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`EXHIBIT 1010
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`FINAL OFFICE ACTION ISSUED ON DECEMBER 8, 2005
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`lnfopia Ex. 1010 pg. 1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`C/ IV '
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent Ind Trademark Office
`Adams: COMMISSIONER FOR PATIENTS
`PD. Box I450
`Algundfin. Virginia 223134450
`www.mpcogov
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`.
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`10/329,044
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`12/23/2002
`
`Sunil o. Anaokar
`
`onzsooouo)
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`7458
`
`PATTON BOGGS
`1660 LINCOLN ST
`SUITEzoso
`DENVER, CO 80264
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`-
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`A
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`V
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`orrOMEn, RALPH}
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`I655
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`DATE MAILED: l2/08/2005
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`PTO-90C (Rev. 10/03)
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`Infopia Ex. 1010 pg. 2
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`Office Aetionlsummary
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`10/329.044
`Examiner
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`ANAOKAR ET AL.
`Art Unit
`
`.
`
`Application No.
`
`Applicant(s)
`
`- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE é MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER lS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(3).
`in no event. however may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`It NO period for replyIs specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will. by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed. may reduce any
`earned patent term adjustment See 37 CFR 1.704(b).
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`Status
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`HE Responsive to communication(s) filed on 18 October 2005.
`23)IZ This action is FINAL.
`2b)I:I This action is non-final.
`3)l:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Ex parte Quayle, 1935 CD. 11, 453 0.6. 213.
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`Disposition of Claims
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`ME Claim(s)g_1;§_Qis/are pending in the application.
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`4a) Of the above claim(s)_ is/are withdrawn from consideration.
`5):] Claim(s) _ is/are allowed.
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`6)EI Claim(s) 21162 is/are rejected.
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`7):} Claim(s) _ is/are objected to.
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`8)I:I Claim(s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`9)D The specification is objected to by the Examiner.
`10)I:I The drawing(s) filed on _ is/are:
`a)L__l accepted or b)I:l objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11”] The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12):) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)I:I All
`b)[:I Some * c)I:I None of:
`11:] Certified copies of the priority documents have been received.
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`2E] Certified copies of the priority documents have been received in Application No. _
`3E] Copies of the certified copies of the priority documents have been received in this National Stage
`application from the international Bureau (PCT Rule 17.2(a)).
`'
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`* See the attached detailed Office action fer a list of the certified copies not received.
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`Attachmenus)
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`
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`1) [:1 Notice of References Cited (PTO-892)
`2) CI Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) D Information Disclosure Statement(s) (PTO-1449 or PTO/SB/Oe)
`Paper No(s)/Mai| Date
`.
`us. Patent and Trademark Office
`PTOL-326 (Rev. 745)
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`4) E] Interview Summary (PTO-413)
`Paper N°(5)/Mall Date.
`5) CI Notlce of Informal Patent Application (PTO-152)
`6) D Other.
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`ornce Action Summary
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`Inf6?ӎf IE3? Wofigzoejm 123
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`

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`Application/Control Number: 10/329,044
`Art Unit: 1655
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`Page 2
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`The response received 10/18/05 has been entered and claims 21-40 are
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`currently pending in this application. The amended title is acceptable. Priority is
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`granted to 12/21/2001.
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title. if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`This application currently names joint inventors.
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`In considering patentability of
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`the claims under 35 U.S.C. 103(a). the examiner presumes that the subject matter of
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`the various claims was commonly owned at the time any inventions covered therein
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`were made absent any evidence to the contrary. Applicant is advised of the obligation
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`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
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`not commonly owned at the time a later invention was made‘ in order for the examiner to
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`consider the applicability‘of 35 U.S.C. 103(0) and potential 35 U.S.C. 102(e), (f) or (9)
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`prior art under’35 U.S.C. 103(a).
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`Claims 21, 23, 30-34 are rejected under 35 U.S.C. 103(a) as being unpatentable
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`over Thakore.
`Thakore (5,135,716) entitled “Direct Measurement of HDL Cholesterol Via Dry
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`Chemistry Strips” teaches in column 4, LDL and VLDL precipitating reactants are added
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`to the plasma separation membrane and the plasma collecting test membrane contains
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`HDL reagents.
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`in column 4 last paragraph bridging to column 5, the precipitant may be
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`lnfopia Ex. 1010 pg. 4
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`Application/Control Number: 10/329,o44
`Art Unit: 1655
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`Page 3
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`placed in the physical transport medium or grooves or channels of the inert substrate for
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`precipitation from whole blood. Or placed for precipitation from plasma. The filtering
`membrane could serve as the precipitant membrane thereby eliminating the carrier'
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`precipitant membrane. A carrier separating membrane placed atop the plasma
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`separation membrane serves dual roles of precipitation and filtration.
