I
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`1
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`1 %
`
`EXHIBIT 1011
`
`APPLICANT’S RESPONSE TO THE FINAL OFFICE ACTION FOR
`
`US. PATENT APPLICATION SERIAL NO. 10/329,044, ISSUED ON
`
`DECEMBER 8, 2005
`
`lnfopia Ex. 1011 pg. 1
`
`
`
`

`

`Feb-Zl-Bfi
`
`01:l5pm
`
`From-PATTON BOGGS LLP
`
`46038949239
`
`T-MQ
`
`P.03
`
`F-150
`
`Docket NO.: 023134.0110PTUS
`(Formerly 01726-0001(G))
`(PATENT)
`
`THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`‘N
`In re Patent AppE‘cation of:
`Sunil G. Anaokar et al.
`
`.
`aseswsa
`CENTEAL SAX 55W
`1- :8 2 I 2006
`
`Application No.: 10/329044
`
`Filed: December 23, 2002
`
`For. TEST STRIP AND METHOD FOR
`DETERMINING HDL CDNCENTRA’IION
`FROM WHOLE BLOOD OR PLASMA
`
`Confirmation No.: 7458
`
`Art Unit: 1655
`
`Emnfinen R. J. Giwmcr
`
`AM
`
`MENT
`
`AL A
`
`37 GER. SF.
`
`1.116
`
`MS AF
`Commissioner for Patents
`P.O. Box 1450
`Alaxandria, VA 22313-1450
`
`Dear Sir.
`
`INTRODUCTORY COMMENTS
`
`In response to the Office Action dated December 8, 2005, finallyrejeccing claims 21 -
`40, please amend the abme-identified US. patent application as follows:
`
`Amendments to the Claims are reflected in the listing of claims which begins on page
`
`2 of this paper.
`
`‘
`
`Remarks/Argumnts begin on page 6 of this paper.
`
`A Declaration ofJames J. Sumr is enclosed.
`
`
`
`Page 1 of 7
`226174VZ
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`PAGE 3117* RCVD AT 212112006 3:25:21 PM [Eastern Standard Time]* SVR:USPTO-EFXRF-0138* DN1S:2738300 ' 081013031111492398 DURATION (mm-3910408
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`lnfopia Ex. 1011 pg. 2
`
`

`

`Feb-Zl-OS
`
`01:259m
`
`From-PATTON BOGGS LLP
`
`+3038949239
`
`T-ME
`
`P.04/l?
`
`F-ISD
`
`
`
`Application No. 10/329044
`Amendment dated February 2.1. 2006
`After Final Office Action of December 8, 2005
`
`Docket No: 023134.01101’I'U‘S
`(Formerly 01726-0001(G))
`
`MENTS
`
`CLAIMS
`
`Cairns 1 — 20 (Canceled)
`21.
`(Cmcmly amended) A method of determining concentration of HDL cholesterol
`in a whole blood sampleMW, said method comprising:
`a)
`providing a test. Stn'p holder and a tes: Strip; said test Strip holder including an
`application window and a 1331: reading window. said windows comprising verticallyaligned openings
`in said holder, said test snip comprising a layered stack comprising a red blood cell separation layer,
`a non-HDL separation chemistry layer, and an HDL reaction layer; said non-HDL cholesterol
`separation chemistry layer containing nOn-HDL cholesterol separation chemicals for separating the
`non-HDL blood components from the HDL blood components so that the non~HDL components
`
`do nor: participate in the reaction in said HDL reaction layer; said HDL reaction layer comaining
`chemicals for reacting with said HDllg], said layers arranged in a vertical stack with said I-IDL
`reaction layer at the bottom of said Stack; said test Strip located in said test strip holder between said
`windows, with said reaction layer adjacent said test reading window,
`b)
`applying blood to the top of said stack through said application window and
`permitting fluid from said blood to flow vertically downward in said stack to said HDL reacu'on
`layer withOut substantial lateral migranOn of fluid belowehetop said Ed blood cg] sew-on layer,
`c)
`separating said red blood cells from a fluid portion of said blood;
`d)
`separating said non-EDI. cholesterol from said HDL cholesterol with said non-
`
`l-lDI. cholesterol separation chemicals;
`e)
`reaming said I-IDL with said chemicals in said I-IDL reaction layer; and
`i)
`reading a property of said reacfion layer through said reading window to determine
`
`said concentration of HDL cholesterol
`
`~
`
`(Previouslypresented) The method of claim 21 wherein:
`22.
`said providing comprises providing said red blood cell separation layer withOut including an
`
`agglutinin or a coagulant;
`and said separating said red blood cells is performed withow: agglutinizing or coagulating
`said red blood cells.
`
`Page 2 of 7
`22mm
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`PAGE 4117* HOW AT 212112005 3:25:21 PM [Eastern Standard Time] * SVR:USPTO-EFXRF-6138 * DNIS:2?38300* CSID:+3038949239 * DURATION (mm-ss):04-38
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`lnfopia Ex. 1011 pg. 3
`
`

