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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
`
`10/08/2021
`
`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):
`
`mweipdocket@mwe.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`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 8/23/2021.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)¥) This action is FINAL.
`2b) (J 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.
`
`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.
`Cj] Claim(s)
`is/are allowed.
`Claim(s) 1-8 and 29-39 is/are rejected.
`(1 Claim(s)__is/are objectedto.
`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) ([] 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 20211005
`
`

`

`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 § 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 requirementsofthis title.
`
`Claims 1-8 and 29-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed
`
`to an abstract idea without significantly more.
`
`Step 1: All claims are drawn to a system, whichis a statutory class of invention.
`
`Step 2A, Prong 1:
`
`The claim(s) recite(s) a processing unit configured to perform the following steps that can be
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`considered either or both of a mental process that can be performed with pen and paper and/or
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`mathematical calculations, which are also an abstract idea:
`
`e Analyzing sensor data from at least one phase to identify aberrations, deviations and/or
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`patterns in reference to historical data,
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`e Calculate a confidence factor based on analysis of the sensor data from the at least one
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`phase, wherein the confidence factor is defined by a percentage number , and the
`
`bigger the percentage number is, the higher likelihood of the one or more mental health
`
`ailments are, and
`
`e
`
`Evaluate the person's mental health and predict likelihood of the one or more mental
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`health ailments, based on the analysis of the sensor data and the confidencefactor.
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 3
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`Under their broadest reasonable interpretation, these steps can practically be performed in the
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`human mind (i.e., with pen and paper). With sensor data from a patient, a human could reasonably
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`subjectively identify aberrations, deviations, and/or patterns; calculate a confidence factor as a
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`percentage and based on the amountof data collected and deviations from normal or predicted levels;
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`and evaluate the person’s mental health and predict likelihood of one or more mental health ailments,
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`based on the analysis of the sensor data and confidence factor. Thus, the claims recite limitations that
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`fall within the “mental processes” grouping of abstract ideas as well as “mathematical concepts.”
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`Step 2A, prong 2:
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`Claim 1 includes the following additional elements:
`
`e Oneor more sensors adapted to detect sensor data relating to the person’s voluntary
`
`and autonomic responses;
`
`e
`
`=6Asignal processing unit
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`e Amemory device storing computer code; and
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`e
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`A database of historical data,
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`e Wherein the sensor data is detected and recorded in at least one phase.
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`This judicial exception is not integrated into a practical application because the sensors and the
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`sensor data being detected and recordedin at least one phaseis insignificant extra-solution activity in
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`the form of mere data gathering (see MPEP 2106.05(g)); and the “signal processing unit,” “memory
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`device storing computer code,” and “database of historical data” are conventional and well known
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`elements of a general purpose computer that are recited at a high level of generality and not “particular
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`machines” within the meaning ofeligibility jurisprudence (see MPEP 2106.05(b)).
`
`Step 2B:
`
`The claim(s) does/do not include additional elements that are sufficient to amount to
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`significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two,the
`
`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 4
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`additional elementsin the claim amount to no more than insignificant extra solution activity and mere
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`instructions to apply the exception using a generic computer component. The same analysis applies here
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`in 2B and does notprovide an inventive concept.
`
`Dependent claims:
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`Claims 2, 3, 29, and 32-39 recite physiological sensors and generic computer elements that are
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`well-known, routine, and conventional in the art, and do not appear to set forth any structural features
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`that go beyond conventional data gathering/general purpose computing.
`
`Claims 4 and 31 recite limitations that further define some unspecified fields of use of
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`calculations (machine learning, artificial intelligence, and data mining).
`
`Claims 5-8 and 30 further recite functionality that can be carried out with the human mind,
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`based on the user’s selection of the types of data that they would like to use.
`
`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
`
`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
`
`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 ordinaryskill in the art to which the
`claimed invention pertains. Patentability shall not be negated by the manner in which the invention
`was made.
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 5
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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
`
`effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised
`
`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
`
`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
`
`against the later invention.
`
`Claim(s) 1-8 and 29-38 is/are rejected under 35 U.S.C. 103 as obvious over Rau etal. (US
`
`2016/0022193, hereinafter “Rau ‘193”) in view of Girouard et al. (US 2016/0166208, hereinafter
`
`“Girouard”), or in the alternative, over Rau ‘193 and Girouard and further in view of Rau et al. (US
`
`2013/0281798, hereinafter “Rau ‘798”).
`
`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 memory device storing computer code (par. 0140), a database of historical
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`data (par. 0153-0154), wherein sensor data is detected and recorded in at least one phase(pars. 0153-
`
`0154); and wherein the signal processing unit is programmed to analyze the sensor data from the at
`
`least one phasefor aberrations, deviations and/or patterns in reference to historical data and evaluate
`
`the person’s mental health and predict one or more mental health ailments based on the analysis (pars.
