`
`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
`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.
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`13/646,784
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`10/08/2012
`
`Masaya TAMURA
`
`MAT—10579US
`
`1082
`
`EXAMINER
`RATNERPRESTIA —
`04’2”“ —
`7590
`52473
`PO. BOX 980
`MARCSISIN, ELLEN JEAN
`VALLEY FORGE, PA 19482-0980
`
`PAPER NUMBER
`
`ART UNIT
`
`1641
`
`
`
` NOT *ICATION DATE
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`DELIVERY MODE
`
`04/25/2013
`
`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
`sparodi @ ratnerprestia.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 13/646,784 TAMURA ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`1641Ellen J. Marcsisin a?”
`
`-- 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)I:I Responsive to communication(s) filed on 8 October 2012.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`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
`
`
`; the restriction requirement and election have been incorporated into this action.
`
`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.
`
`Disposition of Claims
`5)|XI CIaim(s)1-_16is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6)|:l Claim(s) _ is/are allowed.
`7)IZ| Claim(s)_1-16 is/are rejected.
`8)I:I Claim(s) _ is/are objected to.
`
`9)|:l Claim((s)
`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
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`://www.usoto. ov/ atents/init events"
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`h/index.‘s or send an inquiry to PF"I-Ifeedback{<‘buspto.qov.
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`Application Papers
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`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).
`
`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)IZI 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)le AII
`1.I:I Certified copies of the priority documents have been received.
`2.I:I 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
`
`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.
`
`Interim copies:
`
`a)|:l AII
`
`b)I:I Some
`
`c)I:I None of the:
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`Interim copies of the priority documents have been received.
`
`Attachment(s)
`
`1) E Notice of References Cited (PTO-892)
`
`3) I] Interview Summary (PTO-413)
`
`Paper NOISIIMa” Date —
`PTO/SB/08
`t
`St t
`I
`D'
`t'
`f
`2 IXI I
`)
`4) I:I Other:
`a emen (s)(
`Isc osure
`n orma Ion
`)
`Paper No(s)/Mai| Date 10/08/2012.
`US. Patent and Trademark Office
`PTOL-326 (Rev. 03-13)
`
`Part of Paper No./Mai| Date 20130408
`
`Office Action Summary
`
`

`

`Application/Control Number: 13/646,784
`
`Art Unit: 1641
`
`Page 2
`
`Claims 1-16 are pending.
`
`Claims 1-16 are examined.
`
`DETAILED ACTION
`
`Priority
`
`1.
`
`The instant application filed on 10/08/2012 is a Continuation in Part of PCT/JP201 1/002567 filed
`
`on 05/09/2011 and claims foreign priority to Japanese application 2010-109801 filed on 05/12/2010.
`
`Information Disclosure Statement
`
`2.
`
`The Information Disclosure Statement (IDS), entered on 10/08/12, has been considered and
`
`initialed and is attached hereto.
`
`3.
`
`Claim Rejections - 35 USC § 1 12
`
`The following is a quotation of 35 U.S.C. 112(d):
`
`(d) REFERENCE IN DEPENDENT FORMS—Subject to subsection (e), a claim in dependent form shall
`
`contain a reference to a claim previously set forth and then specify a further limitation of the subject
`
`matter claimed. A claim in dependent form shall be construed to incorporate by reference all the
`
`limitations of the claim to which it refers.
`
`4.
`
`Claims 9-11 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA), 4th paragraph, as
`
`being of improper dependent form for failing to further limit the subject matter of the claim upon which it
`
`depends, or for failing to include all the limitations of the claim upon which it depends.
`
`Claim 9 is in dependent form with regards to claim 2 and adds the limitation that the particles are
`
`disposed between the first metal layer and the second metal layer, and the analyte capturing bodies are
`
`chemically adsorbed to surfaces of the particles. This claim is identical to the limitation of claim 2, from
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`which it depends, and claim 2 further limits the sensor of claim 1.
`
`

