Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 1 of 13
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`Exhibit 2
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`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 2 of 13
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`
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMlVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`
`
`
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`14/187,028
`
`02/21/2014
`
`Daniel D. Von Hoff
`
`37901—715307
`
`6832
`
`11/27/2015 —WILSON SONSINI GOODRICH & ROSATI/ CARIS m
`7590
`96600
`LIFE SCIENCES
`SIMS’ JASON M
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304
`
`PAPER NUMBER
`
`1631
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/27/2015
`
`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):
`PATENTDOCKET @WSGRCOM
`
`lgoff@ carisls.c0m
`patent @ carisls.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`Case 1:17—cv—12}94—MLW Dec
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 3 of 13
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`14/187,028
`VON HOFF ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Status
`JASON SIMS
`No
`
`ppllc%fi3%MEI-leagar/WTWaRéI13
`
`
`Office Action Summary
`
`1 631
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date of this communication.
`It NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from 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, even it timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
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`1)IXI Responsive to communication(s) filed on 11/12/2015.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|:| This action is non-final.
`2a)IZ| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
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`; the restriction requirement and election have been incorporated into this action.
`
`4)|:I 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 EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)|:l Claim(s)fl1is/are pending in the application.
`
`5a) Of the above claim(s) 4 78 11 14 15 18 19 21 23 and 24 is/are withdrawn from consideration.
`6 III Claim 3) _ is/are allowed.
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`1-3 5 6 9101213161720 and22 is/are rejected.
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`is/are objected to.
`
`
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`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`htt ://\va.usnto. ov/ atents/init events"
`h/index.‘s
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`
`
`
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`or send an inquiry to PF"l-ifeedback{<‘busr),to.qov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I 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)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some** c)I:I None of the:
`a)|:l All
`1.|:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.|:I Copies of the certified copies of the priority documents have been received in this National Stage
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`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)
`
`
`
`3) D Interview Summary (PT0_413)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) E Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`Paper No(s)/Mai| Date .
`US. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
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`Part of Paper No./Mai| Date 20151122
`
`

`

`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 4 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 4 of 13
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`Application/Control Number: 14/187,028
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`Page 2
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`Art Unit: 1631
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`The present application is being examined under the pre-AIA first to invent
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`provisions.
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`DETAILED ACTION
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`A request for continued examination under 37 CFR 1.114, including the fee set
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`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
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`application is eligible for continued examination under 37 CFR 1.114, and the fee set
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`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
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`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
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`11/12/2015 has been entered.
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`Applicant’s election without traverse of the species of claim 22 in the phone
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`interview held on 10/30/2014 (see interview summary) is acknowledged.
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`Claims 23-24 are withdrawn from further consideration pursuant to 37 CFR
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`1.142(b) as being drawn to a nonelected species, there being no allowable generic or
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`linking claim. Election was made without traverse in the reply on 10/30/2014.
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`Applicant’s election without traverse of species B, E, H, J, and M (equivalent to
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`claims 12, 9, 16, 17, and 20) in the reply filed on 7/3/2014 is acknowledged.
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`Claims 4, 7, 8, 11, 14, 15, 18, 19, and 21 are withdrawn from further
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`consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventive
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`group, there being no allowable generic or linking claim. Election was made without
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`traverse in the reply filed on 7/3/2014.
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`

