EXHIBIT 1009
`
`APPLICANT’S RESPONSE TO THE NON-FINAL OFFICE ACTION
`
`1 FOR US. PATENT APPLICATION SERIAL NO. 10/329,044,
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`ISSUED ON JULY 18, 2005
`
`Infopia Ex. 1009 pg.
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`1
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`DATE:
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`PTO IDENTIFIER:
`
`Application Number
`Patent Number
`
`10/329044»Conf. #7458
`
`Sunii «.1Anaokar etal.
`Inventor:
`—_
`MESSAGE To:
`8 Patent and Trademark Office
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`CONTENTS: Certi cate of Transmission (1 page)
`Am dment in Response to Non-Final Office Action Mailed 07/18/2005 (1 1 pages)
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`Application No. (if knp n): 10/329044
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`Attorney Docke1 No.: 023134.0110PTUS
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`PTO/$8197 (0904)
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`«amber 18 2005
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`(11 pages)
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`Am - ndment in Response to Non—Final Office Action Mailed 07/18/2005
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`Infopia Ex. 1009 pg. 3
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`10-18-05
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`- Docket No.: 023134.0110PTUS
`(Fannedy 01726-0001(G))
`(PATENT)
`
`IN TI'IE
`
`D STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Applicafio . o :
`Sunil G. Anaokar er: a1.
`
`Application No.: 10/32 " 044
`
`Confinnafion No.: 7458
`
`Filed: December 23, 202
`
`An; Unit: 1655
`
`I METHOD FOR
`For: TEST STRIP ‘
`DETERMINING I-IDL CONCENTRATION
`FROM WHOLE I: LOOD OR PLASMA
`
`Examiner: R. J. Gitomer
`
`‘
`
`A Ll Ll.
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`INRESPONSETONON— -x',‘ 03mm A IO
`
`MS Amendment
`Cbmmissioner for Pate - 13
`RC. Box 1450
`
`Alexandria, VA 22313- 450
`
`Dear Sir:
`
`INTRODUCTORY COMNIEMS
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`I
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`~
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`7
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`In response to ac Office Anion dated July 18, 2005, please amend the above-identified US.
`
`patent application as fo ows:
`
`Amendments u the Specification begin on page 2 of this paper.
`
`Amendments .. the Claims are reflected in the listing of claims which begins ‘on page 3 of
`
`this Paper»
`
`. Remafiis/ -
`
`;
`
`ens begin on page 8 of this paper.
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`Serial No. 10/3'29,o44
`Anzendmems And Re .
`Office Action
`Page 1 bf 11
`218431v2
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`- Responsive To
`afled 07/ 18/ 2005
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`lnfopia Ex. 1009 pg. 4
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`30-18-05
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`MENTS TO THE SPECIFICATION
`
`
`ph 2 on page 2 of the Office Action, on page 1, line 5 of the application,
`please amend the title
`follow:
`
`Pursuant to p
`
`WMethod For Determining
`DI. Concexnmfion From Whole Blood Or Plasma
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`
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`Serial No. 10/ 329,044
`Amendments And Re
`Office Action
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`Infopia Ex. 1009 pg. 5
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`10-18—05
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`16:04
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`CLAIM L15 111353
`
`Claims1-20(=ueled)
`
`21.
`
`(Current
`
`amended) A method of ‘detennining concentration of I-IDL cholesceml
`
`in a whole blood samp- , said method comprising:
`
`providin_ a test snip holder and a (25; gig; said m; grip hglder inelgggan
`a)
`Mlicmionwindowanda‘1 t: I I_ ’ Clo'. saidwindo COIIL ;
`61 ll- 38005116;
`
`in said holder said tes
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`_-
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`a-mn'sin_ a layered Slack comprising a red blood cell separation layer,
`
`a non-HDL separation chemisuy layer, and an HDL reaction layer; said non-HDL cholesterol
`
`separation chemistry la "1- cantaining non-HDL cholesterol sepaxation chemicals far sepaxating the
`
`non-HDL blood co - - unents from the HDL blood components so that the non-HDL carnponcnts
`
`- reactiori in said HDL reaction layer, said I-lDL reaction layer containing
`do nor. participate in
`chemicals for reacting -
`. said HD1131, said layers arranged in a vertical stackM
`fiacn'on la -rat the b0 _- u o s'- sun:
`~ Said tesr stri- located in said res: stri- holder bemeen a-
`
`'
`
`._ ws withsaidrea ionla rao.' n s.-i m-srea'
`-_
`' dow;
`b)
`applying blood to the top of said stackWW and
`permitting is [L ‘d from .- - ood to flow vertically downward in said stack to said ‘HDL reaction
`
`layer without subs u -
`
`.
