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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
`
`10/20/2020
`
`ELECTRONIC
`
`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.
`
`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)
`
`

`

`
`
`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`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`CL) Claim(s)
`is/are allowed.
`Claim(s) 1-8 and 29-39 is/are rejected.
`OO Claim(s)__is/are objectedto.
`C) 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)) 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)0) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)X None ofthe:
`b)L) Some**
`a)L) All
`1... 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 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)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`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:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20201015
`
`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
`
`1) Responsive to communication(s) filed on 8/26/2020.
`LC} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)l¥) This action is FINAL.
`2b) (J This action is non-final.
`3) 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\(Z 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.
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`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.
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The specification shall conclude with one or moreclaims 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-AlA), second paragraph:
`The specification shall conclude with one or moreclaims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claims 35 and 36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second
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`paragraph,as being indefinite for failing to particularly point out and distinctly claim the subject matter
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`which the inventor or a joint inventor (or for applications subject to pre-AlA 35 U.S.C. 112, the
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`applicant), regards as the invention. It is unclear if or how the claims limit any structure set forth in the
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`claims.
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`Is this a method step of recording stress/anxiety, or merely a camera and microphone capable of
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`recording stress/anxiety? The examiner is considering the latter for the purposes of applying prior art.
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`Further, the phrase “stress, anxiety” is vague becauseit is unclear if this requires stress and anxiety to
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`be recorded or stress or anxiety.
`
`Claim Rejections - 35 USC § 102
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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 eitherstatus.
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`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 3
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis
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`for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale
`or otherwise available to the public before the effectivefiling date of the claimed invention.
`
`(a)(2) the claimed invention was described in a patent issued under section 151, or in an application
`for patent published or deemed published under section 122(b), in which the patent or application, as
`the case may be, names another inventor and was effectively filed before the effective filing date of
`the claimed invention.
`
`Claim Rejections - 35 USC § 103
`
`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 of rejection if the prior art relied upon, and
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`the rationale supporting the rejection, would be the same under eitherstatus.
`
`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:
`
`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 ordinary skill in the art to which the
`claimed invention pertains. Patentability shall not be negated by the manner in which the invention
`was made.
`
`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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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 4
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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. 102(a)(1) and (a)(2) as being anticipated
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`by Rau et al. (US 2016/0022193, hereinafter “Rau ‘193”) or, in the alternative, under 35 U.S.C. 103 as
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`obvious over Rau ‘193 in view of Rau et al. (US 2013/0281798, hereinafter “Rau ‘798”).
`
`In regards to claim 1, Rau discloses a system for evaluating and predicting the mental health of a
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`person comprising one or more sensors adapted to detect sensor data relating to the person’s voluntary
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`and autonomic responses(pars. 0004, 0015, 0147, 0153, 0157, 0159); a signal processing unit (8010); a
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`databaseofhistorical data (par. 0153-0154), wherein sensor data is detected and recordedin at least
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`one phase (pars. 0153-0154); and wherein the signal processing unit is programmed to analyze the
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`sensor data from the at least one phasefor aberrations, deviations and/or patterns in reference to
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`historical data and evaluate the person’s mental health and predict one or more mental health ailments
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`based on the analysis (pars. 0151-0154, 0157-0163). The examiner’s position is that Rau ‘193 discloses a
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`signal processing unit programmedto analyze the sensor data 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 in the actual text of the documentat, e.g., paragraphs
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`0160-0161 where Rau ‘193 describes outputting from the system itself “a real time risk analysis based
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`on the patient analysis” (see also claim 3). This risk analysis is an evaluation of the person’s mental
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`health and a prediction of one or more mental health ailments as set forth in paragraph 0161-0162. Rau
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`‘193 further describes that data analysis tools starting at paragraph 0167 and indicates in paragraph
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`0158 that the system itself collects variation data and “[t]his same information is collected to generate
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`and accumulatea large reference databaselinking clinician inferences on patient mental healthillness
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`to biometric information and corresponding stimuli, to initiate and successively improve the machine
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 5
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`learning algorithms and processes of the system.” Additionally, Rau ‘193 indicates that the data
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`processing devices and techniquesare “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).
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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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`

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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 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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`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 (or in the
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`alternative Rau ‘193 and Rau ‘798) in view of LeBoeuf et al. (US 2010/0217098, hereinafter “LeBoeuf”).
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`Rau ‘193 (or Rau ‘193 and Rau ‘798) discloses the essential features of the claimed invention, including
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`detecting a substance including alcohol and drugs (par. 0165), with this testing means being part of an
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`overall treatment “system,” but does not expressly and explicitly disclose that a drug or alcohol sensor is
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`a hardware componentof the data acquisition device. However, LeBoeuf teaches a health monitoring
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`system comprising a drug sensor (par. 0065) to provide the predictable results of collecting, storing, and
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 7
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`analyzing additional physiological information from a person during everydaylife activities to enhance
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`healthcare quality (par. 0004). Therefore, it would have been obvious to one having ordinaryskill in the
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`art to modify Rau ‘193 (or Rau ‘193 and Rau ‘798) by providing a drug sensor to provide the predictable
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`results of collecting, storing, and analyzing additional physiological information from a person during
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`everydaylife activities to enhance healthcare quality.
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`Response to Arguments
`
`Applicant's argumentsfiled 8/26/2020 have been fully considered but they are not persuasive.
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`Applicant argued that Rau ‘193fails to disclose the claimed subject matter because the clinician, and not
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`the system, of Rau ‘193 predicts mental health ailments. However, please see the grounds of rejection
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`set forth above. Namely, the examiner respectfully disagrees that the system of Rau ‘193 discloses the
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`subject matter (see rejection above and pars. 0160-0161 and claim 3). Additionally, please see the
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`incorporation of US 2013/0281798 (again, in the rejection above) which more explicitly sets forth the
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`signal processing unit that performs the claimed functions.
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`Conclusion
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`Applicant's amendment necessitated the new ground(s) of rejection presented in this Office
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`action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the
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`extension of time policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE MONTHS from
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`the mailing date of this action.
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`In the eventa first reply is filed within TWO MONTHS ofthe mailing date
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`of this final action and the advisory action is not mailed until after the end of the THREE-MONTH
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`shortened statutory period, then the shortened statutory period will expire on the date the advisory
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`action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing
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`date of the advisory action.
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`In no event, however, will the statutory period for reply expire later than
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`SIX MONTHS from the date of this final action.
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 8
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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.
`
`Examiner interviewsare available via telephone, in-person, and video conferencing using a
`
`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
`
`the USPTO Automated Interview Request(AIR) at http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`
`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
`
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`from either Private PAIR or Public PAIR. Status information for unpublished applications is available
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`9199 (IN USA OR CANADA)or 571-272-1000.
`
`/MICHAEL W KAHELIN/
`Primary Examiner, Art Unit 3792
`
`