www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/436,840
`
`09/07/2021
`
`Brian E. Brooks
`
`82438US006
`
`8993
`
`3M INNOVATIVE PROPERTIES COMPANY
`PO BOX 33427
`ST. PAUL, MN 55133-3427
`
`ALDERSON, ANNE-MARIE K
`
`ART UNIT
`
`3626
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/04/2023
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`Thetime 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):
`
`LegalUSDocketing @ mmm.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-12 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`(J) Claim(s)__ is/are allowed.
`Claim(s) 1-12 is/are rejected.
`Claim(s) 1-12 is/are objectedto.
`1) 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)M The drawing(s) filed on 09/07/21 is/are: a)() accepted or b) objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)0) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)() 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.
`3.2.) 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)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date 03/03/22,12/13/22.
`U.S. Patent and Trademark Office
`
`3)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20230926
`
`Application No.
`Applicant(s)
`17/436 ,840
`Brookset al.
`
`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 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 09/07/2021.
`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)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: 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
`
`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 application filed on 09/07/2021.
`
`2. Claims 3, 4, 7, 8, 10-12 have been amended and are hereby entered.
`
`3. Claims 1-12 are currently pending and have been examined.
`
`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 10/29/19is
`
`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
`
`The information disclosure statements (IDS) submitted on 03/03/22 and 12/13/22 have
`
`been considered by the examiner. The submission is in compliance with the provisions of 37
`
`CFR 1.97.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 3
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`Drawing Objections
`
`The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they
`
`include the following reference character(s) not mentioned in the description: Fig. 4A includes
`
`items 408 and 410, which are not mentioned in the description. Fig. 5 includes item 510 which
`
`is not mentioned in the description. Corrected drawing sheets in compliance with 37 CFR
`
`1.121(d), or amendmentto the specification to add the reference character(s) in the
`
`description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to
`
`avoid abandonmentof the application. Any amended replacement drawing sheet should
`
`include all of the figures appearing on the immediate prior version of the sheet, even if only
`
`one figure is being amended. Each drawing sheet submitted after the filing date of an
`
`application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet”
`
`pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will
`
`be notified and informed of any required corrective action in the next Office action. The
`
`objection to the drawings will not be held in abeyance.
`
`The drawings are objected to because Fig. 4A appears to be a duplicate flow chart of Fig.
`
`3 with corresponding flow chart item numbers updated only (e.g., 302 in Figure 3 is shown as
`
`402 in Figure 4A), and as such, the description of items 402, 404, 406 at pages 22-23 in
`
`specification do not correspond with the flowchart depicted in Fig. 4A. Corrected drawing
`
`sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid
`
`abandonmentof the application. Any amended replacement drawing sheet should include all of
`
`the figures appearing on the immediateprior version of the sheet, even if only one figureis
`
`being amended. The figure or figure number of an amended drawing should not be labeled as
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 4
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`“amended.”If a drawing figure is to be canceled, the appropriate figure must be removed from
`
`the replacement sheet, and where necessary, the remaining figures must be renumbered and
`
`appropriate changes made to the brief description of the several views of the drawings for
`
`consistency. Additional replacement sheets may be necessary to show the renumbering of the
`
`remaining figures. Each drawing sheet submitted after the filing date of an application must be
`
`labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR
`
`1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and
`
`informed of any required corrective action in the next Office action. The objection to the
`
`drawings will not be held in abeyance.
`
`Claim Objections
`
`Claim 1 objected to because of the following informalities: Claim 1 recites “the certain
`
`configuration of input settings” in line 9. Examiner notes that this does not introduce
`
`antecedent basis issues as there is only one “configuration of input settings” recited in Claim 1
`
`(at line 5). However, for increased clarity and coherence of the claim, Examiner recommends
`
`streamlining claim language pertaining to the configuration of input settings (e.g., amend Claim
`
`9 to recite “the configuration of input settings” or amend line 5 and subsequent references to
`
`the configuration to recite “a certain configuration of input settings”). Appropriate correction is
`
`required.
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`Claims 2-12 inherit the deficiencies of parent Claim 1 and are subsequently objected to.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 5
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`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`grounded in public policy (a policy reflected in 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 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be
`
`used to overcome an actual or provisional rejection based on nonstatutory double patenting
`
`provided the reference application or patent either is 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.
