EXHIBIT 1005
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`NON-FINAL OFFICE ACTION FOR U.S. PATENT APPLICATION
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`SERIAL NO. 10/329,044 ISSUED ON JULY 18, 2005
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`lnfopia Ex. 1005 pg. 1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Addreuz COMMISSIONER FOR PATENTS
`PD. Box 1450
`Atmndfla. Virginia 223134450
`www.mpm‘guv
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`'
`
`10/329,044
`
`12/23/2002
`
`Sunil G. Anaokm-
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`mus-0001(0)
`
`7458
`
`PATI‘ON BOGGS
`1660 LINCOLN ST
`surrazoso
`DENVER, CO 80264
`
`‘
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`GITOMER. RALPH]
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`mm
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`I655
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`‘
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`DATE MAILED107/18f2005
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`Please find below and/or attachedan Office communication concerning this application or proceeding.
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`PTO-90C (Rev. 10/03)
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`lnfopia Ex. 1005 pg. 2
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`

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`'1‘ Application No.
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`10/329,044
`
`Applicant(s)
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`.
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`ANAOKAR ET AL.
`
`Office Action Summary
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`I
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`Examine,
`
`Ralph Gilomer
`
`An Unit
`
`1655 -
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTH(S) FROM
`THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date of this communication
`lithe period for reply specified above ls less than thirty (30) days a reply within the statutory minimum of thirty (30) days will be considered timely.
`If No period for reply‘is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date ofthis communication
`Failure to repiy 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 Ofiice later than three months eflerthe mailing date of this communication even if timelyifiled, may reduce any
`earned patent term adjustment See 37 CFR 1.704(b)
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`In no event, however, may a reply be timelyifiled
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`Status
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`HIE Responsive to communication(s) filed on 06 June 2005.
`2a”: This action is FINAL.
`2b)IZ This action is non-final.
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`3):] 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 O.G. 213.
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`. Disposition of Claims
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`MIX Claim(s) L40 is/are pending in the application.
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`4a) Of the above claim(s) __ is/are withdrawn from consideration.
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`~ 5)I:I Claim(s) _ is/are allowed.
`em Claim(s) M is/are rejected.
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`’
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`7)I:I Claim(s) _ is/are objected to.
`8)[:I Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
`10)I:I The drawing(s) filed on __ is/are: a)E] accepted or b)I:| 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).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`101:] The oath or declarationis 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)D Acknowledgment is made of a claim forforeign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)I:| All
`b)[:I Some * c)L___I None of:
`1D Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been‘received in Application No. _
`3.[] Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International BureauiPCT Rule 17.2(a)).
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`,
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`*. See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
`1) IE Notice of References Cited (PTO-892)
`2) C] Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) IE Information Disclosure Slatemenl(s) (PTO—1449 or PTO/SB/OS)
`Paper No(s)/Maii Date
`.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 1-04)
`
`4) D Interview Summary (PTO-413)
`Paper N0(8)/Mai| Date—
`5) [I Notice of Informal Patenl Application (PTCH 52)
`6) El Other:_____
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`15/
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`e"
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`.
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`Office Action Summa
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`W
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`Panof P
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`er N
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`Infopia 93(1ng
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`t 20
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`0706
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`

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`Application/Control Number: 10/329,o44
`Art Unit: 1655
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`Page 2
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`The response received 6/6/05 and the IDS received 1/26/04 have been entered
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`and claims 21-40 are currently pending in this application.
`The title of the invention is not descriptive. A new title is req.uired that is clearly
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`indicative of the invention to which the claims are directed. No priority is granted to the
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`provisional application in view of the statements on page 7 of the present specification.
`Priority is granted to the filing date of this application only, 12/23/2002.
`It appears the point of novelty of the present invention may reside in the
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`precipitation and retention of non-HDL takes place in the same layer of a test strip. The
`presently claimed feature of the sample flows vertically is claimed in such a fashion that
`it is givenno weight. And the presently claimed features directed towards the
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`application layer appear to be old in this art.
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless ~
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`(b) the invention was patented or described in a printed publication in this or a foreign country or in public
`use or on sale in this country, more than one year prior to the date of application for patent in the United
`States.
`’
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`Claims 21, 23, 30-34 are rejected under, 35 U.S.C. 102(b) as being anticipated by
`
`Thakore.
`
`Thakore (5,135,716) entitled “Direct Measurement of HDL Cholesterol Via Dry
`Chemistry Strips’f 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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`Infopia Ex. 1005 pg. 4
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`

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`' Application/Control Number: 10/329,044
`Art Unit: 1655
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`‘
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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
`precipitation from whole blood. Or placed for precipitation from plasma. The filtering
`membrane could serve asthe precipitant membrane thereby eliminating the carrier
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`I 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 precip’itants.
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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:
`
`(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
`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 topoint out the inventor and invention dates of each claim that was
`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(c) 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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`lnfopia Ex. 1005 pg. 5
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`

