`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
`
`APPLICATION NO.
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`
`
`
`
` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
`
`13/646,784
`
`10/08/2012
`
`Masaya TAMURA
`
`MAT—10579US
`
`1082
`
`EXAMINER
`RATNERPRESTIA —
`09/27/2013 —
`7590
`52473
`PO. BOX 980
`MARCSISIN, ELLEN JEAN
`VALLEY FORGE, PA 19482-0980
`
`PAPER NUMBER
`
`ART UNIT
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`1641
`
`
`
`
`NOT *ICATION DATE
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`DELIVERY MODE
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`09/27/2013
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`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`
`ptocorrespondence @ratnerprestia.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 13/646,784 TAMURA ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1641Ellen J. Marcsisin it?“
`
`-- 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 () 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).
`
`Status
`
`1)IZI Responsive to communication(s) filed on 07/25/2013.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|:l This action is non-final.
`2a)|Z| 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.
`
`4)|:| 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 Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)IZI Claim(s) 1-16is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6)I:I Claim(s)
`7)|Z| Claim(s)_1-16 is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
`
`
`are subject to restriction and/or election requirement.
`9)I:I Claim((s)
`* 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
`hit
`:/'I’\WIIW.LIsnto. ovI’ atentS/init events/
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`hI/index.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
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`10)I:l The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 10/08/2012 is/are: a)IXI accepted or b)|:l objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`
`12)IXI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)IZl All
`
`b)|:l Some * c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`SIXI Copies of the certified copies of the priority documents have been received in this National Stage
`
`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)
`
`1) E Notice of References Cited (PTO-892)
`
`3) D Interview Summary (PTO-413)
`
`Paper N°ISI/Ma" Date' —
`PTO/SB/08
`t
`t
`St
`I
`D'
`I'
`f
`2 I] I
`)
`4) I:I Other:
`a emen (s) (
`Isc osure
`n orma Ion
`)
`Paper No(s)/Mai| Date
`U.S. Patent and Trademark Office
`PTOL—326 (Rev. 08-13)
`
`Part of Paper No./Mai| Date 20130921
`
`Office Action Summary
`
`

`

`Application/Control Number: 13/646,784
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`Page 2
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`Art Unit: 1641
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`DETAILED ACTION
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`1.
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`The present application is being examined under the pre—AIA first to invent provisions.
`
`Amendment Entry
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`2.
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`Applicant’s amendment, filed 07/25/2013, is acknowledged and has been entered. Claims
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`1, 8, and 15—16 were amended. Claims 1—16 are pending in the application. Claim 1—16 are
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`subject to examination below.
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`Rejections Withdrawn
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`3.
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`The rejection under 112(d) of claims 9—11 are withdrawn a result of Applicant's
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`amendments to the claims.
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`The rejection under 102(b) of claims 1, 6 and 7, are withdrawn as a result of Applicant’s
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`amendments to the claims.
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`Claim Rejections - 35 USC § 103
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`4.
`
`The following is a quotation of pre—AIA 35 USC. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed
`or described as set forth in section 102 of this title, if the differences between the
`
`subject matter sought to be patented and the prior art are such that the subject
`matter as a whole would have been obvious at the time the invention was made to
`
`a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was
`made.
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`

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`Application/Control Number: 13/646,784
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`Page 3
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`Art Unit: 1641
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`5.
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`Claim 1 is rejected under pre—AIA 35 U.S.C. 103(a) as being unpatentable over Kenichi
`
`et al., JP 09—257702 (1997) (IDS entered on 10/08/2012) in View of Wang et al. PG. Pub. No. US
`
`2007/0252982.