`

`gil1i i 1 ll1 1 ll1lg 1
`
`Feb-Zl-Uli
`
`01:25pm
`
`From-PATTUN BOGGS LLP
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`+3038949239
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`T-MQ
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`P.05/17
`
`F-I50
`
`Application NO. 10/329044
`Amendment dated FebnnryZl, 2006
`After Piml Office ‘Acrion of December 8, 2005
`
`Docket No.: 023134.0110PTUS
`(Formerly 01726-0001(G))
`
`(Previouslypresenred) The method of claim 21 wherein said reaming comprises
`23.
`generating a color response and said method further comprises reading said colored response at a
`location that is Subsmntially vertically aligned with the blood application area of said Stack.
`
`(Previously presented) The method of claim 21 wherein said providing said red
`24.
`blood cell separation layer comprises providing glass fibers having a firs: average diameter and glass
`fibers having a second average diamet- that is less than said first average diameter.
`
`(Previously presented) The method of claim 21 wherein said providing said red
`25.
`blood cell separation layer comprises impregnating said red blood cell separation layer with a salt.
`
`(Previously presented) The method of claim 25 wherein said impregnating .
`26.
`comprises impregnating said red blood cell separation layer with a solution in which the salt
`concentration comprises about 05-10% byweight of said solution.
`
`(I’reviouslypresented) The method of claim 21 wherein said providing said red
`27.
`blood cell separation layer comprises impregnating said red blood cell separation layer with a
`
`wetting agent.
`
`(PreViOuslypre-sented) The method of claim 27 wherein Said providing said red
`28.
`blood cell separation layer comprises impregnating said‘red blood cell separation layer with a Sugar.
`
`(PreviOusly presented) The method of claim 28 wherein said impregnating
`29.
`comprises impregnating said red blood cell separation layer with a sorbitol solution,
`the
`concentration of which comprises 3% tolO°/o sorbitol by weight of said sohm'on.
`
`(Previouslypresented) The method of claim 21 wherein said providing said non-
`30.
`HDL cholesterol separation chemistry layer comprises impregnating said non-HDL cholesterol
`separation chemistry layer with a precipitant, and said separating said non-HDL cholesterol from
`
`said HDL cholesrerol comprises precipitating said non-HDL cholesterol.
`
`Page3 of?
`226174v2
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`
`Infopia Ex. 1011 pg. 4
`
`

`

`Feb-Zl-UB 01:25pm
`
`Frum-PATTON BOGGS LLP
`
`+3038949239
`
`,
`
`T-MS
`
`P.06/17
`
`F-lSD
`
`Application No. 10/329044
`Aniendnrm dated February21, 2006
`After Final Office Action of December 8. 2005
`
`,
`
`'
`
`Docket No.:023134.ouorms
`(Formerly01726-0001(G))
`
`31.
`(PreviOuslypresented) The merhod of claim 30 wherein said providing said non-
`HDL cholesterol separation chemisrry layer comprises impregnating said non-HUI. cholesterol
`
`separation chemisuy layer with phosphotungstic acid (PTA).
`
`(Previously presented) The method of claim 31 wherein said providing said non-
`32.
`HDL cholesterol separation chemisrzry layer comprises irnpregnating said non-HDL cholesterol
`separation chemisu-y layer with said PTA and a divalent cation.
`
`(Previously presented) The method of claim 21 wherein said providing comprises
`33.
`stacking said red blood cell separation layer above said non-HDL cholesterol separaiiorr chemisrry
`
`layer.
`
`34.
`
`(Previouslypresented) The method of claim 33 wherein said providing comprises
`
`providing a red blood cell separation layer campn'sing glass fiber.
`
`(Previously presented) The method of claim 34 wherein said providing said red
`35.
`blood cell separation layer comprises providing a first glass fiber layer with glass fibers having a first
`
`average diameter and providing a second glass fiber layer having'glass fibers having a second average
`
`diameter that is less than said first average diameter.
`
`(Previouslypresenred) The method of claim 35 wherein said providing said non—
`36.
`HDL cholesterol separation layer comprises providing said second. glass
`fiber layer and
`
`impregnating said second glass fiber layer with said non-HDL cholesmrol separation chemicals.
`
`37.
`(Previously presented) The method of claim 21 wherein:
`said providing further comprises providing said layered stack with a dispersernent layer
`above said red blood cell separation layer, said non-I-IDL separation chemisrry layer, and said HDL
`
`detection layer; and
`said method further comprising permitting said blood to disperse laterally across said
`
`dispersement layer.
`
`Page 4 of 7
`226174v2
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`PAGE‘filll‘ RCVD AT 2121l2005 3:25:21 PM {Eastern SlandardTlmel‘SVR1USPTO-EFXRF6138‘011182738300‘ CSID:+3038949239 * DURATION (mm-ss):04-38
`
`Infopia Ex. 1011 pg. 5
`
`
`
`l
`
`
`
`

