`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`wwwusptogov
`
`
`
`
`
`14/374,181
`
`07/23/2014
`
`Takaomi Fukuhara
`
`061352—0530
`
`3739
`
`53080
`7590
`03’04’20”
`McDermon Will and Emery LLP —
`The McDermott Building
`WEIDNER’ ADAM M
`500 North Capitol Street, NW.
`WASHINGTON, DC 20001
`
`PAPER NUMBER
`
`1649
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`03/04/2015
`
`ELECTRONIC
`
`Please find below and/0r 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):
`
`mweipdocket @ mwe.com
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 14/374,181 FUKUHARA ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`ADAM M. WEIDNER its“ 1649
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136( a).
`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).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`
`1)IZI Responsive to communication(s) filed on 7/23/14.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|ZI This action is non-final.
`2a)|:l This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:| 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) 1-13 is/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)_1-13 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/
`
`
`
`iindex.‘s or send an inquiry to PPl-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)I:l 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)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:l 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.
`3.|:| Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`
`
`3) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) E lnformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20150217
`
`

`

`Application/Control Number: 14/374,181
`
`Art Unit: 1649
`
`Page 2
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`The present application is being examined under the pre-AIA first to invent provisions.
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`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and
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`103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for
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`the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale
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`supporting the rejection, would be the same under either status.
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`DETAILED ACTION
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`This action is in response to preliminary claim amendments filed 7/23/14. Claims 1-13 are
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`pending and under examination.
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`Information Disclosure Statement
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`The IDS submitted 7/23/14 has been wholly lined through as it is a duplicate of the form
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`submitted 9/11/14. The references from the 9/11/14 have been considered as indicated as well as the
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`references from the form submitted 1/12/15.
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`Dates have been added to references 6, 8, and 9 on the IDS submitted on 1/12/15 as required by
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`37 CFR 1.98(b)(5). Applicant is reminded that all citations submitted on an Information Disclosure
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`Statement must be accompanied by a date.
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`Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d),
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`which papers have been placed of record in the file.
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`Priority
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`Claim Objections
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`Claim 1
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`is objected to because of the following informalities: “hereinafter, referred to as A13”
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`should be simply "AB" as this would improve the brevity and clarity of the claim while still clearly indicating
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`AB is an abbreviation for amyloid beta peptide. Appropriate correction is required.
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`

`

`Application/Control Number: 14/374,181
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`Art Unit: 1649
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`Page 3
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`Claim 2 and 10 is objected to because of the following informalities: “attached to a collection tool”
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`should be “with a collection tool” as no such attachment has been previously claimed. Appropriate
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`correction is required.
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`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(f):
`
`(f) Element in Claim for a Combination. — An element in a claim for a combination may be
`expressed as a means or step for performing a specified function without the recital of
`structure, material, or acts in support thereof, and such claim shall be construed to cover the
`corresponding structure, material, or acts described in the specification and equivalents
`thereof.
`
`The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
`
`An element in a claim for a combination may be expressed as a means or step for performing
`a specified function without the recital of structure, material, or acts in support thereof, and
`such claim shall be construed to cover the corresponding structure, material, or acts
`described in the specification and equivalents thereof.
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`Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable
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`presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35
`
`U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth
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`paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts
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`within the claim itself to entirely perform the recited function.
`
`Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the
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`claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth
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`paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not
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`invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure,
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`material or acts to perform that function.
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`Claim elements in this application that use the word “means” (or “step for”) are presumed to
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`invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that
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`do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as
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`otherwise indicated in an Office action.
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`

`

`Application/Control Number: 14/374,181
`
`Art Unit: 1649
`
`Page 4
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`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION—The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph,
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`as being indefinite for failing to particularly point out and distinctly claim the subject matter which the
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`inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
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`The claims of the instant method recite “pretreating” an intranasal specimen. There is no
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`particular definition of “pretreating” in the instant specification. The guidance in the instant specification
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`and claims appear to suggest that steps such as simply collecting the sample constitute a pretreatment
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`step (e.g., claim 2). This on its own would simply indicate the claim is broad, not indefinite. However,
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`"pretreating" holds different connotations in different arts and when used for different methods. There is
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`no clear indication as to the metes and bounds of what Applicant considers to be "pretreating". See
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`MPEP §2173 which states that the purpose of this portion of the statute is two-fold: to ensure that the
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`scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of
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`the patent; and to provide a clear measure of what applicants regard as the invention so that it can be
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`determined whether the claimed invention meets all the criteria for patentability and whether the
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`specification meets the criteria of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph with respect
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`to the claimed invention. In this case, the first purpose is not met with the current recitation of “pretreating”
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`as the metes and bounds of the scope of the term “pretreating” are entirely unclear. Given the paucity of
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`guidance in the specification (e.g., collection, dispensing into an extraction liquid, filtering), the skilled
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`artisan is not apprised of the limits of the scope and therefore is not informed of the boundaries which
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`constitute infringement.
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`Claims 12 and 13 recited various “means for” and are therefore being examined under the
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`conventions of §1 12, 6th paragraph. §112(6) serves the purpose of “limiting the scope of the claim to the
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`