`

`Application/Control Number: 13/646,784
`
`Art Unit: 1641
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`Page 3
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`Claim 10 is of dependent from claim 9, previously indicated as an improper dependent claim, and
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`further limits the sensor, wherein the particles are made of metal. This dependent claim is identical to
`
`dependent claim 3 and does not further limit the invention.
`
`Claim 11 is dependent from claim 9, previously indicated as an improper dependent claim, and
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`further limits the sensor, wherein the particles are made of dendrimer. This dependent claim is identical to
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`dependent claim 4 and does not further limit the invention.
`
`Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent
`
`form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s)
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`complies with the statutory requirements.
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for
`
`the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in
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`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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`5.
`
`Claims 1, 6 and 7 are rejected under 35 U.S.C. 102(b) as being anticipated by Kenichi, et al., JP
`
`09-257702 (1997) (IDS, entered on 10/08/2012).
`
`The claims are drawn to a plasmon sensor comprising: a first metal layer having a bottom
`
`surface and a top surface configured to be supplied with an electromagnetic wave; and a second metal
`
`layer having a top surface confronting the bottom surface of the first metal layer, wherein a hollow region
`
`configured to be filled with a specimen containing a medium is provided between the first metal layer and
`
`the second metal layer, and analyte capturing bodies are physically adsorbed to at least one below of the
`
`first metal layer and above of the second metal layer.
`
`

`

`Application/Control Number: 13/646,784
`
`Art Unit: 1641
`
`Page 4
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`Kenichi, et al., (1997, translation) teach a surface plasmon resonance sensor device (abstract)
`
`having a thin metallic layer referred to as a metal thin film surface (abstract and also page 4, para [0004])
`
`and a counter electrode (page 5, para [0008]), addressing the limitation of a second metallic film. The
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`sensor device is subjected to incident light (page 5, para [0004]), which addresses the limitation where
`
`the surfaces are configured to be supplied with an electromagnetic wave, which goes into the metal thin
`
`film and creates an evanescent wave. The two metal surfaces create a hollow region configured to be
`
`filled with a specimen containing a medium, which is taught in the visual depiction of Figure 1, the space
`
`between the embodiments labeled 4 and 6, and the sensor is equipped with antibodies which adsorb
`
`protein, the antibodies are fixed to the outside surface of the metal thin film, indicated by Figure 1,
`
`number 4, page 7, para [0016], addressing the limitation of capture bodies physically adsorbed to at least
`
`one of the metal layers.
`
`Kenichi also teaches at page 7, para [0016], that the protein molecules are attracted to the thin
`
`metallic film side and effectively adsorbed on the antibodies located on the thin metallic film. This
`
`statement suggests that the majority of antibodies are present on the thin metallic film, thereby
`
`suggesting that an uneven density distribution of the antibodies is occurring, addressing the limitation of
`
`claim 6, wherein the analyte capturing bodies are disposed with an uneven density; and at Figure 1 and
`
`also page 7, para [0016], indicates that the analyte capture bodies are adsorbed to the embodiment of
`
`Figure 1, labeled 4, suggesting they are not in the specimen inserting section. Additionally Figure 1
`
`visually shows two openings, which are assumed to be inserting sections, and since the antibodies are to
`
`be adsorbed to embodiment labeled 4, it is also assumed they are not in the insertion sections, thereby
`
`addressing the limitations of claim 7.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all 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
`
`