`

`Fab-Zl-UB Ulz'ZGpm
`
`From-PATTUN 80605 LLP
`
`+3038949239
`
`T449
`
`PJJT/l?
`
`F-l'ill
`
`Application No. 10/329044 '
`Amendment dated February 21, 2006
`AfterFiml Office Action of December 8. 2005
`
`Docket‘No; 023134.0110PTUS
`(Formerly01726-000 1(G))
`,
`
`38.
`
`(Previouslypresemed) A method as
`
`in claim 37 wherein said providing said
`
`dispersement layer comprises providing a woven mesh material
`
`39.
`
`(Currently amended) A method of determining concentratiOn of HDL cholesterol
`
`in a whole blood sample, said method comprising:
`a)
`providing a layered Stack comprising a dispersement layer, a red blood cell separation
`layer, a non-HDL separation chemistry layer, and an HDL reaction layer, said red blood cell
`separation layer not containing an agglutinin or a coagulant; said non-HDL cholesmrol separation
`chemistry layer containing non-HDL cholesterol separation chemicals for separating the non—HDL
`blood components from the HDL blood components so that the non-HDL components do nor
`participate in the reattion in said HDL reacrion layer, said HDL reaction layer containing chemicals
`for reacting with said HDL- Said layers arranged in a vertical stack with said dispersement layer at
`
`the top and said HDL reaCtion layer at the bottom;
`b)
`applying blood to said dispersement layer and permitting fluid from said blood to
`first flow laterally across said dispersetnent layer and then to flow vertically dOanard in said stack
`to said HDL reaction layer without subsuntial
`lateral migration of fluid IIinIl below said
`
`diapersement layer;
`a
`c)
`separating said red blood cells from a fluid portion of said blood in said red blood
`
`cell separation layer;
`d)
`separating Said noanDL cholesterol from said HDL cholesterol using said non-
`
`HDL cholesterol separation chemicals;
`e)
`reacting said HDL in said HDL reactiori layer in a colorimetric reaction; and
`(i)
`determining the HDL cholesrerol concentration in said reaction layer by measuring
`
`the reflecrance of said reaction layer after said colorimetric reaction.
`
`40.
`
`(Previouslypresented) The method of claim 39 wherein said providing comprises
`
`stacking said red blood cell separation layer above said non-HDL cholesterol separation chemistry
`layer.
`7
`
`Pages of 7
`226174v2
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`PAGE ill? " RCVD AT 212112006 3:25:21 PM [Eastern Standard Time] * SVR:USPTO-EFXRF-fil38‘ DNIS:2738300’ CSID:+3038949239' DURATION (mm-ss):04-38
`
`Infopia Ex. 1011 pg. 6
`
`