`
`The claims are drawn to:
`
`A plasmon sensor for use with an electromagnetic wave source that produces an
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`electromagnetic wave, the plasmon sensor comprising: a first metal layer having a bottom
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`surface and a top surface configured to be supplied with the electromagnetic wave; and a second
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`metal layer having a top surface confronting the bottom surface of the first metal layer, wherein
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`a hollow region configured to be filled with a specimen containing a medium is provided
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`between the first metal layer and the second metal layer, a distance between the first metal layer
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`and the second metal layer is substantially equal to (1/2) x x1 x m where 2 is a wavelength of the
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`electromagnetic wave in the hollow space produced by the electromagnetic wave source and m is
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`an integer not smaller than one, and analyte capturing bodies are physically adsorbed to at least
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`one below of the first metal layer and above of the second metal layer.
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`Kenichi et al. (1997) teach a surface plasmon resonance sensor deVice (abstract) having a
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`thin metallic layer referred to as a metal thin film surface (see abstract, and page 4, para [0004])
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`and a counter electrode (page 5, para [0008]), thereby addressing the limitation of a second
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`metallic film. The sensor deVice is subjected to incident light (page 5, para [0004]), thereby
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`addressing the limitation wherein the surfaces are configured to be supplied with an
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`electromagnetic wave, which goes into the metal thin film and creates an evanescent wave. The
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`two metal surfaces create a hollow region configured to be filled with a specimen containing
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`medium (see the Visual depiction of Fig. l, the space between the embodiments labeled 4 and 6),
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`Application/Control Number: 13/646,784
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`Page 4
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`Art Unit: 1641
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`and the sensor is equipped with antibodies which adsorb protein, the antibodies are fixed to the
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`outside surface of the metal thin film, indicated at Fig. 1, number 4, page 7, para [0016], thereby
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`addressing the limitation of capture bodies physically adsorbed to at least one of the metal layers.
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`Kenichi et al. do not specifically teach a distance between the first and second metal
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`layers is substantially equal to (1/2) x 9» x m, where 9» is a wavelength of the electromagnetic
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`wave in the hollow space produced by the electromagnetic wave source and m is an integer not
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`smaller than one.
`
`Wang et al. teach a Raman signal enhancing structure coupled to a tunable resonant
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`cavity (e.g. see page 3, para [0023], page 4, para [0051]), the tunable resonant cavity including a
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`first reflective member, a second reflective member and an electro—optical material. Specifically
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`at page 5, para [0062], Wang et al. teach the effective length of the resonant cavity may be
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`defined as the length L separating the major surfaces of the reflective members (refer to Fig. 2B,
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`embodiment L), multiplied by the refractive indeX of the electro—optical material. Importantly,
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`Wang et al. further teach at para [0062], If the effective length is not equal to an integer multiple
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`of one half of the wavelength of the reflecting electromagnetic radiation (the wavelength of the
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`resonating light), then the rays reflecting back and forth between the reflective members may
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`interfere destructively. If the effective length is equal to an integer multiple of one half of the
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`wavelength of the reflecting light, the rays may interfere constructively, thereby increasing the
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`intensity or power of the electromagnetic radiation within the tunable resonant cavity. Note that
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`although Wang et al. here discuss Raman signaling, the reference makes clear that the resonance
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`at issue is surface plasmon resonance (see, e.g., [0047], [0060]); as in Kenichi et al.
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`Page 5
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`Art Unit: 1641
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`It would have been primafacie obvious to one of ordinary skill in the art, at the time the
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`invention was made, to have used a distance equal to (1/2) x 9» x n, where 9» is a wavelength of
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`the resonating electromagnetic wave in the space and n is an integer not smaller than one to
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`define the space between two reflective members, as taught by the invention of Wang et al., to
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`have modified the plasmon biosensor of Kenichi et al., to arrive at the claimed invention because
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`Wang et al. specifically teaches that if the space between two reflective members is not equal to
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`said equation, where the variable n is an integer value, destructive interference may occur. It
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`would be obvious to avoid a distance that would result in destructive interference because there
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`would be no signal to detect, as the reflected beams would cancel each other out. Rather the
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`ordinarily skilled artisan would be motivated to provide a distance equal to said equation, using
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`an integer value of n because the beams would be expected to constructively interfere, causing an
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`increased intensity for detection. The ordinarily skilled artisan would have a reasonable
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`expectation of success modifying the plasmon sensor of Kenichi et al. so that the space between
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`the reflective planes would be equal the equation of Wang et al. because one would recognize
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`that both inventions are analogous (i.e. the tunable cavity of Wang et al. and the plasmon sensor
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`of Kenichi et al.) with respect to the propagation of a wave through a space created by two
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`reflective planes, and therefore the distance would necessarily have to be set so as to avoid
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`destructive interference.