`
`0151-0154, 0157-0163). The examiner’s position is that Rau ‘193 discloses a signal processing unit
`
`programmed to analyze the sensor data for aberrations, deviations, and/or patterns in reference to
`
`historical data and evaluate the person’s mental health and predict one or more mental health ailments
`
`based on the analysis in the actual text of the documentat, e.g., paragraphs 0160-0161 where Rau ‘193
`
`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 6
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`describes outputting from the system itself “a real time risk analysis based on the patient analysis” (see
`
`also claim 3). This risk analysis is an evaluation of the person’s mental health and a prediction of one or
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`more mental health ailments as set forth in paragraph 0161-0162. Rau ‘193 further describes that data
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`analysis tools starting at paragraph 0167 and indicates in paragraph 0158 that the system itself collects
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`variation data and “[t]his same information is collected to generate and accumulate a large reference
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`databaselinking clinician inferences on patient mental health illness to biometric information and
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`correspondingstimuli, to initiate and successively improve the machine learning algorithms and
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`processesof the system.” Additionally, Rau ‘193 indicates that the data processing devices and
`
`techniques are “as described in published U.S. Patent Application US20130281798” (par. 0166). This
`
`Rau ‘798 clearly indicates that the data analysis is performed by a signal processing unit (pars. O040-
`
`0042). The examiner’s position is that this disclosure is anticipatory because the Rau ‘193 document
`
`indicates that the devices and techniques “are as described in” the Rau ‘798 document-- effectively
`
`incorporating by reference the ‘798 document. Alternatively and additionally, it would have been
`
`obvious to one having ordinaryskill in the art at the time the application was filed to utilize the devices
`
`and methods of the ‘798 document(as the ‘193 documentexpressly directs) that include a processing
`
`unit programmedto analyze and evaluate as claimed to provide the predictable results of building the
`
`capability to process large volumes of complex data into useful information to improve decision making
`
`processes by reducing the false alarm rates in diagnoses (Rau ‘193, par. 0166). Rau ‘193 does not
`
`expressly disclose calculating a confidence factor based on analysis of sensor data from at least one
`
`phase, wherein the confidence factor is defined by a percentage number and the bigger the percentage
`
`number is, the higher the likelihood of the one or more mental health ailments are. However, Girouard
`
`teaches a system for detecting the health state of a patient (abstract), wherein this prediction is
`
`assigned a confidence factor based on sensor data from at least one phase defined by a percentage
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`number and the bigger the percentage number is, the higher the likelihood of the one or more mental
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 7
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`health ailments are (par. 0162) to provide the predictable results of providing a more accurate and
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`robust model of the patient’s health state (e.g., pars. 0007-0008). Therefore, it would have been
`
`obvious to one having ordinaryskill in the art before the effective filing date of the claimed invention to
`
`modify Rau ‘193 by assigning the prediction a confidence factor based on analysis of sensor data from at
`
`least one phase and defined by a percentage number, and the bigger the percentage number is, the
`
`higher the likelihood of the one or more mental health ailments are to provide the predictable results of
`
`providing a more accurate and robust model of the patient’s state.
`
`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).
`
`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).
`
`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).
`
`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).
`
`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).
`
`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).
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 8
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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).
`
`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).
`
`In regards to claims 34, the one or more sensors include a motion sensor (par. 0034).
`
`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).
`
`In regards to claim 37, the system detects a substance secreted from the patient (par. 0136,
`
`“sweat”).
`
`In regards to claim 38, the system detects a substancein a patient’s system (par. 0143; blood
`
`oxygenation).
`
`Claim 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rau ‘193 and Girouard
`
`(or in the alternative Rau ‘193, Girouard, and Rau ‘798) further in view of LeBoeufet al. (US
`
`2010/0217098, hereinafter “LeBoeuf”). Rau ‘193 (or Rau ‘193 and Rau ‘798) discloses the essential
`
`features of the claimed invention, including detecting a substance including alcohol and drugs(par.
`
`0165), with this testing means being part of an overall treatment “system,” but does not expressly and
`
`explicitly disclose that a drug or alcohol sensor is a hardware componentofthe data acquisition device.
`
`However, LeBoeuf teaches a health monitoring system comprising a drug sensor (par. 0065) to provide
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`the predictable results of collecting, storing, and analyzing additional physiological information from a
`
`person during everydaylife activities to enhance healthcare quality (par. 0004). Therefore, it would
`
`have been obvious to one having ordinary skill in the art to modify Rau ‘193 (or Rau ‘193 and Rau ‘798)
`
`by providing a drug sensor to provide the predictable results of collecting, storing, and analyzing
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 9
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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
`
`Applicant's argumentsfiled 8/23/2021 have been fully considered but they are not persuasive.