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`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 5 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 5 of 13
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`Application/Control Number: 14/187,028
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`Page 3
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`Art Unit: 1631
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`Applicant’s arguments, filed 11/12/2015, have been fully considered. The
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`following rejections and/or objections are either reiterated or newly applied. They
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`constitute the complete set presently being applied to the instant application.
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`Claims 1-3, 5-6, 9-10, 12-13, 16-17, 20, and 22 are the current claims hereby
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`under examination.
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`Information Disclosure Statement
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`The information disclosure statement (IDS) submitted on 1/16/2015 and
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`5/12/2015 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the
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`information disclosure statements have been considered by the examiner.
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`Claim Rejections - 35 USC § 101-maintained/modified
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`35 U.S.C. 101 reads as follows:
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`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 of this title.
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`Claims 1-3, 5-6, 9-10, 12-13, 16-17, 20 and 22 are rejected under 35 U.S.C. 101
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`because the claimed invention is directed to non-statutory subject matter because the
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`claim(s) as a whole, considering all claim elements both individually and in combination,
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`do not amount to significantly more than an abstract idea.
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`The instant claims are directed towards a method/program/system comprising a
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`database and instructions for inputting molecular profile data and using said data to
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`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 6 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 6 of 13
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`Application/Control Number: 14/187,028
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`Page 4
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`Art Unit: 1631
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`identify a therapeutic agent with a likely benefit and to generate a report. According to
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`the 2014 interim Eligibility Guidance an initial two step analysis is required for
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`determining statutory eligibility. Step 1 requires a determination of whether the claims
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`are directed to a process, machine, manufacture, or a composition of matter.
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`In the
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`instant case the Step 1 requirement is satisfied as the claims are directed towards a
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`system. The Step 2 analysis is a two-part analysis, Step 2A and Step 2B, with the first
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`part Step 2A requiring a determination of whether the claims are directed towards a
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`judicial exception, Le. a law of nature, natural phenomenon, or an abstract idea.
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`In the instant case, the claims as stated are drawn to system comprising a
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`database and instructions for inputting molecular profile data and using said data to
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`identify a therapeutic agent with a likely benefit and to generate a report comprising
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`process steps implemented on a computer. The recited process involves the abstract
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`and computational steps of obtaining data, comparing data, and generating a report. As
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`such, the instant claims are drawn only to an abstract process that only manipulates
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`data and, therefore, are not directed to statutory subject matter. Therefore the result of
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`Step 2A analysis is that the claims are directed towards a judicial exception, i.e. an
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`abstract idea. With regards to the claims being directed to a process implemented on a
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`computer system or embedded on a computer readable medium comprising instructions
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`for carrying out the method, it is the underlying invention that is analyzed to determine
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`subject matter eligibility, not just the use of a computer system or computer program
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`product.
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`In the instant case, the claims are directed to only the manipulation of data as
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`described above. The method steps themselves are considered to be an abstract idea
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`

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`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 7 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 7 of 13
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`Application/Control Number: 14/187,028
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`Page 5
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`Art Unit: 1631
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`because they do not purport to improve the functioning of the computer itself, there is no
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`specific or limitation recitation of improved computer technology, nor do they effect an
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`improvement in any other technology or technical field.
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`The instant ciaiina are focused on the rnathentaticai manipulation of data, eg.
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`data proceeaing as; described above. The maineinaticai algorithme/forn‘iolaa for
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`obtaining data, comparing data, and generating a report are mathematical atgorithina
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`aiiniiar to titoee found by the courts. to be abstract.
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`In particular, the courts have found
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`mathematical algorithms to be abstract ideas (e.g., a mathematical procedure for
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`converting one form of numerical representation to another in Benson, or an algorithm
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`for calculating parameters indicating an abnormal condition in Grams). Therefore, the
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`claim is directed to an abstract idea. With regards to the use of a computer/processor,
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`the courts have found that simply limiting the use of the abstract idea to a particular
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`technological environment is not significantly more. (See, e.g., F/ook.) Even though the
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`disclosed invention may improve computer technology, the claimed invention provides
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`no meaningful limitations such that this improvement is realized. Therefore, the claim
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`does not amount to significantly more than the abstract idea itself. The courts
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`summarized much of the wording used in the Alice v. CLS court case, which although
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`the actual claimed invention may be different, the concepts are similar and/or described
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`throughout the case.
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`Furthermore, the steps of obtaining data, comparing data, and generating a
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`report can be performed mentally and is an idea of itself. The concepts of obtaining and
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`comparing data being abstract ideas are similar in nature (e.g. obtaining and comparing
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`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 8 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 8 of 13
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`Application/Control Number: 14/187,028
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`Page 6
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`Art Unit: 1631
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`data) to what were found to be abstract by the courts.
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`It is similar to other concepts that
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`have been identified as abstract by the courts, such as using categories to organize,
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`store and transmit information in Cyberfone, or comparing new and stored information
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`and using rules to identify options in SmartGene. The use of a computer to perform
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`such concepts are recited at a high level of generality and its broadest reasonable
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`interpretation comprises only a microprocessor, memory and transmitter to simply
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`perform the generic computer functions of receiving, processing and transmitting
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`information. Generic computers performing generic computer functions, alone, do not
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`amount to significantly more than the abstract idea. The etep of outputting a iiieeeege
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`is alse merely an instruction to implement the abstract idea.
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`As per the interim guidelines July 2015:
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`Several cases have found concepts relating to processes of comparing data that
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`can be performed mentally abstract, such as comparing information regarding a sample
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`or test subject to a control or target data (Ambry, Myriad CAFC), collecting and
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`comparing known information (Classen), comparing data to determine a risk level
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`(Perkin-Elmer), diagnosing an abnormal condition by performing clinical tests and
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`thinking about the results (In re Grams),13 obtaining and comparing intangible data
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`(Cybersource), and comparing new and stored information and using rules to identify
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`options (SmartGene).
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`The second part, Step 2B of the two step analysis is to determine whether any
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`element or combination of elements, in the claim is sufficient to ensure that the claim as
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`a whole amounts to significantly more than the judicial exception.
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`It is noted that some
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`