`

`l
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`1
`3
`i
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`i
`1
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`i
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`{ l l
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`l
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`Feb-21-05
`
`01:28:)!"
`
`From-PATTUN BOGGS LLP
`
`+3038949239
`
`T-l49
`
`P.08/l?
`
`F-ISU
`
`Application No. 10/329044
`Amendment dated FebmeryZl. 2006
`After Firml Office Action of December 8, 2005
`
`Docket Nae 023134.0110PTUS
`(Farmerly 01726-0001(G))
`
`M
`
`Claims 21 — 40 are currently pending inthis application. ADeclatmzion of James J. Sitter
`
`(hereinafter “the Declaration”) is enclosed. This Declaration was nor. provided earlier because it
`could not be anticipated that the Examiner would nor give a significant claim limitation little or no
`
`weight.
`
`Claims 21, 23; and 30 — 34 have been rejected under 35 USC 103(a) as being
`
`unpatentable over Thakore (US Patent No. 5,135,716). This rejection is respecefullymvezsed. The
`Office Action admits that 'I'helsore differs from the claims inthat the claims specifythat the blood
`flows vertically downward, but gives this no paxemable weight. First, we note that all of the
`limitations of a claim ImJST. be considered when weighing the differences between the clamed
`
`invention and the prior art in determining the ObVlOUSHCSS of a method claim (MPEP 2116.01 and
`2143.03), which it appears that the Examiner is awe of because the Examiner was careful to
`indicate that the weight given was little consideration. However, it does make a difference, because
`the blood spreads much more when the flowis upward, which results in more blood being required
`to do the teen. More imponantly, this difference is huge because it is unexpecred and makes the
`snip two to three times more acme See the Declaration, §§6 — 17. Thus, claim 21 is patenxable.
`Claims 23 and 30 — 34 depend on claim 21 and contain all its limitations, and are patemable at least
`for that reason. In rer‘m, 5 USPQ 2d 1596, 1600 (Fed. Cir. 1988) at headnow 4. In addition,
`claims 21 and 31 — 34 conmin limitations 110: found in Thakore and no: discussed in the Office
`
`Action, and thus are separatelypatentable on their own.
`
`.
`Claims 22, 27, and 37 - 40 have been rcjeCted under 35 USC 103(a) as being unpatentable
`over the combination of Thakore (US Patent No. 5,135,716) in view of Kozalt (US Patent No.
`5,460,974). This rejecdon is respecrfullymversed. Claims 22, 27, 37, and 38 all depend on claim
`21, which is patenmble forthe reasons given above; and therefore are patentahle as specified inInre
`Fine. In addition, claim 27 claims a wctting agent that does not appear to be mentioned in the
`I
`references or discussed in the OfficeActiori, and claims 37 and 38 recite a dispersement layer above
`the red blood cell segaration layerthat does not appear to be mentioned in the references or
`discussed in the Office Action; thus, they are patenmble on their own. With respect to cleim 39,
`again, this rejection is based on the position in the Office Action that term strips are not positionally
`
`Page 6 of 7
`226174v2
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`L
`lnfopia Ex. 1011 pg. 7
`
`

`

`Fah-Zl-UG thfipm
`
`From-PATTON BOGGS LLP
`
`+3038949239
`
`T-I49
`
`P.09/l?
`
`F-l50
`
`ApplicationNo. 10/329044
`Amendment dated Febnnry21,2006
`Alter Fun! Office [Video of December 8, 2005
`
`DodmNo.:02313-1~.0110FI’US
`(Formerly‘01726-0001(G))
`
`sensitive, Which is travetsed for reasons given in the Declaration. Therefore, forthe reasom given
`above, claim 39 is patenmble. Claim 40 depends on claim 39 and is patentable as stated in ImeFim
`
`Claim 24 - 29 have been rejected under USC 103(a) as being unpatentable over
`’I'hakore (US Patent No. 5,135,716) as applied to claims 21, 23, and 30 ~ 34 above, and further in
`view of Canal] (US Patent No. 6,040,195). This rejeCtionis respemfuily traversed. This rejection is
`also based on the premise that blood flow vertically downwmd should be given little or no weight,
`
`and is respectfully traversed for the reasons given in the Declamen.
`
`Claims 35 and 36 have been rejected under USC 103(9) as being unpatenmble over
`
`Thakore (US Patent No. 5,135,716)'as applied to claims 21, 23, and 30 - 34 above, and further in
`view of each of Rittersdorf (US Patent No. 5,426,030) and Goldman (US Patent No. 6,488,149).
`This rejection is respethully traversed. This rejeceion is also based on the premh‘te that blood flow
`vertically downward should be given little or no weight, and is respeafully traversed for the reasons
`given in the Declaration.
`7
`
`Claims 21 — 40 have been reiecred under 35 USC 112, second paragraph, as being
`
`indefinite for failing to partiCularly point out and disrincrly claim the subject matter which
`Applicants tegard as the invention based on lack of antecedent basis for specific terms in claim 21
`and a typogmphical error in claim 39. These claims have been amended to overcome this rejeCtion.
`
`In view of the above amendments and remarks, Applicants believe the pending appliCation
`is iii-condition for allowance. Applicants believe no fee is due with this response. However, if a fee
`
`is due, please charge our Deposit Accomt No. 50-1848, under Order No. 023134.0110PTUS from
`
`which the undersigned is audwnzed to draw.
`
`Dated: February 21, 2006
`
`Respectfully submitted,
`S LLP
`
`Regismtion No.: 28,494
`(303) 894-6114
`(303) 894-9239 (Fax)
`Attorneyfor Applicants
`
`Customer No. 24283
`
`.
`
`Page 7 of 7
`22617W2
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`Infopia Ex. 1011 pg. 8
`
`