`
`lateral migration of fluidMy,
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`c)
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`sepaia-n'g said red blood cells from a fluid portion of said blood ia—said—sed—bleed
`
`eeilsepfifiim
`
`d)
`
`sepamt'
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`; said non-HDL cholesnerol from said HDL cholesterol twangW
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`said non-HDL i . - 0 _-.ins with said non-HDL cholesterol separation chemicals; and
`
`e)
`
`reactingaid HDLW'm said HDL reaction layergnnd
`
`ofsaid reaccionla rthro ;h saidre .
`:-_-me
`_. 9.:
`f)
`risen- [in If d’LChO ' ten .
`
`.19
`
`;‘ not a an: 3:
`
`22.
`
`(Previo 1y presented) The method of claim 21 wherein:
`
`said providing c ompzises Providing Said red blood cell separation layer Mthout including an
`
`agglutinin or a coagulan ;
`
`Serial NO. 10/329,044
`Amendments And Be
`Office Action '
`Page 3 of 11
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`fits Responsive To
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`InfopialEx. 1009 pg. 6
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`

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`10-18-05
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`and said sepata ' g said red blood cells is performed without agglutinizing 0r coagulating
`
`said red blood cells.
`
`
`
`23.
`
`(Previo lypresented) The method of claim 21 wherein Said reaming compriSes
`
`generating a color res
`location that is subs
`
`
`
`use and said method further comprises reading said colored response at a
`
`vertically aligned with the blood application area of said snack.
`
`24.
`
`blood cell separation
`
`(Previo 1y presented) The method of claim 21 wherein said providing said red
`r comprises providing glass fibexs having 21 EM average diameter and glass
`
`fibers having a second
`
`emge diameter that is less than said first average diameter.
`
`
`
`25.
`
`(Previo 1y presented) The method of claim 21 wherein said providing said red
`
`blood cell separation la
`
`r comprises impregnating said red blood cell sepsmtion layer with a salt.
`
`26.
`
`(vaio lypresemed) The mthod of claim 25 whexein said impregnating comprises
`
`impregnating said red load cell separation layer with a solutiou in which the salt concentratioii
`
`‘ camprises about 0.56.0 /o byweight of said solution
`
`27.
`(Previo lypresented) The method of claim 21 wherein said providing said red
`blood cell separation la
`r comprises impregnating Said red blood cell separatiOn layer with a wetting
`
`agent.
`
`
`
`28.
`
`(I’revio lypresented) The method of claim 27 wherein said providing said red
`
`blood cell separation in
`
`r comprises impregnating said red blood cell separation layer with a sugar.
`
`29.
`
`(Previo ly presented) The method of claim 28 wherein said impregnating comprises
`
`impregnating said red b ood cell separation layer with a sorbitol solution, the concentratiOn of which
`compriScs 3% tolO°/o s rbitol by weight of said solution.
`
`
`
`l‘ks Responsive To
`ailed 07/ 18/2005
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`Serial No. 10/329,044
`Amendments And Re
`Office Action
`Page 4 of 11
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`.
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`lnfopia Ex. 1009 pg. 7
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`said I-lDL cholesrerol c mprises precipitating said non-HDL cholesterol.
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`
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`31.
`
`(Previo lypresented) The method of claim 30 wherein said providing saidn‘on-
`
`HDL cholesrerol sep
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`tion chemistry layer comprises impregmring said non-HDL cholesterol
`
`separation chemistry la
`
`rwith phosphonmgscic acid (PTA).