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`Application/Control Number: 14/374,181
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`Art Unit: 1649
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`Page 5
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`particular structure disclosed, together with equivalents” (MPEP §2181). While the skilled artisan is aware
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`of a variety of means for comparing, displaying, and calculating gathered data, this “in no way relieves the
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`patentee of adequately disclosing sufficient structure in the specification. It is not enough for the patentee
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`simply to state or later argue that persons of ordinary skill in the art would know what structures to use to
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`accomplish the claimed function” (MPEP §2181). In this case, the specification does not disclose any
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`structural limitations regarding a means for accomplishing these tasks, only stating that these tasks were
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`accomplished. No identification of any corresponding structure, material, or acts for performing the
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`claimed functions is possible given the instant disclosure.
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`Therefore, claims 1-13 are indefinite. For the purpose of prosecution, any step which is
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`determined to meet the limitations of a pretreatment step will be articulated in the relevant rejection. Any
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`means capable of performing the functions claimed will be considered to meet the limitations of claims
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`12-13. Note that the "detecting" step of claim 12 is associated with sufficient structure (the disclosed
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`ELISA kits) to meet the burden of a structural disclosure under §112(6).
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`35 U.S.C. 101 reads as follows:
`
`Claim Rejections - 35 USC § 101
`
`Whoever invents or discovers any new and useful process, machine, manufacture, or
`composition of matter, or any new and useful improvement thereof, may obtain a patent
`therefor, subject to the conditions and requirements of this title.
`
`Claims 1-13 are rejected under 35 U.S.C. § 101 because the claims as a whole are not directed
`
`to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, these
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`claims do not recite something significantly different than a judicial exception. The rationale for this
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`determination is explained below:
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`New guidance with respect to patent eligibility under 35 U.S.C. § 101 has been provided, effective
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`16 December 2014 and published in the Federal Register V 79 No 241 (please visit
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`http://www.uspto.gov/patents/law/exam/interim_guidance_subject_matter_eligibility.jsp for the published
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`guidance). This guidance has been provided in light of recent court decisions such as Association for
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`Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106, USPQ2d 1972
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`

`

`Application/Control Number: 14/374,181
`
`Art Unit: 1649
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`Page 6
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`(2013), Mayo Collaborative Serivices v. Prometheus Laboratories, Inc., 566 U.S. _, 132 S. Ct. 1289, 101
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`USPQ2d 1961 (2012), and Alice Corporation PTY. LTD v CLS Bank International.
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`The first step under this guidance is determining if the claim is directed to one of the four statutory
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`categories (process, machine, manufacture, or composition of matter). In this case, the claims are
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`directed to a method (a process). The second step is determining if the claims recite or involve judicial
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`exception(s), such as laws of nature, natural phenomena, natural products, or an abstract idea. In this
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`case, claims 1-11 are drawn to the observing a natural phenomenon (“detect tau compare values”
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`"display results”; natural phenomenon and abstract ideas) while claims 12 and 13 are drawn to a generic
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`system and abstract ideas (means for detecting/comparing/displaying/calculating) .
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`Thus, it must be determined if the claim as a whole recites something significantly different than
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`the judicial exceptions.
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`Claim 1
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`is drawn to a method of diagnosing Alzheimer's disease (AD) by pretreating an intranasal
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`sample, detecting either tau or A8, comparing these values with some predetermined value, and
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`displaying the results. Thus, claim 1 amounts to no more than observing the levels of A8 or tau in an
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`intranasal specimen. There is no requirement that any particular pretreatment step is used and may
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`include simply collecting the specimen itself. The detection step covers every possible process for
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`detecting both proteins. The comparing step covers any possible comparison to any possible
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`predetermined value. The displaying step may use any possible means of displaying the comparison. The
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`claim does not actually require any diagnosis is made or even a requirement that, once displayed, the
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`result is seen or used by anyone. The claim itself amounts to no more than an attempt to foreclose others
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`from detecting tau or A8 in intranasal specimens for any reason, as the comparing and displaying steps
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`must be used by others to generate any meaning from the collected data. No specific machine is required
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`and no transformation of the data is achieved. The method simply informs a relevant audience about the
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`natural relationship, the relationship being a natural consequence of how the body expresses tau and the
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`natural, unaltered relationship between tau and a tauopathy. There is nothing in the claim that requires
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`the gathered data is applied in any meaningful way, and it would effectively monopolize the judicial
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`exception itself.
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`