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`Claims 2—3 and 5—7 are rejected under pre—AIA 35 U.S.C. 103(a) as being unpatentable
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`over Kenichi et al., JP 09—257702 (1997) (IDS entered on 10/08/2012) in view of Wang et al.
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`Page 6
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`Art Unit: 1641
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`PG. Pub. No. US 2007/0252982 as applied to claim 1 above, and further in view of Lyon et al., J.
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`Phys. Chem. B, 103 (1999), p. 5826—5831.
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`Kenichi et al. and Wang et al. are as discussed in detail above, which teach an apparatus
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`substantially as claimed, but which fail to specifically teach wherein particles are disposed
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`between the first metal layer and the second metal layer, and that the analyte capturing bodies are
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`chemically adsorbed to the surfaces of the particles.
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`Lyon et al. (1999) teach throughout the document and at page 5826, col. 1—2, para [1] the
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`use of an antibody and a gold particle joined together, investigating the influence of the
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`conjugate pair on surface plasmon resonance and its ability to amplify a sensor’s biosensing
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`ability. Specifically, Lyon et al. refer to reports that indicate amplified biosensing where large
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`particles are coupled to biomolecules, causing large refractive indeX shifts during bimolecular
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`recognitions events; and also Lyon et al. teach reporting a similar approach wherein colloidal
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`gold was employed as the biocompatible tag for a sandwich immunoassay. Lyon et al. teach
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`there was a greater than 20—fold increase in plasmon angle shift over the observed assay that
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`employed an unlabeled antibody. The gold particles are disposed on the gold thin film surface,
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`e.g. page5827, Fig. 1. Furthermore, at page 5826, col. 2, para 1, Lyon et al. teach that colloidal
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`particles pose excellent tags for the determination of extremely low quantities of analyte that are
`
`not routinely observable using traditional assay methods. Also, at page 5826, col. 2 para 1, Lyon
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`et al. teach that their results demonstrate that by using colloidal gold particles in a sensing
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`device, one provides the potential for significant improvement in the sensitivity and dynamic
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`range of colloidal gold amplified bio—sensing, which is based on the size of the particle.
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`Application/Control Number: 13/646,784
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`Page 7
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`Art Unit: 1641
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`It would have been primafacie obvious to one of ordinary skill in the art, at the time of
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`the invention to have used a conjugate metal antibody pair, disposed on a metallic thin film, as
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`taught by Lyon et al., to have modified the plasmon sensor as described the combination Kenichi
`
`et al. and Wang et al., to arrive the claimed invention because Lyon et al. teach colloidal gold
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`particle/antibody conjugate pairs perform as excellent signal enhancement of up to a greater than
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`20—fold increase in plasmon angle shift over the observed assay that employed an unlabeled
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`antibody and further because Lyon et al. teach that colloidal particles pose excellent tags for the
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`determination of extremely low quantities of analyte that are not routinely observable using
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`traditional assay methods. Additionally, the ordinarily skilled artisan would be motivated to
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`perform said modification because Lyon et al. teach that their results demonstrate that by using
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`colloidal gold particles in a sensing device, one provides the potential for significant
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`improvement in the sensitivity and dynamic range of colloidal gold amplified bio—sensing. It
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`would be obvious to improve an apparatus to enhance sensitivity of detection. The ordinarily
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`skilled artisan would have a reasonable expectation of success in performing the modification of
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`the apparatus as described by the combination of Kenichi et al. and Wang et al. with the colloidal
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`gold metallic particles of Lyon et al. because said modification would not be expected to change
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`the device so as to alter the way it is used, but rather would be expected to improve the detection
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`capabilities of the device.
