`
`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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`
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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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`
`
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`CONF {MATION NO.
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`11/388,723
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`03/24/2006
`
`Timothy M. Kemp
`
`30696—712201
`
`9311
`
`02/27/2009
`7590
`21971
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
`
`EXAMINER
`
`GORDON, BRIAN R
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`ART UNIT
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`1797
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`MAIL DATE
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`02/27/2009
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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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`

`

`
`
`Application No.
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`11/388,723
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`Applicant(s)
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`KEMP ET AL.
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`Office Action Summary
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`Examiner
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`Brian R. Gordon
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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 05 December 2008.
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`2a)IZI This action is FINAL.
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`2b)I:I 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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`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 21-23 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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`
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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) D 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
`.
`U.S. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper N0(S)/IVI3II 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 20090226
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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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`1.
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`Applicant's arguments filed December 5, 2008 have been fully considered but
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`they are not persuasive. Applicant has amended claim 1 to incorporate the phrase
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`“through which optical signals are detected;" The phrase is directed to the intended use
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`of sites. It has been held that a recitation with respect to the manner in which a claimed
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`apparatus is intended to be employed does not differentiate the claimed apparatus from
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`a prior art apparatus satisfying the claimed structural limitations. The claims is directed
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`to an apparatus not a method in which the device is used in specific process. There is
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`10
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`no optical system claimed that includes a signal source or detector for detecting such a
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`signal. Applicant’s argument's directed to the “optical barrier" are directed to the use of
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`the barrier rather than the structure of the barrier. It is only required that the prior art
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`disclose a structure that is capable of functioning to retard optical radiation. As such,
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`the opaque material of which the device of Childers is comprised meets the limitation of
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`15
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`the claim. It is not required that the prior art disclose the device as being used in the
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`same manner or intended function as that desired by applicant.
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`Claim Rejections - 35 USC § 103
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`1.
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`The text of those sections of Title 35, U.S. Code not included in this action can
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`20
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`be found in a prior Office action.
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`