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`Application/Control Number: 14/374,181
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`Art Unit: 1649
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`Page 7
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`Claims 2-8 include limitations to the pretreatment step. However, the elements in these claims
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`are no more than what was routine and conventional in the art (using swabs and metering tools to collect
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`intranasal specimens, using formic acid to detect AB, etc). Moreover, there is still no requirement that the
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`gathered data is actually used in any way. While the claim is a method of diagnosing AD, there is no
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`requirement that any particular machine is used or transformation of the data is performed. Rather, the
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`claims observe natural intranasal AB and/or tau levels using well-established techniques, compare the
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`information in any way to any value, and the results are then displayed. This is similar to the fact pattern
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`in Mayo where the concluding step—that the gathered data “indicated” a certain need—did not in fact
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`require any treatment modification was performed, only that the data indicated the need. The data
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`indicate this need regardless of recognition by another, in the same way displaying a comparison result
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`does not require any actual diagnosis is made.
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`Claim 9 is the same as claim 1 excepting that both tau and AB must be detected; this is ineligible
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`for the same reasons.
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`Claim 10 includes using a collection tool, eluting the sample, extracting in ultrapure water, and
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`extracting AB in formic acid. These steps were all routine and conventional in the art and none of these
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`steps add significantly more than observing the phenomenon itself, dissociated from any conclusion or
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`diagnosis.
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`Claim 11 requires a generic mathematical formula is applied to compare the values. This does
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`not transform the data into anything other than what it was, nor is it considered to add significantly more
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`than observing the phenomenon itself. There is no indication as to how the comparison is meant to lead
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`the artisan to a diagnosis of AD and the claims as a whole amount to no more than a suggestion that
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`intranasal AB and tau should be measured and that the practitioner should "apply it" somehow.
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`Claims 12 and 13 are drawn to generic means for accomplishing certain tasks. No specific
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`machine is required and several steps (comparing and calculating) may be entirely mental, while the
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`displaying step could be performed by simply writing the information on a piece of paper. While the
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`detection step would require a machine of some sort, the breadth of such devices capable of performing
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`this function indicates that only a generic computer and general reagents, all well-known and routinely
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`

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`Application/Control Number: 14/374,181
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`Art Unit: 1649
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`Page 8
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`used in the art, are required in order to gather data which is then observed. Essentially, the claims are
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`directed to performing generic, well-understood detection methods followed by abstract, mental steps.
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`Inasmuch as a machine might be required, any generic computer would suffice.
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`Therefore, claims 1-13 are drawn to patent ineligible subject matter.
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`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the
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`basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
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`Claims 12 and 13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Matson
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`(US 6194217; citation 1 on IDS filed 1/12/15.
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`Instant claims 12 and 13 invoke USC §112, paragraph six. The "system" is not a structural
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`limitation and the remaining limitations are only described by their function (means for
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`detecting/comparing/displaying/calculating). Note that the “means for detecting” is considered to refer to
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`the ELISA technology disclosed in the instant specification as well as equivalents thereof. There is
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`insufficient structure in the specification to analyze the means for comparing/displaying/calcuIating under
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`§112, 6th paragraph, and therefore any means which accomplishes this goal is considered an equivalent.
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`Matson discloses a means for detecting tau and AB (such as the liquid chromatography/electrical
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`detection system explicitly used to detect AB), considered an equivalent to the instantly disclosed ELISA
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`kits as both quantitatively detect the proteins, resulting in a value representing the physical concentration
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`of the protein in the sample. Matson compares and displays the information (see figures), clearly
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`anticipating a means for doing so. Any generic computer possesses the means for performing the
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`claimed calculations and Matson anticipates using computer analysis as the figures presented by Matson
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`clearly employed the use of a computer to generate graphs and probability statistics.
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`Therefore, claims 12 and 13 are anticipated by Matson.
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`