`
`In regards to the rejection under section 101, Applicant argued that the claims cannot be performed
`
`entirely within the human mind, and that a similar claim (claim 2) in Example 46 of the October 2019
`
`Update is indicated as patent-eligible.
`
`In regards to the argumentthat the claims cannot be performed
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`entirely by the human mind, the examiner agrees, but the claim elements that are not purely mental
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`activity fail to integrate the judicial exception (i.e., mental activity) into a practical application or amount
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`to significantly more than the judicial exception itself.
`
`In regards to Example 46 of the October 2019,
`
`the examiner agrees that the example is informative, but the instant claims more closely resemble claim
`
`1 (indicated as patent ineligible in the example) than claim 2 (indicated as patent eligible). Like the
`
`example for claim 1, the signal processing unit, memory device, and databaseare recited so generically
`
`that they represent no more than mereinstructions to apply the judicial exception to a computer.
`
`Courts have made it clear that mere physicality or tangibility of an additional element or elements is not
`
`relevant to the eligibility analysis. See MPEP 2106.05(I). Further, the examiner disagrees that processor
`
`programmedto “evaluate the person’s mental health and predictlikelihood of the one or more mental
`
`health ailments, based on the analysis of the sensor data and the confidence factor”links the judicial
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`exception to a technical field and adds a meaningful limitation, similar to limitation (d) from claim 2 in
`
`Example 46. The examiner’s position is that the above limitation from the instant claim 1 is more akin to
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`limitations (b) and (c) of ineligible claim 1 in Example 46, as opposed to limitation (d) of eligible claim 2.
`
`Unlike claim 2 of Example 46, the instant claims do not provide any sort of control of anything, do not
`
`specify any sort of specific ailment, and broadly recites evaluating mental health based on aberrations,
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`deviations, and/or patterns. This appears to be whatclinicians have done for decadesin a mental
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 10
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`fashion with the claims limiting this to “do it with a computer.” The specification does not appear to set
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`forth any determined relationships between specific inputs and health ailments, but instead appears to
`
`be a research plan to find these relationships using “artificial intelligence,”
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`“machine learning,” and “big
`
`Ma
`
`data.” The examiner respectfully maintains the rejection above as being morelike ineligible claim 1 of
`
`Example 46 and lesslike eligible claim 2 of the example.
`
`In regards to the prior art rejection, Applicant argued that Girouardfails to disclose a confidence
`
`factor defined by a percentage number with a larger percentage corresponding to a higher likelihood of
`
`ailments, but instead that a higher value of the average deviation percentage would be excluded from
`
`qualified samples. Howeveras set forth in par. 0141 and 0162, at least one embodiment sets forth the
`
`average deviation percentage(i.e., “confidence factor” as claimed) accordingly: “as shownin step 142,
`
`samples included amongthe group with an average deviation percentage above the minimum threshold
`
`value of average deviation percentage may then be deemed to meet aggregate property qualification.
`
`For example, referring back to method 10, in some embodiments, samples of the group may then be
`
`identified in a second group of qualified-clonic-phase bursts as shown in step 26” (par. 0141).
`
`In other
`
`words, sampleswith a high average deviation percentage are deemedto indicate qualified-clonic-phase
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`bursts, which are indicators of the mental health ailment of seizures. Accordingly, the examiner
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`respectfully maintains the prior art rejections set forth above.
`
`Conclusion
`
`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).
`
`A shortened statutory period for reply to this final action is set to expire THREE MONTHS from
`
`the mailing date of this action.
`
`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
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 11
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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
`
`date of the advisory action.
`
`In no event, however, will the statutory period for reply expire later than
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`SIX MONTHS from the dateof this final action.
`
`Any inquiry concerning this communication or earlier communications from the examiner
`
`should be directed to MICHAEL WILLIAM KAHELIN whose telephone number is (571)272-8688. The
`
`examiner can normally be reached 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 numberfor the organization where this
`
`application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of published or unpublished applications may be obtained from
`
`Patent Center. Unpublished application information in Patent Center is available to registered users. To
`
`file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit
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`https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and
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`https://www.uspto.gov/patents/docx for information aboutfiling in DOCX format. For additional
`
`questions, contact the Electronic Business Center (EBC) at 866-217-9197(toll-free). If you would like
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`assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA)or
`
`571-272-1000.
`
`/MICHAEL W KAHELIN/
`Primary Examiner, Art Unit 3792
`
`