`

`Application/Control Number: 13/646,784
`
`Art Unit: 1641
`
`Page 5
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`the prior art are such that the subject matter as a whole would have been obvious at the time the
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`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
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`Patentability shall not be negatived by the manner in which the invention was made.
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`This application currently namesjoint inventors.
`
`In considering patentability of the claims under
`
`35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly
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`owned at the time any inventions covered therein were made absent any evidence to the contrary.
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`Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of
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`each claim that was not commonly owned at the time a later invention was made in order for the
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`examiner to consider the applicability of 35 U.S.C. 103(0) and potential 35 U.S.C. 102(e), (f) or (g) prior
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`art under 35 U.S.C. 103(a).
`
`6.
`
`Claims 1-3 and 5-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kenichi, et
`
`al., JP 09-257702 (1997) (IDS, entered on 10/08/2012) and further in view of Lyon, et al., J. Phys. Chem.
`
`B, 103, (1999), p. 5826-5831.
`
`The claim is drawn to a plasmon sensor comprising: a first metal layer having a bottom surface
`
`and a top surface configured to be supplied with an electromagnetic wave; and a second metal layer
`
`having a top surface confronting the bottom surface of the first metal layer, wherein a hollow region
`
`configured to be filled with a specimen containing medium is provided between the first metal layer and
`
`the second metal layer, and analyte capturing bodies are physically adsorbed to at least one below of the
`
`first metal layer and above of the second metal layer.
`
`Kenichi, et al., (1997) teaches a surface plasmon resonance sensor device (abstract) having a
`
`thin metallic layer referred to as a metal thin film surface (abstract and also page 4, para [0004]) and a
`
`counter electrode (page 5, para [0008]), addressing the limitation of a second metallic film. The sensor
`
`device is subjected to incident light (page 5, para [0004]), which addresses the limitation where the
`
`surfaces are configured to be supplied with an electromagnetic wave, which goes into the metal thin film
`
`and creates an evanescent wave. The two metal surfaces create a hollow region configured to be filled
`
`

`

`Application/Control Number: 13/646,784
`
`Art Unit: 1641
`
`Page 6
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`with a specimen containing medium, which is taught in the visual depiction of Figure 1, the space
`
`between the embodiments labeled 4 and 6, and the sensor is equipped with antibodies which adsorb
`
`protein, the antibodies are fixed to the outside surface of the metal thin film, indicated by Figure 1,
`
`number 4, page 7, para [0016], addressing the limitation of capture bodies physically adsorbed to at least
`
`one of the metal layers.
`
`Kenichi also teaches at page 7, para [0016], that the protein molecules are attracted to the thin
`
`metallic film side and effectively adsorbed on the antibodies located on the thin metallic film. This
`
`statement suggests that the majority of antibodies are present on the thin metallic film, thereby
`
`suggesting that an uneven density distribution of the antibodies is occurring, addressing the limitation of
`
`claim 6, wherein the analyte capturing bodies are disposed with an uneven density; and at Figure 1 and
`
`also page 7, para [0016], indicates that the analyte capture bodies are adsorbed to the embodiment of
`
`Figure 1, labeled 4, suggesting they are not in the specimen inserting section. Additionally Figure 1
`
`visually shows two openings, which are assumed to be inserting sections, and since the antibodies are to
`
`be adsorbed to embodiment labeled 4, it is also assumed they are not in the insertion sections, thereby
`
`addressing the limitations of claim 7.
`
`Kenichi does not teach the plasmon sensor according to claim 2, wherein the particles are made
`
`of metal, as in claim 3, or wherein the particles are made of dendrimer, as in claim 4. Additionally Kenichi
`
`does not teach the sensor of claim 1, wherein an additive is physically adsorbed together with the analyte
`
`capturing body, as is the limitation of claim 5.
`
`Lyon, et al., (1999) teaches throughout the document and at page 5826, col. 1-col. 2, para [1] the
`
`use of an antibody and a gold particle joined together, and they investigated the influence of the
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`conjugate pair on surface plasmon resonance and its ability to amplify a sensor's bio-sensing ability,
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`addressing the limitation of claim 3 wherein metal particles are that which the capture antibodies of the
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`biosensor are adsorbed to.
`
`