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`Regarding claim 3, the analyses of Lyon et al. addresses the further limitation of claim 3,
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`as gold is a metal.
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`Page 8
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`Art Unit: 1641
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`Regarding claim 5, the gold colloidal particle above is considered to be an additive
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`physically adsorbed together with the analyte capturing body (i.e. antibody). As indicated in the
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`analyses above, it would be obvious to use colloidal gold to enhance detection.
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`Regarding claim 6, Kenichi et al. also teach at page 7, para [0016] that the protein
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`molecule are attracted to the thin metallic film side and effectively adsorbed on the antibodies
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`located on the thin metallic film. This statement suggests that the majority of antibodies are
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`present on the thin metallic film, thereby suggesting that an uneven density distribution of the
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`antibodies is occurring; Thereby addressing the limitation wherein the analyte capturing bodies
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`are disposed with an uneven density.
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`Regarding claim 7, Fig. 1 of Kenichi et al. visually demonstrates two openings, which are
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`considered to be insertion sections. Also, since the antibodies are to be adsorbed to the
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`embodiment labeled 4, it is also assumed that the antibodies are not in the insertion sections;
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`thereby addressing a specimen insertion section for insertion of a specimen containing an analyte
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`into a hollow region, wherein the analyte capturing bodies are not disposed in the specimen
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`insertion section.
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`Claim 4 is rejected under pre—AIA 35 U.S.C. 103(a) as being unpatentable over Kenichi
`
`et al., JP 09—257702 (1997) (IDS entered on 10/08/2012) in view of Wang et al. PG. Pub. No. US
`
`2007/0252982 and Lyon et al., J. Phys. Chem. B, 103 (1999), p. 5826—5831 as applied to claim 2
`
`above, and further in view of Yamaguchi et al., Top. Curr. Chem., 288, (2003), p. 237—258.
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`

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`Application/Control Number: 13/646,784
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`Page 9
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`Art Unit: 1641
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`Kenichi et al., Wang et al., and Lyon et al. are as discussed in detail above, which teach
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`an apparatus substantially as claimed, but which fail to specifically teach wherein the particles
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`are made of dendrimer.
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`Yamaguchi et al. (2003), at page 254, para 2, teach that antibody biosensor technique
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`based on surface plasmon resonance using antibody dendrimer, allows an advantageous
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`amplification of the detection of signals for antigens. At page 254, para 2, Yamaguchi et al. teach
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`that antibody dendrimer produces an increased signal intensity over the signal of just one
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`antibody alone. Additionally at page 240, para 2, Yamaguchi et al. teach that surface plasmon
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`resonance response reflects a change in mass concentration at the detector surface as molecules
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`bind or dissociate and the specific sensing of substrates with low molecular weight is difficult,
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`therefore functional molecules with high molecular weight (e. g. antibody dendrimers) have a
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`great potential for amplification.
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`It would have been primafacie obvious to one of ordinary skill in the art, at the time the
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`invention was made, to have used antibody dendrimer (i.e. dendrimer particles), as taught by the
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`method of Yamaguchi et al., to modify the plasmon sensor as taught by the combination of
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`Kenichi et al., Wang et al., and Lyon et al., to arrive the claimed invention because Yamaguchi et
`
`al. specifically teach that particles made of antibody dendrimer are advantageous for surface
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`plasmon resonance, specifically that antibody dendrimer allows amplification of detected signal.
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`It would be obvious to amplify signal of a detection apparatus, thereby improving the
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`performance of the apparatus. Furthermore, the ordinarily skilled artisan would be motivated to
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`use antibody dendrimer to modify Kenichi et al. and achieve amplification of signal because
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`Kenichi et al. teach a problem that their invention aims to solve is to detect protein molecule at
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`Page 10
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`Art Unit: 1641
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`very low concentration. It would be obvious to use known methods to amplify signal when
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`detecting low concentration analyte. The ordinarily skilled artisan would have a reasonable
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`expectation of success because the choice of particle would only enhance the performance of the
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`sensor, and not change its mode of operation.
