www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/436,840
`
`09/07/2021
`
`Brian E. Brooks
`
`82438US006
`
`8993
`
`Solventum Intellectual Properties Company
`2510 Conway Ave E
`3M Center, 275-6E-21
`St Paul, MN 5514
`
`ALDERSON, ANNE-MARIE K
`
`3626
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`08/19/2024
`
`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):
`
`IPDocketing @ Solventum.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-7 and 9-16 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`5a) Of the above claim(s) _ is/are withdrawn from consideration.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) 1-7 and 9-16 is/are rejected.
`Claim(s) 1-7 and 9-16 is/are objected to.
`C) Claim(s
`are subject to restriction and/or election requirement
`)
`* 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:/Awww.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)() The drawing(s) filedon__ is/are: a)C) 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).) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`—_c)LJ None ofthe:
`b)LJ Some**
`a)D) 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.
`3.2.) 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)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240806
`
`Application No.
`Applicant(s)
`17/436,840
`Brooksetal.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`ANNE-MARIE K ALDERSON
`3626
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof 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 7/19/24.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)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)(2) 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: 17/436,840
`Art Unit: 3626
`
`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
`
`inventor to file provisions of the AIA.
`
`Status of Claims
`
`1. This action is in reply to the RCE filed on 07/19/2024.
`
`2. Claim 1 has been amendedand is hereby entered.
`
`3. Claim 8 was previously been canceled.
`
`4. Claim 16 has been added.
`
`5. Claims 1-7, 9-16 are currently pending and have been examined.
`
`Continued Examination Under 37 CFR 1.114
`
`A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR
`
`1.17(e), was filed in this application after final rejection. Since this application is eligible for continued
`
`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
`
`submission filed on 07/19/24 has been entered.
`
`Priority
`
`Applicant’s claim to priority to the following applications is acknowledged: Provisional
`
`application 62/818,816 filed on 03/15/2019 and Provisional application 62/898,821 filed on 09/11/2019.
`
`Status of this application as a 371 of PCT/IB19/59227filed on 10/29/19 is acknowledged. A certified
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 3
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`copy of foreign priority application was received on 09/07/2021. As such, a priority date of 03/15/2019
`
`has been given to this application.
`
`Claim Objections
`
`Claim 1 is objected to for the following informalities: Claim 1 has been amended to include
`
`recitation of “wherein each control setting includes one or more possible settings and each possible
`
`setting includes an impact measurement that represents the impact of the possible setting relative to
`
`other possible settings of the respective control setting and a confidence interval corresponding to the
`
`impact measurement that represents the current level of system uncertainty about the causal effects of
`
`the possible setting” (Emphasis Examiner). While the underlined portions do not cause true antecedent
`
`basis issues, Examiner recommends amending as follows, or amending in a similar manner, for improved
`
`clarity:
`
`wherein each control setting includes one or more possible settings and each possible setting
`
`includes an impact measurement that represents an impact of the possible setting relative to other
`
`possible settings of a respective control setting and a confidence interval corresponding to the impact
`
`measurementthat represents a current level of system uncertainty about the causal effects of the
`
`possible setting
`
`Claims 2-7, 9-16 are subsequently objected to as they depend from Claim 1.
`
`Claim 16 is objected to because of the following informalities: Claim 16 appears to contain an
`
`accidental omission of the claim from which it depends. As presented, Claim 16 recites the preamble
`
`“The methodof claim, further comprising...”. For purposes of examination,it is being interpreted as
`
`depending from Claim 1. Appropriate correction is required.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 4
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`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 requirements ofthis title.
`
`Claims 1-7, 9-16 are rejected under 35 U.S.C.101 because the claimed inventionis directed to a
`
`judicial exception (an abstract idea) withoutsignificantly more.
`
`Step 1
`
`Claims 1-7, 9-16 are drawn to a method, whichis within the four statutory categories. Claims 1-
`
`7, 9-16 are further directed to an abstract idea on the grounds set out in detail below.
