UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`15/437,666
`
`02/21/2017
`
`Teruhisa OKUYA
`
`NIIPP0189US
`
`1308
`
`MARK D. SARALINO (PAN)
`RENNER, OTTO, BOISSELLE & SKLAR, LLP
`1621 EUCLID AVENUE
`19TH FLOOR
`CLEVELAND, OH 44115
`
`MELHUS~ BENJAMIN S
`
`ART UNIT
`3791
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`10/29/2019
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
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`ipdoeket@rennerotto.eom
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`PTOL-90A (Rev. 04/07)
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`

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`0/7709 A0170” Summary
`
`Application No.
`15/437,666
`Examiner
`BENJAMIN s MELHUS
`
`Applicant(s)
`OKUYA et al.
`Art Unit
`3791
`
`AIA (FITF) Status
`Yes
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 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 CFR 1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`|f NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
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`1). Responsive to communication(s) filed on 7/25/19.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a). This action is FINAL.
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`2b) C] This action is non-final.
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`3)[:] 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.
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`4)[:] Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)
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`Claim(s) fl is/are pending in the application.
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`5a) Of the above claim(s) g is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) 1—2 and 4—7 is/are rejected.
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`E] Claim(s) _ is/are objected to.
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`) ) ) )
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`6 7
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`8
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`
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`are subject to restriction and/or election requirement
`[:1 Claim(s)
`9
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.uspto.gov/patents/init events/pph/index.'sp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
`10):] The specification is objected to by the Examiner.
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`11):] The drawing(s) filed on
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`is/are: a)C] accepted or b)Ej objected to by the Examiner.
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`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)C] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)CI All
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`b)C] Some**
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`c)CI None of the:
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`1C] Certified copies of the priority documents have been received.
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`2C] Certified copies of the priority documents have been received in Application No.
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`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)).
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`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) C] Notice of References Cited (PTO-892)
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`2) D Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
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`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20191020
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`

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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 2
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`DETAILED ACTION
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`The text of those sections of Title 35, U.S. Code not included in this action can
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`be found in a prior Office action.
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`Notice of Pre-AIA or AIA Status
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`The present application, filed on or after March 16, 2013, is being examined
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`under the first inventor to file provisions of the AIA.
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`Claim Objections
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`Claim 1
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`is objected to because of the following informalities:
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`the phrase “th_e
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`processor performs to:” is not grammatically correct. Appropriate correction is required.
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`Claim Interpretation
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`This application includes one or more claim limitations that do not use the word
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`“means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35
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`U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder
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`that is coupled with functional language without reciting sufficient structure to perform
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`the recited function and the generic placeholder is not preceded by a structural modifier.
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`Such claim limitation(s) is/are: “the biological signal measurer measures a first amount
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`of sweat” and “the biological noise measurer measures a second amount of sweat” in
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`claim 7.
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`Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C.
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`112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to
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`

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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 3
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`cover the corresponding structure described in the specification as performing the
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`claimed function, and equivalents thereof.
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`lf applicant does not intend to have this/these limitation(s) interpreted under 35
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`U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may:
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`(1) amend the
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`claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA
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`35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the
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`claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s)
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`sufficient structure to perform the claimed function so as to avoid it/them being
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`interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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`Claim Rejections - 35 USC § 1 12(b)
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`Claim(s) 7 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA),
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`second paragraph, as being indefinite for failing to particularly point out and distinctly
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`claim the subject matter which the inventor or a joint inventor, or for pre-AIA the
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`applicant regards as the invention.
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`The terms “the biological signal measurer” and “the biological noise measurer” in
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`claim 7 now lack antecedent basis.
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`Claim Rejections - 35 USC § 103
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`Claims 1, 2, 4, 5, and 7 is/are rejected under 35 U.S.C. 103 as being
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`unpatentable over Shin in view of Nakamura (all previously cited).
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`