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`In colUmn 5 lines
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`43-44, phosphotungstic acid and MgCl2 are precipitants. See Figures 1-5.
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`The claims differ from Thakore in that they specify the blood flows vertically -
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`downward through the layers of the test strip.
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`It would have been obvious to one of ordinary skill in this art at the time the
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`invention was made in view of Thakore to have the blood flow vertically either upwards
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`or downwards because it is capillary action that makes the blood flow and turning the
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`test strip in any direction including upside down would make no difference to capillary
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`action based flow and the blood would flow through the same layers and the test strip
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`would work in the same fashion irrespective of orientation.
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`Applicant's arguments filed 10/18/05 have been fully considered but they are not
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`persuasive.
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`Applicants argue that Thakore teaches a test strip where the blood flows
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`vertically upwards and the present claims are drawn to a test strip where the blood flows
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`vertically downwards.
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`lnfopia Ex. 1010 pg. 5
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`Application/Control Number: 10/329,044
`Art Unit: 1655
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`‘
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`Page 4
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`It is the examiner’s position that capillary action based test strips are not
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`positionally sensitive in general and no unexpected result is seen in positioning a .
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`known test strip upside down with the expected funtion. An undisclosed advantage is
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`given little or no patentable weight.
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`Claims 22, 27, 37—40 are rejected under 35 U.S.C. 103(a)¥ as being unpatentable
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`over the combination of Thakore in view of Kozak.
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`The claims differ from Thakore in that they specify a separation layer without an
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`agglutinin or coagulant to enable a whole blood sample to be determined directly.
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`Kozak (5,460,974) entitled “Method of Assaying Whole Blood for HDL
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`Cholesterol” teaches in column 7 last paragraph, a test device having a separation area
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`including a first zone that separates and retains the cellular components of the whole
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`blood sample and a second zone that separates the LDL and VLDL fraction in contact
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`In column 11 first full paragraph, a third zone may be included
`with a test area for HDL.
`in the separation area and it is not treated with a reagent to remove final traces of
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`cellular components and LDL, VLDL fractions.
`zone optionally has a cell separating reagent.
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`in column 14 last paragraph, the first
`In column 16 last paragraph, the
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`separation area can include more than one carrier matrix and mixtures of chemical
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`compositions.
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`In columns 17 and 18, untreated and treated matrices of the separation
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`area are discussed.
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`Infopia Ex. 1010 pg.‘6
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`Application/Control Number: 10/329,044
`Art Unit: 1655
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`‘
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`Page 5
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`it would have been obvious to one of ordinary skill in this art at the time the ,
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`invention was made to employ a cell separating layer as shown by Kozak in the test
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`strip of Thakore because Thakore teaches obtaining plasma from whole blood to
`determine HDL directly and such layers to remove cells from whole blood are well
`known in this art. To employ a well known layer such'as that taught by Kozak in any
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`know test strip intended to be employed for determining whole blood with the expected
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`results would have been obvious. Methods to remove cellular components from whole
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`blood in test strips is well known.
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`Applicant's arguments filed 10/18/05 have been fully considered but they are not
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`persuasive.
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`Applicants argue that Kozak teaches a test strip where the blood flows laterally
`andthe present claims are drawn to a test strip where the blood flows vertically
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`downwards. And certain features such as agglutinin or coagulant are optional.
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`.
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`It is the examiner’s position that capillary based test strips are not positionally
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`sensitive in general and no unexpected result is seen in positioning a known test strip
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`upside down. An undisclosed advantage is given little or no patentable weight. Further,
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`a teaching that a feature may be optionally included renders obvious that feature being
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`positively recited as present.
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`lnfopia Ex. 1010‘ pg. 7
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`Application/Control Number: 10/329,044
`Art Unit: 1655
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`Page 6
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`Claims 24-29 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Thakore as applied to claims 21, 23, 30-34 above, and further in view of Carroll.
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`The claims differ from Thakore in that they specify features of the separation
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`layer.
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`Carroll (6,040,195) entitled “Diagnostic Sanitary Test Strip” teaches in column 2
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`In column 6 a spreading layer with a receiving
`line 33, an HDL cholesterol test strip.
`port which uniformly distributes the sample of whole blood. The separating layer
`contains salt. Further details are given regarding the separating layer in stages, lysing,
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`bonding agents, and- other issues.
