`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`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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`
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`CONF {MATION NO.
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`13/355,458
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`01/20/2012
`
`Ian Gibbons
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`30696—733201
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`1056
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`21971
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`7590
`
`11/05/2013
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`WILSON, SONSINI, GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304-1050
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`EXAMINER
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`REYES, CHRISTOPHER R
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`ART UNIT
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`1639
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`MAIL DATE
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`11/05/2013
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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/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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`PTOL—90A (Rev. 04/07)
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`

`

`
`
`Applicant(s)
`Application No.
` 13/355,453 GIBBONS ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`1639CHRISTOPHER REYES first“
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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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`
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE _1MONTH(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 () 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 24 June 2013.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)lX| This action is non-final.
`a)I:| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`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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`5)|XI Claim(s) 1-35 37-64 72-82 and 92-106 is/are pending in the application.
`5a) Of the above claim(s) 1-33,38-64 and 72-82 is/are withdrawn from consideration.
`6)|:l Claim(s) _ is/are allowed.
`7)I:l Claim(s)_ is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
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`9)|XI Claim((s) 34 35 37 and 92-106 are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://www.usoto. ov/ atents/init events"
`
`
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`h/index.‘3 or send an inquiry to PRI-Ifeedback{<‘buspto.qov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I: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).
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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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`Priority under 35 U.S.C. § 119
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some * c)I:I None of the:
`a)|:l All
`1.|:| Certified copies of the priority documents have been received.
`2.|:| Certified copies of the priority documents have been received in Application No.
`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)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
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`1) D Notice of References Cited (PTO-892)
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`3) I] Interview Summary (PTO-413)
`
`Paper NOISI/Ma” Date —
`PTO/SB/08
`t
`St t
`I
`D'
`t'
`f
`2 I:l I
`)
`4) I:I Other:
`a emen (s)(
`Isc osure
`n orma Ion
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`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`PTOL-326 (Rev. 08-13)
`
`Part of Paper No./Mai| Date 20131030
`
`Office Action Summary
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`