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`Application/Control Number: 14/374,181
`
`Art Unit: 1649
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`Page 9
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`Claims 12 and 13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Luminex
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`(cited on form 892).
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`Luminex teaches measuring AB and tau from brain tissue, CSF samples, and tissue culture
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`supernatant (p.22 C1). Luminex teaches pretreating the samples (homogenization, centrifugation,
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`addition of formic acid) and preparing the sample in ultrapure water (see protocol inset, p.23). Luminex
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`compares these values to a predetermined value (AD v control in figure 1; reference to standard curves
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`on page 23) and displays the results (figure 1). The detection method of Luminex is an equivalent of the
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`ELISA kit instantly disclosed as both are immunoassays that operate by the same biochemical principles
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`and generate the same quantification of protein concentration, the only difference being the former binds
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`antibodies to a bead while the latter binds antibody to a plate. Luminex clearly possesses a means for
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`comparing and displaying results (see graphs). Further, the "Luminexm xMAP(R) system” is a computer,
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`which is capable of performing the calculating step as any generic computer is capable of such
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`calculations.
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`Therefore, claims 12-13 are anticipated by Luminex.
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`Claims 1-4, 6, and 7 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nanjoh
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`(WO 2011/092796; FOR citation 3 on IDS submitted 9/11/14). Note that for the purpose of this action,
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`citation references will be made with respect to PGPUB 20130137120, taken as an English translation of
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`the ‘796 document as indicated on the IDS (Citation 1 on IDS submitted 9/11/14).
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`Nanjoh claims an AB measurement method comprising treating an irrigated nasal mucosa
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`specimen (claim 20) with a solubilizer (pretreatment) and measuring the AB quantitatively (claim 3).
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`Nanjoh teaches measuring AB involves comparing the sample value to a standard curve (paragraph 100;
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`comparing with a predetermined value) and displaying the results (paragraph 102, "the measurement
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`results are shown in Fig. 2"). Nanjoh teaches this method in the context of diagnosing AD (paragraphs 3-
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`10). Thus, Nanjoh teaches each active step of the instantly claimed method, thus anticipating instant
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`claim 1.
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`

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`Application/Control Number: 14/374,181
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`Art Unit: 1649
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`Page 10
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`With respect to claim 2, Nanjoh teaches placing the nasal specimen attached to a collection tool
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`(mucus attached to cotton swab) into 80% formic acid (paragraphs 97-98; an extraction liquid) in order to
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`“extract [i.e., elute] and solubilize the sample contained in the cotton swab”.
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`With respect to claims 3 and 4, Nanjoh teaches that irrigation solutions result in a salt build-up in
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`the sample, which adversely affects subsequent measurement by enzyme immunoassays. Nanjoh
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`teaches using ultrafiltration to overcome this hurdle (paragraph 84). Thus, Nanjoh anticipates filtering the
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`extraction liquid containing the intranasal specimen. Note that the claim language "for fractionation" does
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`not require fractionation actually occur, only that such filtration would be suitable for this purpose. Absent
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`evidence to the contrary, the filtration step of Nanjoh may be used for subsequent fractionation. As the
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`purpose of the filter is to reduce the salt concentration, the filter is clearly capable of fractionation (i.e.,
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`separating the protein from the salt).
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`With respect to claim 6, Nanjoh teaches the solubilizer is formic acid (claim 13).
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`With respect to claim 7, Nanjoh teaches collecting the nasal mucus with a cotton swab
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`(paragraph 97).
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`Therefore, claims 1-4, 6, and 7 are anticipated by Nanjoh.
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`Claims 1, 8, 9, and 12-13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by
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`Yamagishi (citation 9 on IDS filed 1/12/15).
`
`Yamagishi teaches pretreating an intranasal specimen collected from a nasal cavity (p. 421, C2:
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`“olfactory mucosa was obtained...by means of the special biopsy instruments we routinely use in our
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`small clinic”; p.422, C1: “the specimens were fixed...dehydrated...and embedded”). Yamagishi teaches
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`detecting tau in the sample (table on page 425), comparing this value with predetermined values
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`(compared to healthy controls, see table on p.425; compared to positive and negative control values to
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`validate the assay, see p.422 C1 -2), and displaying the comparisons (see figures and table throughout).
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`Yamagishi teaches this meathod for its use as a definitive diagnosis of AD (abstract). Thus, Yamagishi
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`anticipates instant claim 1.
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`

