`
`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
`www.uspto.gov
`
`
`
`
`
`13/378,448
`
`12/15/2011
`
`Katsuhiko Maruo
`
`89884(316697)
`
`1084
`
`Locke Lord LLP
`PO. BOX 55874
`BOSTON, MA 02205
`
`SIMS, JASONM
`
`PAPER NUIVIBER
`
`ART UNIT
`
`1631
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`02/26/2015
`
`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):
`
`patent @ lockelord.com
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 13/378,448 MARUO, KATSUHIKO
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1631JASON SIMS its“
`
`-- 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 12/23/2014.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|ZI This action is non-final.
`2a)|:l This action is FINAL.
`3)|: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)|:| 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) fl? is/are pending in the application.
`5a) Of the above claim(s) 2-6 and 8-19 is/are withdrawn from consideration.
`
`is/are allowed.
`6)|:I Claim(s)
`7)|Z| Claim(s)_1and7is/are rejected.
`8)|Z| CIaim(s)_1is/are objected to.
`
`
`are subject to restriction and/or election requirement.
`9)|:I Claim((s)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`
`
`
`hit z/thvvvtlsnto. ovI’ atentS/init events/
`hI/index.‘s orsend an inquiryto PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 12/15/2011 is/are: a)IXI accepted or b)|:l objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`
`12)IXI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)IZl All
`
`b)|:l Some” c)I:l None of the:
`
`1.IXI 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
`
`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 InformatIon 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 20150222
`
`

`

`Application/Control Number: 13/378,448
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`Page 2
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`Art Unit: 1631
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`The present application is being examined under the pre-AIA first to invent
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`provisions.
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`DETAILED ACTION
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`Applicant’s election without traverse of Species E, claim 7, in the reply filed on
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`12/23/2014 is acknowledged.
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`Claims 2-6 and 8-19 are withdrawn from further consideration pursuant to 37
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`CFR 1.142(b) as being drawn to a nonelected inventive group, there being no allowable
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`generic or linking claim. Election was made without traverse in the reply filed on
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`12/23/2014.
`
`Claims 1 and 7 are the current claims hereby under examination.
`
`Claim Objections
`
`Claim 1
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`is objected to because of the following informalities: Claim 1 comprises
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`the wording “for non-invasively calculate,” wherein it appears the wording should either
`
`read “to non-invasively calculate” or “for non-invasively calculating.” Appropriate
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`correction is required.
`
`Claim Rejections - 35 USC § 1 12
`
`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:
`
`

`

`Application/Control Number: 13/378,448
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`Page 3
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`Art Unit: 1631
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`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.
`
`Claims 1 and 7 are being interpreted under 35 USC 112 Sixth Paragraph
`
`because claims 1 and 7 use non-structural phrases “a calibration model” and “a blood
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`sugar value estimation apparatus” with regular and generic placeholding functional
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`language of “means configured to” and “configured to” where there is no specific
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`structure identified in the specification to correspond to the claimed regular and generic
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`placeholding functional language of “means configured to” and “configured to.”
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`Furthermore, the non-structural term is not preceded by a structural modifier. The non-
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`structural phrases “a calibration model” and “a blood sugar value estimation apparatus”
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`“configured to” are not recognized as the name of a structure but merely a substitute for
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`the term “means for” because the phrases are not modified by sufficient structure,
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`material, or acts for achieving the specified function of “create the calibration model
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`from a plurality of calibration models,
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`set a reference spectrum by measuring a bio-
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`spectrum of a person,
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`calculate a difference spectrum," and "make a change of the
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`calibration model" respectively.
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`A consideration of the understanding of one skilled in the art in no way relieves
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`the patentee of adequately disclosing sufficient structure in the specification for such
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`means plus function. For the instant indefiniteness analysis it is asked first whether a
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`structure is described in the specification, and, if so, whether one skilled in the art would
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`identify the structure from the description. The inquiry is whether one of skill
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`in the art
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`would understand the specification itself to disclose a structure, not simply whether that
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`