`
`Step 2A Prong 1
`
`Claim 1 recites implementing the stepsof:
`
`-
`
`-
`
`receiving one or more external inputs to optimize patient selection for one or moreclinical
`
`trials;
`
`generating, based on the one or more external inputs, one or more baseline valuesto a plurality
`
`of internal parameters, wherein the plurality of internal parameters defines how to update a
`
`causal model and how to determine which control settings to select given a current causal
`
`model;
`
`-
`
`accessing a current causal model that measures one or more causal relationships between one
`
`or more control settings and a measure of successof a clinical trial, wherein each control setting
`
`includes one or more possible settings and each possible setting includes an impact
`
`measurementthat represents the impact of the possible setting relative to other possible
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 5
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`settings of the respective control setting and a confidence interval corresponding to the impact
`
`measurementthat represents the current level of system uncertainty about the causal effects of
`
`the possible setting
`
`-
`
`-
`
`selecting, based on the accessed current causal model and the plurality of internal parameters,
`
`one or more control settings that specify one or more controllable aspects of the clinical trial;
`
`repeatedly performing the following:
`
`o
`
`selecting, from a population of patients, one or morepatients for being treated with the
`
`treatment intended by the clinical trial, wherein the treatmentis defined, at least in part
`
`on the one or more control settings and the selecting is based, at least in part, on the
`
`current causal model and the plurality of internal parameters;
`
`©
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`automatically determining one or more measuresof success of the clinical trial for
`
`which patients were selected, wherein the one or more measuresof success are based,
`
`at least in part on, the one or more control settings; and
`
`©
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`automatically adjusting, based on the measure of successof the clinical trial and the
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`plurality of internal parameters, the current causal model.
`
`These steps amount to managing personal behavior or relationships or interactions
`
`between people and therefore recite certain methods of organizing human activity. Configuring the
`
`control settings of a causal model for selecting patients for being treated in a clinical trial, determining a
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`measureof success of the trial, and subsequently updating the model based on the measure of success,
`
`is a personal behavior that may be performed bya clinical trial coordinator/investigator or healthcare
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`provider.
`
`Claim 1 is therefore directed to an abstract idea.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Step 2A Prong 2
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`Page 6
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`This judicial exception is not integrated into a practical application because the additional
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`elements within the claims only amountto:
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`A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f
`
`Claim 1 additionally recites:
`
`-
`
`acontrol system as implementing the steps of the abstract idea
`
`Regarding recitation of the control system, the specification does not appear to provide any
`
`particular structure of this element. Per paras. [0333]-[0334], [0339], [0342]-[0343], this elementis
`
`understood to be a control system implemented on a general purpose computer. The broad recitation
`
`of general purpose computing elements at a high level of generality only amounts to mere instructions
`
`to implement the abstract idea using computing componentsas tools.
`
`This elementis therefore not sufficient to integrate the abstract idea into a practical application.
`
`Looking at the limitations as an ordered combination adds nothingthatis not already present when
`
`looking at the elements taken individually.
`
`Claim 1, as a whole,is therefore directed to an abstract idea.
`
`Step2B
`
`The present claims do notinclude additional elements that are sufficient to amount to
`
`more than the abstract idea because the additional elements or combination of elements amount to no
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`more than a recitation of:
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 7
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`A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f
`
`As explained above, claim 1 only recites the aforementioned “control system”as a tool for
`
`performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a
`
`computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
`
`Thus, taken alone, the additional elements do not amountto significantly more than the
`
`above-identified judicial exception. Looking at the limitations as an ordered combination adds
`
`nothing that is not already present when looking at the elements taken individually. Their
`
`collective functions merely provide conventional computer implementation.
`
`Depending Claims
`
`Dependentclaims 2-7, 9-16 recite additional limitations which either narrow the scope of the
`
`independent claims or are also certain methods of organizing human activity.
`
`Claim 2 recites adjusting the internal parameters based on the adjusted causal model, whichis
`
`also certain methods of organizing human activity including managing personal behaviors, as a clinical
`
`trial coordinator/investigator adjust the internal parameters based on based on the adjusted causal
`
`model.
`
`Claim 3 recites wherein the one or more measuresof successof the clinical trial comprises one
`
`or more of: a measure of effectiveness of the treatment; or one or more biomarker levels in patients,
`
`whichfurther limits the scope of the abstract idea set out above.
`
`Claim 4 recites wherein the control settings comprise one or more of: one or more personal
`
`characteristics of the selected patients; or one or more settings related to a construction of the clinical
`
`trial, which further limits the scope of the abstract idea set out above.
`
`Claim 5 recites wherein the personal characteristics comprise one or more of: one or more
`
`measures of general health of the selected patients; an age of the selected patients; a gender of the
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 8
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`selected patients; a weight of the selected patients; a body mass index of the selected patients; an
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`average caloric intake of the selected patients; a type of food consumedby the selected patients; an
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`activity level of the selected patients; one or more preexisting conditions of the selected patients; or
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`one or more genetic markers in the selected patients, which further limits the scope of the abstract idea
`
`set out above.