`

`
`
`(
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`r
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`Fab-Zi-UB 01:279m
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`Frum-PATTDN BOGGS LLP
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`+3038949239
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`T-i49
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`P.l0/l?
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`02/26/2006
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`15:55
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`3178705610 7
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`POLYMER TECHNDGV
`
`PAGE
`
`82/05
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`this 2 l 2006
`
`V
`
`EEQEWED
`CW women
`
`Group Art Unit:
`
`1655
`
`‘
`
`'
`
`Examiner:
`
`Gitomer. Ralth.
`
`Docket No.: 023134.0110PTUS
`
`Confirmation No.:
`
`7458
`
`.
`
`) i i
`
`U.S. Patent Application No.:
`
`10/329.044
`
`Fiiing Date: December 23. 20032
`
`)
`For: Test Strip and Method For Determining
`HDL Concentration From Whole Blood )
`Or Plasma
`
`) ) )
`
`Applicants: Sunil G. Anaokar et al.
`
`)
`
`DECLARATION OF JAMES J. SUTOR
`
`1, James J. Sutor, hereby declare:
`
`1 .
`
`I am the Senior Scientist at Polymer Technology Systems at 7736 Zionsville
`
`Road. Indianapolis. W 46268, where I am involved in conducting various research and
`
`development activities, which include analytiml test strip development. All statements
`
`made herein of my own knowledge are two, and all statements made on information and
`
`belief are believed to be true.
`
`2.
`
`l have worked for over 34 years as a chemist, and for more than eight years
`
`in the specific area of blood anatysis. l have six issued patents in the area of microbiology
`
`and related chemistry. A copy of my curriculum vitae is attached hereto as Exhibit A.
`
`3.
`
`Polymer Technology Systems is the assignee of the above-identified
`
`application (hereinafter, "the Application").
`
`4.
`
`lsubmit this Declaration to present to the-Examiner, in an authenticated
`
`manner. facts concerning the Office Action dated December 8, 2005 (hereinafter "the
`
`,
`Office Action") and the patentability of the claims.
`5.
`l have read the Application including the current claims, the Office Action, and
`
`the references-cited by the Examiner, i.e.. US. Patent No. 5,135,718. August 4; 1992, to
`
`Yatin B. Thakore (hereinafter "Thakore"), US Patent No. 5.460.974 issued October 24.
`
`1995 to Mary B- Kozak et al. (hereinafter "KOZak et at"); United States Patent No.
`
`6,040,195 issued March 21., 2000 to Patrick Carroll et al. (hereinafter. "Carroll et al."),
`
`Serial No. 101329.044»
`, Declaration of James Smol-
`Page 1
`23ii952v1
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`lnfopla Ex. 1011 pg. 9
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`

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`Feb-Zi-OB 01:279m
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`From-PATTDN BUGGS LLP
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`+3039949239
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`T449 PJi/l?
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`PAGE
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`
`United States Patent No. 5,426,030 issued January 20, 1995 to Walter Ridersdorf et at.
`(hereinafter. “Rittersdorf et at). and United States Patent No. 6,844,149 issued January 18.
`2005 to Richard Mark Goldman (hereinafter. ”Goldman").
`
`6.
`
`The Office Action states that itwould have been obvious to one skilled in the
`
`art to have the blood flow either upwards or downwards because it is capillary action that
`
`makes the blood flow and turning the test strip in any direction would make no difference to
`capillary action and thus the test strip would work’ in the same fashion irrespective or
`
`orientation. The Office Action further states that test strips are not positionaily sensitive in
`
`general and no unexpected result is seen in positioning a known test strip upside down.
`
`White the Examiner is correct in that capillary action is involved in the operation of both the
`
`test strip of the prior art and the test Strip of the invention. the portions of these statements
`
`that state or imply that the orientation of the test strip makes no difference and that one of»
`
`ordinary skill in the art would know to have the blood flow vertically either upwards or
`downwards is incorrect.
`.
`7.
`First, I note that Thaimre would not work upside down. since there would be
`no practical way to apply the blood to area 11.
`‘
`8.
`Until the teachings of the present application, it was thought that blood had to
`flow either laterally or upward in a test strip in which it was required to separate different
`
`types of cholesterol, because such test strips depended on precipitation.
`
`it was thought
`
`that if blood flowed laterallyor upward, the precipitates would be left well clear of the
`analytical test area of the strip. That is. the capillary action would work on the plasma. but
`not on the undesired precipitates. However. lithe strip was turned so that the blood flowed
`downward. gravity would cause the precipitates to move downward to either impede the
`flow ofthe plasma through the capillaries or get into the analytic area to interfere with the
`
`test.
`
`While the above is logical. it turns out that lateral and upward flow have
`9.
`serious disadvantages, and surprisingly, vertical flow works much better in test strips in
`which one or more cholesterol-bearing lipoproteins are segregated.
`'10.
`As pointed out in the Background of the Application, such testfiow strips with
`purely lateral
`flow. have problems associated with timing and are difficult to make work
`
`Serial No. 101329.044
`Declaration of James Sutar'
`Page 2
`W52!”
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`’
`
`Infopia Ex. 1011 pg. 10
`
`