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`Application/Control Number: 13/378,448
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`Page 4
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`Art Unit: 1631
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`person would be capable of implementing a structure. Accordingly, a bare statement
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`that known techniques or methods can be used does not disclose structure. To
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`conclude othenNise would vitiate the language of the statute requiring “corresponding
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`structure, material, or acts described in the specification. Therefore, it is not enough to
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`say one of ordinary skill
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`in the art would know how to implement said means plus
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`function, but the patentee must state a specific structure, which one of ordinary skill
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`in
`
`the art would recognize as implementing said means.
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`A review of the specification does not show what applicant considers to be the
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`corresponding structure. The closest disclosures described in the specification for the
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`35 U.S.C. 112, sixth paragraph limitation:
`
`.
`
`.
`
`For “a calibration model creating means" paragraph [0029] of the
`published specification discloses “comprises a reference spectrum setting
`means, a measurement spectrum setting means, a difference spectrum
`calculating means, and a calibration model changing means.”
`
`For “blook sugar estimation apparatus", paragraph [0019], [0030], [0101]
`of the specification generally states “The difference spectrum calculating
`means is configured to calculate a first difference spectrum which is
`defined by a difference between the first measurement spectrum and the
`reference spectrum. The difference spectrum calculating means is
`configured to calculate a second difference spectrum which is defined by a
`difference between the second measurement spectrum and the reference
`spectrum. The difference spectrum calculating means is configured to
`calculate a variation of a difference spectrum which is defined by a
`difference between the first difference spectrum and the second difference
`spectrum. The calibration model changing means is configured to make
`the change of the calibration model for calculating on the basis of the
`variation of the difference spectrum.”
`
`Therefore, it is unclear as to how to interpret the corresponding structures as
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`applicant does not appear to recite what is considered to be a corresponding structure
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`

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`Application/Control Number: 13/378,448
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`Page 5
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`Art Unit: 1631
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`or any equivalent structures thereof in light of the specification. However, the calibration
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`model creating means will be interpreted as any type of calibration means from using
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`equations to algorithms, etc. Similarly, the apparatus being configured "to set a
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`reference spectrum,
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`calculate a difference spectrum” and “make a change of the
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`calibration model” will be broadly interpreted as any type of modeling, programming,
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`processing that is capable of performing the broadly claimed limitations.
`
`lf applicant wishes to provide further explanation or dispute the examiner’s
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`interpretation of the corresponding structure, applicant must identify the corresponding
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`structure with reference to the specification by page and line number, and to the
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`drawing, if any, by reference characters in response to this Office action.
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`If applicant does not wish to have the claim limitation treated under 35 U.S.C.
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`112, sixth paragraph, applicant may amend the claim so that it will clearly not invoke 35
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`U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites
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`sufficient structure, material, or acts for performing the claimed function to preclude
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`application of 35 U.S.C. 112, sixth paragraph.
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`For more information, see Supplementary Examination Guidelines for
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`Determining Compliance with 35 U. S. C. § 112 and for Treatment of Related Issues in
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`Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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`Regarding claims 1-6, the following means/step (or configured to) plus function
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`limitations are vague and indefinite:
`
`.
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`“calibration model creating means configured to create the calibration
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`model”
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`

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`Application/Control Number: 13/378,448
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`Page 6
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`Art Unit: 1631
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`.
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`“ apparatus configured to "to set a reference spectrum,
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`calculate a
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`difference spectrum” and “make a change of the calibration model”
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`The specification as filed does not set forth specific structures for
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`performing the means recited. The recited “configured to” language lacks specific
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`related structures in the specification. See MPEP § 2181 for guidance in
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`determining whether an applicant has complied with the requirements of 35
`
`U.S.C. 112, second paragraph, when 35 U.S.C. 112, sixth paragraph, is invoked.
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`35 U.S.C. 112, sixth paragraph states that a claim limitation expressed in means-
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`plus-function language “shall be construed to cover the corresponding
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`structure...described in the specification and equivalents thereof.
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`If one
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`employs means plus function language in a claim, one must set forth in the
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`specification an adequate disclosure showing what is meant by that language. If
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`an applicant fails to set forth an adequate disclosure, the applicant has in effect
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`failed to particularly point out and distinctly claim the invention as required by the
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`second paragraph of section 112.” In re Donaldson Co., 16 F.3d 1189, 1195, 29
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`USPQ2d 1845, 1850 (Fed. Cir. 1994) (in banc).
`
`Claims 1 (and all claims dependent therefrom) are rejected under 35 U.S.C.
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`112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to
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`particularly point out and distinctly claim the subject matter which the inventor or a joint
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`inventor, or for pre-AIA the applicant regards as the invention.
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`

