Application No. 14/374,181
`Reply to Office Action of March 4, 2015
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`Docket No.: 061352—0530
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`Introduction
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`REMARKS
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`The specification was amended at paragraphs [0048] and [0049] to correct for typographical
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`errors, including identifying the “vertical” axis for Fig. 3 and noting that the values in the figure
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`represent a square “root”, which can be seen from the values themselves. The amendment is also
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`supported by paragraph [0028] of the original application.
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`Further, by this amendment, claims 3-4, 7-10, 12, 14 are currently pending in this
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`application. Claims 1-2, 5—6, 11 and 13 were canceled without prejudice or disclaimer thereto.
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`Claims 3, 7, 8, 9—10, 12 have been amended and claim 14 is new.
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`Independent claim 9 was amended to describe the term “AB” and to recite a calculating step
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`and to define the pretreating step. Claims 3 and 7-8 were amended to depend on claim 9 and claim
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`3 was further amended to recite that the filtering step includes fractionation to remove proteins
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`having a molecular weight of greater than 100 kDa. Support for these amendments can be found
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`throughout the originally filed application including at paragraph 28 and claim 11 which describes
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`the calculation step of claim 9; paragraph 20, which describes extracting the intranasal specimen
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`with an extraction liquid of claim 9; paragraph 20, which describes fractionation to remove proteins
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`having a molecular weight of greater than 100 kDa of claim 3; and paragraphs 38 and 18, which
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`describes use of ultrapure water for extracting tau protein and an extraction liquid that decomposes
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`AB as recited in claim 10.
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`Independent claim 12 was amended to describe the term “AB” and to delete the term “means
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`for” throughout the claim so that the claim does not invoke the provisions under 35 U.S.C. § 112,
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`$6. Claim 12 was also amended to include the step of calculating a square root value from the sum
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`Application No. 14/374,181
`Reply to Office Action of March 4, 2015
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`Docket No.: 061352—0530
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`of the square of a value of the tau protein obtained in the detection step together with a square of a
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`value of the AB obtained in the detection step, which is supported at paragraph 28 and claim 11.
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`New claim 14 recites the step of determining whether the calculated values for the tau protein
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`and/or the AB fall within a predetermined range of values for Alzheimer’s disease. Support for the
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`amendment can be found in paragraph 26, for example. Accordingly, Applicant respectfully submits
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`that these amendments do not add new matter to the application. Entry of the amendments and
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`reconsideration of the application are respectfully solicited.
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`Objection to the Claims
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`Claims 1, 2 and 10 were objected to because of informalities, which included the use of the
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`terms “hereinafter, referred to as AB” and “attached to a collection tool”. The rejection is traversed.
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`Claims 1—2 were canceled. Accordingly, the rejection of these claims is moot. Claim 10 was
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`amended to delete the term “attached to a collection tool”. Accordingly, the rejection is no longer
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`applicable. Accordingly,
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`reconsideration and withdrawal of the rejection of claim 10 are
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`respectfully solicited.
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`Claim Re'ections Under 35 U.S.C.
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`112
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`Claims 1-13 were rejected as indefinite on grounds that the “pretreating” step was unclear.
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`The rejection is traversed.
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`Claims
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`1—2, 5-6,
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`11 and 13 were canceled without prejudice or disclaimer thereto.
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`Accordingly, the rejection of these claims is moot.
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`Application No. 14/374,181
`Reply to Office Action of March 4, 2015
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`Docket No.: 061352-0530
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`Independent claim 9 was amended to clarify that the pretreating step comprises extracting
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`the intranasal specimen with an extraction liquid. Accordingly, reconsideration and withdrawal of
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`the rejection as to indefiniteness of claims 1-13 are respectfully solicited.
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`Claims 12-13 were rejected as indefinite on grounds that the claims include the term “means
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`for” but the specification does not disclose sufficient structure to invoke this term under 35 USC
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`112, sixth paragraph. The rejection is traversed.
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`Claim 13 was canceled. Accordingly, the rejection of this claim is moot. Claim 12 was
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`amended to delete the term “means for” throughout the claim so that the claim does not invoke the
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`provisions under 35 U.S.C. § 112, $16. Accordingly, reconsideration and withdrawal of the rejection
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`as to indefiniteness of claims 12—13 are respectfully solicited.
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`Claim Rejection Under 35 U.S.C. § 101
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`Claims 1-13 have been rejected under 35 U.S.C. § 101 because the claims as a whole are not
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`directed to patent eligible subject matter. The rejection is traversed.
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`Initially, Applicant notes that claims 1-2, 5—6, 11 and 13 were canceled without prejudice or
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`disclaimer thereto. Accordingly, the rejection of these claims is moot.
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`1n formulating the rejection of the claims, the Examiner contends that claim 1 amounts to no
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`more than observing the levels of tau protein or AB and that the pretreatment limitations of claims
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`2-8 were routine. Office Action at 6—7. The Examiner further contends that “claim 9 is the same as
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`claim 1 excepting that both tau and A13 must be detected; this is ineligible for the same reasons”.
