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
`
`04/19/2024
`
`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)
`
`

`

`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 01/04/24.
`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) 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.
`
`Disposition of Claims*
`1-7 and 9-15 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 9-15 is/are rejected.
`(] Claim(s)__ is/are objectedto.
`C] Claim(s
`are subjectto 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://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)7) 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
`1.1.) Certified copies of the priority documents have been received.
`2.2) 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)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`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 20240412
`
`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 2
`
`DETAILED ACTION
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`Notice of Pre-AlA or AIA Status
`
`The presentapplication, filed on or after March 16, 2013,
`
`is being examined underthe
`
`first inventor to file provisions of the AIA.
`
`Status of Claims
`
`1. This action is in reply to the amendment filed on 01/04/2024.
`
`2. Claims 1-3, 7, 9-10 have been amended and are hereby entered.
`
`3. Claim 8 has beencanceled.
`
`4. Claims 13-15 have been added.
`
`5. Claims 1-7, 9-15 are currently pending and have been examined.
`
`6. This action is made final.
`
`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/IB19/59227 filed on 10/29/19 is
`
`acknowledged. A certified 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.
`
`IDS
`
`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 3
`
`The information disclosure statements (IDS) submitted on 04/05/24 has been
`
`considered by the examiner. The submission is in compliance with the provisions of 37
`
`CFR 1.97.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`grounded in public policy (a policy reflectedin the statute) so as to prevent the unjustified or
`
`improper timewise extension of the “right to exclude” granted by a patent and to prevent
`
`possible harassment by multiple assignees. A nonstatutory double patenting rejection is
`
`appropriate where the conflicting claims are not identical, but at least one examined
`
`application claim is not patentably distinct from the reference claim(s) because the examined
`
`application claim is either anticipated by, or would have been obvious over, the reference
`
`claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998);
`
`In re Goodman,
`
`11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed.
`
`Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d
`
`438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be
`
`usedto overcome an actual or provisional rejection based on nonstat utory double patenting
`
`provided the reference application or patent eitheris shown to be commonly owned with the
`
`examined application, or claims an invention made as a result of activities undertaken within
`
`the scope of a joint research agreement. See MPEP § 717.02 for applications subject to
`
`examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159.
`
`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 4
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`See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to
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`file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`1.321(b).
`
`The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory
`
`double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be
`
`accompanied by a reply requesting reconsideration of the prior Office action. Even where the
`
`NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection |.B.1. For
`
`a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37
`
`CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be
`
`filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
`
`The USPTO Internet website contains terminal disclaimer forms which may be used.
`
`Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in
`
`whichthe form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or
`
`PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may befilled out completely
`
`online using web-screens. An eTerminal Disclaimer that meetsall requirements is auto-
`
`processed and approved immediately upon submission. For more information about eTerminal
`
`Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
`
`Claims 1, 2, 8 are provisionally rejected on the ground of nonstatutory double
`
`patenting as being unpatentable over claims 1, 2, 20, respectively, of copending Application
`
`No. 17/436,797 in view of Angell at. al. (US Publication 20090006125A 1).
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`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 5
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`This is a provisional nonstatutory double patenting rejection because the patentably
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`indistinct claims have not in fact been patented.
`
`Claim 1 of the instant application recites substantially similar limitations as Claim 1 of
`
`co-pending application 17/436,797. The main difference is that Claim 1 of the instant
`
`application pertains to selection of patients for a clinical trial using a causal model that
`
`measures causal relationships between input settings and outcomes (e.g., successofclinical
`
`trial), and co-pending application 17/436,797 pertains to optimizing healthcarefacility
`
`operations using a causal model that measures causal relationships between input settings and
`
`outcomes (success of healthcare facility operation), however, the frameworkof using and
`
`adjusting a causal model is substantially similar, which would be obvious over Angell to use a
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`causal model to measure relationships between input settings and success of operation of
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`healthcare facility with motivation of optimizing healthcare delivery for the benefit of a
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`particular individual (Angell [0113]). Dependent claims 2 and 8 of instant application recite the
`
`same or substantially similar limitations as claims 2 and 20 of co-pending application
`
`17/436,797. The only significant differences are addressed above with respectto the
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`differences between the corresponding independent claims which are obvious over Angell.
