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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
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`APPLICATION NO.
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF {MATION NO.
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`11/388,723
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`03/24/2006
`
`Timothy M. Kemp
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`30696—712201
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`9311
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`09/05/2008
`7590
`21971
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
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`EXAMINER
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`SINES, BRIAN J
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`ART UNIT
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`4111
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`MAIL DATE
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`09/05/2008
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`PAPER NUMBER
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`DELIVERY MODE
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`PAPER
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`Please find below and/0r attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL—90A (Rev. 04/07)
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`

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`Office Action Summary
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`Application No.
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`11/388,723
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`Examiner
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`Applicant(s)
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`KEMP ET AL.
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`Art Unit
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`1797 -
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event however may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is 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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`1)IXI Responsive to communication(s) filed on 21 July 2008.
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`2a)I:I This action is FINAL.
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`2b)IZI This action is non-final.
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`3)I: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 O.G. 213.
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`
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`Disposition of Claims
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`4)IZI Claim(s)fl is/are pending in the application.
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`4a) Of the above claim(s) 12-20 is/are withdrawn from consideration.
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`5)I:I Claim(s)
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`is/are allowed.
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`6)IXI Claim(s) 1-11 and 21 is/are rejected.
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`7)I:I 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)I:I The specification is objected to by the Examiner.
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`10)I:I The drawing(s) filed on
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`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
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`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)I:I 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)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
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`a)I:I All
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`b)I:I Some * c)I:I None of:
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`Certified copies of the priority documents have been received.
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`Certified copies of the priority documents have been received in Application No.
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`Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attach ment(s)
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`1) IZI Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| Date 5/8/2008.
`U.S. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper No(s)/Mai| Date. _
`5) I:I Notice of Informal Patent Application
`6) D Other:
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20080901
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`

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`Application/Control Number: 11/388,723
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`Page 2
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`Art Unit: 1797
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`DETAILED ACTION
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`Response to Arguments
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`Applicant's arguments with respect to the present claims have been considered but are
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`moot in view of the new ground(s) of rejection.
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`Claim Rejections - 35 USC § 1 03
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`The following is a quotation of 35 USC. 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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`The factual inquiries set forth in Graham V. John Deere C0., 383 US. 1, 148 USPQ 459
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`(1966), that are applied for establishing a background for determining obviousness under 35
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`USC. 103(a) are summarized as follows:
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`:hS’JN.H
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`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating obviousness
`or nonobviousness.
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`10
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`15
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`20
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`1.
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`Claims 1 — 11 and 21 are rejected under 35 USC. 103(a) as being unpatentable over
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`Childers et al. (US. Pat. Appl. No. 2004/0086872) in view of Parce et al. (US. Pat. No.
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`25
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`5,885,470).
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`Regarding claims 1 and 3, Childers et al. teaches an apparatus structure (cartridge 14)
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`comprising: a sample collection unit (sample input 50) for introducing a biological fluid sample
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`in fluid communication with a reaction site (assay chamber 68); a plurality of reactant chambers
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`(reagent reservoir 52) in fluid communication with the reaction site 68; a system of fluidic
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`