`

`Application/Control Number: 13/646,784
`
`Art Unit: 1641
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`Page 7
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`It would have been prima facie obvious at the time the invention was made, for one of ordinary
`
`skill in the art to have made or used the conjugate antibody/metal particle pair as is taught by Lyon to
`
`have made or used the plasmon biosensor as taught by Kenichi.
`
`One of ordinary skill in the art would have been motivated to have used colloidal particles
`
`attached to antibodies as analyte capturing bodies as taught by Lyon to have made or used the plasmon
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`biosensor as taught by Kenichi because at page 5826, col. 2, para [1], lines 5-7 Lyon teaches that
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`colloidal particles pose excellent tags for the determination of extremely low quantities of analyte that are
`
`not routinely observable using traditional assay methods. Additionally at page 5826, col. 2, para [1], lines
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`24-27, Lyon teaches that their results demonstrate that using colloidal gold particles in a sensing device,
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`demonstrates the potential for significant improvement in the sensitivity and dynamic range of colloidal
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`gold amplified bio-sensing and that it is based on the size of the particle. Kenichi, at page 1 (the abstract),
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`indicates that the problem to be solved by their invention is to detect a protein molecule even when
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`concentration of the protein molecule in a sample is low. Therefore it would be obvious to one skilled in
`
`the art to use the enhancement techniques as taught by Lyon for detection of low quantities of analyte to
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`improve the bio-sensing capabilities of the sensor as taught by Kenichi.
`
`One of ordinary skill in the art would have had a reasonable expectation of success in using
`
`colloidal particles attached to antibodies as an analyte capturing body because Lyon specifically
`
`demonstrates that this modification creates an enhancement of signal and additionally, functionalizing the
`
`antibodies with a metallic nanoparticle would not change the concept of the biosensor. Additionally Lyon
`
`indicates at page 5826, col. 1-2, that their work demonstrated a 20 fold increase in plasmon angle shift
`
`over that using an unlabeled antibody.
`
`7.
`
`Claims 1-3 and 4 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kenichi, et al.,
`
`JP 09-257702 (1997) (IDS, entered on 10/08/2012) and further in view of Yamaguchi, et al., Top. Curr.
`
`Chem., 228, (2003), p. 237-258.
`
`Kenichi, as applied supra, is herein applied for the same teachings in its entirety in regards to the
`
`teachings for a surface plasmon resonance sensor device.
`
`

`

`Application/Control Number: 13/646,784
`
`Art Unit: 1641
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`Page 8
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`As indicated previously, Kenichi does not teach the limitation of claim 4, wherein the particles
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`adsorbed to the analyte capturing bodies are made of dendrimer.
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`Yamaguchi, et al., (2003) at page 254, para [2], lines 1-3 teaches that the antibody biosensor
`
`technique based on surface plasmon resonance shows that antibody dendrimer allows an advantageous
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`amplification of the detection signals for antigens.
`
`It would have been prima facie obvious at the time the invention was made, for one of ordinary
`
`skill in the art to have incorporated antibody dendrimers as is taught by Yamaguchi for detection of
`
`analyte into the teachings of Kenichi to have made or used a surface plasmon resonance biosensor
`
`device.
`
`One of ordinary skill in the art would have been motivated to have incorporated antibody
`
`dendrimers as is taught by Yamaguchi for detection of analyte into the teachings of Kenichi to have made
`
`or used a surface plasmon resonance biosensor device because, as taught by Yamaguchi at page 254,
`
`para [2], antibody dendrimer produces an increased signal intensity over that of just antibody alone. Also,
`
`as indicated by Kenichi, page 1 (abstract), the problem their invention aims to solve is to detect protein
`
`molecule at very low concentrations. Therefore one would be motivated to use the antibody dendrimer
`
`modification, to capture the analyte as taught by Yamaguchi, into the biosensor device as taught by
`
`Kenichi because the modification would improve signal detection.
`
`One of ordinary skill in the art would have had a reasonable expectation of success in using
`
`antibody dendrimer to capture analyte in a surface plasmon resonance biosensor device as taught by
`
`Kenichi because Yamaguchi explicitly teaches at page 255, Figure 13a-e, a hapten molecule immobilized
`
`on the surface of a surface plasmon resonance sensor chip, where the results show a greater signal
`
`intensity with the addition of dendritic complexes. It is obvious that the antibody dendrimer would result in
`
`great signal amplification because Yamaguchi, page 240, para [2], teaches that surface plasmon
`
`resonance response reflects a change in mass concentration at the detector surface as molecules bind or
`
`dissociate and the specific sensing of substrates with low molecular weight is difficult, therefore functional
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`molecules with a high molecular weight such as antibodies have a great potential for amplification.
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`