`
`Claim Rejections - 35 USC § 101
`
`35 U.S.C. 101 reads as follows:
`
`Whoever invents or discoversany new and useful process, machine, manufacture, or
`composition of matter, or any newand useful improvement thereof, may obtain a patent
`therefor, subject to the conditions and requirementsofthis title.
`
`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 6
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`Claims 1-7, 9-15 are rejected under 35 U.S.C.101 because the claimedinvention is directed toa
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`judicial exception (an abstract idea) without significantly more.
`
`Step 1
`
`Claims 1-7,9-15 are drawn to a method, which is within the four statutory categories. Claims 1-
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`7, 9-15 are further directed to anabstract idea on the groundsset out in detail below.
`
`Step 2A Prong 1
`
`Claim 1 recites implementing the stepsof:
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`-
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`-
`
`-
`
`-
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`-
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`receiving one or more external inputs;
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`generating, based on the one or more external inputs, one or more baseline values to a plurality
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`of internal parameters, wherein the plurality of internal parameters defines how to update a
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`causal model and how to determine which control settings toselect given a current causal
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`model;
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`accessing acurrent causal model that measures one or more causal relationships between one
`
`or more control settings anda measure of success ofa clinical trial;
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`selecting, based on the accessed current causal model and the plurality of internal parameters,
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`one or more control settings that specify one or more controllable aspects of the clinical trial;
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`repeatedly performing the following:
`
`o
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`selecting, froma population of patients, one or more patients 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 andthe selecting is based, at least in part, on the
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`current causal model and the plurality of internal parameters;
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`

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`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 7
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`©
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`automatically determining one or more measures of success of the clinical trial for
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`which patients were selected, wherein the one or more measuresof success are based,
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`at least in part on, the one or more control settings; and
`
`©
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`automatically adjusting, based on the measure of success of the clinical trial and the
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`plurality of internal parameters, the current causal model.
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`These steps amount to managing personal behavior or relationships or interactions
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`between people and therefore recite certain methods of organizing human activity. Configuring the
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`control settings of a causal model for selecting patients for being treated in a clinical trial, determining a
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`measure of success of the trial, and subsequently updating the model based on the measure of success,
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`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.
`
`Step 2A Prong 2
`
`This judicial exception is not integrated into a practical application because the additional
`
`elements within the claims only amountto:
`
`A. Instructions tolmplement the Judicial Exception. MPEP 2106.05(f
`
`Claim 1 additionally recites:
`
`-
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`acontrolsystem configured to automatically optimize patient selection for one or more
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`clinical trials as implementing the steps of the abstract idea
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`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 8
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`Regarding recitation of the controlsystem,the specification does not appear to provide any
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`particular structure of this element. Per para. [(0342]-[0343], no particulars of the system architecture
`
`are presented. As such, it is understood to be a control system implemented on a general purpose
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`computer. The broad recitation of general purpose computing elements ata high level of generality only
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`amounts to mereinstructions to implement the abstract idea using computing componentsas tools.
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`This element is therefore not sufficient to integrate the abstract idea into a practical application.
`
`Looking at the limitations as an ordered combination adds nothing that is not already present when
`
`looking at the elements taken individually.
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`Claim 1, asa whole,is therefore directed to an abstract idea.
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`Step 2B
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`The present claims do not include additional elements that are sufficient to amount to
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`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:
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`A. Instructions tol mplement the Judicial Exception. MPEP 2106.05(f
`
`As explained above, claim 1 only recites the aforementioned “control system”as a tool for
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`performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a
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`computer is not sufficient to amount tosignificantly more than the abstract idea. MPEP 2106.05(f).
`
`Thus, taken alone, the additional elements do not amountto significantly more than the
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`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
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`collective functions merely provide conventional computer implementation.
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`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Depending Claims
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`Page 9
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`Dependent claims2-7, 9-15 recite additional limitations which either narrow the scope of the
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`independentclaims or are also certain methods of organizing human activity.