`
`See MPEP § 2146et seq. for applications not subject to examination under the first inventor to
`
`file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`1.321(b).
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 6
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`The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory
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`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
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`NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.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
`
`which the 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 meets all 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, 5, 8 are provisionally rejected on the ground of nonstatutory double
`
`patenting as being unpatentable over claims 1, 2, 18, 16, respectively, of co-pending
`
`Application No. 17/436,743 in view of Hartman et. al. (US Publication 20150095044A1).
`
`This is a provisional nonstatutory double patenting rejection because the patentably
`
`indistinct claims have not in fact been patented.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 7
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`Claim 1 of the instant application recites substantially similar limitations as Claim 1 of
`
`co-pending application 17/436,743. 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., success ofclinical
`
`trial), and co-pending application 17/436,743 pertains to providing a treatment to a patient
`
`using a causal model that measures causal relationships between input settings and outcomes
`
`(effective of treatment on patient), however, the frameworkof using and adjusting a causal
`
`model is substantially similar; which would be obvious over Hartman with the motivation of
`
`using patient data to determine input values to different estimation functions for different
`
`types of treatment, to ultimately determine an optimal treatment plan for the patient
`
`(Abstract). Dependentclaims 2, 5, and 8 of instant application recite the same or substantially
`
`similar limitations as claims 2, 18, and 16, respectively, of co-pending application 17/436,743.
`
`The only significant differences are addressed above with respect to the differences between
`
`the corresponding independent claims which are obvious over Hartman.
`
`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 20090006125A1).
`
`This is a provisional nonstatutory double patenting rejection because the patentably
`
`indistinct claims have not in fact been patented.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 8
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`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., 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 (successof healthcare facility operation), however, the framework of 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
`
`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 abovewith respect to the
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`differences between the corresponding independent claims which are obvious over Angell.
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The specification shall conclude with one or moreclaims particularly pointing
`out and distinctly claiming the subject matter which the inventor or a joint inventor regards as
`the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or moreclaims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 9
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`Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second
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`paragraph,as beingindefinite for failing to particularly point out and distinctly claim the
`
`subject matter which the inventoror a joint inventor (or for applications subject to pre-AlA
`
`35 U.S.C. 112, the applicant), regards as the invention.
`
`Claim 7 recites the limitation "the frequency of the treatment" in 6. Thereis insufficient
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`antecedentbasis for this limitation in the claim. Examiner is interpreting this limitation to be “a
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`frequency of the treatment”.
`
`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 1-12 are rejected under 35 U.S.C.101 because the claimed inventionis directed
`
`to a judicial exception (an abstract idea) without significantly more.
`
`Step 1
`
`Claims 1-12 are drawn to a method, which is within the four statutory categories.
`
`Claims 1-12 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:
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 10
`
`-
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`repeatedly performing the following:
`
`o
`
`selecting, from a population of patients, patients for being treated with the
`
`treatment using a configuration of input settings, wherein the configuration is
`
`selected based on a causal model that measures current causal relationships
`
`between input settings and a measure of success of the clinical trial;
`
`o
`
`determining the measureof successofthe clinical trial for which patients were
`
`selected using the certain configuration of input settings; and
`
`o
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`adjusting, based on the measure of successof the clinical trial, the causal
`
`model.
`
`These steps amount to managing personal behavior or relationships or interactions
`
`between people and therefore recite certain methods of organizing human activity. Selecting
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`patients for being treated in a clinical trial using a causal model to select input settings,
`
`determining a measure ofsuccess ofthe 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 provider.
`
`Step 2A Prong 2
`
`This judicial exception is not integrated into a practical application because Claim 1 does
`
`not contain any additional elements to integrate the judicial exception into a practical
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`application.
`
`Step 2B
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 11
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`As stated above with respect to Step 2A, Claim 1 does not contain any additional
`
`elements. With respect to 2B, the claim does not contain any additional elements to amount to
`
`significantly more than the judicial exception.
`
`Depending Claims
`
`Dependentclaims 2-12 recite additional limitations which either narrow the scope of
`
`the independentclaims or are also certain methods of organizing human activity.