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`It would have been obvious to one of ordinary skill in this art at the time the
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`invention was made to employ a separation layer with the features taught by-Carroll in
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`the test strip of Thakore because separation layers are shown by Thakore and to select
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`known types of separation layers with the expected results Would have been obvious.
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`Applicant's arguments filed 10/18/05 have been fully considered but they are not
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`persuasive.
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`Applicants argue that Carroll teaches a test strip where the blood flows laterally /
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`and the present claims are drawn to a test strip where the blood flows vertically
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`downwards. And Carroll is not specifically directed to determining HDL.
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`lnfopia EX.-1010 pg. 8
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`Application/Control Number: 10/329,044
`Art Unit: 1655
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`Page 7
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`-
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`It is the examiner’s position that capillary based test strips are not positionally
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`sensitive in general and no unexpected result is seen in positioning a known test strip
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`upside down. An undisclosed advantage is given little or no patentable weight. Further,
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`a teaching regarding HDL is sufficient to apply this reference for determining HDL.
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`Claims 35-36 are rejected under 35 U.S.C. 103(a) as being 'unpatentable over
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`Thakore as applied to claims 21, 23, 30-34 above, and fuvther in view of each of
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`Rittersdorf and Goldman.
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`The claims differ from Thakore in that they specify glass fibers in the separation
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`layer.
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`Rittersdorf (5,426,030) entitled “Apparatus for Determination of HDL Cholesterol”
`teaches in Column 3, glass fibers with a diameter of 0.2 to 10.0 microns.
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`Goldman (6,844,149) entitled “Method, System, and Apparatus for Measurement
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`and Recording of Blood Chemistry and Other Physiological Measurements" teachesin
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`column 27, a stack of layers on a dry reagent strip containing a glass felt containing
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`silica for filtering red blood cells and capturing HDL, a glass fiber layer containing
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`heparin and MgCl2 and a filter layer, then a cholesterol indicating membrane.
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`It would have been obvious to one of ordinary skill in this art at the time the
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`invention to employ various glass fiber layers in the test strip separation layer of
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`Thakore to remove cellular components from whole blood as taught by each of
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`Rittersdorf and Goldman because such separation layers are well known and to employ
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`any known glass fiber layers with the expected results would have been obvious. it
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`lnfopia Ex. 1010 pg. 9
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`Application/Control Number: 10/329,044
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`Page 8
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`Art Unit: 1655
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`would appear the diameter of the fibers is less significant than the resulting pore size,
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`Many of the references cited herein discuss glass fiber layers of various types for
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`various functions and list their parameters. These fiber layers are commercially
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`available.
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`Applicant's arguments filed 10/18/05 have been fully considered but they are not
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`persuasive.
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`Applicants argue that both Rittersdorf and Goldman teaches a test strip where
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`the blood flowslaterally and the present claims are drawn to a test strip where the blood
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`flows vertically doanards.
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`It is the examiner’s position that capillary based test strips are not positionally
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`sensitive in general and no unexpected result is seen in positioning a known test strip
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`upside down. An undisclosed advantage is given little or no patentable weight.
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`‘
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`The following is a quotation of the second paragraph of 35 U.S.C. 112:
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`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
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`Claims 21-40 are rejected under 35 U.S.C. 112, second paragraph, as being
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`indefinite for failing to particularly point out and distinctly claim the subject matter which
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`applicant regards as the invention, Each of the following applies in all occurrences.
`ln claim 21(b) “below the top layer’l lacks antecedent basis.
`In claim 21(d) “said
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`non-HDL lipoproteins” lacks antecedent basis.
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`in claim 39(b) “in below” is not
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`understood in context.
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`lnfopia Ex. 1010 pg. 10
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`Application/Control Number: 10/329,044
`Art Unit: 1655
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`Page 9
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
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`CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`in the eVent a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and‘any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`_In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`Any inquiry concerning this communication or earlier communicationsfrom the
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`examiner should be directed to Ralph Gitomer whose telephone number is (571) 272—
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`0916. The examiner can normally be reached on Monday - Friday.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Terry McKelvey can be reached on (571) 272-0775. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273-8300.
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`lnfopia Ex. 1010 pg. 11
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`Application/Control Number: 10/329,044
`Art Unit: 1655
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`Page 10
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`Information regarding the status of an application may be obtained from the '
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair—direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free).
`
`Ralph Gitomer
`Primary Examiner
`Art Unit 1655
`
`RALPH GITQMER
`PRIMARY EXAMINE
`GROUP 1200
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`lnfopia Ex. 1010 pg. 12
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`PA‘I’ENT APPUCATiON FEE DETERMINATION RECORD
`Effective VOctober- L 2001
`
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`lnfopia Ex. 1010 pg. 13
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