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`Application/Control Number: 13/355,458
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`Page 2
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`Art Unit: 1639
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`DETAILED ACTION
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`Responsive to communications entered 24 June 2013.
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`Claims 1-35, 37-64, 72-82, 92-106 are pending.
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`Claims 36, 65-71, 83-91 are canceled.
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`Claims 1-33, 38-64, 72-82 are withdrawn.
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`Claims 34, 35, 37, 92-106 are subject to election/restriction requirement as follows:
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`The following election of species has been necessitated by applicant’s amendment to
`the claims of 6/24/2013 therein introducing species previously not considered over
`examination of the elected invention.
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`Election/Restrictions
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`This application contains claims directed to the following patentably distinct
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`species:
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`Each genus is indicated below in bold.
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`Species election 1 : Applicant is required to elect a species of sample as in
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`claims 95 and 99.
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`Applicant is required to specify: (i) as to whether the sample is suitable for
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`storage in a pipette tip or not; and (ii) as to whether the sample is biological in nature.
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`Note: Regarding species election 1, claims 34, 35, 37, 92-94, 96-98, 105, and
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`106 are generic.
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`The species are independent or distinct because the species have different
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`designs, modes of operation, and effects. A non-biological sample that is suitable for
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`storage in a pipette tip includes water samples. A sample that is not suitable for storage
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`in a pipette tip includes prepared histological sample.
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`In a water sample, analyte is
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`Application/Control Number: 13/355,458
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`Page 3
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`Art Unit: 1639
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`homogeneously distributed whereas in a prepared histological sample analyte is
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`localized to certain regions of a tissue. That is, imaging the water sample can only
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`indicate whether an analyte is present or not whereas imaging the histological sample
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`can indicate how an analyte is distributed within tissue. Furthermore, whereas a
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`histological sample requires a microscope slide as container, a water sample requires a
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`container capable of holding a liquid appropriately for imaging.
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`In addition, these
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`species are not obvious variants of each other based on the current record.
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`Species election 2: Applicant is required to elect a species of analyte detection
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`as in claim 92.
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`Applicant is required to elect whether the analyte is reacted with reagents that
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`specifically react with the analyte to generate an optically detectable signal or not.
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`Note: Regarding species election 2, claims 34, 35, 37, 95, 99-104 are generic.
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`The species are independent or distinct because the species have distinct
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`designs, modes of operation, and effects.
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`If the analyte is detected without reagents
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`that specifically interact with the analyte, then the analyte may be imaged using dyes
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`that generically bind molecules, such as binding of proteins by Coomassie Brilliant Blue
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`stain.
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`If the analyte is detected with reagents that specifically interact with the analyte,
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`then the detection requires a molecule capable of specifically recognizing and reacting
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`with the analyte such as an antibody. Accordingly, the species have different reagent
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`requirements and are suitable for different degrees of discrimination among analyte
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`molecules (e.g. Coomassie stain will bind all protein whereas a more specific reagent
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`Page 4
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`Art Unit: 1639
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`targets and images of only the analyte of interest).
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`In addition, these species are not
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`obvious variants of each other based on the current record.
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`Species election 3:
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`If Applicant elects that the sample is suitable for storage in a
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`pipette tip, Applicant is further required to elect a species of imaging as in claim 99.
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`Applicant is required to elect whether the sample is imaged while in a pipette tip
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`or not.
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`Note: Regarding species election 3, claims 34, 35, 37, 92-98, 105, and 106 are
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`generic.
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`The species are independent or distinct because the species have distinct
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`designs, modes of operation, and effects. A sample that is not imaged in a pipette tip
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`may instead be imaged in a cuvette.
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`In addition to requiring different materials to
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`accomplish imaging, the species are also distinguished by the data that is yielded.
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`Whereas cuvettes are designed to be suitable for applications wherein light absorption
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`or emission by a sample is precisely measured, common pipette tips are not.
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`Accordingly, imaging in a pipette tip requires considerations, such as whether the
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`pipette tip material absorbs strongly at a wavelength of interest, that are not issues
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`when cuvettes are properly applied.
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`In addition, these species are not obvious variants
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`of each other based on the current record.
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`Species election 4:
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`If Applicant elects that analyte detection is performed by
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`reaction with one or more reagents to generate an optically detectable signal, Applicant
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`Page 5
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`Art Unit: 1639
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`is further required to elect a species of measuring the plurality of detection regions
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`as in claims 97 and 98.
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`Applicant is required to elect whether the plurality of detection spectral regions is
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`measured simultaneously or whether they are measured sequentially.
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`Note: Regarding species election 4, claims 34, 35, 37, 92-96, 99-106 are
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`generic.
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`The species are independent or distinct because they have different designs and
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`modes of operation.
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`In a species that measures the detection spectral regions
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`sequentially, the experimental setup requires a monochromator. In a species that
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`measures the detection spectral regions simultaneously, no monochromator is
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`necessary and the image may be recorded by simply taking a color snap shot of the
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`sample with a common camera.
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`In addition, these species are not obvious variants of
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`each other based on the current record.
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`Species election 5:
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`If Applicant elects that the sample is imaged while in a
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`pipette tip, Applicant is further required to elect a species of illumination-imaging
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`device configuration as in claims 100 and 101.
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`Applicant is required to elect whether the illumination source is located on the
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`same side of the pipette tip as the imaging device or whether the illumination source is
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`located on an opposing side of the pipette tip as the imaging device.
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`Note: Regarding species election 5, claims 34, 35, 37, 92-99, 102-106 are
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`generic.
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`Page 6
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`Art Unit: 1639
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`The species are independent or distinct because the species have different
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`designs, modes of operation, and effects. When the illumination source and imaging
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`device are on opposing sides of the pipette tip, they are appropriately arranged to
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`enable measurement of absorption of light passing through the sample, which in turn
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`may be used to detect analyte. When the illumination source and imaging device are
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`on the same side of the pipette tip, they are not in proper alignment to measure
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`absorption but instead they are setup to measure light reflected back by the sample.
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`This latter arrangement is analogous to the flash of a camera which permits enhanced
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`visualization of the colors emitted by the sample.
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`In addition, these species are not
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`obvious variants of each other based on the current record.
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`Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or
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`a single grouping of patentably indistinct species, for prosecution on the merits to which
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`the claims shall be restricted if no generic claim is finally held to be allowable.
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`There is a search and/or examination burden for the patentably distinct species
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`as set forth above because at least the following reason(s) apply:
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`There is a search and/or examination burden for the patentably distinct species
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`as set forth above because at least the following reason(s) apply:
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`the species or groupings of patentably indistinct species have acquired a
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`separate status in the art in view of their different classification
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`the species or groupings of patentably indistinct species have acquired a
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`separate status in the art due to their recognized divergent subject matter -- For
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`example, the non-patent literature applicable to one species would not likely be
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`Page 7
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`applicable to another species even if some of the species may be classified in the same
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`class/subclass)
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`the species or groupings of patentably indistinct species require a different field
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`of search (e.g., searching different classes/subclasses or electronic resources, or
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`employing different search strategies or queries). -- For example, the species require
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`different non-overlapping fields of search of concerning particular classes/subclasses,
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`and/or databases and/or or employing different search techniques
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`In other words, the search required for one species not required for the other(s)
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`and prior art applicable to one species would not necessarily be applicable to another
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`species. Moreover, in terms of overall examination, each species raises unique non-
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`prior art issues concerning subject matter eligibility and/or the disclosure providing an
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`adequate and enabling description thereof each.
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`Accordingly, the foregoing embodiment election of particular species for
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`examination purposes is indicated as proper otherwise a serious and undue burden
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`would be placed on the Office.
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`Applicant is advised that the reply to this requirement to be complete must
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`include (i) an election of a species to be examined even though the requirement
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`may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
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`the elected species or grouping of patentably indistinct species, including any
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`claims subsequently added. An argument that a claim is allowable or that all claims are
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`generic is considered nonresponsive unless accompanied by an election.
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`The election may be made with or without traverse. To preserve a right to
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`petition, the election must be made with traverse. If the reply does not distinctly and
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`specifically point out supposed errors in the election of species requirement, the election
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`Page 8
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`shall be treated as an election without traverse. Traversal must be presented at the time
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`of election in order to be considered timely. Failure to timely traverse the requirement
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`will result in the loss of right to petition under 37 CFR 1.144. If claims are added after
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`the election, applicant must indicate which of these claims are readable on the elected
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`species or grouping of patentably indistinct species.
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`Should applicant traverse on the ground that the species, or groupings of
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`patentably indistinct species from which election is required, are not patentably distinct,
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`applicant should submit evidence or identify such evidence now of record showing them
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`to be obvious variants or clearly admit on the record that this is the case. In either
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`instance, if the examiner finds one of the species unpatentable over the prior art, the
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`evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35
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`U.S.C. 103(a) of the other species.
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`Upon the allowance of a generic claim, applicant will be entitled to consideration
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`of claims to additional species which depend from or otherwise require all the limitations
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`of an allowable generic claim as provided by 37 CFR 1.141.
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`Applicant is reminded that upon the cancellation of claims to a non-elected
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`invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one
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`or more of the currently named inventors is no longer an inventor of at least one claim
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`remaining in the application. A request to correct inventorship under 37 CFR 1.48(a)
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`must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that
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`identifies each inventor by his or her legal name and by the processing fee required
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`under 37 CFR1.17(i).
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