`
`Claim 2 recites selecting patients comprises selecting patients based on a setof internal
`
`control parameters, and the method further comprises adjusting the internal control
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`parameters based on the measure of success of the clinical trial, which is also certain methods
`
`of organizing human activity including managing personal behaviors, as a clinical trial
`
`coordinator/investigator may select patients for a trial based on internal control parameters
`
`and adjust the internal control parameters based on the measure of successof the trial.
`
`Claim 3 recites wherein the measure of successofthe clinical trial comprises one or
`
`more of: a measure of effectiveness of the treatment; or one or more biomarker levels in
`
`patients, which further limits the scope of the abstract idea set out above.
`
`Claim 4 recites wherein the input settings comprise one or moreof: one or more
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`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
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`more measures of general health of the selected patients; an age of the selected patients; a
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`gender of the selected patients; a weight of the selected patients; a body mass index of the
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`selected patients; an averagecaloric intake of the selected patients; a type of food consumed
`
`by the selected patients; an activity level of the selected patients; one or more preexisting
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 12
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`conditions of the selected patients; or one or more genetic markers in the selected patients,
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`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 measure
`
`of 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 more of: a relative proportion of patients to whom the treatmentis given
`
`compared to patients to whom a placebois given; a dose amountof 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 8 recites wherein: selecting the configuration of input settings comprises selecting
`
`the configuration based on the causal model and respective measures of a predetermined set
`
`of external variables; and the method further comprises adjusting internal control parameters
`
`that parameterize an impact of the predetermined set of external variables on the selecting of
`
`the configuration, which is also certain methods of organizing human activity including
`
`managing personal behaviors, asaclinical trial coordinator/investigator may select
`
`configurations based on a model and adjust modeling parameters/variables for selecting
`
`patientsin a clinical trial.
`
`Claim 9 recites wherein the predetermined set of external variables comprises a
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`demographic distribution 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 control parameters includes a first parameter that
`
`identifies an experimental unit, where the experimental unit characterizes a number of selected
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 13
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`patients and a 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 more storage
`
`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 recites
`
`additional elements. The specification discloses the system architecture at a high level of
`
`generality (first paragraph on page 45) 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 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 ofclaim 1, which recites additional elements. The specification
`
`discloses the computer system architecture at a high level of generality (first paragraph on page
`
`45), which amounts to more than mereinstructions to implementthe judicial exception. This is
`
`not sufficient to integrate the judicial exception into a practical application or amount to
`
`significantly more than the judicial exception.
`
`Dependentclaims 2-12, 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 withoutsignificantly more. 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
`
`improvesthe functioning of a computer or improves any other technology. Their collective
`
`functions merely provide conventional computer implementation. These claims fail to remedy
`
`the deficiencies of their parent claims above, and are therefore rejected for at least the same
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`rationale as applied to their parent claims above, and incorporated herein.
`
`

`

`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 14
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`For the reasons stated, Claims 1-12 fail the Subject Matter Eligibility Test and are
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`consequently rejected under 35 U.S.C. 101.
`
`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 statutorybasis (i.e., changing from AIA to pre-AlA) for the rejection will not be
`
`considered a new ground ofrejection if the prior art relied upon, and 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 beforethe effectivefiling date of the claimed invention to a person having ordinary
`skill in the art to which the claimed invention pertains. Patentability shall not be negated by the
`manner in which the invention was made.
`
`The factual inquiries for establishing a background for determining obviousness under
`
`35 U.S.C. 103 are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
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`2. Ascertaining the differences between the prior art and the claims at issue.
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`3. Resolving the level of ordinary skill in the pertinent art.
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`4. Considering objective evidence present in the application indicating obviousnessor
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`nonobviousness.
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`

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`Application/Control Number: 17/436,840
`Art Unit: 3626
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`Page 15
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`Claim(s) 1, 3-7, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over
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`Ennist et. al. (US Publication 20200105380A1) in view of Friedrich et. al. (US Publication
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`20070026365A1).