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`Applicant respectfully submits that these contentions are in error.
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`Application No. 14/374,181
`Reply to Office Action of March 4, 2015
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`Docket N0.: 061352-0530
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`Independent claim 9 is directed to a method for diagnosing Alzheimer’s disease comprising
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`the steps of: pretreating an intranasal specimen collected from a nasal cavity; detecting tau protein
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`and amyloid beta peptide (“AB”) in the intranasal specimen pretreated in the pretreatment step;
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`calculating a square root of a sum of a square of a value of the tau protein obtained in the detection
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`step and a square of a value of the AB obtained in the detection step; comparing the square root
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`calculated in the calculating step with predetermined values; and displaying a comparison result
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`obtained in the comparison step; wherein the pretreating step comprises extracting the intranasal
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`specimen with an extraction liquid. Claims 3-4, 7-10 depend on claim 9.
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`Independent claim 12 is directed to a system for diagnosing Alzheimer’s disease comprising:
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`detecting tau protein and amyloid beta peptide (“AB”) in an intranasal specimen collected from a
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`nasal cavity; calculating a square root of a sum of a square of a value of the tau protein obtained in
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`the detection step and a square of a value of the AB obtained in the detection step; comparing the
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`square root calculated in the calculating step with predetermined values; and displaying a
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`comparison result for the compared values; wherein tau protein and AB are detected by an
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`immunoassay. Claim 14 depends on claim 12.
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`Applicant respectfully submits that the presently claimed subject matter does significantly
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`more than observing and detecting the levels of tau protein or AB. As explained in the present
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`application, conventional methods for diagnosing Alzheimer’s disease typically involved highly-
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`invasive techniques and the attendant risk of infections. See background section of the present
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`application.
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`In contrast, the presently claimed subject matter provides methods for diagnosing
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`Alzheimer’s disease which is capable of minimizing invasiveness to reduce the risk of infection.
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`See, e.g., paragraphs 14-15.
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`Application No. 14/374,181
`Reply to Office Action of March 4, 2015
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`Docket No.: 061352—0530
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`As further explained in the present application,
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`the concentration of AB is low in an
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`intranasal specimen and tau protein has not been readily detected in an intranasal specimen. See
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`paragraphs 17—18 of the present application.
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`In contrast, the present application describes and
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`claims a method of diagnosing Alzheimer’s disease using an intranasal specimen. As reported by
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`the application, the pretreatment step is significant in allowing detection of these proteins.
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`In addition, the claims calculate a square root value from the sum of the squares of the
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`detected the tau protein and AB for comparison.
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`Hence, Applicant respectfully submits that the contentions that the claims of the present
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`application is nothing more than observing and detecting the levels of tau protein or AB are
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`factually incorrect. Moreover, Applicant respectfully submits that
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`the claimed steps are not
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`conventional. For example, the pretreating step allows detection of the proteins and AB and such
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`steps were not taught or suggested by the prior art and permits a diagnosis method that is different
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`and in many respects better than convention diagnosis methods. Thus, the claimed subject matter
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`adds significantly more than any natural phenomena. Accordingly, reconsideration and withdrawal
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`of the rejections of claims 3-4, 7—10, 12 predicated on grounds of lacking subject matter eligibility
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`are respectfully solicited.
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`Re’ection of Claims 12-13 Under 35 U.S.C.
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`102
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`Claims 12 and 13 stand rejected under 35 U.S.C. § 102(b) as being anticipated by US.
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`Patent No. 6,194,217 (“Matson”) and Luminex (“Identifying Alzheimer’s Disease Biomarkers from
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`Human Brain Tissue”, Bioprobes 54:22-23). The rejection is traversed and reconsideration is
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`respectfully solicited.
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`Application No. 14/374,181
`Reply to Office Action of March 4, 2015
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`Docket No.: 061352-0530
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`In formulating the rejection, the Examiner gave no weight to the language relating to the
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`specimen collected from a nasal cavity. Claim 12 was amended to delete the “means for” language
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`and to recite steps including detecting, comparing and displaying. The cited patents to Matson or
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`Luminex do not disclose these steps. Accordingly, claim 12 cannot be anticipated by the cited
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`references. Reconsideration and withdrawal of the rejection of claim 12 are solicited.
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`Rejection of claims 1-4, 6 and 7 Under 35 U.S.C. § 102
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`Claims 1-4, 6 and 7 stand rejected under 35 U.S.C. § 102(b) as being anticipated by
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`WO2011/092796 (“Nanjoh”). The rejection is traversed and reconsideration is solicited.
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`As noted above, claims 1-2, were canceled without prejudice or disclaimer thereto. Claims
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`3, 4 and 7 were amended to depend on independent claim 9. Accordingly, the rejection of claims 1—
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`4, 6 and 7 is moot.
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`Rejection of claims 1, 8, 9, 12 and 13 Under 35 U.S.C. § 102
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`Claims 1, 8, 9, 12 and 13 stand rejected under 35 U.S.C. § 102(b) as being anticipated by
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`Yamagishi (“Pathology of Olfactory Mucosa in Patients with Alzheimer’s Disease”, hereinafter
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`c‘Yamagishi”). The rejection is traversed and reconsideration is solicited.
