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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`15/888,895
`
`02/05/2018
`
`Ariel BECK
`
`083710-1975
`
`1160
`
`McDermott Will and Emery LLP
`The McDermott Building
`500 North Capitol Street, N.W.
`Washinaton, BC 2000
`
`KAHELIN, MICHAEL WILLIAM
`
`3792
`
`04/20/2021
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`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
`following e-mail address(es):
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`mweipdocket@mwe.com
`
`PTOL-90A (Rev. 04/07)
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`

`

`
`
`Disposition of Claims*
`1-8 and 29-39 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`C} Claim(s)
`is/are allowed.
`Claim(s) 1-8 and 29-39 is/are rejected.
`S)
`) © Claim(s)____is/are objected to.
`Cj) Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)(J accepted or b)() 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)1) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.2 Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin 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)
`
`1)
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`Notice of References Cited (PTO-892)
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`2) (J Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
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`4)
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mail Date 20210415
`
`Application No.
`Applicant(s)
`15/888,895
`BECK etal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`MICHAEL W KAHELIN
`3792
`Yes
`
`
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom 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) MONTHSfrom 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, evenif 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 1/14/2021.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
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`2a)L) This action is FINAL. 2b)¥)This action is non-final.
`3)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4\0) 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
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`Page 2
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`DETAILED ACTION
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`Notice of Pre-AlA or AIA Status
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`The present application, filed on or after March 16, 2013, is being examined under the first
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`inventor to file provisions of the AIA.
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`Continued Examination Under 37 CFR 1.114
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`A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR
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`1.17(e), was filed in this application after final rejection. Since this application is eligible for continued
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`examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the
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`finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's
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`submission filed on 1/14/2021 has been entered.
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`Claim Rejections - 35 USC § 103
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`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102
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`and 103 (or as subject to pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory
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`basis for the rejection will not be considered a new ground ofrejection if the prior art relied upon, and
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`the rationale supporting the rejection, would be the same under either status.
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`The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections
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`set forth in this Office action:
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`A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is
`not identically disclosed as set forth in section 102,if the differences between the claimed invention
`and the prior art are such that the claimed invention as a whole would have been obvious before the
`effective filing date of the claimed invention to a person having ordinaryskill in the art to which the
`claimed invention pertains. Patentability shall not be negated by the manner in which the invention
`was made.
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
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`Page 3
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`This application currently names joint inventors. In considering patentability of the claims the
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`examiner presumesthat the subject matter of the various claims was commonly ownedas of the
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`effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised
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`of the obligation under 37 CFR 1.56 to point out the inventor and effectivefiling dates of each claim that
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`was not commonly ownedas of the effective filing date of the later invention in order for the examiner
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`to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art
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`against the later invention.
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`Claim(s) 1-8 and 29-38 is/are rejected under 35 U.S.C. 103 as obvious over Rau etal. (US
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`2016/0022193, hereinafter “Rau ‘193”) in view of Lee et al. (US 2019/0138096, hereinafter “Lee”), or in
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`the alternative, over Rau ‘193 and Lee and further in view of Rau et al. (US 2013/0281798, hereinafter
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`“Rau ‘798”).
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`In regards to claim 1, Rau ‘193 discloses a system for evaluating and predicting the mental
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`health of a person comprising one or more sensors adapted to detect sensor data relating to the
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`person’s voluntary and autonomic responses(pars. 0004, 0015, 0147, 0153, 0157, 0159); a signal
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`processing unit (8010); a databaseofhistorical data (par. 0153-0154), wherein sensor data is detected
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`and recorded in at least one phase (pars. 0153-0154); and wherein the signal processing unitis
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`programmed to analyze the sensor data from the at least one phase for aberrations, deviations and/or
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`patterns in reference to historical data and evaluate the person’s mental health and predict one or more
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`mental health ailments based on the analysis (pars. 0151-0154, 0157-0163). The examiner’s position is
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`that Rau ‘193 discloses a signal processing unit programmedto analyze the sensor data for aberrations,
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`deviations, and/or patterns in reference to historical data and evaluate the person’s mental health and
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`predict one or more mental health ailments based on the analysis in the actual text of the documentat,
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`e.g., paragraphs 0160-0161 where Rau ‘193 describes outputting from the system itself “a real time risk
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
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`Page 4
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`analysis based on the patient analysis” (see also claim 3). This risk analysis is an evaluation of the
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`person’s mental health and a prediction of one or more mental health ailments as set forth in paragraph
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`0161-0162. Rau ‘193 further describes that data analysis tools starting at paragraph 0167 and indicates
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`in paragraph 0158that the system itself collects variation data and “[t]his same information is collected
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`to generate and accumulatea large reference databaselinking clinician inferences on patient mental
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`health illness to biometric information and corresponding stimuli, to initiate and successively improve
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`the machine learning algorithms and processes of the system.” Additionally, Rau ‘193 indicates that the
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`data processing devices and techniques are “as described in published U.S. Patent Application
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`US20130281798” (par. 0166). This Rau ‘798 clearly indicates that the data analysis is performed by a
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`signal processing unit (pars. 0040-0042). The examiner’s position is that this disclosure is anticipatory
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`because the Rau ‘193 documentindicates that the devices and techniques “are as described in” the Rau
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`‘798 document-- effectively incorporating by reference the ‘798 document. Alternatively and
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`additionally, it would have been obvious to one having ordinaryskill in the art at the time the
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`application was filed to utilize the devices and methods of the ‘798 document(as the ‘193 document
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`expressly directs) that include a processing unit programmedto analyze and evaluate as claimed to
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`provide the predictable results of building the capability to process large volumes of complex data into
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`useful information to improve decision making processes by reducing the false alarm rates in diagnoses
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`(Rau ‘193, par. 0166). Rau ‘193 does not expressly disclose calculating a confidence factor, wherein the
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`confidencefactor is defined by a percentage number and is used to predict the likelihood of the one or
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`more mental health ailments, and the confidence factor is based on an amount of data collected or
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`utilized as well as the deviations from normal or predicted levels. However, Lee teaches a system for
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`detecting the emotional state of a patient, wherein this prediction is assigned a confidence factor
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`defined by a percentage number and used to predict the likelihood of the calculation and based on an
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`amountof data collected (i.e., the number of action units) as well as the deviations from normal levels
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
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`Page 5
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`(i.e., the presence of the action unit versus an absence of the presence of the action unit) (pars. 0041-
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`0042, 0056-0058, 0060-0062) to provide the predictable results of providing a more accurate model of
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`the patient’s state (e.g., pars. 0056-0058). Therefore, it would have been obvious to one having
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`ordinary skill in the art before the effective filing date of the claimed invention to modify Rau ‘193 by
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`assigning the prediction a confidencefactor defined by a percentage number and used to predict the
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`likelihood of the calculation and based on an amount of data collected as well as the deviations from
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`normal levels to provide the predictable results of providing a more accurate model of the patient’s
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`state
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`In regards to claims 2 and 3, the sensors comprises a camera, microphone, and a skin
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`conductivity sensor (pars. 0136, 0141, 0150, 0159).