`

`Application/Control Number: 13/646,784
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`Art Unit: 1641
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`Page 9
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`Antibody dendrimers would result in even greater weight so one would expect a greater signal
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`amplification allowing the detection of analyte at small concentrations.
`
`8.
`
`Claims 8, 13, and 14 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kenichi, et
`
`al., JP 09-257702 (1997) (IDS, entered on 10/08/2012) and further in view of Bonroy, et al., Journal of
`
`Immunological Methods, 312, (2006), p. 167-181.
`
`The claims are drawn to a plasmon sensor comprising: a first metal layer, having a bottom
`
`surface and a top surface configured to be supplied with an electromagnetic wave; and a second metal
`
`layer, having a top surface confronting the bottom surface of the first metal layer, wherein a hollow region
`
`configured to be filled with a specimen containing a medium is provided between the first metal layer and
`
`the second metal layer, analyte capturing bodies are disposed at least one of below the first metal layer
`
`and above the second metal layer, and the analyte capturing bodies are not oriented.
`
`Kenichi, as applied supra, is herein applied for the same teachings in its entirety in regards to a
`
`surface plasmon resonance sensor device, wherein the analyte capturing bodies are disposed with an
`
`uneven density and wherein the sensor comprises a specimen inserting section where the analyte
`
`capturing bodies are not disposed in the insertion section.
`
`Bonroy, et al., (2006) at page 168, col. 1, para [2] to page 168, col. 2, para [1] teaches several
`
`examples of literature that utilize randomly oriented antibody immobilization in regards to surface plasmon
`
`resonance devices, addressing the limitation of claim 9 not taught by Kenichi, wherein the analyte
`
`capturing bodies are not oriented on the biosensor.
`
`It would have been prima facie obvious at the time the invention was made, for one of ordinary
`
`skill in the art to have randomly oriented antibodies immobilized on the sensor surface to have made or
`
`used a surface plasmon resonance biosensor device as taught by Kenichi.
`
`One of ordinary skill in the art would have been motivated to have used randomly oriented
`
`antibodies immobilized on a biosensor because, based on the progress in the art in general, and the art
`
`set forth in the introduction of Bonroy; scientists have modified methods to develop control over the
`
`orientation to improve the performance of biosensor. Bonroy specifically performs a comparison study of
`
`