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`As noted above, claims 1 and 13 were canceled without prejudice or disclaimer thereto.
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`Accordingly, the rejection of claims 1 and 13 is moot.
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`Independent claim 9 is directed to a method for diagnosing Alzheimer’s disease and includes
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`the step of pretreating an intranasal specimen collected from a nasal cavity wherein the pretreating
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`step comprises extracting the intranasal specimen with an extraction liquid. Claim 9 also includes
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`the step of calculating a square root of a sum of a square of a value of the tau protein obtained in the
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`Application No. 14/374,181
`Reply to Ofiice Action of March 4, 2015
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`Docket No.: 061352—0530
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`detection step and a square of a value of the AB obtained in the detection step. Yamagishi does not
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`teach or disclose at
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`least these elements of claim 9 and thus cannot anticipate claim 9 or its
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`dependent claim 8.
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`Independent claim 12 is directed to a system for diagnosing Alzheimer’s disease and also
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`includes calculating a square root of a sum of a square of a value of the tau protein obtained in the
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`detection step and a square of a value of the AB obtained in the detection step. Yamagishi does not
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`teach or disclose at least this element of claim 12 and thus cannot anticipate claim 12.
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`Accordingly, reconsideration and withdrawal of the rejections of claims 1, 8, 9, l2 and 13 as
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`anticipated by Yamagishi are respectfully solicited.
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`Re'ection Under 35 U.S.C.
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`103
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`Claims 1, 2, 7, 9, 12 and 13 stand rejected under 35 U.S.C. § 103(a) as being unpatentable
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`over Matson.
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`Claims 1—10, 12 and 13 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over
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`Nanjoh in View of Yamagishi and further in View of Luminex.
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`Claims 1-13 have been rejected under 35 U.S.C. § 103(a) as being unpatentable over Nanjoh
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`in View of Yamagishi and further in View of Luminex and Caroli (“The Dynamics of Alzheimer’s
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`Disease Biomarkers in the Alzheimer’s Disease Neuroimaging Initiative Cohort” Neurobiol Aging
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`31(8):]263-1274).
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`The rejections are traversed and reconsideration is solicited.
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`As noted above, claims 1-2, 5-6, 11 and 13 were canceled without prejudice or disclaimer
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`thereto. Accordingly, the rejection of these claims is moot.
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`Application No. 14/374,181
`Reply to Office Action of March 4, 2015
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`Docket No: 061352-0530
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`Independent claim 9 is directed to a method for diagnosing Alzheimer’s disease and includes
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`the step of pretreating an intranasal specimen collected from a nasal cavity wherein the pretreating
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`step comprises extracting the intranasal specimen with an extraction liquid and the step of
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`calculating a square root value from the sum of square values of the tau protein and the AB.
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`Independent claim 12 is directed to a system for diagnosing Alzheimer’s disease and also includes
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`calculating a square root value from the sum of square values of the tau protein and the AB.
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`As acknowledged by the Examiner on page 15 of the Office Action, the combination of
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`Nanjoh, Yamagishi, Luminex “do not teach calculating a sum of squares to use when comparing a
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`predetermined value”. Applicant respectfully submits that the combination of references further do
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`not teach or suggest “calculating a square root of a sum of a square of a value of the tau protein
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`obtained in the detection step and a square of a value of the AB obtained in the detection step”, as
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`recited in either claims 9 or 12. Madson, alone or in combination with the other references,iis
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`similarly deficient.
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`To fill this gap, Caroli is cited for “using a sum of squares analysis to determine goodness of
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`fit (abstract; p5, section 2.6)”. However, Caroli merely discloses comparing sum of squares on page
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`5. Caroli fails to teach or suggest calculating a square root of a sum of a square of a value of the tau
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`protein and a square of a value of the AB, and comparing the calculated square root with
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`predetermined values. Hence, even when Caroli is combined with the other cited references, the
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`combination of references fails to teach or suggest all of the features of the claimed subject matter.
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`Accordingly, Applicant respectfully submits that pending claims 3-4, 7-10, 12, 14 are patentable
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`over the combination of references. Reconsideration and withdrawal of the rejection of obviousness
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`of claims 3-4, 7-10, 12, 14 are respectfully solicited.
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`Application No. 14/374,181
`Reply to Office Action of March 4, 2015
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`Conclusion
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`Docket No: 061352-0530
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`In View of the above amendments and remarks, Applicant submits 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
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`to expedite the prosecution of the application.
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`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,
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`M
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`RMOTT WILL & EMERY LLP
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`Daniel Buc’ca
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`Registration No. 42,3 68
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`Please recognize our Customer No. 53080 as
`our correspondence address.
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`500 North Capitol Street, NW.
`Washington, DC 20001
`Phone: (202) 756~8612 DB:apr
`Facsimile:
`(202) 756—8087
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`Date: May 28, 2015
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`DM_US 61584924-1 061 352.0530
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