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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 4
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`For claim 1, Shin teaches a biological signal measurement system [entire
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`document - see at least abstract] comprising: a processor [300, 400|,' a biological sensor
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`[100, 200, 500 - where any/all three of the units measure a biological signal of
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`movement, brainwaves, and/or other signals per [[51 et seq.] which combined with the
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`processor, is configured to measure a biological signal including external noise of
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`biological noise and of environmental noise [1[39: drowsiness, unconscious movements,
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`reflex movements constitute both biological noise and “environmental” noise (i.e., noise
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`that is influenced by environment such as reflexes based on environmental factors)];
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`a biological noise sensor, which combined with the processor, is configured to
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`measure a signal including predominantly the biological noise [camera 500 measures
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`twitches and other unintentional movements per [[39 that measures a signal including
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`the biological noise; detector 200 per Fig. 4 measures a plurality of signals including
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`those which contribute noise to brainwaves/other body signal measurements per [[39]
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`an environmental noise sensor [other of 500 and/or Fig. 4 with sensors within
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`detector 200] which, combined with the processor, is configured to measure a signal
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`including predominantly the environmental noise [e.g., movements or change in body
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`signals (noise of any one or more of: GSR, temp, facial muscles, HR, respiration) can
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`be influenced by environment and thereby constitute environmental “noise”];
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`wherein the processor (is configured) to:
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`calculate a biological signal in consideration of an effect of the external noise,
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`using the biological signal measured by the biological sensor [[39 and [[77: controller
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`accounts for movement/noise/undesired signal by coordinating (i.e., “considers”)
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`camera recording and synchronized body signals (i.e., of Fig. 4)];
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`

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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 5
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`For claims 1 and 2, Shin fails to teach the processor configured to: estimate the
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`biological noise from the signal measured by the biological noise sensor; estimate the
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`environmental noise from the signal measured by the environmental noise sensor;
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`calculate the biological signal in consideration of (inter alia) the estimated biological
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`noise and the estimated environmental noise;
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`wherein the processor estimates the biological noise to be a first signal obtained
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`by multiplying the signal measured by the biological sensor by a first constant,
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`estimates the environmental noise to be a second signal obtained by multiplying the
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`signal measured by the environmental noise sensor by a second constant; and
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`calculates the biological signal in consideration of the effect of the external noise by
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`subtracting the first signal and the second signal from the biological signal measured by
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`the biological sensor.
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`Nakamura teaches a biological signal measurement system [abstract] including a
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`noise estimator (i.e., either/both biological and/or environmental noise) [relevant portion
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`of 7] which estimates noise within a signal (Le, a noise signal) by (inter alia) multiplying
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`a signal by a constant [col. 3 II. 15-55]; where a calculator calculates a biological signal
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`[EEG discussed throughout] in consideration of the effect of external noise by
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`subtracting the estimated noise signal from the biological signal measured by the
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`biological signal sensor [col. 3 II. 34-35: determination of actual EEG signal Xm(t) as the
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`subtraction of a noise signal Zm(k) from a measured EEG signal Ym(t)].
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`It would have been obvious to one of ordinary skill at the time the invention was
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`filed to modify the processor of Shin to incorporate the noise estimation(s) of Nakamura
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`

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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 6
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`(i.e., as each a biological and environmental noise estimations determining a first and
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`second signal respectively) and subsequent calculations of Nakamura in order to
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`determine a more accurate biological signal measurement [Nakamura col. 3 II. 38-48;
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`col. 1
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`l. 45 - col. 2 l. 5].
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`For claim 4, Shin teaches the biological signal measurement system according
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`to claim 1,
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`wherein the biological signal is brain waves [discussed throughout entire
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`document - see at least Fig. 1 with unit 100; see also claim 1];
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`the biological signal sensor has a first electrode attachable to a head of a user
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`[Fig. 3], and
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`the biological noise sensor has a second electrode attachable to a vicinity of at
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`least one of a throat, an eye, and a temple of the user [Fig. 3; Fig. 7].
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`For claim 5, Shin teaches the biological signal measurement system according
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`to claim 1,
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`wherein the biological signal is related to a temperature of at least one of a hand
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`fingertip [1]57; Fig. 5 with sensor 230 on pinky finger], the nose, an instep and a foot
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`fingertip of a user [1]57-58: mention of attachment to fingers and toes],
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`the biological signal sensor is attachable to at least one of a hand fingertip [Fig. 5
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`with sensor 230 on pinky finger], the nose, an instep and a foot fingertip of the user
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`[1]57-58: mention of attachment to fingers and toes], and
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`