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`Regarding Claim 1, Ennist discloses the following:
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`repeatedly performing the following ([0024] teaches on the process by which patients
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`are selected for a clinical trial by using data of previous clinical trial participants and efficacy
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`outcomes to identify those with highest efficacy to use a predictive model to predict outcomes
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`for patients having a particular screening criteria identified from the earlier cohort; [0026] and
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`[0061] teach on training of a model; performing the steps below ofselecting patients by using a
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`model and adjusting the model using an outcome “repeatedly” amounts to duplication of parts
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`which has no patentable significance unless a new and unexpected result is produced; see
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`MPEP 2144.04(VI)(B). The limitation of “repeatedly” performing the subsequentsteps is merely
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`repeating the steps of the process again and again, and does yield a new or unexpected result).
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`selecting, from a population of patients, patients for being treated with the treatment
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`using a configuration of input settings, wherein the configuration is selected based ona
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`model that measures currentrelationships between input settings and a measure of success
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`of the clinical trial ([(0024] teaches on enrolling candidatesinto a clinical trial for a treatmentin
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`which patients are selected based on a predictive model that was built based on clinical data of
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`a different group of patients having the condition being treated — e.g., configuration settings
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`are the clinical data of the earlier group of patients undergoing treatment in clinical trial;
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`clinical data for first group of patients was grouped into subsetsofclinical trial data for a
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`

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`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 16
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`subgroup of patients; [0024] further teaches on using the modeling processto identify which
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`subgroupsof patients (input settings per [0068]) had higher efficacy than other subgroups(e.g.,
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`a higher efficacy is measure of success); a screening criteria is subsequently identified from the
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`higher efficacy subset which is used as a basis for selecting patient for clinical trial; Additionally,
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`[0068] teaches on building predictive models by training the model using clinical data of
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`patients having the condition and how the disease progressed over time; patient data included
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`patient information such as height, weight, pulse, genetic data, biomarker data, gender, age,
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`smoking/drinking habits, etc.; Examiner is construing the aforementioned patient data to read
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`on “input settings” and “how the disease progressed over time” to read on “a measure of
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`success’);
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`determining the measureof successofthe clinical trial for which patients were
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`selected using the certain configuration of input settings ([0024] teaches on identifying at least
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`one subset of the plurality of patients that has a measure of efficacy of the treatment that is
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`higher than the measure of efficacy for the first group of patients; [0061] further teaches on
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`identifying one or more subgroups of patients that showed an “improved outcome”(e.g., a
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`measureof success) relative to the full trial population and identifying characteristics of that
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`subgroup to screen candidates for a new trial; Examiner is interpreting “one or more
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`characteristics of the subgroup” to read on “certain configuration of input settings”); and
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`adjusting, based on the measure of successof theclinical trial, the causal model
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`([0026] teaches on training the predictive model using clinical data for a second group of
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`patients, which Examiner is construing to read on “adjusting” a model based on earlier data;
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`per [0024], the efficacy data (e.g., measure of success) of a group of patients within a particular
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`

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`Application/Control Number: 17/436,840
`Art Unit: 3626
`
`Page 17
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`subset of clinical data is used to identify a screening criteria correlated with a higher efficacy;
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`prediction data for patients with the screening criteria is generated using the prediction model).
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`Ennist teaches a predictive model which determines relationships between clinical data
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`of patients and an efficacy of those within a subgroup of similar clinical data, but does not
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`explicitly teach a causal model/causal relationships.
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`Friedrich, which is directed to defining patient populations in a clinical trial, teaches a
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`causal model/causal relationships ([0052] teaches on use of a computational model which may
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`be a causal model to link two or more causally-related variables).
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`Therefore, it would have been obvious to one of ordinaryskill in the art before the
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`effective filing date of the claimed invention, to modify Ennist with these teachings of Friedrich
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`to use a causal model to measure causal relationships, with the motivation of allowing for the
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`identification of causal relationships of interest between variables in a clinical trial (Friedrich
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`[0101]).
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`Regarding Claim 3, Ennist/Friedrich teach the limitations of Claim 1. Ennist further
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`discloses wherein the measureof success ofthe clinical trial comprises one or moreof: a
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`measureof effectiveness of the treatment; or one or more biomarker levels in patients
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`([0070] teaches on useful outcomesfor the trial which may include survival or disease
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`recurrence (Examiner is construing this to read on “effectiveness of the treatment” if one
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`survives following treatment), and “a lab value