`

`Application/Control Number: 13/378,448
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`Page 7
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`Art Unit: 1631
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`Claims 1 (and all claims dependent therefrom) are rejected under 35 U.S.C. 112,
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`second paragraph, for failing to particularly point out and distinctly define the metes and
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`bounds of the subject matter that will be protected by the patent grant. The preamble
`
`states “apparatus for non-invasively calculate a blood sugar value with time on the basis
`
`of an optical spectrum” while the method steps recite a calibration model means to
`
`create a calibration model, an apparatus configured to set a reference spectrum,
`
`calculate a difference spectrum and make a change to the calibration model. The
`
`metes and bounds of claim 1
`
`is not clear because it is not clear whether the preamble
`
`reciting “apparatus for non-invasively calculate a blood sugar value with time on the
`
`basis of an optical spectrum”, or the method steps control the metes and bounds of said
`
`claim 1.
`
`Claim Rejections - 35 USC § 101
`
`35 U.S.C. 101 reads as follows:
`
`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 and 7 (also being interpreted as essentially method claims implemented
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`on a system) are rejected under 35 U.S.C. 101 because the claimed invention is
`
`directed to non-statutory subject matter because the claimed invention is not directed to
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`patent eligible subject matter. Based upon an analysis with respect to the claim as a
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`whole, claim(s) 1-6 do not recite something significantly different than a judicial
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`exception. The rationale for this determination is explained below:
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`

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`Application/Control Number: 13/378,448
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`Page 8
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`Art Unit: 1631
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`The instant claims are directed towards a apparatus for non-invasively calculate
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`a blood sugar value with time on the basis of an optical spectrum. According to the
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`2014 interim Eligibility Guidance an initial two step analysis is required for determining
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`statutory eligibility. Step 1 requires a determination of whether the claims are directed
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`to a process, machine, manufacture, or a composition of matter.
`
`In the instant case the
`
`Step 1 requirement is satisfied as the claims are directed towards a
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`system/process/machine. The Step 2 analysis is a two-part analysis, Step 2A and Step
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`28, with the first part Step 2A requiring a determination of whether the claims are
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`directed towards ajudicial exception, Le. a law of nature, natural phenomenon, or an
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`abstract idea.
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`In the instant case, the claims as being interpreted under 35 USC 101 state an
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`apparatus for performing the method without any structural limitations being recited.
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`Therefore under 35 USC 101, these claims are being interpreted essentially as method
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`claims but being implemented on a system, i.e. computer. The recited process involves
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`the abstract and computational steps creating a calibration model, setting a reference
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`spectrum, calculating a difference spectrum and adjusting the calibration model. As
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`such, the instant claims are drawn only to an abstract process that only manipulates
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`data and, therefore, are not directed to statutory subject matter. Therefore the result of
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`Step 2A analysis is that the claims are directed towards a judicial exception. With
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`regards to the claims being directed to a process implemented on a computer system or
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`embedded on a computer readable medium comprising instructions for carrying out the
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`method, it is the underlying invention that is analyzed to determine subject matter
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`