`

`Application/Control Number: 13/646,784
`
`Art Unit: 1641
`
`Page 10
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`random versus oriented antibodies using surface plasmon resonance, and at page 179, col. 1, para [2]
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`teaches that oriented immobilization resulted in a larger biosensor response. Bonroys comparison study
`
`of random versus oriented mobilization of antibodies is suggestive that the ability to orient the antibodies
`
`is an improvement in the art and that random orientation was the method of immobilization in the past, for
`
`early surface plasmon resonance devices and therefor is obvious.
`
`One of ordinary skill in the art would have had a reasonable expectation of success in using
`
`randomly oriented antibodies immobilized on a sensor surface, as is one of the methods taught by
`
`Bonroy, to have made or used a surface plasmon resonance biosensor device as taught by Kenichi
`
`because the ability to randomly orient antibodies is demonstrated by Bonroy, even though at page 179,
`
`col. 1, para [2] Bonroy teaches that controlled orientation results in amplification of the sensor signal over
`
`the method where antibodies are randomly oriented. Although Bonroy teaches that controlled antibody
`
`orientation is favorable, Bonroy also still teaches that random orientation has been performed. Although
`
`the method of orienting the antibody would influence the strength of the detection signal, it would not
`
`change the working concept of the biosensor and the surface plasmon biosensor device would still be
`
`expected to work.
`
`9.
`
`Claims 8 and 12-14 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kenichi, et
`
`al., JP 09257702 (1997) (IDS, entered on 10/08/2012); Bonroy, et. al., Journal of Immunological
`
`Methods, 312, (2006), p. 167-181; and further in view of Lyon, et al., J. Phys. Chem. B, 103, (1999), p.
`
`5826-5831.
`
`Kenichi, as applied supra, is herein applied for the same teachings in its entirety in regards to the
`
`teachings for a surface plasmon resonance biosensor device.
`
`Bonroy, as applied supra, is herein applied for the same teachings in its entirety in regards to the
`
`teachings the random orientation of antibodies as analyte capturing bodies in a surface plasmon
`
`resonance biosensor device.
`
`Lyon, as applied supra, is herein applied for the same teachings in its entirety in regards to the
`
`teachings for an antibody gold conjugate pair as an analyte capturing body. In instant application, the
`
`

`

`Application/Control Number: 13/646,784
`
`Art Unit: 1641
`
`Page 11
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`limitation of claim 12, the gold particle is considered to be an additive physically adsorbed together with
`
`the antibody (the analyte capturing body).
`
`It would have been prima facie obvious at the time the invention was made, for one of ordinary
`
`skill in the art to have made or used methods incorporating gold particles physically adsorbed together
`
`with the antibody, as taught by Lyon, to have made or used a surface plasmon resonance biosensor
`
`device, as taught by Kenichi.
`
`One of ordinary skill in the art would have been motivated to have incorporated an additive, for
`
`example gold nanoparticles, physically adsorbed to the analyte capturing bodies, such as antibodies, to
`
`have made or used a surface plasmon resonance biosensor because some additives, such as gold
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`nanoparticles, have been shown to amplify detected signal making it easier to detect small concentrations
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`of analyte, as is taught by Lyon at page 5826, col. 2, para [1], lines 5-7 and also at page 5826, col. 2,
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`para [1].
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`One of ordinary skill in the art would have had a reasonable expectation of success to incorporate
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`an additive (for example a gold particle) attached to antibodies to serve as an analyte capturing body
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`because Lyon specifically demonstrates that this modification creates an enhancement of signal.
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`Additionally, functionalizing the antibodies with a metallic nanoparticle would not change the concept of
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`the biosensor. Lyon teaches, at page 5826, col. 1-2, a 20 fold increase in plasmon angle shift over that
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`using an unlabeled antibody, so one would reasonable expect success in enhancing signal.
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`10.
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`Claim 15 is rejected under 35 U.S.C. 103(a) as being unpatentable over Kenichi, et al., JP 09-
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`257702 (1997) (IDS, entered on 10/08/2012) and further in view of Shanks, et al., US 4,978,503 (1990).
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`The claim is drawn to a method for using a plasmon sensor, the plasmon sensor comprising: a
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`first metal layer having a top surface and a bottom surface, a second metal layer having a top surface
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`confronting the bottom surface of the first metal layer, wherein a hollow region is provided between the
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`first metal layer and the second metal layer, and analyte capturing bodies are physically adsorbed at least
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`one below the first metal layer and above the second metal layer, the method comprising: inserting a
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`specimen into the hollow region with an aid of capillarity; supplying an electromagnetic wave to a top
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`