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`Claims 15—16 are rejected under pre—AIA 35 U.S.C. 103(a) as being unpatentable over
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`Kenichi et al., JP 09—257702 (1997) (IDS entered on 10/08/2012) in view of Wang et al. PG.
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`Pub. No. US 2007/0252982 and Shanks et al., US 4,978,503 (1990).
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`Kenichi et al. is as discussed in detail above, teaching a plasmon sensor substantially as
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`claimed, Kenichi et al. further teaching at page 4, para [0003] wherein a beam of light is imposed
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`on the surface of the metal thin film and the reflected light is detected using a photo detector.
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`Also Kenichi et al. further teach at page 4, para [0004], that as a result of the incident beam,
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`energy is lost, and the reflected light intensity is deteriorated, thereby addressing wherein an
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`electromagnetic wave is supplied to the surface of the first metal layer and a change in the
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`reflected light is detected.
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`In regards to instant claims 15—16, Kenichi et al. teach methods of using the plasmon
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`sensor as well as methods of making the sensor (throughout the reference and especially at
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`[0015]—[0015].
`
`However, Kenichi et al. do not specifically teach a distance between the first and second
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`metal layers is substantially equal to (1/2) x 9» x m, where 9» is a wavelength of the
`
`electromagnetic wave in the hollow space produced by the electromagnetic wave source and m is
`
`an integer not smaller than one. Furthermore, Kenichi et al. do not specifically teach insertion of
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`Page 11
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`Art Unit: 1641
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`the specimen into the hollow region between the metallic plates/films is performed with the aid
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`of capillarity.
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`Finally, Kenichi et al. do not teach drying the medium after insertion of the analyte
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`capturing bodies into the hollow region so as to dispose the analyte capturing bodies at least one
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`of below the first metal layer and above the second metal layer, as in claim 16.
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`Wang et al. is as discussed in detail above, teaching a distance equal to (1/2) x 9» x n,
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`where 9» is a wavelength of the resonating electromagnetic wave in the space and n is an integer
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`not smaller than one, to define the space between two reflective members with regard to surface
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`plasmon resonance. Applicant is referred to the preceding rejection of claim 1 for detailed
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`analysis of the teachings of Kenichi et al. and Wang et al.
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`Shanks et al. (1990) teach at page 11, col. 13, para 5 and claim 5, a sample testing device
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`capable of showing surface plasmon resonance effect, wherein when used, the sample collection
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`and testing device (page 10 col. 12, claim 1 to page 11, col 12, para 1) comprises a capillary cell
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`for the collection and retention of a volume of sample liquid to be tested. Shanks et al., at page 6,
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`col. 3, para 1, teach a drop of sample liquid can be placed on a collection surface of the device,
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`or that the device can be dipped into a quantity of sample liquid. Shanks teaches at page 5, col. 1,
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`line 67 to col. 2, line 2, that capillary fill cell devices can be conveniently manufactured and are
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`provided to facilitate specific binding assays using very small liquids.
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`It would have been primafacie obvious to one of ordinary skill in the art, at the time of
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`the invention to have employed methods using capillary action to draw a sample into the testing
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`area, as taught by Shanks et al., wherein the space between reflective members is equal to the
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`equation as defined by Wang et al., to modify the method of using a surface plasmon resonance
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`Page 12
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`Art Unit: 1641
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`apparatus, as taught by Kenichi et al., to arrive at the claimed invention for the following
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`reasons. One of ordinary skill would recognize that both inventions are analogous (i.e. the
`
`tunable cavity of Wang et al. and the plasmon sensor of Kenichi et al.) with respect to the
`
`propagation of a wave through a space created by two reflective planes, and therefore the
`
`distance would necessarily have to be set so as to avoid destructive interference, resulting in
`
`reasonable success.
