Application No. 13/521,683
`Response to Office Action dated February 20, 2015
`
`Docket No: 061352-0478
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`REMARKS
`
`Introduction
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`Claims 1-9, 12—17 and 20-24 are pending in this application, of which claims 1, 3, and 24 are
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`independent. By this response, claims 10, ll, 18, and 19 have been cancelled without prejudice or
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`disclaimer thereto. Claims 1, 3 and 24 were amended to recite that the steps are performed in the
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`order set out in the claims and to recite that the concentration step includes reducing an amount of
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`solvent contained in the sample “without drying and solidifying the sample” by a concentration
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`operation. Support for these amendments can be found throughout the specification including, for
`
`example, in paragraphs [0040] and [0041].
`
`Entry of the above claim amendments and reconsideration of this application for allowance
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`of all pending claims are hereby respectfully requested in View of the following remarks.
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`Claim Rejection Under 35 U.S.C. § 103
`
`Claims
`
`l-10 and 12-24 were rejected under pre-AIA 35 U.S.C.
`
`§ 103(a) as being
`
`unpatentable over US. Patent Application Publication No. 2009/0123952 (hereinafter “‘Slemmon”)
`
`in view of US. Publication No. 2010/0129847 or EP1882944 (hereinafter “Navarrete”), Neurosci.
`
`Lett. 2007, 429: 75-80 (hereinafter “Gupta”) and Ann Otol. Rhinol. Laryngol. 1994. 103: 421-7
`
`(hereinafter “Yamagishi”). Applicants respectfully traverse.
`
`As noted above,
`
`the claims are directed to an amyloid [3 measurement method and
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`independent claims 1, 3 and 24 were amended to recite a concentration step, or a second
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`concentration step in claim 3,
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`in which a solubilizer that solubilizes amyloid B is added to the
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`sample in the sample treatment vessel and an amount of solvent contained in the sample is reduced
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`DMFUS 613734734 ,06l352.0478
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`6
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`Response to Office Action dated February 20, 2015
`
`Docket No: 061352-0478
`
`REMARKS
`
`Introduction
`
`Claims 1-9, 12—17 and 20-24 are pending in this application, of which claims 1, 3, and 24 are
`
`independent. By this response, claims 10, ll, 18, and 19 have been cancelled without prejudice or
`
`disclaimer thereto. Claims 1, 3 and 24 were amended to recite that the steps are performed in the
`
`order set out in the claims and to recite that the concentration step includes reducing an amount of
`
`solvent contained in the sample “without drying and solidifying the sample” by a concentration
`
`operation. Support for these amendments can be found throughout the specification including, for
`
`example, in paragraphs [0040] and [0041].
`
`Entry of the above claim amendments and reconsideration of this application for allowance
`
`of all pending claims are hereby respectfully requested in View of the following remarks.
`
`Claim Rejection Under 35 U.S.C. § 103
`
`Claims
`
`l-10 and 12-24 were rejected under pre-AIA 35 U.S.C.
`
`§ 103(a) as being
`
`unpatentable over US. Patent Application Publication No. 2009/0123952 (hereinafter “‘Slemmon”)
`
`in view of US. Publication No. 2010/0129847 or EP1882944 (hereinafter “Navarrete”), Neurosci.
`
`Lett. 2007, 429: 75-80 (hereinafter “Gupta”) and Ann Otol. Rhinol. Laryngol. 1994. 103: 421-7
`
`(hereinafter “Yamagishi”). Applicants respectfully traverse.
`
`As noted above,
`
`the claims are directed to an amyloid [3 measurement method and
`
`independent claims 1, 3 and 24 were amended to recite a concentration step, or a second
`
`concentration step in claim 3,
`
`in which a solubilizer that solubilizes amyloid B is added to the
`
`sample in the sample treatment vessel and an amount of solvent contained in the sample is reduced
`
`DMFUS 613734734 ,06l352.0478
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`6
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`Application No. 13/521,683
`Response to Office Action dated February 20, 2015
`
`Docket N0.: 061352—0478
`
`without drying and solidifying the sample by a concentration operation. As explained in the
`
`specification, the phrase “drying and solidifying the sample” means that the amount of solvent
`
`contained in the sample becomes relatively small so that the sample loses fluidity as a whole and is
`
`solidified. See paragraph [0041] of the instant specification. Therefore, in order to concentrate the
`
`sample without drying and solidifying it, the concentration step needs to be finished in a state where
`
`the liquid sample keeps its fluidity.
`
`Id.
`
`In contrast, Slemmon teaches away from at least this aspect of the claimed subject matter.
`
`Slemmon discloses on paragraphs [0026] and [0068] that bound peptides are eluted in a proper
`
`eluant such as a solution including trifluoroacetic acid, and then the peptide fractions are recovered
`
`
`and then dried by appropriate means, such as in a vacuum system. Slemmon further discloses on
`
`paragraph [0070]
`
`that after reverse-phase HPLC,
`
`
`the elution of peptide fractions were dried
`
`overnight. Hence, Slemmon does not suggest the claimed concentration step in which an amount of
`
`solvent contained in the sample is reduced without drying and solidifying the sangpl_e by a
`
`concentration operation.
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`According to the claimed invention, an amount of solvent contained in the sample after
`
`adding the solubilizer is reduced without drying and solidifying the sample.
`
`Therefore,
`
`the
`
`concentration step following addition of a solubilizer is conducted without increasing the amount of
`
`insoluble AB polymers, that is, AB monomers obtained by adding the solubilizer are kept as they
`
`are, which makes it possible to quantitatively measure AB accurately. See paragraph [0040] of the
`
`instant specification.