`

`Application/Control Number: 13/378,448
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`Page 9
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`Art Unit: 1631
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`eligibility, not just the use of a computer system or computer program product.
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`In the
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`instant case, the claims are directed to only the manipulation of data as described
`
`above. The method steps themselves are considered to be an abstract idea because
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`they do not purport to improve the functioning of the computer itself, there is no specific
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`or limitation recitation of improved computer technology, nor do they effect an
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`improvement in any other technology or technical field.
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`The second part, Step 28 of the two step analysis is to determine whether any
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`element or combination of elements, in the claim is sufficient to ensure that the claim as
`
`a whole amounts to significantly more than the judicial exception. No additional steps
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`are recited in the instantly claimed invention that would amount to significantly more
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`than the judicial exception. Without additional limitations, a process that empioys
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`mathematicai algorithms to meniptiiate existing information te generate additionai
`
`information is not patent eiigibie. Furthermore, if a ciairri is directed essentiaiiy to a
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`method of caicniating, using a mathematicai tormuia, even it the soiution is for a specific
`
`purpose, the ciaimed method is non—statutory.
`
`in other words, patenting abstract ideas
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`cannet be circumvented by attempting to iimit the use [the ideaj te a particuier
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`iechnoiogicei environment. in the instant ciaima, the computer and/or program/product
`
`amount to mere instruction to impiement an abstract idea, The hardware recited by the
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`system ciaims do not offer a meaningtui iirnitation beyond generaiiy iinking “the use of
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`the method to a partisaiar technoiogieai environment,’ that is, irnpierrientation via
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`computers.” see Aiice Corp v. CLS Bank int’i 573 U3. {25M}.
`
`Claim Rejections - 35 USC § 102
`
`

`

`Application/Control Number: 13/378,448
`
`Page 10
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`Art Unit: 1631
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`The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C.
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`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 public use or on sale in this country, more than one year prior to the date of application
`for patent in the United States.
`
`Claim 1
`
`is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by
`
`Ruchti et al. US (P/N 2007/0179367).
`
`Ruchti et at. describe at paragraphs [0045] and [008ija methed that comprises
`
`making a reference spectrum arid obtaining measurement spectrum aierig with the time
`
`ef the measurement. Ruehtt at at. describe at paragraphs [0087] m [0000] fiiterir‘rg the
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`spectra, but further describe at paragraph [0091] there are marry different epsratiehs
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`that can be perfermed on the spectra to EiQEi-itwaSiVSiy ebtaih arr anai'y‘te value: Ruehtt
`
`et al. describe wherein the spectra processing is used fer salibratieh deveiopmeht
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`based art a pturality at data sets, see paragraphs [0069] at‘tfj [0181] m [0217’].
`
`Claims 1 and 7 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated
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`by Ota et al. US (P/N 2006/0063987)
`
`Ota et al. at the abstract, paragraphs [0004] and [0043] — [0063] describe the
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`instantly claimed method.
`
`Claims 1 and 7 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated
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`by Maruo et al. US (P/N 2004/0142402)
`
`

`

`Application/Control Number: 13/378,448
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`Page 11
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`Art Unit: 1631
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`Maruo et al. at the abstract and paragraphs [0035] - [0080] describe the instantly
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`claimed method.
`
`Claims 1 and 7 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated
`
`by Maruo et al. "Noninvasive Near-Infrared Blood Glucose monitoring using a
`
`Callibration Model Built by a Numerical Simulation Method: Trial Application to Patients
`
`in an Intensive Care Unit, Applied Spectroscopy, 2006, Volume 60, Number 12, pages
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`1423-1431.
`
`Maruo et al. describe the claimed method at the abstract and pages 1426-1430.
`
`No claim is allowed
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Jason Sims, whose telephone number is (571 )-272—
`7540.
`
`If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s
`supervisor, Marjorie Moran can be reached via telephone (571)-272—0720.
`
`Papers related to this application may be submitted to Technical Center 1600 by
`facsimile transmission. Papers should be faxed to Technical Center 1600 via the
`Central PTO Fax Center. The faxing of such papers must conform with the notices
`published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61
`(November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)).
`The Central PTO Fax Center number is (571)-273-8300.
`
`Information regarding the status of an application may be obtained from the
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`

`

`Application/Control Number: 13/378,448
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`Page 12
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`Art Unit: 1631
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`published applications may be obtained from either Private PAIR or Public PAIR.
`Status information for unpublished applications is available through Private PAIR only.
`For more information about the PAIR system, see httg://pair—direct.usptogov. Should
`you have questions on access to the Private PAIR system, contact the Electronic
`Business Center (EBC) at 866-217-9197 (toll-free).
`
`/Jason Sims/
`
`Primary Examiner, Art Unit 1631
`
`