`

`ii ilil i i
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`Feb-Zi-DB Dl:‘27pm
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`From-PATTON BOGGS LLP
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`+3038949239
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`T449
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`P.|2/iT
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`82/28/ 26215
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`15: 56
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`317876561 8
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`F’CL‘NER -'i'E(}tl‘~lDGY
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`PAGE
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`84/65
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`.
`property. See, page 2. line 24 through page 4, line 7.
`it is suggested that the
`11.
`On page 4, lines 3 — 4 of the Office Action,
`advantages of downward vertical flow are not disclosed. To a certain extent this is true,
`since it was admitted in the application that the exact mechanism why the inventive test
`
`strips work so well was not certain (see page 7, lines 10-11),
`12.
`However. the Applim’tion does, in fact, disclose advantages of the downward
`vertical flow device. As disclosed on page 7, lines 16 — 21, the inventive test strip is
`unexpectedly accurate. Further, the test strip according to the invention permits a smaller
`blood Sample and a more compact test strip. See. page 7. line 22 through page 8. line 2.
`In addition, the inventive test strip does not require time-dependent chromatographic flow
`schemes, which are complex and hard to make work Well. See. page 8, lines 3-11.
`18.
`Perhaps. more importantly. since the Application was written, time has
`shown, and it has become more and more clear, that the downward vertical flow has huge
`advantages in both simplicity of design and operation and accuracy in the claimed
`
`cholesterol test strips.
`
`,
`
`14. Atthe time of writing of the Application, it was difficult even for the inventors
`
`to break away from the state-of-knowledge of the art that lateral flow of some kind was
`
`necessary in these test strips. See. page 7. lines 25 -— 26.
`15.
`However, as we have become more familiar and experiean with downward
`vertical flow, we have made the test strips ever more compact. and have designed them to
`use less and less blood.
`it turns out that, that vertical downward flow permits much less
`' blood to be used. This is because the blood does not Spread out as much as it does when
`the blood flows lateral or upward, and flows more directly and more quickly down to the test
`layer. The lesser quantity of blood is not only welcomed by the user, but it allows less
`
`chemicals to be used, which makes the strip easier to make and more economical.
`16.
`However. the most important advantage is the accuracy pointed to in the
`Application. The lesser amount of blood and the flow downward assisted by both gravity
`
`and capillarity, allows the flow to the reaction area to be more direct and faster, and the
`
`reaction to be more controllable. As we have learned to trust the vertically dowanard flow
`
`Serial No. 1 01329,044
`Declaration of James Sutor
`Page 3
`5895'th
`
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`lnfopia Ex. 1011 pg. 11
`
`

`

`i
`‘
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`l
`
`'
`
`ii i
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`
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`‘
`
`Fab-Zl-OB 01:27“!
`
`From-PATTON BOGGS LLP ,
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`+3038949239
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`T-149
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`P.13/17
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`F-ISEI
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`62/28/2085
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`15:56
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`31787165610
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`-
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`PDLYNER TECHNUGY
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`V
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`PAGE
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`65/85
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`device, accuracy has shot upward. Test strips using the downward vertical flow are two to
`three times more accurate than prior art test strips using upward or lateral flow.
`17.
`l respectfully suggest to the Examiner that while the position taken in the
`office action. that vertical downward flow makes no difference, is logical, this position
`actually proves the patentability of the present invention. That is. since the logical and
`expected result as expressed in the Office Action, is that vertically downward flew makes
`no difference. and since vertical downward flow does have significant advantages in the
`
`claimed test strips, these advantages are unexpected. and therefore patentable.
`18.
`I hereby, declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to be true; and
`flutter that these statements were made with the knowledge that willful false statements
`
`and the like are punishable by fine or imprisonment. or both. under 18 U.S.C. §1001, and
`
`that such willful false statements mayl‘eopardize the validity of the application or any patent
`
`issued thereon.
`
`3,. 30 l-aooa‘,
`
`Date
`‘
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`.
`
`5
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`Jam sJ.Sutor
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`'
`
`I
`
`Serial No. 101329.044
`Declaration of James Sutor
`Page 4
`22er
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`PAGE 13117 ' RCVD AT 212112006 3:25:21 PM [Easlem Standard Time] * SVR:USPTO£FXRF-6138 * DNlS:2738300 * CSID:+3038949239 “ DURATION (mm-ss):04-38
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`‘
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`lnfopia Ex. 1011 pg. 12
`
`