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`Claim 2 recites adjusting the internal parameters based on the adjusted causal model, which is
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`alsocertain methods of organizing human activity including managing personal behaviors, asaclinical
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`trial coordinator/investigator adjust the internal parameters based on based on the adjusted causal
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`model.
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`Claim 3 recites wherein the one or more measures of success of the clinical trial comprises one
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`or more of: a measure of effectiveness of the treatment; or one or more biomarker levels in patients,
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`which further limits the scope of the abstract idea set out above.
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`Claim 4 recites wherein the control settings comprise one or more of: one or more personal
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`characteristics of the selected patients; or one or more settings related toa construction of the clinical
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`trial, which further limits the scope of the abstract idea set out above.
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`Claim 5 recites wherein the personal characteristics comprise one or more of: one or more
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`measuresof general health of the selected patients; an age of the selected patients; a gender of the
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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 consumed by 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 markersin the selected patients, which further limits the scope of the abstract idea
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`set out above.
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`Claim 6 recites wherein the measures of general health of the selected patients comprise one or
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`more of: a blood pressure of the selected patients; a heart rate of the selected patients; an EKG of the
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`selected patients; a heart rhythm of the selected patients; ora measure of lung function of the selected
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`patients, which further limits the scope of the abstract idea set out above.
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`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 10
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`Claim 7 recites wherein the settings related tothe construction of the clinical trial comprise one
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`or moreof: a relative proportion of patients towhom the treatmentis given compared to patients to
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`whom a placebois given; a dose amount of the treatment; the frequency of the treatment; ora total
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`number of doses given, which further limits the scope of the abstract idea set out above.
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`Claim 9 recites wherein the at least one of the one or more external inputs comprises a
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`demographic distribution of patients who volunteer for the clinical trial, which further limits the scope
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`of the abstract idea set out above.
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`Claim 10 recites wherein the internal input parametersincludes a first parameter that identifies
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`an experimental unit, where the experimental unit characterizes a number of selected patients anda
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`length of time of the clinical trial, which further limits the scope of the abstract idea set out above.
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`Claim 11 recites asystem comprising one or more computers and one or morestorage devices
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`storing instructions that when executed by the one or more computers cause the one or more
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`computers to perform the operations of the method of claim 1, which recites additional elements. The
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`specification discloses the system architecture at a high level of generality (first paragraph on page 45)
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`which amounts to more than mere instructions to implementthe judicial exception. This is not sufficient
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`to integrate the judicial exception into a practical application or amountto significantly more than the
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`judicial exception.
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`Claim 12 recites one or more computer-readable storage media storing instructions that when
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`executed by one or more computers cause the one or more computersto perform the operations of the
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`method of claim 1, which recites additional elements. The specification discloses the computer system
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`architecture at a high level of generality (first paragraph on page 45), which amounts to more than mere
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`instructions to implement the judicial exception. This is not sufficient to integrate the judicial exception
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`into a practical application or amount to significantly more than the judicial exception.
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`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 11
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`Claim 13 recites wherein the plurality of internal parameters comprisesat least one of one or
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`morespatial extents and one or more temporal extents, which further limits the scope of the abstract
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`idea set out above.
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`Claim 14 recites wherein the external inputs define a search space of possible combinations of
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`control settings, which further limits the scope of the abstract idea set out above.
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`Claim 15 recites wherein the internal parameters include one or more clustering parameters
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`that define the hyperparametersof the clustering technique, which further limits the scope of the
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`abstract idea set out above.
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`Dependent claims 2-7, 9-15 recite additional subject matter which amounts to additional
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`elements consistent with those identified in the analysis of Claim 1 above. As discussed above with
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`respect to Claim 1 and integration of the abstract idea into a practical application, recitation of these
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`additional elements (e.g., control system) only amounts to invoking computers as a tool to perform the
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`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..
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`Dependent claims 2-7, 9-15, 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 anabstract 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
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`improves any other technology. Their collective functions merely provide conventional computer
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`implementation. These claimsfail to remedy the deficiencies of their parent claims above, and are
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`therefore rejected for at least the same rationale as applied to their parent claims above, and
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`incorporated herein.
