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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
`
`06/18/2021
`
`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)
`
`

`

`
`
`Disposition of Claims*
`1-8 and 29-40 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`5a) Of the above claim(s) ___ is/are withdrawn from consideration.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 29-40is/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)
`
`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 20210615
`
`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 5/17/2021.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`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.
`
`

`

`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 the first paragraph of 35 U.S.C. 112(a):
`
`(a) IN GENERAL.—The specification shall contain a written description of the invention, and
`of the manner and process of making and using it, in suchfull, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with whichit is most nearly connected, to
`makeand use the same,and shall set forth the best mode contemplated by the inventor or joint
`inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AlA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner and
`process of making and using it, in such full, clear, concise, and exact terms as to enable any person
`skilled in the art to which it pertains, or with whichit is most nearly connected, to make and use the
`same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
`
`Claim 40 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph,as failing
`
`to comply with the written description requirement. The claim(s) contains subject matter which was not
`
`described in the specification in such a way as to reasonably conveyto one skilled in the relevant art
`
`that the inventor or a joint inventor, or for applications subject to pre-AlA 35 U.S.C. 112, the inventor(s),
`
`at the time the application was filed, had possession of the claimed invention. Claim 1 sets forth
`
`determining a confidence factor defined by a percentage number usedto predict the likelihood of one
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`or more mental health ailments, and claim 40 appearsto possibly set forth calculation of a second
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`percentage numbervariable. The examiner was able to locate disclosure of percentages being
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`calculated only in par. 0087 of Applicant’s disclosure, but not that a first percentage variable is
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`calculated as well as a second percentagevariable.
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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 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 1-8 and 29-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second
`
`paragraph,as being indefinite for failing to particularly point out and distinctly claim the subject matter
`
`which the inventor or a joint inventor (or for applications subject to pre-AlA 35 U.S.C. 112, the
`
`applicant), regards as the invention.
`
`In regards to claim 1, “the deviations from normal or predicted levels” is vague. Does this refer
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`back to the results from the “analyz[ing] the sensor data from the at least one phase for aberrations,
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`deviations and/or patterns in reference to the historical data,” or is this attempting to set forth
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`additional functionality that the signal processing unit is further programmedto determine normal or
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`predicted levels for variables and then determine a deviation of the sensor data from the predicted
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`levels? Currently, there is no programming set forth to actually determine an amountof data collected
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`or determine a deviation. Further, it is unclear whether “amount of data collected” refers to sensor
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`data, historical data, or some third set of data. Further,it is unclear if the confidence factor being “used
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`to predict the likelihood of one or more mental health ailments”is just a subjective intended use of the
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`user/clinician, or whether the processing unit is configured to “evaluate the person’s mental
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`health...based on the analysis of the sensor data and the confidence factor.” There appears to be no link
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`or nexus betweenthe “calculate a confidence factor” functionality and the “evaluate the person’s
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`mental health” functionality. The dependentclaims inherit this deficiency.
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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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`In regards to claim 40, it is unclear whether two percentagevariables are being calculated (this
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`does not appear to be supported by the original disclosure) or whether claim 40is just further limiting
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`“the confidencefactor” of claim 1. The examiner is considering the latter for purposes of applying prior
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`art, but should be clarified.
`
`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:
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`e Analyzing sensor data from at least one phase to identify aberrations, deviations and/or
`
`patterns in reference to historical data
`
`e Calculate a confidence factor, wherein the confidence factor is defined by a percentage
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`number andis used to predict the likelihood of one or more mental health ailments, and
`
`the confidence factor is based on an amount of data collected or utilized as well as the
`
`deviations from normal or predicted levels, 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.
`
`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 5
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`Under their broadest reasonable interpretation, these steps can practically be performedin 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 confidencefactor. 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:
`
`Claim 1 includes the following additional elements:
`
`e One or more sensors adapted to detect sensor data relating to the person’s voluntary
`
`and autonomic responses;
`
`e
`
`e
`
`=6Asignal processing unit; and
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`A database of historical data,
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`e Wherein the sensor data is detected and recordedin 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” and “database
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`of historical data” are conventional and well known elements of a general purpose computer that are
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`recited at a high level of generality and not “particular machines” within the meaning ofeligibility
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`jurisprudence (see MPEP 2106.05(b)).
`
`Step 2B:
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`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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`additional elementsin the claim amount to no more than insignificant extra solution activity and mere
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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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`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.
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`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.
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`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, 30, and 40 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 ofrejection if the prior art relied upon, and
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`the rationale supporting the rejection, would be the same under either status.
`
`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.
`
`This application currently names joint inventors. In considering patentability of the claims the
`
`examiner presumesthat the subject matter of the various claims was commonly ownedas of the
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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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`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
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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.
`
`Claim(s) 1-8, 29-38, and 40 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 claims 1 and 40, Rau ‘193 discloses a system for evaluating and predicting the
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`mental health of a person comprising one or more sensors adapted to detect sensor data relating to the
`
`person’s voluntary and autonomic responses(pars. 0004, 0015, 0147, 0153, 0157, 0159); a signal
`
`processing unit (8010); a databaseofhistorical data (par. 0153-0154), wherein sensor data is detected
`
`and recorded in at least one phase (pars. 0153-0154); and wherein the signal processing unitis
`
`programmed to analyze the sensor data from the at least one phase 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 (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,
`
`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,
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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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`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
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 8
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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
`
`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
`
`US20130281798” (par. 0166). This Rau ‘798 clearly indicates that the data analysis is performed by a
`
`signal processing unit (pars. 0040-0042). The examiner’s position is that this disclosure is anticipatory
`
`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
`
`expressly 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
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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 health ailments with a larger percentage corresponding to a higher likelihood of ailments, and the
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`confidence factor is based on an amount of data collected or utilized as well as the deviations from
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`normal or predicted levels. However, Girouard teaches a system for detecting the health state of a
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`patient (abstract), wherein this prediction is assigned a confidence factor defined by a percentage
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`number with a larger percentage correspondingto a higher likelihood of ailments (par. 0162) and used
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`to predict the likelihood of the calculation and based on an amountof data collected (step 124; based
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`on there being enough samples to constitute a train) as well as the deviations from normal or predicted
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 9
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`levels (step 138) to provide the predictable results of providing a more accurate and robust model of the
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`patient’s health state (e.g., pars. 0007-0008). Therefore, it would have been obvious to one having
`
`ordinary skill in the art before the effective filing date of the claimed invention to modify Rau ‘193 by
`
`assigning the prediction a confidence factor defined by a percentage number with a larger percentage
`
`correspondingto a higher likelihood of ailments and used to predict the likelihood of the calculation and
`
`based on an amountof data collected as well as the deviations from normal levels to provide the
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`predictable results of providing a more accurate and robust model of the patient’s 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).
`
`