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`DM_US 61373473-10613520478
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`Application No. 13/521,683
`Response to Office Action dated February 20, 2015
`
`Docket No.: 061352—0478
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`If the sample is dried and solidified in the concentration step, the measurement sensitivity of
`
`AB is reduced due to aggregation of AB monomers or soluble oligomers. See paragraphs [0041] of
`
`the instant specification.
`
`This is demonstrated in Example 3 (paragraphs [0096] — [0103] and Figure 6). This
`
`example shows that when the sample was not dried and solidified in the concentration step
`
`performed after adding a solubilizer according to the claimed invention, the recovery rates of A042
`
`and AB40 were very high, e.g., as high as 80% and 100%, respectively. But when the sampled was
`
`dried and solidified in the concentration step performed after adding a solubilizer as disclosed by
`
`Slemmon, the recovery rates of AB42 and A1340 were very low, e.g. as low as less than 10% and
`
`less than 20%, respectively.
`
`From these results, it has been found that the recovery rate of AB, that is, measurement
`
`sensitivity, is significantly improved by concentrating a sample without drying and solidifying it in
`
`the concentration step performed after adding a solubilizer. Thus, the claimed invention attains an
`
`advantageous result which cannot be expected by the teachings of Slemmon, either alone or in
`
`combination with Gupta and/or Yamagishi.
`
`Further, Applicants respectfully submit that the rejection of the claims over Slemmon, Gupta
`
`and Yamagishi is in error.
`
`It is incumbent on the Examiner to set forth clearly the bases to reject the
`
`claims. See KSR International Co. v. Teleflex Inc, 550 US. 398 at 418 (2007) (“‘[R]ejections on
`
`obviousness cannot be sustained by mere conclusory statements;
`
`instead,
`
`there must be some
`
`articulated reasoning with some rational underpinning to support
`
`the legal conclusion of
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`obviousness”); In re Mullin, 481 F.2d 1333, 179 USPQ 97 (CCPA 1973).
`
`In the Office Action,
`
`the Examiner essentially repeats the pending claims and cites broadly to the applied references.
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`Application No. 13/521,683
`Response to Office Action dated February 20, 2015
`
`Docket No: 061352—0478
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`However, it is not clear how the applied references support the Examiner’s positions. Accordingly,
`
`Applicants respectfully request clarification and specificity of any rejection of the claims for
`
`obviousness.
`
`Applicants therefore submit that the rejection of claims is overcome and respectfully request
`
`that the rejection of claims under 35 U.S.C. § 103 be withdrawn.
`
`Claim Rejection Under 35 U.S.C. § 112
`
`Claims 10, 18, and 19 were rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. §112,
`
`fourth paragraph, as being of improper dependent form.
`
`Claims 10, 18, and 19 were also rejected under 35 U.S.C. 112(b) or pre—AIA 35 U.S.C.
`
`§112, second paragraph, as being indefinite.
`
`The rejections are traversed. Applicants have canceled claims 10, 18 and 19. Accordingly,
`
`the rejections of these claims are moot. Reconsideration and withdrawal of the rejections of claims
`
`10, 18 and 19 are solicited.
`
`Claim Rejection Under 35 U.S.C. § 101
`
`Claims 1-10 and 12-24 were rejected under pre-AIA 35 U.S.C. § 101 because the claimed
`
`invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an
`
`abstract idea) without significantly more. The rejection is traversed and reconsideration respectfully
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`solicited.
`
`As explained above for non~obviousness,
`
`the claims are directed to an amyloid [5
`
`measurement method and independent claims 1, 3 and 24 were amended to recite a concentration
`
`step, or a second concentration step in claim 3, in which a solubilizer that solubilizes amyloid [3 is
`
`DM__US 61373473-1 0613520478
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`Application No. 13/521,683
`Response to Office Action dated February 20, 2015
`
`Docket No.2 061352-0478
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`added to the sample in the sample treatment vessel and an amount of solvent contained in the
`
`sample is reduced without drying and solidifying the sample by a concentration operation. The
`
`specification of the present application explains the significance of this aspect of the claimed subject
`
`matter
`
`including quantitatively measuring AB accurately and improving sensitivity of the
`
`measurement.
`
`As further explained above for non-obviousness, the claimed steps are not conventional.
`
`The primary reference, Slemmon,
`
`teaches away from this step and the combination of cited
`
`references to Slemmon, Gupta and Yamagishi would not have expected the advantages of the
`
`presently claimed method.
`
`Applicants therefore submit that the rejection of claims 1-10 and 12~24 is overcome and
`
`respectfully request that the rejection of claims 1—10 and 12-24 under pre—AIA 35 U.S.C. § 101 be
`
`withdrawn.
`
`Conclusion
`
`In view of the above amendments and remarks, Applicants submit that this application
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`should be allowed and the case passed to issue.
`
`If there are any questions regarding this
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`Amendment or the application in general, a telephone call to the undersigned would be appreciated
`
`to expedite the prosecution of the application.
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`
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`Application No. 13/521,683
`Response to Office Action dated February 20, 2015
`
`Docket No.: 061352—0478
`
`To the extent necessary, a petition for an extension of time under 37 C.F.R. 1.136 is hereby
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`made. Please charge any shortage in fees due in connection with the filing of this paper, including
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`extension of time fees, to Deposit Account 500417 and please credit any excess fees to such deposit
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`account.
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`Respectfully submitted,
`
`MCDERMOTT WILL & EMERY LLP
`
`Daniel Bucca
`
`Registration No. 42,368
`
`Please recognize our Customer No. 53080 as
`our correspondence address.
`
`500 North Capitol Street, NW.
`Washington, DC 20001
`Phone: (202) 756—8916 Dthnl
`Facsimile: (202) 756—8087
`Date: May 18, 2015
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`DM_US 6137347310613520478
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