`
`Claim 6 recites wherein the measures of general health of the selected patients comprise one or
`
`more of: a blood pressure of the selected patients; a heart rate of the selected patients; an EKG of the
`
`selected patients; a heart rhythm of the selected patients; or a measureof lung function of the selected
`
`patients, which further limits the scope of the abstract idea set out above.
`
`Claim 7 recites wherein the settings related to the construction of the clinical trial comprise one
`
`or moreof: a relative proportion of patients to whom the treatmentis given compared to patients to
`
`whom a placebois given; a dose amount of the treatment; the frequency of the treatment; or a total
`
`number of doses given, which further limits the scope of the abstract idea set out above.
`
`Claim 9 recites wherein the at least one of the one or more external inputs comprises a
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`demographicdistribution of patients who volunteer for the clinical trial, which further limits the scope
`
`of the abstract idea set out above.
`
`Claim 10 recites wherein the internal input parameters includesa first parameter that identifies
`
`an experimental unit, where the experimental unit characterizes a number of selected patients and a
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`length of time of the clinical trial, which further limits the scope of the abstract idea set out above.
`
`Claim 11 recites a system comprising one or more computers and one or morestorage devices
`
`storing instructions that when executed by the one or more computers cause the one or more
`
`computers to perform the operations of the method of claim 1, which comprises additional elements.
`
`The specification discloses the system architecture at a high level of generality (see instant specification,
`
`at least [0333]-[0334], [0339], [0342]-[0343]) which amounts to more than mereinstructions to
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 9
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`implement the judicial exception. This is not sufficient to integrate the judicial exception into a practical
`
`application or amountto significantly more than the judicial exception.
`
`Claim 12 recites one or more computer-readable storage media storing instructions that when
`
`executed by one or more computers cause the one or more computers to perform the operations of the
`
`method of claim 1, which comprises additional elements. The specification discloses the computer
`
`system architecture at a high level of generality (see instant specification, at least [0333]-[0334], [0339],
`
`[0342]-[0343]), which amounts to more than mereinstructions to implement the judicial exception. This
`
`is not sufficient to integrate the judicial exception into a practical application or amountto significantly
`
`more than the judicial exception.
`
`Claim 13 recites wherein the plurality of internal parameters comprises at least one of one or
`
`more spatial extents and one or more temporal extents, which further limits the scope of the abstract
`
`idea set out above.
`
`Claim 14 recites wherein the external inputs define a search space of possible combinations of
`
`control settings, which further limits the scope of the abstract idea set out above.
`
`Claim 15 recites wherein the internal parameters include one or more clustering parameters
`
`that define the hyperparameters of the clustering technique, which further limits the scope of the
`
`abstract idea set out above.
`
`Claim 16 recites determining, using all of the confidence intervals for each possible setting in the
`
`causal model, which ones of the one or more control settings are clinically significant and selecting only
`
`selects one or morecontrol settings that are determined to beclinically significant, which is also certain
`
`methods of organizing human activity including managing personal behavior, as a clinical trial
`
`coordinator/investigator may determine clinically significant control settings and select only those
`
`determined to beclinically significant.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 10
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`Dependentclaims 2-7, 9-16 recite additional subject matter which amountsto additional
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`elements consistent with those identified in the analysis of Claim 1 above. As discussed above with
`
`respect to Claim 1 and integration of the abstract idea into a practical application, recitation of these
`
`additional elements(e.g., recitation of “control system” in Claims 2, 15, 16) only amounts to invoking
`
`computers as a tool to perform the abstract idea. Looking at the limitations as an ordered combination
`
`adds nothing that is not already present when looking at the elements taken individually. There is no
`
`indication that the combination of elements improves the functioning of a computer or improves any
`
`other technology. Their collective functions merely provide conventional computer implementation..
`
`Dependentclaims 2-7, 9-16, when analyzed as a whole, are held to be patentineligible under 35
`
`U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not
`
`directed to an abstract idea without significantly more. Looking at the limitations as an ordered
`
`combination adds nothing that is not already present when looking at the elements taken individually.
`
`Thereis no indication that the combination of elements improves the functioning of a computer or
`
`improves any other technology. Their collective functions merely provide conventional computer
`
`implementation. Theseclaims fail to remedy the deficiencies of their parent claims above, and are
`
`therefore rejected for at least the same rationale as applied to their parent claims above, and
`
`incorporated herein.
`
`For the reasonsstated, Claims 1-7, 9-16 fail the Subject Matter Eligibility Test and are
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`consequently rejected under 35 U.S.C. 101.