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`Application/Control Number: 14/374,181
`
`Art Unit: 1649
`
`Page 11
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`With respect to claim 8, the biopsy tool used by Yamagishi meets the limitations of a metering
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`collection tool.
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`With respect to claim 9, Yamagishi uses both tau and AB antibodies in order to detect these
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`proteins in the sample and states an “extracellular mass was found in the olfactory epithelium, and it
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`reacted strongly to an anti-tau antiserum and weakly to an anti-amyloid-B protein antiserum” (abstract).
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`This demonstrates that Yamagishi anticipates including detection of both AB and tau when probing
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`intranasal specimens and comparing these values to predetermined values (“strongly” and "weakly" are
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`comparative terms).
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`With respect to claims 12 and 13, Yamagishi teaches a means for detecting both tau and AB
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`(primary antibodies to both, demonstrated detection in an abnormal nasal aggregate; abstract), a means
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`for comparing values of tau and A13 to predetermined values (see table and figures as well as reference to
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`using positive and negative controls), a means for displaying comparison results (see table and figures),
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`and a means for calculating values (see references to percentage calculations, e.g., p.424 C2, and note
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`that any generic computer is a means for calculating such values).
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`Therefore, claims 1, 8, 9, and 12-13 are anticipated by Yamagishi.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness
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`rejections set forth in this Office action:
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`(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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`This application currently names joint inventors. In considering patentability of the claims under
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`pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was
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`commonly owned at the time any inventions covered therein were made absent any evidence to the
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`contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention
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`

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`Application/Control Number: 14/374,181
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`Art Unit: 1649
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`Page 12
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`dates of 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e),
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`(f) or (g) prior art under pre-AlA 35 U.S.C. 103(a).
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`Claims 1, 2, 7, 9, and 12-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable
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`over Matson (US 6194217; cited on IDS).
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`Claims 12-13 are anticipated by, and therefore obvious over, Matson as described above.
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`Further, Matson claims a method of diagnosis wherein healthy individuals and diseased individuals are
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`both sampled for molecular constituents (claim 1). Matson claims comparing these detected constituents
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`in a database for conformity to patterns representative of predetermined constituents in a test patient in
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`order to screen the test patient for the disorder (claim 1). In other words, Matson claims a method of
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`comparing the levels of a molecule in a test patient to a known, predetermined value aggregated from
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`either healthy or diseased individuals in order to diagnose the test individual. Matson claims the sample is
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`from the nasal mucosa (claim 6). Matson claims the disorder is Alzheimer’s disease (claim 12) and that
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`the molecule is fragments of AB (claim 29). Matson teaches that tau is also found in the nasal epithelium
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`and that “the possibility of using biopsy of nasal epithelium as a clinical marker of Alzheimer's disease
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`during life was suggested" (C19 L40-48). Matson displays the results of detecting AB in a saline
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`suspension of mucosa (figure 7) as well as displays the results of making a diagnosis of AD (figure 2).
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`While Matson teaches the individual components of the claim, Matson does not teach them in an
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`arrangement consistent with §102.
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`Nevertheless, one of ordinary skill in the art at the time the invention was made would have found
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`it obvious to detect tau and/or AB from an intranasal specimen and then to compare these values with
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`other values and display the result, arriving at the instant method. Matson clearly teaches that tau is
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`found in intranasal specimens and claims that the screening assay may also detect AB in an AD patient
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`as well as indicating the sample may be intranasal. Thus, one of ordinary skill in the art at the time the
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`invention was made would have found it obvious to take an intranasal specimen and detect tau and/or AB
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`using the methods disclosed by Matson. As Matson teaches the samples must be "prepared and flowed
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`

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`Application/Control Number: 14/374,181
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`Art Unit: 1649
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`Page 13
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`through a chromatographic column" for the sensors to detect the proteins (C6), Matson clearly teaches
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`pretreating the sample. The crux of the method of Matson is comparing the values of markers with
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`predetermined values (either healthy or diseased baselines); therefore, it would have been obvious that
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`the purpose of detecting the proteins (AB and/or tau) in the intranasal specimen was for the purpose of
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`comparing it to the known baseline values. As Matson displays the results of this detection, it would have
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`been obvious to one of ordinary skill in the art at the time of the invention to do so as well. Moreover, it is
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`noted that comparing detected values to known (predetermined) values is a basic scientific practice and
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`that, without any definition as to what a predetermined value is, the claim encompasses comparing the
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`detected value to a blank/zero value as is common when validating assays. Further, displaying results--
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`from computer displays to generating figures for publishing papers to medical reports—is also a basic
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`scientific tool and would have been an obvious step to anyone of ordinary skill in the art set to detect
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`intranasal A8 or tau. Thus, instant claims 1 and 9 would have been obvious.
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`As Matson teaches transferring a sample from a swab (collection tool) and eluting the samples
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`prior to detection using liquid chromatography (e.g. claim 10), it would have been obvious to perform the
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`same step, on point to instant claim 2.
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`Matson teaches use of a swab, rendering its use obvious (instant claim 7).
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`Therefore, claims 1, 2, 7, 9 and 12-13 would have been obvious over Matson.
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`Claims 1-10, and 12-13 are rejected under pre-AIA 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 (cited on form 892).
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`Claims 1-4, 6, and 7 are anticipated by, and therefore obvious over, Nanjoh as descr