`

`Feb-Zl-UG Ol:28pm
`
`From-PATTON BUGGS LLP
`
`”039949239
`
`7-149
`
`Ptl4/l7
`
`F'l50
`
`James}. Sutor
`287 Meander Way
`Greenwood, Indiana 461428537
`317-888-4678 home
`317-865-3568 fax
`317-445—5926 mobile
`
`Polymer Technology Systems, Indianapolis, IN
`Senior Scientist
`
`2002 - 2006
`
`1998 — 2002
`Seradyn, Incl, an Apogen’t Company, Indianapolis, IN
`1990 - 1998
`’
`Seradyn, Inc., Division ofMitsubishi, Indianapolis, IN
`Senior Research Scientist — reporting to the President -- responsible for the research and development of
`all monodispersed micrOSpheree made by Seradyn
`
`»
`
`1974 — 1990
`V
`Reilly Industries
`Product Manager Chemical Specialties — Responsible for production yields and throughput of the
`processes within the Chemical Specialties Group
`Unit Manager — reporting to the Manager of the Chemical Specialties Group._ DeveloPed control
`strategies for and supervisod the operation of a fitlly automated batch sequence controlled plant.
`Research Chemist
`
`1973 — 1974
`American Monitor Corporation, indianapolis, IN
`Production Chemist -— ReSponsible for the large scale isolation of enzymes for use in clinical diagnostic
`tcsr kits.
`'
`
`Patents
`
`‘
`
`US 4,386,209
`US 5,003,069
`EP 0 098 684
`US 5,648,124
`W0 9,537,313
`
`McGill; Charles K.; Sitter; James J., Chichibabin Reaction
`McGill; Charles K.; Sutor; James 1., Chichibabin ReaCtion
`McGill; Charles K; Sutor, James.J., Chichibabin Reaction
`Sutor; James J., Process for Preparing Magnetically Responsive Microparticlen
`Sutor; James J., Magnetically Responsive Microparticles and Pmcess for their
`Production
`
`Publications
`Griffin; C.; Sutor; J.; Shun; B., Microparticle Reagent Optimization, Setadyn, Inc., Indianapolis, Ind
`Owen; Rt, Snell; B., Lowe; M., Sitter; J., Shun; B., Friedman; 11., The Detection of Mlcrospheres
`Comaining Gadolinium Via Magnetic Resonance Irnaging, Journal of Investigative Medicine, fl. 2, 59a
`(1999)
`
`_
`
`Education
`13.8. Chemistry 1972
`Graduate Study 1973
`
`Continuing Education
`ACS
`AICI-Ie
`Cmr for Prof Advmt
`Lehigh UniVersity
`Fisher Controls
`Hobbs
`Mcgrawnfiill
`PSI
`SkillPath
`Yokagawa
`
`Rose-Hulxnan Institute of Technology»
`Eastern Illinois University
`
`‘
`Computer Applications in Chemistry
`Fundamentals of Electrochemical Engineering
`Statistical Process Control
`‘
`Advances in Emulsion Polymerization and Latex Technology
`Provo): Distributed Controls System
`‘
`Time-Power Management
`Catalyst and Catalyst Technology
`‘
`Effective Process Plant Supervision
`- Managing Multiple Projects, Priorities, and Deadlines
`Yewpack Distributed Control System
`
`EXEIIBIT 5
`PAGE 14117‘ RCVD AT 2l21l2006 3:25:21 PM {Eastern Standard Time] ’ SVRIUSPTO-EFXRF'WB " DNIS:2738300* CSID:+3038949239* DURATION (mmss):04-38
`Infopia Ex. 1011’ pg. 13
`
`