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`Application/Control Number: 10/329,044
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`Art Unit: 1655
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`‘
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`Page 4
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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 inview 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
`
`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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`with a test area for HDL.
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`In column 11 first full paragraph, a third zone may be included
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`~ in the separation area and it is not treated with a reagent to remove final traces of
`cellular components and LDL, VLDL fractions.
`in column 14 last paragraph, the first
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`zone optionally has a cell separating reagent.
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`in column16 lastparagraph, 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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`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
`strip of Thakore because Thakore teaches obtaining plasma from whole blood to
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`‘
`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
`
`know test strip intended to be employed for determining whole blbod with the expected
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`lnfopia Ex. 1005 pg. 6
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`Application/Control Number: 10/329,044
`Art Unit: 1655
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`Page 5
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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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`_' Claims 24-29 are rejected under 35 U.S.C. 103(a) as beingunpatentable 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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`‘
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`The claims differ from Thakore in that they specify features of the separation
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`flayen
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`Carroll (6,040,195) entitled "Diagnostic Sanitary Test Strip" teaches in column 2
`line 33, an HDL cholesterol test strip.
`In column 6 a spreading layer with a receiving
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`port which uniformly distributes the'sample of whole blood. The separating layer
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`contains salt. Further details are given regarding the separating layer in stages, lyslng,
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`bonding agents, and other issues.
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`.
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`V
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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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`.
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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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`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 further 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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`layen
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`lnfopia ‘Ex. 1005 pg. 7
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`

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`Application/Control Number: 10/329,044
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`Art Unit: 1655
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`'
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`Page 6
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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” teaches in
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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 ‘
`heparin and MgCl2 and a filter layer, then a cholesterol indicating membrane.
`It would have been obvious to one of ordinary skill in this art at the time the
`. invention to employ various glass fiber layers in the test strip separation layer of
`Thakore to remove cellular components from. whole blood as taught by’each of
`Rittersdorf and Goldman because such separation layers are well known and to employ
`
`It
`any known glass fiber layers with the expected results would have been obvious.
`would appear the diameter of the fibers is less significant than the resulting pore size.
`Many of the references cited herein discuss glass fiber layers. of various types for
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`various functionsand list their parameters. These fiber layers are commercially
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`available.
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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 matterwhich 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.
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`lnfopia Ex. 1005 pg. 8
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`

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`Application/Control Number: 10/329,044
`
`Art Unit: 1655
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`,
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`'
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`Page 7
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`- In claim 21(d) it is unclear how chemicals would be used, “reacting with” may be
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`more standard terminology. Method claim 21 is incomplete where it does not contain
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`any determining step or correlating to accomplish the preamble.
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`In claim 23 “said
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`colored" and “the blood application area” lack antecedent basis.
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`The prior art made of record and not relied upon is considered pertinent to
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`applicant‘s disclosure.
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`Rittersdor‘f (6,171,849) teaches an HDL test strip.
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`Figueras (4,144,306) teaches a layered test strip.
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`Jones (US 2003/0224471 A1) entitled “High Density Lipoprotein Assay Device and
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`Methbd" teaches on page 6 paragraph 72, a binding reagent may be contained in the
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`sieving matrix, the sample distribution matrix, or in a separate reagent pad to remove
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`non-HDL components.
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`‘ Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Ralph Citomer whose telephone number is (571) 272-
`0916.. The examiner can normally be reached on Monday - Friday.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`supervisor. Bruce Campell can be reached on (571 ) 272-0974. The fax phone number
`
`.
`
`for the organization where this application or proceeding is assigned is 703-872-9306.
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`'lnfopia Ex. 1005 pg. 9
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`

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`Application/Control Number: 10/329,044
`Art Unit: 1655
`
`V
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`Page 8
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`Information regarding the status of an application may be obtained from the
`
`Patent Application information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`For more information about the PAIR system, see httpt/lpair-direct.uspto.gov. Should ’
`
`you have questions on access to the Private PAIR system, contactthe Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free).
`
`Ralph Gitomer
`Primary Examiner
`Art Unit 1655
`
`RALPH GITOMER
`PRIMARY EXAMINER
`GROUP 1200
`
`Infopia EX. 1005 pg. 10
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`