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`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 12
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`For the reasons stated, Claims 1-7, 9-15 fail the Subject MatterEligibility Test and are
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`consequently rejected under 35 U.S.C. 101.
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`Response to Applicant’s Remarks/Arguments
`
`Please note: Whenreferencing page numbers of Applicant’s response, references are to page numbers as
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`printed.
`
`Drawing Objections
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`The drawing objections detailed in NFOA dated 10/04/23 are withdrawn in view of Applicant’s
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`submission of revised Fig. 4A and amendmentto specification to incorporate the missing reference
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`number “510” shown in Fig. 5.
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`Claim Objections
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`The objection to Claim 1 detailed in NFOA dated 10/04/23 is withdrawn in view of Applicant’s
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`amendment to Claim 1.
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`Double Patenting
`
`The double patenting rejections of Claims 1, 2, 5, 8 over co-pending Application No. 17/436,743
`
`are withdrawn in view of Applicant’s amendments to claims. Examiner notes that should co-pending
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`Application 17/436, 743 be amended similarly to the instant application, the Double Patenting rejection
`
`may be reinstated.
`
`The double patenting rejections of Claims 1, 2, 8 over Claims 1, 2 and 20 of co-pending
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`Application No. 17/436,797 are maintained. Examiner notes that co-pending application 17/436, 797 has
`
`been amendedsimilarly to the instant application. The main difference is that Claim 1 of the instant
`
`

`

`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 13
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`application pertains to selection of patients for a clinical trial using a causal model that measures causal
`
`relationships between input settings and outcomes(e.g., success ofclinical trial), and co-pending
`
`application 17/436, 797 pertains to optimizing healthcare facility operations using a causal model that
`
`measures causal relationships between input settings and outcomes(success of healthcarefacility
`
`operation), however, the frameworkof using and adjusting a causal model is substantially similar.
`
`112(b) Rejections
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`The 112(b) rejection of Claim7for lack of antecedentbasis is withdrawnin view of Applicant’s
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`amendment to Claim 7.
`
`101 Rejections
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`Applicant’s remarks have been considered but are not persuasive. Regarding remarks beginning
`
`at page 11 directed to Step 2A Prong 1, Examiner respectfully disagrees with Applicant’s position. With
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`respect to “improving the accuracy of computing technology”, any purported improvements may come
`
`from the abstractidea itself (e.g., the type of data fed into the causal model by selecting different
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`control settings suchas demographics). Per, MPEP 2106.05(a): “It is important to note, the judicial
`
`exception alone cannot provide the improvement. The improvementcan be provided by one or more
`
`additional elements.” As explained above in the 101 analysis section, the broadest reasonable
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`interpretation of the “control system”is understood to be general purpose computing elements.
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`Applicant has not citedto, nor can Examiner find, evidence of how the control sys tem itself provides a
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`technical improvement over prior art systems.
`
`Regarding remarks at pages 11-12 directed to Example 39, Examiner respectfully disagrees that
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`the instant claims are analogous. In 101 section above,it isshown how Claim1is directed to methods of
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`organizing human activities. Example 39 is drawnto subject matter that inherently lies in the realm of
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`

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`Application/Control Number: 17/436 ,840
`Art Unit: 3626
`
`Page 14
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`computers(e.g., rotating, mirroring, smoothing images to detect human facesin images); the limitations
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`of Example 39 cannot be performed by a personand/or cannot be performed repeatably by a
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`person/people. Inthe instant application, nothing precludes the steps of from being able to be
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`performed by a human; Examiner is not able to find any instances of technologies that are inherently
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`limited to computers.
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`In the instant application claims, the computer is merely applying the abstract
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`idea. Examiner acknowledges Applicant’s statement that training a machine learning model involves
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`different steps than updating a causal model, but respectfully disagrees that the twoare 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 withan
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`updated training set containing the false positives, which created a combination of features that
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`provides a robust facial detection model that can detect faces in distorted images while limiting the
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`number of false positives; as earlier stated, the facial detection methodis inherently in the realm of
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`computers. As the instant claims are directed to a “causal model”
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`|”
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`rather thana neural network and as
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`such, the recited methodis not inherently limited to computers. Regarding Applicant’s assertion that
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`“the methods embodied by the respective claims cannot be practicably performed by humans”,
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`Applicant has not citedto, nor can Examiner find, evidence of why the instant claims cannot be
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`performed by humans(e.g., vast amountof data to consider). For these reasons, the above arguments
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`are not persuasive.
