
`4}“ ‘__
`0
`054/8
`(2
`W63
`”49
`
`-—0R——
`U ll. (For Self-Employedinventorel That I (we) made and
`conceived this invention on my {our} own time using
`only my (our) own facilities, equipment. materials.
`funds. information ant services. Other relevant factors
`are
`
`The undersigned lnventorsis) declare tunnel that all statements made herein at his or nor (their) own knowledge
`are true and that all statements made on information and belief are believed to be true and further that these
`statements are made with the knowlege that willful false statements and the like so made are punishable by
`a
`= m n 1001 at Title 18 of the United States Code and that such willlul false
`
`
`
`
`Date:
`
`
`Inventor‘s Signature:
`
`3
`‘
`i
`i
`i
`
`IlII l
`
`Post Office Address:
`
`
`
`
`Date:
`
`
`
`1449 of 1754
`1449 of 1754
`
`

`

`05/04/2009 15:23 FAX
`
`812 492 7077
`
`FREDR I KSON St BYRON
`
`.008/009
`
`‘lhe following is an exemph at an acceptable property rights statement. Statements 0! this type are. at course.
`onty suitable tor situations In which NO Agency tends or other considerations were Involved In the melting or
`conception of the invention. Whlle this example is In the form of a declaration. a sworn document is equally
`acceptable.
`
`Bmee l: Baleehracci
`
`KWB)
`
`citizens of
`
`US
`
`404 Ham-ton Lane. Ieelin, NJ 03830
`
`residing at
`
`declare:
`
`That llvrre) made and conceived the invention decorated and claimed in patent application:
`June 11. 2003
`
`Serial NUWIMM in the United States at America on
`
`(Mendmnpietemtoriibebw)
`
`{check I» end’or it! belo