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`In regards to claim 4, the system uses computer learning and/or artificial intelligence to analyze
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`sensor data for aberrations, deviations, and/or patterns in reference to historical data to evaluate the
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`patient (pars. 0158, 0170, 0200).
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`In regards to claim 5, the system further comprises a user interface for a healthcare provider to
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`submit patient data from a patient evaluation, and wherein patient data is included to evaluate the
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`person (pars. 0140, 0153, 0154).
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`In regards to claim 6, the at least one phase includes a baseline phase, wherein the sensors
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`identify and record baseline sensor data on the person to establish a level from which aberrations,
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`deviations, and/or patterns are detected (pars. 0149, 0153, 0154).
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`In regards to claim 7, historical data comprises sensor data of the person that was previously
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`detected and recorded(pars. 0149, 0153, 0154, 0159, 0163).
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`In regards to claim 8, historical data comprises data compiled from multiple healthy individuals
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`or multiple individuals with known mental health ailments (par. 0150, 0159).
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`In regards to claim 29, the camera detects facial behavior (par. 0034).
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
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`Page 6
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`In regards to claims 30 and 31,the historical data includes physiological data and is compiled by
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`data mining (pars. 0107, 0150, 0151).
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`In regards to claims 32 and 33, the signal processing unit is a central processing unit executed on
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`one or more servers (Rau ‘193 at claim 3; Rau ‘798 at par. 0054 and 0055).
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`In regards to claims 34, the one or more sensors include a motion sensor (par. 0034).
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`In regards to claims 35 and 36, the camera and microphone is capable of recording stress or
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`anxiety from facial expressions and the person’s voice (par. 0130).
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`In regards to claim 37, the system detects a substance secreted from the patient (par. 0136,
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`“sweat”).
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`In regards to claim 38, the system detects a substancein a patient’s system (par. 0143; blood
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`oxygenation).
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`Claim 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rau ‘193 and Lee(or in
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`the alternative Rau ‘193, Lee, and Rau ‘798) further in view of LeBoeufet al. (US 2010/0217098,
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`hereinafter “LeBoeuf”). Rau ‘193 (or Rau ‘193 and Rau ‘798) discloses the essential features of the
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`claimed invention, including detecting a substance including alcohol and drugs(par. 0165), with this
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`testing means being part of an overall treatment “system,” but does not expressly and explicitly disclose
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`that a drug or alcohol sensor is a hardware componentof the data acquisition device. However,
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`LeBoeuf teaches a health monitoring system comprising a drug sensor (par. 0065) to provide the
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`predictable results of collecting, storing, and analyzing additional physiological information from a
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`person during everydaylife activities to enhance healthcare quality (par. 0004). Therefore, it would
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`have been obvious to one having ordinaryskill in the art to modify Rau ‘193 (or Rau ‘193 and Rau ‘798)
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`by providing a drug sensor to provide the predictable results of collecting, storing, and analyzing
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
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`Page 7
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`additional physiological information from a person during everydaylife activities to enhance healthcare
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`quality.
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`Response to Arguments
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`Applicant’s arguments with respect to claim(s) 1-8 and 29-39 have been considered but are
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`moot because the new ground ofrejection does not rely on any reference applied in the prior rejection
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`of record for any teaching or matter specifically challenged in the argument.
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`Conclusion
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`The prior art made of record and not relied upon is considered pertinent to applicant's
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`disclosure. Samecet al. (US 2017/0323485) is another example of determining confidence of a
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`calculation based on amountof data and deviation from normal values (par. 0300).
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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to MICHAEL WILLIAM KAHELIN whose telephone number is (571)272-8688. The
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`examiner can normally be reached on M-F, 8-5.
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`Examiner interviewsare available via telephone, in-person, and video conferencing using a
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`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
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`the USPTO Automated Interview Request(AIR) at http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this
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`application or proceeding is assigned 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 published applications may be obtained
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`from either Private PAIR or Public PAIR. Status information for unpublished applications is available
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`through Private PAIR only. For more information about the PAIR system, see https://ppair-
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`my.uspto.gov/pair/PrivatePair. Should you have questions on accessto the Private PAIR system, contact
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
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`Page 8
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`the Electronic Business Center (EBC) at 866-217-9197(toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information system, call 800-786-
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`9199 (IN USA OR CANADA)or 571-272-1000.
`
`/MICHAEL W KAHELIN/
`Primary Examiner, Art Unit 3792
`
`