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`Regarding arguments directed to Step 2A prong 2 beginning at page 13, Examiner respectfully
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`disagrees that the judicial exception is integrated into a practical application. Regarding “improvements
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`to speed and accuracy”, as stated earlier, any purported improvements appear to come from the
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`abstract idea itself (e.g., the type of data being used in the model) and as such, are not technical
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`improvements per MPEP 2106.05. Similarly, the paragraphs excerpted by Applicant at page 13 also may
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`provide improvements to the abstractidea itself (e.g., using data for demographicsofa clinical trial and
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`Application/Control Number: 17/436 ,840
`Art Unit: 3626
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`Page 15
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`the success of theclinical trial for various configurations of environmentcharacteristics; selecting
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`control settings that are only within certain rangesof values), which is not sufficient to integrate the
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`judicial exception into a practical application.
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`Regarding arguments directed to Step 2B beginning at page 14, Examiner respectfully disagrees
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`with Applicant’s position that “the limitations as claimed provide an improvement to the technical
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`process of optimizing patient selection for clinical medical trials”. As stated above, any purported
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`improvements may be improvements to the abstract idea of optimizing patient selection for clinical
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`trials, but are not technical improvements per MPEP 2106.05(a) (“It is important to note, the judicial
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`exception alone cannot provide the improvement. The improvementcan be provided by one or more
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`additional elements”). Examiner prospectively notes that with respect to Applicant’s reference to Diehr,
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`the claims were directed to a novel method of curing rubber by using an equation to constantly monitor
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`the temperature of the rubber mold to determine when to open the mold, to solve problems of the
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`prior art systems with under/over-curing rubber. The instant claims do not recite using the judicial
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`exception to control an external device in a particular way.
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`For the above reasons, the 101 rejections of Claims 1-7, 9-15 are maintained.
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`103 Rejections
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`The 103 rejections are withdrawnin view of Applicant’s amendments to claims. The closest
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`prior artis understood to be the art of record. Ennist teaches on using a predictive model andclinical
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`data associated witha group of patients in atrial to determine a measureof efficacy of the treatment
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`and establish screeningcriteria for the trial. Weber et. al. (US Publication 20170061102A1) teaches ona
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`method of identifying high-value patients in a clinical trial which adjusts or optimizes parameters related
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`to the determination of a patient’s value in a clinical trial. Neither Ennist nor Weber teaches on the
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`particulars of the instant claim language pertaining to updating, selecting and accessing a causal model
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`

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`Application/Control Number: 17/436 ,840
`Art Unit: 3626
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`Page 16
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`that measures causal relationships between one or more control settings anda measure of success of
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`the trialin order to select patients for being treated. Asearchof publicly available prior art fails to yield
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`a reference or combination of references that would make the claimed combination of elements
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`obvious when considered as a whole.
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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 amendments in future correspondence.
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`THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension
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`of time policy as set forth in 37 CFR 1.136(a).
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`A shortenedstatutory period for reply to this final action is set to expire THREE MONTHS from
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`the mailing date of this action. Inthe event a first reply is filed within TWO MONTHSof the mailing date
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`of this final action and the advisory action is not mailed until after the end of the THREE-MONTH
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`shortened statutory period, then the shortened statutory period will expire on the date the advisory
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`action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing
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`date of the advisory action.
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`In no event, however, will the statutory period for reply expire later than
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`SIX MONTHS from the date ofthis final action.
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`Anyinquiry concerning this communication or earlier communications from the examiner
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`should be directed to ANNE-MARIE K ALDERSON whose telephone 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 interviews are 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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`Application/Control Number: 17/436 ,840
`Art Unit: 3626
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`Page 17
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`If attempts to reachthe 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 wherethis
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`application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent Application
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`Information Retrieval (PAIR) system. Status information for published applications may be obtained
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`from either Private PAIR or Public PAIR. Status information for unpublished applica