`

`Fab-21418
`
`01:2.8mn
`
`From-PATTON BOGGS LLP
`
`+3038949239
`
`T-l49
`
`P.15/17
`
`F-IEO
`
`Feb 21 08 03:01p
`
`Palamer‘Technologa Susnems
`
`-
`317—704 6824
`
`1.2
`F
`
`PTO/$8182 (an-06)
`
`ATTORNEY WITH
`NEW POWER OF ATTORNEY
`AND
`CHANGE OF CORRESPONDENCE ADDRESS
`
`E] A Pmr of Attorney is submmed herewith.
`OR '
`
`
`
`
`
` REVOCATION OF POWER OF
`
`
`
`
`
`
`
`
`
`023134.0110PTUS
`
`
`
`Former 01726-0001 (3
`AROme anaemumber_
`I hereby mvoka all previous powers of attorney given In the above-(dammed application.
`
`
`
`
`
`{:1 I henaby appoint lhe ptacdfloners associated with the Customer Number. :2
`
`
`
`D Please change the correspondence address for the above-identified applixfion to:
`D The address amciated with
`Customer Number.
`
`OR
`
`.
`
`
`
`D Applicant/Inventor.
`m Assignee of‘recond ofthe entire imerESt. See 37 CFR 3.71. V
`
`
`Stalemom under 37 CFR a 73(b) ls enclosed (Farm PTO/SB/QG)
`
`
`
`
`.1” ,. mgmh
`
`
`-//////II?“
`
`
`
`
`
`Robert Huffstodt
`
`
`
`
`317-870-5610
`Telephone
`February 2'1. 2006
`NOTE: Siqnmumsut dime MW nr assign»: of mom cflha entire imam: arma‘r mpfiemuvqe) an mquirud. Subml: mumpla
`
`
`forms 1! maro than one signature in mm. see bahw'.
`loans are submitted.
`
`
`
`
`2.29”?“
`
`
`
`Infopia Ex. 1011 pg. 14
`
`

`

`u
`
`Feb-ZI-OB Dlréflpm
`
`igrnm-PATTON BOGGS LLP
`
`+3039949239
`
`T-149
`
`PJ‘s/i7
`
`F-ISD
`
`Feb 21 06 03:02p
`
`PolamerTéchnologs Sustems
`
`317—704-8924-
`
`p.3
`
`CENTRALEAXOEN‘TEFI
`
`Applicant/PatemOwner:
`Application No.IPatent
`December gs. 2002
`Filed/issue Date:
`10/329044
`Nd./COntmi Na.:
`TEST STRIP AND METHOD FOR DETERMINiNG HDL CONCENTRATION FROM WHOLE
`Entitled:
`BLOOD 0R PLASMA
`MM
`Palmer Technology astems inc’.
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`[E] the asaignee of the entire right. this. and interest; or
`1.
`2. D an assigned at late than the entire right. title and interest.
`
`(The extem (by percentage) of in ownership Miami is
`in the patent applicatiortlpamnt identified above by virtue of either:
`A. E] An assignment from the Inventor-(s) of the patent application/patent identified above. The assignment
`was recorded in the United States Patent and Tradematk Office at Ree!
`014002
`,
`Frame
`0616
`. or a hue copy of the nriginai assignment is attached.
`OR
`
`%)
`
`
`
`
`
`
`
`a. D A chain crime from the inventorts). uftha patent application/patent identified above, to the current
`assignee as follows:
`
` States Patent and Trademark Office at
`
`
`, Frame
`. orfor which a copy thereof ls attached.
`To:WI._..
`2. From:
`The document was remitted in the United States Patent and Trademark Office at
`
`Reel
`‘
`, Frame
`. or torwhinh a capy thereof is attachad
`3. From:
`To:
`———--—-—-—-«——-——-..—_
`—-—-—-——~—————.._.__.
`The dammant was rewarded in the United States Patent and Trademark China at
`
`
`Real
`, Frame
`. or forwhich a copy thereof is attached.
`[3 Additiomai documents in me chain attitia are rated on a supplemental sheet.
`As required by 37 CFR 3.73!“th the dommentary evidence of the chain of titta tram the originat owner
`tn the assignee was, or concurrentiy in being, submlnnd for retardation pursuant to 57 CFR 3.11.
`[NOTE Asaparaie capy 0.6., a true copy of the originai assignment docurnentts» must be submitted to
`Assignment Divisicn in accordance with 37 CFR Part 3, to record the assigmnent in the records oftha USFTO.
`m MPEF’ 302.08]
`.
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`/ow) lsauthorizedio act On behaitottheassisnee.
`"
`Februaa 21. 2006
`
`Date
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`The unde v. m”
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`1
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`Robert Huffstcxtt
`Printed or WEE Name
`.
`Authorized Sig‘ner forASaignee
`Title
`
`
`
`
`317-870-5610
`Teieghone Nurhber
`
`929173”
`
`Hits 15117 *icvoAT mums 32551 PM [Easiem Stan—daiti may SVR:USPTO£FXRF-6i38‘DNIS:2738300 * csm:+3033949239*numo~ (mmss):04-38
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`‘
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`’
`
`lnfopia Ex.