`

`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 10
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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).
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`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,
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`“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 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
`
`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)
`
`by providing a drug sensor to provide the predictable results of collecting, storing, and analyzing
`
`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 11
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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 arguments, see “Remarks,”filed 5/17/2021, with respect to the rejection(s) of
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`claim(s) 1-8 and 29-40 under section 103 have been fully considered and are persuasive. Therefore, the
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`rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is
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`made in view of Girouard above. This office action is non-final.
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`Conclusion
`
`The prior art made of record and not relied upon is considered pertinent to applicant's
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`disclosure. Pettus (US 2015/0363567, hereinafter “Pettus”) is another example of calculating a
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`confidence score for physiological data (par. 0088).
`
`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 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
`
`Information Retrieval (PAIR) system. Status information for published applications may be obtained
`
`from either Private PAIR or Public PAIR. Status information for unpublished applications is available
`
`through Private PAIR only. For more information about the PAIR system, see https://ppair-
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`

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`Application/Control Number: 15/888,895
`Art Unit: 3792
`
`Page 12
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`my.uspto.gov/pair/PrivatePair. Should you have questions on accessto the Private PAIR system, contact
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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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`9199 (IN USA OR CANADA)or 571-272-1000.
`
`/MICHAEL W KAHELIN/
`Primary Examiner, Art Unit 3792
`
`