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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 7
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`the biological noise sensor is attachable to at least one of a wrist, a back of a
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`hand, a palm, a first joint of a finger, a forehead, an ankle and an instep of the user [i.e.,
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`other of 220, 210, 230 is attached to finger including a first joint per Fig. 5].
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`For claim 7, Shin teaches the biological signal measurement system according
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`to claim 1,
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`wherein the biological signal is related to emotional sweating [1151-55: GSR:
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`conductivity due to sweating including emotional sweating; Fig. 4 and 5],
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`the biological signal measurer measures a first amount of sweat produced by a
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`user due to emotional sweating [1151-55: GSR: conductivity is a measurement of an
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`amount of sweat (i.e., including due to sweating)], and
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`the biological noise measurer measures a second amount of sweat produced
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`due to a change in body temperature of the user [1151-55: GSR: conductivity is a
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`measurement of an amount of sweat produced (i.e., including due to temperature
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`changefl.
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`Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin
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`in view of Nakamura, Kato, and Sutin (all previously cited).
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`For claim 6, Shin fails to teach the biological signal is related to a cerebral blood
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`flow, the biological sensor measures a first absorbance at a point of attention of a head
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`of a user, and the biological sensor measures a second absorbance of the whole brain
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`of the user.
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`

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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 8
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`Kato teaches a biological signal measurement system [abstract] including a
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`biological signal measurer that measures a biological signal is related to a cerebral
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`blood flow [discussed throughout entire document - see at least 1[1[37-38, 1[1[44-55 et
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`seq.], where the biological signal measurer measures an absorbance at a point of
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`attention of a head of a user [e.g., Figs. 2-4]. Sutin similarly teaches a biological signal
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`measurement system [abstract] which measures an absorbance of the whole brain of
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`the user [discussed throughout entire document: CBF and CBV (brain flow and volume)
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`are determined from pDCS (pulsatile spectroscopy) and NIRS of inflow and outflow
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`vessels of cerebral region (neck and brain arteries and veins) - see at least 1[1[58-75,
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`consider also [[76, [[78].
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`It would have been obvious to one of ordinary skill at the time the invention was
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`filed to modify the system of Shin to incorporate the cerebral flow measurement and
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`whole-brain absorption measurement of Kato and Sutin in order to determine a subject’s
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`mental status [Kato W841] and to monitor a patient’s (i.e., subject/user) critical brain
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`parameters in an accurate, non-invasive, and continuous manner [Sutin 1[1[16-17].
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`Response to Arguments
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`Applicant's arguments filed 7/25/19 have been fully considered but they are
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`not persuasive.
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`For the argument that Shin fails to teach measuring a signal including
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`predominantly environmental noise, Examiner respectfully disagrees. Applicant
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`appears to argue a scope of the term “environmental noise” which is not readily
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`

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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 9
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`apparent from the claims as written. Notably, the claims (such as claim 1) in no way
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`preclude the GSR, temperature, facial muscle signal, HR signal, or respiration signal
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`from constituting at least a form ofenvironmental noise. Even with the now
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`incorporation of the modifier “predominantly” — the claims do not actively limit what
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`specific signal source constitutes environmental noise such that it would distinguish
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`from the measured signals taught by Shin. Applicant appears to be arguing limitations
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`which are not claimed (i.e., environmental noise of Shin is not the type of environmental
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`noise as disclosed in the specification). Although the claims are interpreted in light of
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`the specification, limitations from the specification are not read into the claims. See In
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`re Van Geuns, 988 F.2d 1181, 26 USPQZd 1057 (Fed. Cir. 1993). Accordingly, if
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`Applicant wishes to distinguish the type/form ofenvironmental noise, then the claims
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`should actively recite such a distinguishing type/form (i.e., particular source,
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`particular signal type, particular environmental configuration).
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`Conclusion
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37
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`CFR1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`

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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 10
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to BENJAMIN S MELHUS whose telephone number is
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`Application/Control Number: 15/437,666
`Art Unit: 3791
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`Page 11
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`/BENJAM|N S MELHUS/
`
`Examiner, Art Unit 3791
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`/SEAN P DOUGHERTY/
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`Primary Examiner, Art Unit 3791
`
`