`
`As discussed previously, one would be motivated to modify Kenichi et al. so that the
`
`space between reflective members is equal to the equation of Wang et al. because Wang et al.
`
`specifically teach that if the space between two reflective members is not equal to said equation,
`
`where the variable n is an integer value, destructive interference may occur. It would be obvious
`
`to avoid a distance that would result in destructive interference because there would be no signal
`
`to detect, as the reflected beams would cancel each other out. Rather the ordinarily skilled artisan
`
`would be motivated to provide a distance equal to said equation, using an integer value of n
`
`because the beams would be expected to constructively interfere, causing an increased intensity
`
`for detection.
`
`Additionally, one would have been motivated to have used capillary action (as taught by
`
`Shanks et al.) to draw a sample into the testing area when performing a method using the surface
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`plasmon sensor as taught by Kenichi et al., and modified by Wang et al., because Shanks et al.
`
`teach a drop of sample can either be placed on the device, or the device can be dipped into a
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`quantity of sample liquid; thereby suggesting the capillarity of the device makes the device more
`
`versatile to the mode of sample introduction. Additionally, Shanks et al. teach capillary fill
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`devices can be conveniently manufactured and can facilitate the use of very small amounts of
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`Page 13
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`Art Unit: 1641
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`liquid. Therefore, it would have been obvious to apply the known technique of Shanks et al. of
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`adding liquid to a sensor using capillarity when adding sample or analyte capturing bodies to the
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`sensor of Kenichi et al. The ordinarily skilled artisan would have a reasonable expectation of
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`success in utilizing capillary action to draw sample into a surface plasmon biosensor device
`
`because capillary phenomenon is a typically used technique for small liquid sample delivery and
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`would not alter how the device operates, it would merely provide a way of delivering the sample
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`to the testing location of the biosensor.
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`Regarding claims 16; at page 7, col. 1 para 2, Shanks et al. further teach that reagents,
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`such as immobilized antibodies or antigens, and can be simply be coated and dried onto the
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`carrier surface, Shanks et al. indicating methods for immobilization of reagent to solid surfaces
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`commonly known in the art.
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`It would have been primafacie obvious to one of ordinary skill in the art, at the time the
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`invention was made, to have used the commonly known method of Shanks et al. for
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`immobilizing reagent on a surface, to immobilize antibodies on the surface of a surface plasmon
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`sensor, as taught by the combination of Kenichi et al. and Wang et al. to arrive the claimed
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`invention because one ordinarily skilled in the art would recognize that drying reagents onto a
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`surface as a common strategy, involving minimal steps. Therefore, because the method was
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`commonly known, and provides as an easy method for immobilization of reagent, it would be
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`obvious to make use of it. The ordinarily skilled artisan would have a reasonable expectation of
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`success immobilizing capture antibodies on the carrier surface of a surface plasmon sensor
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`device, because Shanks et al. suggest this is a simple technique for reagent immobilization and
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`therefore one would not expect it to hinder success of the device.
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`Application/Control Number: 13/646,784
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`Page 14
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`Art Unit: 1641
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`Claims 8—10 and 12—14 are rejected under pre—AIA 35 U.S.C. 103(a) as being
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`unpatentable over Kenichi et al., JP 09—257702 (1997) (IDS entered on 10/08/2012) in View of
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`Wang et al. PG. Pub. No. US 2007/0252982, and Lyon et al., J. Phys. Chem. B, 103 (1999), p.
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`5826—5831
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`Kenichi et al. is as discussed in detail above, teaching a plasmon sensor substantially as
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`claimed. Applicant is referred to the preceding rejections for detailed analysis of the reference
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`teachings. In regards to instant claim 8, Kenichi et al. further teach at page 4, para [0003] that a
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`beam of light is imposed on the surface of the metal thin film and the reflected light is detected
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`using a photo detector. Also Kenichi et al. further teach at page 4, para [0004], that as a result of
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`the incident beam, energy is lost, and the reflected light intensity is deteriorated, thereby
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`addressing wherein an electromagnetic wave is supplied to the surface of the first metal layer and
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`a change in the reflected light is detected.
