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`UNITED STATES PATENT AND TRADEMARK OFFICE
`fl
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450 _
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`Alexandria. Virginia 22313-1450
`www.uspto.gov
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`I ”388,723
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`03/24/2006
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`Timothy M. Kemp
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`30696-712201
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`93] l
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`EXAMINER
`WILSON SONSINI GOODRICH & ROSATI _
`650 PAGE MILL ROAD
`SINES. BRIAN]
`PALO ALTO, CA 94304— 1050
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`PAPER NUMBER
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`ART UNIT
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`1797
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`MAIL DATE
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`03/21/2008
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`DELIVERY MODE
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`PAPER
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`Please find below and/or 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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`P'I‘OL-9OA (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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`.
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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 timelylfiled
`afier 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 alter the mailing date of this com municalion. even it timely filed. may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
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`DE Responsive to communication(s) filed on 10/25/2007.
`2a)EI This action is FINAL.
`2mg 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 Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
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`ME Claim(s) fl) is/are pending in the application.-
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`4a) Of the above Claim(s) fig is/are withdrawn from consideration.
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`5)[] Claim(s) _ is/are allowed.
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`6)E Claim(s) 1_-1_1 is/are rejected.
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`7)I:] Claim(s) __ is/are objected to.
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`8)D Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`9):] The specification is objected to by the Examiner.
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`10)|:l The drawing(s) filed on _ is/are: a)E] accepted or b)|:l 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):] 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)D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)[] All
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`b)|:] Some * c)l:I None of:
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`LC] Certified copies of the priority documents have been received.
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`2.1] Certified copies ofthe priority documents have been received in Application No. _
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`3.|:I 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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`Attachment(s)
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`1) IE Notice of References Cited (PTO-892)
`2) CI Notice of Draflsperson's Patent Drawing Review (PTO-948)
`3) IX] Information Disclosure Statement(s) (PTO/SB/OB)
`Paper No(s)/Mai| Date
`.
`US. Patent and Trademark Off‘ce
`PTOL-326 (Rev. 08-06)
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`4) [:I Interview Summary (PTO-413)
`Paper No(s)/Mai| Date. _
`5) I:I Notice of Informal Patent Application
`6) C] Other:
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`Office Action Summary
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`Part of Paper No./Mai| Date 20080106
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`

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`Application/Control Number:
`1 1/3 88,723
`Art Unit: 1797
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`Page 2
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`DETAILED ACTION
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`Election/Restrictions
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`Applicant’s election without traverse of group I comprising claims 1 — 11 in the reply
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`filed on 10/25/2007 is acknowledged.
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`Claims 12 — 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as
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`being drawn to a nonelected invention, there being no allowable generic or linking claim.
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`Claim Rejections - 35 USC § 102
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`The following is a quotation of the appropriate paragraphs of 35 USC. 102 that form the
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`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 1 — 11 are rejected under 35 USC. 102(b) as being anticipated by Parce et al.
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`(US. Pat. No. 5,942,443; filed June 28, 1996; issued Aug. 24, 1999) (“Parce”).
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`Regarding claims 1 and 3, Parce teaches an apparatus structure 300 comprising: a sample
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`collection unit (e.g., sample injection channel 304) for introducing a biological fluid in fluid
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`communication with a plurality of reaction sites; (b) a plurality of reaction chambers (e. g., bead
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`resting wells 326 — 338) carrying a plurality of reactants in fluid communication with the
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`reaction sites, wherein the plurality of reaction sites comprise a plurality of reactants bound
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`thereto; and (c) a system of fluidic channels (e. g., reaction channels 312 — 324, seeding channel
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`306, etc.) to permit fluid flow within the apparatus, wherein at least one channel located between
`the plurality of reactiOn sites comprise an optical barrier (see figures 3 and 4A — 4F; col. 16, lines
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`1 — 65). The plurality of reaction sites comprising a plurality of test‘compounds or reactants can
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`

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`Application/Control Number:
`1 1/3 88,723
`Art Unit: 1797
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`I
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`Page 3
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`be bound or immobilized on beads that are contained within bead resting wells 326 — 338 (see,
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`e.g., col. 7, lines 3 — 19; col. 16, line 47 — col. 17, line 67; col. 18, lines 31 - 50). Apparatus
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`claims must be structurally distinguishable from the prior art in terms of structure, not function.
`The manner of operating an apparatus does not differentiate an apparatus claim from the prior
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`art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP §
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`2114 & § 2173.05(g)).
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`
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`Regarding claim 2, Parce teaches the incorporation of an additional chamber structure
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`(e.g., indicated at 344) in fluidic communication with at least one of the reaction sites (see figure
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`3).
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`Regarding claim 4, Parce teaches the incorporation of nonlinear fluidic channels, such as
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`serpentine or saw tooth fluidic channels, with the disclosed apparatus (see, e.g., col. 8, lines 43 —
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`57).
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`

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`Application/Control Number:
`11/388,723
`Art Unit: 1797
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`Page 4
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`Regarding claims 5 and 6, the volume amount of biological fluid that can be processed is
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`considered a statement of intended use. These claims do not recited any specific channel
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`dimensions, such as channel width or length,
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`that would enable the claimed device to process
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`the recited volume amount of biological fluid. Since these claims are drawn to an apparatus.
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`statutory class of invention, the structure of the apparatus must be positively recited.
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`Regarding claims 7 and 9, Parce anticipates the use and incorporation of immunoassay
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`reagents, e. g., antibody/antigen binding pairs, with the disclosed apparatus. Parce additionally
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`anticipates the detection of complementary nucleic acids (see, e.g., col. 6, lines 8 — 22).
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`Regarding claim 8, this claim is considered a statement of intended use or a functional
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`attribute of the apparatus. This claim does not positively recite any kind of structure that would
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`enable the recited detection function. Parce does teach the incorporation of an optical detection
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`system (see, e.g., col. 10, lines 5 — 17).
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`Regarding claim 10, Parce anticipates the detection of various biomarkers, such as
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`growth factors and enzymes, or drugs comprising small organic or inorganic molecules, etc. (see,
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`e.g., col. 5, line 10 — col. 7, line 39; col. 4, lines 49 — 67).
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`Regarding claim 11, Parce teaches the incorporation of a luminescent or fluorescent
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`detection system (see, e.g., col. 7, lines 40 - 65).
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directedto 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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`Application/Control Number:
`11/388,723
`Art Unit: 1797
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`Page 5
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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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`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
`
`/Brian J. Sines/'
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`Primary, Examiner, Art Unit 1797
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`