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`ATTY. DOCKET No.1 1842-0012
`APPIJCATION N0. 10,329.05“
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`BEST AVAILABLE copy _
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`APPUCANT: Anaokar el al.
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`'
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`'
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`FILING DATE: December 23, 2003
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`GROUP ART UNI
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`5’— m—r
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`.U.S. PATENT DOCUMENTS
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`EXAMINER
`INITIAL
`DOCUMENT
` DATE
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`NUMBER
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`fil-
`ififiig
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`AA
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`Dr
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`C I 1
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`DOCUMENT '
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`NUMBER
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`J K
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`P‘
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`IIIIIIIIIIEiIIIIIIIIl“
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`
`
`
`Ziegenhom el al.
`Riflersdorfet al.
`Connolly
`FOREIGN PATENT DOCUMENTS
`
`EXAMINER
`SUB-
`INITIAL
`CLASS
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`NAME
`
`'
`
`CLASS
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`SUB-
`CLASS
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`k
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`FILING DATE
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`08/04/1992
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`05/25/1993
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`05/15/1994
`05/31/1994
`04/18/1995
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`05/02/1995
`06/20/1995
`10/24/1995
`
`Thakorc
`
`Jones
`
`Law et 21].
`Jones
`
`Ziegenhom el al.
`Law at a].
`Rillersdorl‘ el al.
`
`Kozak et ul.
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`07/02/1996
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`l2/03/I996
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`0|/28/l997
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`II
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`c... -II
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`"I I' "‘
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`I
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`I I ~
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`DATE
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`NAME
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`CLASS
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`TRANSLATION
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`.Iilllll
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`V YesI.6
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`‘39.!395
`~<~<~<
`OTHER (Including Author, Title, Date, Pertinent Pages, etc.)
`a)O
`
`AR
`
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`
`
`
`
`Yes
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`
`
`
`
`DATE CONSID ' ED
`EXAMINER
`7 ' é bf
`[61 mm
`.
`,
`lnilial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in
`EXAMINER:
`conformance and not considered. Include copy of this form with next communicalion to ApplicanL
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`.
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`
`BEST AVAILABLE COPY
`
`
`
` FORM PTO-I449
`I'Mm'im ISCLOSURE STATEMENT
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`ATTY. DOCKET NO.: 18420012
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`'
`I APPLICATION NO. 10/329,044
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`Pm92d2
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`APPLICANT: Anaokar eIaI.
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`'
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`FILING DATE: December23, 2003
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`GROUPART UNIW/érr‘
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`EXAMINER
`INITIAL
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`DQCUMENT\
`,NIJMBER
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`B
`U:
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`B
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`BC '
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`IT}
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`5,786,|64
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`5,807,696
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`5,814,472
`5 879 90I
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`6 ”I 849
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`6,2” 570
`
`
`U.S. PATENT DOCUMENTS
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`DATE
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`NAME
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`07/28/I998
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`09/ Lil I998
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`09/29/I998
`03/09/l999
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`Ol/O9/200]
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`04/I0/200]
`
`Rittersdorf et aI.
`
`Miyauchi ct ai.
`
`FutaIsugi at al.
`Rittersdorfct aI.
`
`Rittersdorf et al.
`
`CLASS
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`SUB-
`CLASS
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`FILING DATE
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`g).< 9‘
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`. B 38709
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`FOREIGN PATENT DOCUMENTS EXAMINER
`CUCDon{5CDUS7:'—:2:0-=1
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`‘4-<,-<
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`INITIAL
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`DOCUMENT
`NUMBER
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`DATE
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`NAME
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`CLASS
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`.
`SUB-
`CLASS
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`TRANSLATION
`
`.-
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`.-
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`Yes
`
`Yes
`2o
`
` OTHER (Including Author, Title, Date, Pertinent Pages, etc.)
`
`co U:
`
`|EXAMINER
`7/é/0r
`2691Way
`EXAMINER: Initial if reference considered, whether or not citation is in conformancc with MPEP 609, Draw line through citation if not in
`conformance and not considered. Include copy ofthis form with next communication to AppIicanI.
`
`DATECONfiDERED
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`

`

`
`Applicant(s)/Paieni Under
`
`Application/Control No,
`Reexamination
`ANAOKAR ET AL.
`
`
`
`
`
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`Notice of References Cited
`
`10/329,044
`
`Examiner
`
`Art Unit
`
`
`
`U.S. PATENT DOCUMENTS
`
`I
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` I--
`I___
`In—_—
`I—_—
`II__—
`In
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`n———— -
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`FOREIGN PATENT DOCUMENTS
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`I I
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`‘A copy of ihis reference is not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM-YYYY formai are publication dates. Classifications may be US or foreign.
`US Patent and Trademark Office
`
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20050706
`
`Infopia Ex. 1005 pg. 13
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`

`

`Search Notes
`
`Application/Control No.
`
`
`
`Applicant(s)IPatent under
`Reexamination
`
`10/329,o44
`
`ANAOKAR ET AL.
`
`.
`
`
`HINHIIM
`llllH IIIIIHIM
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`'
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`
`
`Ralh Gitomer
`
`1655
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`
`SEARCHED
`
`435
`
`422
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`56, 57
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`436 '
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`71., 170
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`
`SEARCH NOTES
`'
`(INCLUDING SEARCH STRATEGY)
`,
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`
`West, Chem Abstracts
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`7/6/2005
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`169, 177
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`U.S. Patem and Trademark Office
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`‘
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`Part of Paper No, 20050706
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`Infopia Ex. 1005 pg. 14
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`