`
`
`
`(Previo lypresenred) The method of claim 31 wherein said providing said non-
`32.
`HDL cholesterol sep
`u'on chemisrry layer comprises impregiating said non-HDL cholesterol
`
`separation chemisn-yla
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`33.
`
`rwith Said PTA and a divalent. cation.
`
`
`(Previo lypresentcd) The method of claim 21 whemin said providing comprises
`
`smoking said red blood cell separation layer above saidnon-HDL cholesrerol separation chemistry
`
`
`
`‘ (Previo 1ypresented) The method of claim 33 wherein said providing comprises
`34.
`providing a red blood c ll separation layer comprising glass fiber.
`
`"
`
`
`. (Previo 1y presented) The method of claim 34 wherein said providing said red
`35.
`blood cell separation la er comprises providing a first glass fiber layer with glass fibers having a firm
`average diameter and p
`'
`'
`a second glass fiber layer having glans fibers having a seCOnd average
`
`said first average diameter.
`
`
`diameter that is less
`
`36.
`
`(Previo lypresenred) The method of claim 35 wherein said providing Said nOn-
`
`HDL cholesrerol se
`
`
`
` '
`
`:1 layer comprises providing said second glass fiber layer andunpregnating
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`said second glass fiber yer with said non-HDL cholescerol separation chemicals
`
`
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`Serial No. 10/329,044
`Amendments And Re
`Oflice Action
`Page 5 of 11
`218431v2
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`firs ResPonsive To
`ailed 07/ 18/2005
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`lnfopia Ex. 1009 pg. 8
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`10-48-05
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`l6:04'
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`(Previo 1ypresented) The method of claim 21 wherein:
`37.
`said providing unher comprises providing said layered Stack with a di3persement layer
`above said red blood
`separation layer, said non-HDL sepamtiou chemistry layer, and said HD1—
`detecrion layer; and
`
`said method f
`
`
`er comprising permitting said blood to disperse laterally across said
`’
`‘
`
`dispersement layer.
`
`
`
`layer, a non-HDL se
`nation chemisny layer, and an I-IDL motion layer; Said red blood cell
`separation layer not co taining an agglutirfin or a coagulant; said non-HDL cholesterol separation
`chemistry layer con '
`non-HDL cholesterol separation chemicals for separating the nonJ-iDL
`
`blood components fro
`the HDL blood components so that the non-HDL components do not
`participate in the meal 11 in said HDL reaction layer; said HDL reaction layer containing chemicals
`for reacdng with said
`L; said layers arranged in a vertical stackwith said dispersement layer at the
`
`top and said HDL reac n layer at the bottom;
`b)
`applying blood to said dispersemmt layer and permitting itMM to
`first flow latenally acres said dispersement layer and then to flow vertically downward in said stack
`
`to said HDL reaction 1
`
`layer;
`
`‘
`
`c)
`
`sepa
`
`I withom subsmntial lateral migration of fluid in below said d__:§_p‘exsement
`
`
`
`' g said red blood cells from a fluid portion of said blood in said red blood
`
`cell separation layer,
`
`
`
`d)
`
`sepam ' g said non—HDL cholesterol from said HDL cholesterol using said neu-
`
`HDL cholesmrol se
`
`'on chemicals;
`
`‘
`
`e)
`
`reacting aid HDL in said HDL reaction layer in a colorimetric reaction; and '
`
`Serial No. 10/329,044
`Responsive To
`Amendments And Re
`
`iled 07/ 18/2005 .
`Office Action
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`Page 6 of 11
`mom
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`Infopia Ex. 1009 pg. 9
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`10-18-115
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`(f)
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`dete
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`the HDL cholesterol concentration in said reacdon layer by measuring
`
`the reflectance of said
`
`acfion layer after said colorimetric reaccion.
`
`40.
`
`(Previo lypresented) The method of claim 39 wherein said providing comprises
`
`stacking said red blood cell separation layer above said n0nuHDL cholesmrol separation chemistry
`
`
`
`Serial No. 10/329,044
`Amendments And Rc
`Office Action
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`Page 7 of 11
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`filed 07/18/2005
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`A Infopia Ex. 1009 pg. 10
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`10-18-05
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`W
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`Claim 21 — 4O ..