`
`Response to Applicant’s Remarks/Arguments
`
`Please note: When referencing page numbers of Applicant’s response, references are to page numbers as
`
`printed.
`
`Double Patenting
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`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 11
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`The double patenting rejections of Claims 1, 2, 8 over claims 1, 2, 20 of co-pending Application
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`No. 17/436,797 are withdrawnin view of Applicant’s amendmentsto claims. Examiner submits that
`
`should co-pending Application 17/436,797 be amendedsimilarly to the instant application, the Double
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`Patenting rejection maybe reinstated in the future.
`
`101 Rejections
`
`Applicant’s remarks have been fully considered but are not persuasive. Applicant asserts that,
`
`for brevity of the instant responsefiled 7/19/24, the remarks in response dated 6/19/2024 are
`
`incorporated. As such, Examiner will first address those arguments incorporated from the 6/19/24
`
`response, and subsequently address the argumentsin the instant response.
`
`With respect to arguments in Applicant’s response dated 6/19/24:
`
`Applicant's remarks have been considered but are not persuasive. Regarding remarks at page 6
`
`that the instant invention is not directed to certain methods of organizing human activity, Examiner
`
`respectfully disagrees. The broadest reasonable interpretation of the claims, as detailed age page 6 of
`
`Final Action dated 4/12/24, recite steps that include certain methods of organizing human activity(e.g.,
`
`including receiving inputs; generating, based on the inputs, baseline values to a plurality of internal
`
`parameters, wherein the plurality of internal parameters define how to update a causal model and how
`
`to determine which control settings to select given a current causal model). Regarding remarks to a
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`“complex collection of interrelated data that inextricably links the technique to a realm of computer-
`
`based model generation’, Examiner is unable to find evidence of the claims being inextricably linked to
`
`computer based model generation.
`
`Regarding remarks at page 7 directed to DDR Holdings and Example 39, Examiner respectfully
`
`disagrees that the instant claims are analogous. In 101 section above,it is shown how Claim 1 is directed
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 12
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`to certain methods of organizing human activities by identifying limitations within the scope of the
`
`abstract idea. Regarding DDR Holdings, the claims recited an improvementto the functioning of
`
`computers/computer technologies to solve a problem caused by the technical environment to which the
`
`claim was confined (computers accessing websitesvia the internet); this technical problem was
`
`disclosed by the specification. Regarding comparison to Example 39, Examiner submits that the
`
`difference between the instant claim and Example 39 is that the analysis of Example 39 does notidentify
`
`an abstract idea present in the claim; The claim in Example 39 is drawn to subject matter that inherently
`
`lies in the realm of computers(e.g., rotating, mirroring, smoothing images to detect human facesin
`
`digital images). In the instant application, an abstract idea has been identified (e.g., configuring control
`
`settings of a causal model for selecting patients for being treated in a clinical trial, determining a
`
`measureof success of the trial, and subsequently updating the model based on the measure of success).
`
`Recitation of the causal model in the instant claims only amounts to using a modelas a tool to apply the
`
`abstract idea. Further, Examiner submits that the limitations of Example 39 cannot be performed bya
`
`person (e.g., modifying digital images by rotating, shifting, or contrast reduction to create modified
`
`digital images).
`
`In the instant application, nothing precludes the steps from being able to be performed
`
`by a human; Examiner is not able to find any instances of technologies that are inherently limited to
`
`computers.
`
`In the instant application claims, the computer and model are merely applying the abstract
`
`idea. Examiner acknowledges Applicant's statement that training a machine learning model involves
`
`different steps than updating a causal model, but respectfully disagrees that the two are analogous. The
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`improvementto the neural network in Example 39 was the result of an expandedtraining set to train
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`the neural network and implementation of an iterative training algorithm to retrain the system with an
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`updatedtraining set containing the false positives, which created a combination of features that
`
`provides a robustfacial detection model that can detect faces in distorted images while limiting the
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`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 13
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`number offalse positives; as earlier stated, facial detection of digital images lies inherently in the realm
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`of computers.
`
`Regarding remarks beginning at page 7 directed to amendedlimitation “particular configuration
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`of the causal model” being “a meaningful limitation that is more than extra-solution activity”, Examiner
`
`respectfully disagrees and submits that these limitations fall within the scope of the abstract idea. At
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`most, the amended limitations as recited only further narrow the scope of the abstract idea by further
`
`describing the control setting configurations. Examiner further submits that the amendedlimitation
`
`falls within the scope of certain methods of organizing human activity as an individual could measure
`
`the impacts of different settings with respect to each other and calculate a confidence interval
`
`corresponding to an impact measurement.