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`Application/Control Number: 13/646,784
`
`Art Unit: 1641
`
`Page 12
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`surface side of the first metal layer; and sensing at least one of a change in amplitude of an
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`electromagnetic wave reflected or radiated from the top surface of the first metal layer and a change in
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`resonance wavelength.
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`Kenichi, as applied supra, is herein applied for the same teachings in its entirety in regards to the
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`teachings for a surface plasmon resonance sensor device, wherein the analyte capturing bodies are
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`disposed in a region between a first metal layer and second metal layer (and are physically adsorbed),
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`and wherein the sensor comprises a specimen inserting section where the analyte capturing bodies are
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`not disposed in the insertion section.
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`Kenichi also teaches at page 4, para [0003] that a beam of light is imposed on the surface of the
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`metal thin film and the reflected light is detected using a photodetector. At page 4, para [0004] Kenichi
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`teaches that as a result energy is lost, and the reflected light intensity is deteriorated, thereby addressing
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`the additional limitations of claim 15, wherein an electromagnetic wave is supplied to the surface of the
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`first metal layer and a change in the reflected light is detected.
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`Kenichi does not teach that insertion of the specimen into the hollow region between the metallic
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`plates/films is performed with the aid of capillarity.
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`Shanks, et al., (1990), at page 11, col. 13, para [5] at claim 5, does teach a sample testing
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`device capable of showing surface plasmon resonance effect, wherein the sample collection and testing
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`device, page 10, col. 12, at claim 1 to page 11, col. 12, para [1], comprises a capillary cell for the
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`collection and retention of a volume of sample liquid to be tested. The capillary cavity of the testing device
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`addresses the limitation of claim 15 wherein the specimen is inserted into the hollow region of the sensor
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`via capillarity.
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`It would have been prima facie obvious at the time the invention was made, for one of ordinary
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`skill in the art to have made or used methods utilizing capillary action to draw a sample into the testing
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`area, as taught by Shanks, of a surface plasmon resonance biosensor as taught by Kenichi.
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`One of ordinary skill in the art would have been motivated to have used capillary action to draw a
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`sample into a testing area of surface plasmon resonance biosensor device because capillary action
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`enables convenient sample collection and analysis, as is suggested about the design of the device of
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`

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`Application/Control Number: 13/646,784
`
`Art Unit: 1641
`
`Page 13
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`Shanks at page 5, col. 2, para [3]. Shanks, at page 6, col. 3, para [1] teaches a drop of sample liquid can
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`be placed on a collection surface of the device, or that the device can also be dipped into a quantity of
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`sample liquid.
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`It appears that the capillarity of the device makes the device more versatile. Additionally,
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`Shanks teaches at page 5, col. 1, line 67 to col. 2, line 2 that capillary fill cell devices can be conveniently
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`manufactured and are provided to facilitate specific binding assays using very small liquids, therefore it
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`would be obvious to use in a surface plasmon biosensor as taught by Kenichi.
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`One of ordinary skill in the art would have had a reasonable expectation of success in utilizing
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`capillary action to draw sample into a surface plasmon resonance biosensor device because capillary
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`phenomenon is a typically used technique for small liquid sample delivery and would not alter the device
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`or how the device operates, it is merely a way of delivering the sample to the testing location of the
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`biosensor. Therefore, one would expect success in coupling this delivery method with the surface
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`plasmon resonance biosensor device of Kenichi as this would not alter the method of using the sensor.
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`11.
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`Claim 16 is rejected under 35 U.S.C. 103(a) as being unpatentable over Kenichi, et al., JP 09-
`
`257702 (1997) (IDS, entered on 10/08/2012) and further in view of Shanks, et al., US 4,978,503 (1990).
`
`The claim is drawn to a method for manufacturing a plasmon sensor, the method comprising:
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`preparing a plasmon sensor structure which has a first metal layer having a bottom surface and a top
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`surface configured to be supplied with an electromagnetic wave, and a second metal layer having a top
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`surface confronting the bottom surface of the first metal layer, and in which a hollow region is provided
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`between the first metal layer and the second metal layer; inserting a medium containing analyte capturing
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`bodies into the hollow region with an aid o