`
`- cunentlypending in the inseam application.
`
`The undersigne thanls the Examinersfor the telephone conversation on October 18,2005,
`
`which clarified several pects of the Office Acrion. These aspecrs will be pointed out below and
`
`comprise a complete - nnd of the telephone conversation.WW
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`wlicants’ ($5.001 _. t.
`
`f _L' issues herein ‘
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`is s;an ..i
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`-
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`.-
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`.‘e
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`,_ 1-,...Ju; _'._
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`the undersi-ned to schea ule an interview so tha . nlicant can discuss the issue with the Examiner.
`
`In the Office ' . “'13, the Examiner, States that the title is nOt descriptive. Applicants assume
`
`the Examiner means
`
`u .t the worth “Test Strip” are no longer applicable because, due to the
`
`resm'ction requirement,
`
`a present claims are now all method claim. Applicants have amendedthe .
`
`title based on this ass
`
`ption.
`
`The Office Action sures that no priority is granted in View of statements on page. 7 of the
`
`the telephone conversation the Examiner confirmed that he is referring to
`present Specification. I
`the statement at page ', lines 10 - 21, and agreed tlmt this statement, at most relates only to
`insomuch of the provis anal that discloses that the red blood cells are completely separated in the
`
`first glass fiber layer.
`1 us, all Other aspects, including the order of the layers and the downward
`vertical flow do have p . on'tyto the provisional application.
`‘
`
`The Office Actinn states that the presently claimed feature of the saniple flows verticallyis ‘
`
`given no weight. In th telephone conversation, the Examiner pointed out that the basis for this
`
`mtcment was that cla'- 21 did no: adequately define what flowing downward meant, because the
`location of’ the layer
`blood was flowing to was nor. given This has been corrected by
`amendment. While u
`. .. g this amendment,it was noted that there was some lack of clarityin the
`
`claim, because the b c . A- was indicated to be flawing downward to the reaction layer, Whereas it is
`
`onlythe blood fluid tha flows dOanard, and at lean some of the red blood cells are retained in the
`
`upper layers. This has . 0 been clarified by amendment.
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`Serial No. 10/329,044
`Responsive To
`Amendments And Re - ,
`Office Action I had 07/ 18/ 2005
`Page 8 of 11
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`‘Infopia Ex. 1009 pg. 11 *
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`

`

`
`
`10-18-05
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`16:05-
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`The Examiner s
`
`tes that he believes the present invention may reside in the precipitation
`
`and retention of non-
`
`L takes place in the same layer of a teSt strip. As indicated below,
`
`
`
`The Examiner
`anticipated by Thakore
`
`discloses a method of
`
`as rejected claims 21, 23, and 30 — 34‘ under 35 use 102(b) as being
`Patent No. 5,135,716). This rejection is respectfully traversed.
`'Ihakore
`
`
`aSuremem: of HDL cholesterol via dry chemistry test Strips in which the
`
`
`flow of blood is vertica
`
`upward to an HDL reaction layer 6. Thus, it does no: show the feature of
`
`
`claim 21 that the HD reacrion layer is on the borrom of the Stack and the blood fhfid flows
`
`downward to the HDL eaction layer. Claims 23 and 30 - 34 depend on claim 21 and include all its ‘
`limitations, and for at 1e
`t this reason arealso patenmble.
`
`
`tejecred claims 22,‘ 27, and 37 — 40 under 35 USC 103(a) as being
`The Examiner
`unpatenmble over the ombination of Thakore (US Patent No. 5,135,716) in View of Kozak (US
`Patent No. 5,460,974). This rejection is respectfully traversed. The combination of 'I'haloore with
`
`system where the blood fluid flows vertically downward with substantially
`
`Kozak does not teach
`
`the red blood cell separation and HDL chemistry layers. Kozak teaches
`no lateral flow throu
`
`lateral flow for the s m to work in all its embodiments. In the first three embodiments, Kozak
`
`
`
`'
`
`flow.