`
`Regarding arguments directed to new claim 16, Examiner submits that as shown abovein 101
`
`analysis section, Claim 16 also includes certain methods of organizing human activity as it includes
`
`making a determination and selection ofa clinically significant control setting. With respect to these
`
`arguments and specification excerpts on page 8, Examiner submits that any purported improvements
`
`may be improvementsto the abstract idea of configuring control settings of a causal model for selecting
`
`patients for being treated in a clinical trial, determining a measure of successofthe trial, and
`
`subsequently updating the model based on the measureof success.
`
`Regarding remarks directed to Enfish, Examiner respectfully disagrees that the claims are
`
`analogous. Regarding Enfish, the court concluded the claims were not directed to an abstract idea, but
`
`rather an improvement to computer functionality. It was the specification’s discussion of the prior art
`
`and how the invention improved the way the computer stores and retrieves data in memoryin
`
`combination with the specific data structure recited in the claims that demonstratedeligibility (MPEP
`
`2106.05(a)); the claimed invention improved the functioning of the computer itself.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Regarding Applicant’s remarks dated 07/19/24:
`
`Page 14
`
`Regarding remarks at page 6-7 directed to amended features of the claims and being
`
`inextricably linked to computer-based model generation, Examinerrespectfully disagrees. The amended
`
`limitation has been identified as being within the scope of the abstract idea. At most, the amended
`
`limitations as recited only further narrow the scopeof the abstract idea by further describing the control
`
`setting configurations. Examiner further submits that the amendedlimitation falls within the scope of
`
`certain methods of organizing human activity as an individual could measure the impactsof different
`
`settings with respect to each other and calculate a confidence interval corresponding to an impact
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`measurement. With respect to amendmentand recitation of “control settings”, Examiner submits that
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`per specification [0049]-[0052], control settings appear to simply be variables such as patient
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`demographicsor trial parameters such as age, gender, weight, measures of patient health (blood
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`pressure, heart rate, lung function, etc.), average caloric intake/foods consumed, or a dosage amountof
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`a treatment — and are not actively “controlling” anything.
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`Applicant has provided citations to various paragraphs at bottom of page 6, however, none of
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`the cited paragraphs appear to disclose how the claimed invention is inextricably linked to computers,
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`nor do the citations appear to provide evidence of a technological improvement. Any purported
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`improvements appear to be an improvementto the abstract idea, e.g., using a feedback loop to update
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`a model to improveits accuracy based on a successful outcome. Regarding remarksat page 7 pertaining
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`to interrelationships of data causing an “exponential growth” in complexity, Examiner submits that the
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`claims do not appear to reflect an improvement to the technological environmentof the claim. Even if
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`there is an exponential growth in complexity, nothing in the current claims precludes them from
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`including certain methods of organizing human activity.
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`Examiner prospectively notes that the specification discloses, at para. [0013], “Using the method
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`described in this specification allows conductorsofclinical trials to quickly determine the population for
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`

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`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 15
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`whom the treatmentis most effective. By repeatedly selecting different control settings, including
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`demographics of the participants of the clinical trial, and measuring the impact of the control settings on
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`the successof the clinical trial, a control system is able to generate a causal model that models the
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`causal relationships between control settings and the successofthe clinical trial more quickly and more
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`accurately than other prior art control systems. Thus, the length of time that the clinical trial must be
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`conducted can be shortened, allowing the treatment to be released sooner”. The causal model is being
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`used as a tool to provide an improvementto a non-technological problem (reducing time ofa clinical
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`trial to release treatment sooner). Examineris unable to find evidence in specification of specifically how
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`the control system itself is improved with respect to other prior art control systems. The current claims
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`are broad enough that the causal model could be any kind of model, e.g., a set of rules to follow, to
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`achieve optimal patient selection to reduceclinical trial time.
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`For all of the above reasons,the rejections of Claims 1-7, 9-15 under 35 U.S.C. 101 are
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`maintained.
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`Conclusion
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`In the interest of expediting prosecution, Examiner respectfully requests that Applicant provides
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`citations to relevant paragraphs of specification for support for amendmentsin future correspondence.
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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to ANNE-MARIE K ALDERSON whosetelephone number is (571)272-3370. The
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`examiner can normally be reached on Mon-Fri 9:00am-5:00pm EST.
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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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`

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`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 16
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Fonya Long, can be reached on 571-270-5096. The fax phone number for the organization where this
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`application or proceeding is assigned is 571-273-8300.
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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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