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`
`
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`suppom‘ — SAMPLE
`52.,
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`STORAGE
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`REAGENTS ‘ INPUT
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`PROCESSING
`CHAMBER{S)
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`Application/Control Number: 11/388,723
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`Page 3
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`Art Unit: 1797
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`channels (fluid network 46 & 48) to allow the biological fluid sample and reactants to flow in the
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`apparatus (see paragraphs 40 — 52 and 57; figures 1 — 3).
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`
`
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`
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`Childers et a1. indicates that the apparatus can be configured to detect various types of
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`analytes other than nucleic acids, including proteins, hormones and metabolites (see paragraphs
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`23,121,122 and 125).
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`Childers et a1. teaches that the deVice is suitable for diagnostic use purposes on clinical
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`samples, such as for drug screens (see paragraph 122).
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`Application/Control Number: 11/388,723
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`Page 4
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`Art Unit: 1797
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`Childers et al. teaches that the information storage device 62 on the cartridge 14 may
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`store information that relates to the cartridge, such as fluid network configuration, reservoir
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`contents, assay capabilities, assay parameters, etc. (see paragraph 48; figure 3).
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`Childers et al. filrther teaches the incorporates a fluid network 46 & 48 comprising a
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`channel between and connecting each of the chambers and having an optical barrier comprising a
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`cover 170 that is optically opaque (see paragraphs 41 & 74; figures 3 & 12).
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`A?”
`163.1641}
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`150
`"
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`.
`166-
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`163%
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`Childers et al. does not specifically teach the incorporation of a plurality of assay
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`chambers 68.
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`10
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`15
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`However, it would have been obvious to a person of ordinary skill in the art to
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`incorporate a plurality of assay chambers with the disclosed apparatus. The Courts have held that
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`the mere duplication of parts, without any new or unexpected results, is within the ambit of one
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`of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04).
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`Regarding claims 1 and 21, Childers et al. does not specifically teach that the apparatus
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`structure is constructed from an opaque material that can filnction as an optical barrier. However,
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`as indicated by Parce et al.,
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`the use of opaque materials in microfluidic device fabrication is
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`well known in the art (see col. 5, lines 52 — 67). The combination of familiar elements is likely to
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`be obvious when it does no more than yield predictable results. See KSR Int ’1 v. Teleflex Inc,
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`127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143). Furthermore, the
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`Application/Control Number: 11/388,723
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`Page 5
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`Art Unit: 1797
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`Courts have held that the selection of a known material, which is based upon its suitability for
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`the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125
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`USPQ 416 (CCPA 1960) (see MPEP § 2144.07). Therefore, it would have been obvious to a
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`person of ordinary skill in the art to incorporate the use of optically opaque materials in the
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`fabrication of the disclosed microfluidic device.
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`Regarding claim 2, Childers et al. teaches the incorporation of more than one waste
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`chamber 56 (see paragraphs 44 & 50; figure 3). It would have been further obvious to a person
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`of ordinary skill in the art to incorporate a plurality of waste chambers that would correspond to
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`the plurality of assay chambers.
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`10
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`15
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`Regarding claims 4 and 6, Childers et al. teaches that the apparatus can process very
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`small sample volumes, such as with the use of fluid chambers having less than about 50
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`microliters, and 10 microliters, and preferably less than one microliter in volume (see
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`paragraphs 30 & 112). Therefore, it would have been obvious to a person of ordinary skill in the
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`art to incorporate a sample collection unit (sample input 50) that is able provide the required
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`amount of sample volume that is less than about 50 microliters with the disclosed apparatus.
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`Regarding claim 5, Childers et al. does not specifically teach the incorporation of a
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`nonlinear fluidic channel connecting the various chambers.
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`Parce does teach the incorporation of nonlinear fluidic channels between various
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`chambers of a microfluidic device. For example, Parce teaches a nonlinear or curved channel
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`20
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`structure (e. g., 218 and 204) connecting various fluidic chambers in microfluidic device 100 (see
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`col. 12, lines 7 — 44; figure 2). The combination of familiar elements is likely to be obvious when
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`it does no more than yield predictable results. Furthermore, the simple substitution of one known
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`Application/Control Number: 11/388,723
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`Page 6
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`Art Unit: 1797
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`element for another is likely to be obvious when predictable results are achieved. See KSR Int ’1
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`v. Teleflex Inc, 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
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`Therefore, it would have been obvious to a person of ordinary skill in the art to incorporate a
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`nonlinear fluidic with the disclosed microfluidic device.
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`Since the nonlinear fluidic channel disclosed by the prior art has the same structure of the
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`optical barrier in the device as claimed, it is inherently anticipated that it would also serve as an
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`optical barrier. Regarding product and apparatus claims, when the structure recited in the
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`reference is substantially identical to that of the claims, claimed properties or fimctions are
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`presumed to be inherent (see MPEP § 2112.01). The Courts have held that it is well settled that
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`where there is a reason to believe that a functional characteristic would be inherent in the prior
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`art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary.
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`See In re Schrez'ber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir.
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`1 997).
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`Regarding claim 7, Childers et al. teaches the incorporation of immunoassay reagents
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`comprising antibodies that bind an analyte. Childers et al. further indicates that the antibodies
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`can be immobilized or positioned in a fixed position within a microfluidic compartment of the
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`apparatus (see paragraphs 135, Table 1).
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`10
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`15
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`Regarding claims 8 — 11, Childers et al. teaches that the disclosed apparatus is capable of
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`luminescent signal detection (see paragraphs 107 and 108). The disclosed apparatus is capable
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`20
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`of detecting the presence or identifying the analyte and the level or concentration of the analyte,
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`be it a nucleic acid, protein, hormone or metabolite (see paragraphs 121, 122, 125, 126, 132 and
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`135; Table 1). Regarding product and apparatus claims, when the structure recited in the
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`Application/Control Number: 11/388,723
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`Page 7
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`Art Unit: 1797
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`reference is substantially identical to that of the claims, claimed properties or fianctions are
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`presumed to be inherent (see MPEP § 2112.01). The Courts have held that it is well settled that
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`where there is a reason to believe that a functional characteristic would be inherent in the prior
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`art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary.
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`See In re Schrez'ber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir.
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`1997).
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`Regarding claims 9 and 10, Childers et al. teaches the use of immunoassay reagents in
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`facilitating the detection of various analytes (see paragraphs 121, 122, 132 and 135; Table 1).
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`The use of known specif1c immunoassay reagents for detecting the various known recited
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`analytes is notoriously well known in the art (see MPEP § 2144.03). The combination of
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`familiar elements is likely to be obvious when it does no more than yield predictable results. See
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`KSR Int’l v. Teleflex Inc, 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP §
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`2143). Furthermore, the Courts have held that the selection of a known material, which is based
`
`upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See
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`In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07). Therefore, it would have
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`been obvious to a person of ordinary skill in the art to incorporate the use of known specific
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`immunoassay reagents for detecting the various known recited analytes with the apparatus taught
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`by the cited prior art.
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`Conclusion
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`The prior art made of record and not relied upon is considered pertinent to applicant's
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`disclosure: Kricka et al. (US. Pat. No. 5,744,366) teaches a microfluidic device incorporating a
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`10
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`15
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`20
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`Application/Control Number: 11/388,723
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`Page 8
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`Art Unit: 1797
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`nonlinear or serpentine fluidic channel structure (see figures 4 — 7 and 11); Reber et al. (US. Pat.
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`No. 5,961,451) and Buechler et al. (US. Pat. No. 6,074,616) teach pertinent assay devices.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Brian J. Sines Whose telephone number is (571) 272-1263. The
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`examiner can normally be reached on Monday - Friday (11 AM - 8 PM EST).
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Jill A. Warden can be reached on (571) 272-1267. The fax phone number for the
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`organization where this application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent
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`10
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`15
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http://pair-direct.uspto. gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
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`like assistance from a USPTO Customer Service Representative or access to the automated
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`information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`Brian J. Sines
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`Primary Patent Examiner
`Art Unit 1797
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`20
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`/Brian J. Sines/
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`Primary Examiner, Art Unit 1797
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`