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`As preViously indicated, Kenichi et al. do not specifically teach a distance between the
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`first and second metal layers is substantially equal to (1/2) x 9» x m, where 9» is a wavelength of
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`the electromagnetic wave in the hollow space produced by the electromagnetic wave source and
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`m is an integer not smaller than one.
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`Furthermore, Kenichi et al. is silent as to whether their antibodies (analyte capturing
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`bodies) are not oriented.
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`With respect to claim 9 (which now depends from claim 8), Kenichi et al. does not
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`specifically teach that particles are disposed between the first metal layer and the second metal
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`Application/Control Number: 13/646,784
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`Page 15
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`Art Unit: 1641
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`layer, or that the analyte capturing bodies are chemically adsorbed to the surfaces of the
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`particles.
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`Wang et al. is as discussed in detail above, teaching a distance equal to (1/2) x 9» x n,
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`where 9» is a wavelength of the resonating electromagnetic wave in the space and n is an integer
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`not smaller than one, to define the space between two reflective members with regard to surface
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`plasmon.
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`Lyon et al. (1999) is as previously discussed, teaching the use of an antibody and a gold
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`particle joined together, investigating the influence of the conjugate pair on surface plasmon
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`resonance and its ability to amplify a sensor’s biosensing ability. Providing an antibody on a
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`particle (as in Lyon et al.) is interpreted to mean that the antibody would not be oriented because
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`of the spherical nature of particles as well as due to the fact that being immobilized to particles
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`rather than directly onto the sensor surface, the antibodies would exhibit various different
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`orientations rather than all being oriented in a two—dimensional array.
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`As previously indicated, it would have been prima facie obvious to one of ordinary skill
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`in the art, at the time of the invention to have used a conjugate metal antibody pair, disposed on a
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`metallic thin film, as taught by Lyon et al., to have modified the plasmon sensor as described the
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`combination Kenichi et al. and Wang et al., to arrive the claimed invention because Lyon et al.
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`teach colloidal gold particle/antibody conjugate pairs perform as excellent signal enhancement of
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`up to a greater than 20—fold increase in plasmon angle shift over the observed assay that
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`employed an unlabeled antibody and further because Lyon et al. teach that colloidal particles
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`pose excellent tags for the determination of extremely low quantities of analyte that are not
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`routinely observable using traditional assay methods. Additionally, the ordinarily skilled artisan
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`Page 16
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`Art Unit: 1641
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`would be motivated to perform said modification because Lyon et al. teach that their results
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`demonstrate that by using colloidal gold particles in a sensing device, one provides the potential
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`for significant improvement in the sensitivity and dynamic range of colloidal gold amplified bio—
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`sensing. It would be obvious to improve an apparatus to enhance sensitivity of detection. The
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`ordinarily skilled artisan would have a reasonable expectation of success in performing the
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`modification of the apparatus as described by the combination of Kenichi et al. and Wang et al.
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`with the colloidal gold metallic particles of Lyon et al. because said modification would not be
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`expected to change the device so as to alter the way it is used, but rather would be expected to
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`improve the detection capabilities of the device.
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`Lyon et al. as indicated above in the rejection of claim 3, which teach the use of a
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`colloidal metal/antibody conjugate for signal enhancement disposed on a metal layer; thereby
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`also addressing the limitations of claims 9 and 10 for the following reasons.
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`It would have been primafacie obvious to one of ordinary skill in the art, at the time of
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`the invention to have used a conjugate metal antibody pair, disposed on a metallic thin film, as
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`taught by Lyon et al., to have modified the plasmon sensor as described the combination Kenichi
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`et al., Wang et al., and Shanks et al. to arrive the claimed invention because Lyon et al. teach
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`colloidal gold particle/antibody conjugate pairs perform as excellent signal enhancement of up t