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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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`2.
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`Claims 1 — 11 and 21-23 are rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Childers et al. (U.S. Pat. Appl. No. 2004/0086872) in view of Parce
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`et al. (U.S. Pat. No. 5,885,470).
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`Regarding claims 1 and 3, Childers et al. teaches an apparatus structure
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`(cartridge 14) comprising: a sample collection unit (sample input 50) for introducing a
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`biological fluid sample in fluid communication with a reaction site (assay chamber 68); a
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`plurality of reactant chambers (reagent reservoir 52) in fluid communication with the
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`reaction site 68; a system of fluidic channels (fluid network 46 & 48) to allow the
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`biological fluid sample and reactants to flow in the apparatus (see paragraphs 40 — 52
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`10
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`and 57; figures 1 — 3).
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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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`PRE-
`, PROCESSWG
`cameras;
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`,
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`‘
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`INFDRMATtL—I‘N
`DEWCE
`_62
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`STORAGE
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`CHIP
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`H SUFPDRT m SAMPLE
`‘51”)
`{-54
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`REAGENTS ‘ lNPUT
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`ELECTRONlCS
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`Childers et al. indicates that the apparatus can be configured to detect various
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`types of analytes other than nucleic acids, including proteins, hormones and metabolites
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`(see paragraphs 23, 121, 122 and 125).
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`Childers et al. teaches that the device is suitable for diagnostic use purposes on
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`clinical samples, such as for drug screens (see paragraph 122).
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`Childers et al. teaches that the information storage device 62 on the cartridge 14
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`may store information that relates to the cartridge, such as fluid network configuration,
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`reservoir contents, assay capabilities, assay parameters, etc. (see paragraph 48; figure
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`10
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`3).
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`Childers et al. further teaches the incorporates a fluid network 46 & 48
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`comprising a channel between and connecting each of the chambers and having an
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`optical barrier comprising a cover 170 that is optically opaque (see paragraphs 41 & 74;
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`figures 3 & 12).
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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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`
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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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`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
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`have held that the mere duplication of parts, without any new or unexpected results, is
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`within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378
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`(CCPA 1960) (see MPEP § 2144.04).
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`Regarding claims 1 and 21, Childers et al. does not specifically teach that the
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`10
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`apparatus structure is constructed from an opaque material that can function as an
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`optical barrier. However, as indicated by Parce et al.,
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`the use of opaque materials in
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`microfluidic device fabrication is well known in the art (see col. 5, lines 52 — 67). The
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`combination of familiar elements is likely to be obvious when it does no more than yield
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`predictable results. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d
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`15
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`1385, 1397 (2007) (see MPEP § 2143). Furthermore, the Courts have held that the
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`selection of a known material, which is based upon its suitability for the intended use, is
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`within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416
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`(CCPA 1960) (see MPEP § 2144.07). Therefore, it would have been obvious to a
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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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`person of ordinary skill in the art to incorporate the use of optically opaque materials in
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`the fabrication of the disclosed microfluidic device.
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`Regarding claim 2, Childers et al. teaches the incorporation of more than one
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`waste chamber 56 (see paragraphs 44 & 50; figure 3). It would have been further
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`obvious to a person of ordinary skill in the art to incorporate a plurality of waste
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`chambers that would correspond to the plurality of assay chambers.
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`Regarding claims 4 and 6, Childers et al. teaches that the apparatus can process
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`very small sample volumes, such as with the use of fluid chambers having less than
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`about 50 microliters, and 10 microliters, and preferably less than one microliter in
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`10
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`volume (see paragraphs 30 & 112). Therefore, it would have been obvious to a person
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`of ordinary skill in the art to incorporate a sample collection unit (sample input 50) that
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`is able provide the required amount of sample volume that is less than about 50
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`microliters with the disclosed apparatus.
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`Regarding claim 5, Childers et al. does not specifically teach the incorporation of
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`15
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`a 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
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`channel structure (e.g., 218 and 204) connecting various fluidic chambers in microfluidic
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`device 100 (see col. 12, lines 7 — 44; figure 2). The combination of familiar elements is
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`20
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`likely to be obvious when it does no more than yield predictable results. Furthermore,
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`the simple substitution of one known element for another is likely to be obvious when
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`predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727,
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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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`1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143). Therefore, it would have
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`been obvious to a person of ordinary skill in the art to incorporate a nonlinear fluidic with
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`the disclosed microfluidic device.
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`Since the nonlinear fluidic channel disclosed by the prior art has the same
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`structure of the optical barrier in the device as claimed, it is inherently anticipated that it
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`would also serve as an optical barrier. Regarding product and apparatus claims, when
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`the structure recited in the reference is substantially identical to that of the claims,
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`claimed properties or functions are presumed to be inherent (see MPEP § 2112.01).
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`The Courts have held that it is well settled that where there is a reason to believe that a
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`10
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`functional characteristic would be inherent in the prior art, the burden of proof then shifts
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`to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128
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`F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997).
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`Regarding claims 7 and 22-23, Childers et al. teaches the incorporation of
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`immunoassay reagents comprising antibodies that bind an analyte. Childers et al.
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`15
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`further indicates that the antibodies can be immobilized or positioned in a fixed position
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`within a microfluidic compartment of the apparatus (see paragraphs 135, Table 1).
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`Regarding claims 8 — 11, Childers et al. teaches that the disclosed apparatus is
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`capable of luminescent signal detection (see paragraphs 107 and 108). The disclosed
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`apparatus is capable of detecting the presence or identifying the analyte and the level
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`20
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`or concentration of the analyte, be it a nucleic acid, protein, hormone or metabolite (see
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`paragraphs 121, 122, 125, 126, 132 and 135; Table 1). Regarding product and
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`apparatus claims, when the structure recited in the reference is substantially identical to
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`

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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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`that of the claims, claimed properties or functions are presumed to be inherent (see
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`MPEP § 2112.01). The Courts have held that it is well settled that where there is a
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`reason to believe that a functional characteristic would be inherent in the prior art, the
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`burden of proof then shifts to the applicant to provide objective evidence to the contrary.
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`See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed.
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`Cir. 1997).
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`Regarding claims 9 and 10, Childers et al. teaches the use of immunoassay
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`reagents in facilitating the detection of various analytes (see paragraphs 121, 122, 132
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`and 135; Table 1). The use of known specific immunoassay reagents for detecting the
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`10
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`various known recited analytes is notoriously well known in the art (see MPEP §
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`2144.03). The combination of familiar elements is likely to be obvious when it does no
`
`more than yield predictable results. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727,
`
`1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143). Furthermore, the Courts
`
`have held that the selection of a known material, which is based upon its suitability for
`
`15
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`the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin,
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`125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07). Therefore, it would have been
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`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
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`apparatus taught by the cited prior art.
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`20
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`Conclusion
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`3.
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`TTHIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`

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`Application/Control Number: 11/388,723
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`Page 9
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`Art Unit: 1797
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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 mailing date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`10
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`examiner should be directed to Brian R. Gordon whose telephone number is 571-272-
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`1258. The examiner can normally be reached on M-F, 1st Fri. Off.
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`lf attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Jill Warden can be reached on 571-272—1267. The fax phone number for
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`the organization where this application or proceeding is assigned is 571 -273-8300.
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`

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`Application/Control Number: 11/388,723
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`Page 10
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`Art Unit: 1797
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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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`5
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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). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272—1000.
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`10
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`/Brian R Gordon/
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`Primary Examiner
`Art Unit 1797
`
`