`
`In the embodiment of FIG. 4, lateral flow is not discussed, but
`
`since there is no disPe ement layer and there is a closed bottom 82, significant lateral flow will
`
`inherently occur in th lower layers. Momover, while at column 14, line 64, Kozak says the
`
`agglutinin 0r coagulan is optional,
`
`
`if the entire disclosure is read, it is apparent that this is
`
`considered optional, be ause in the embOdimenrs of FIGS. 1 and 2 Where there is required Interal
`'d away from the test layers, it is optional In the embodiment of FIG. 4,
`flow which moves the
`
`'
`an agglutinin, namely
`, was incmpomted into each tesr: sample, and there is no discussion of
`this being optional. Se column 25, lines 44 - 58 and column 30, lines 64 —: 66. Thus, key'features
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`Serial No. 10/329,044
`Amendments And Re
`Office Action
`Page 9 of 11
`218431v2
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`Infopia EX. 1009 pg. 12
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`

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`10-18-05
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`18:05
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`From-PATTUN 801368
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`+
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`T-073
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`P.12/13
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`F-925
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`BEST AVAILABLE COPY
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`of claims 21, 22, and 39 are not included in the combination. Since claims 27, 37, and 38 depend on
`
`.
`
`claim 21, and claim 40
`
`pends on claim 39, these claims are patenmble for at least this reason.
`
`The Examiner
`rejected claims 24 — 29 under 35 USC103(a) as being unpatentable over
`
`Thakore (US Patent N . 5,135,716) as applied to claims 21, 23, and 30 — 34 above, and funher in
`view of Carroll (US Pa nt No. 6,040,195). This rejection is respeccfully traversed. Carroll does not
`
`' n of claim 21, since it requires substantial lateral HOW below the top layer.
`add anything to the reje
`It also does not teach, HDL detection system While LDL and HDL cholesuerol is mentioned in
`column 2, line 33 and olumn 3, line 47, there is no further discussion of HDL in thepatent that
`would suggest how to s Ive the problems the present invention solves. Claims 24 - 29 depend on
`claim 21 and include
`its limitations, and therefore these claims an: patenmble at least for that
`reason.
`
`
`
`rejected claims 35 and 36 finder 35 USC 103(3) as being unpatenmble
`The Examiner
`over 'I'hakore (US Pate t No.‘ 5,135,716) as applicdto claims 21, 23, and 30— 34 above, and further
`in View of each of Ri
`dorf (US Patent No. 5,426,030) and Goldman (US Patent No. 6,844,1.49)
`
`traversed. Both Rittersdod and Goldman require subStantial lateral
`
`
`This rejection is respe
`flow below the top laye , and thus teach against the above-discussed limitations of claim 21. Claims
`35 and 36 depend on claim 21 and include all
`its limitations, and therefom these claims are
`t reason.
`
`patenmble at least for
`
`
`
`The Examiner
`indefinite for failing
`
`
`rejected claims 21- 40 under 35 USC 112, second paragraph, as being
`particularly point out and distinctly claim the subject matter which
`
`in condition for allo
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`Serial No. 10/ 329,044
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`V Page 10 of 11
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`Infopia Ex. 1009 pg. 13’
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`

`

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`eposit Accoam No. 50-1848, under Order No. 023134.0110PT’US from
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`Respectfully submitted,
`PATTON BOGGS LLP
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`By:
`Carl A. onest
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`Registration No.: 28,494
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`E303) 894-6114
`303) 894-9239 (Fax)
`Attorney for Applicants
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`Serial No. 10/329,044
`Amendmenm And Re
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`218431v2
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`rks Responsive To
`iled 07/ 13/2005
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`' PAGE 13!13 ‘ RCVD AT 10118l2005 6:05:41 PM [Eastern Daylight Time]‘ SVRiUSPTO-EFXRF-Bm * DNIS:2738300‘ CSlDFI’t DURATION (mm-ss):02-50
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`lnfopia Ex. 1009 pg. 14
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`