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`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 9 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 9 of 13
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`Application/Control Number: 14/187,028
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`Page 7
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`Art Unit: 1631
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`claims comprise additional limitations that result in essentially an “apply it” limitation,
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`such as generating a report that comprises a list of the molecular targets for which the
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`comparison to the reference value indicated a likely benefit and at least one therapeutic
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`agent. The generation of a report is considered to be an additional step that does not
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`add a substantial practical application as no direct application is required based upon
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`said report. The result of said report is a likely benefit, but no direct benefit or
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`improvement is realized or directly falls from the claimed system.
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`In addition, the step
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`of using a device to assay molecular targets is also considered the addition of a step
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`that is well known, routine, and conventional. The general recitation of said assay
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`limitations reads on limitations that would be well known, conventional and routine to
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`one of ordinary skill in the art. Courts have not identified a situation in which evidence
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`was required to support a finding that the additional elements were well-understood,
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`routine or conventional, but rather treat the issue as a matter appropriate for judicial
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`notice. As such, a rejection should only be made if an examiner relying on his or her
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`expertise in the art can readily conclude in the Step 2B inquiry that the additional
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`elements do not amount to significantly more (Step 28: NO).
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`If the elements or functions
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`are beyond those recognized in the art or by the courts as being well-understood,
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`routine or conventional, then the elements or functions will in most cases amount to
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`significantly more (Step 2B: YES).
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`Therefore, no additional steps are recited in the instantly claimed invention that
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`would amount to significantly more than the judicial exception. Without additional
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`limitations, a process that eii'ipioys mathematical aigoriihms to manipuiate existing
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`

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`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 10 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 10 of 13
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`Application/Control Number: 14/187,028
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`Page 8
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`Art Unit: 1631
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`irrferrrtetierr to generate additierrai iniermatterr is net patent eligihie. Furthermere, ii a
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`stain": is directed essentiaiiy t0 a rhethed 0i caicuiatirtg. using a matt‘rerheticai termuia.
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`even it the seititien is ier e specific purpese, the Cieimed methed is nen~stetutery.
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`in
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`ether wertis. patenting ehstreet ideae eartrtet be circumvented by attempting te limit the
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`use [the idea} te a pertietitar techneiegicai ehvirertn’ient. Courts have held computer-
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`implemented processes not to be significantly more than an abstract idea (and thus
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`ineligible) where the claim as a whole amounts to nothing more than generic computer
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`functions merely used to implement an abstract idea, such as an idea that could be
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`done by a human analog (i.e., by hand or by merely thinking).
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`irt the instant etairrre, the
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`computer arid/er pregrem/preduct emeeht to mere instrtretieri to implement an abstract
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`Erie-e. The hardware recited by the system eiairris de net otter a meanihgtui iimitatien
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`beyend generaity iinking “the use at the methect te a particular techneiegicat
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`envirenment,‘ that is, Emplementatien vie computers.” see Aiiee Carp v. CLS Bank tnt’t
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`57:3 Lie. (2014i.
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`Response to Arguments
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`Applicant's arguments filed 11/12/2015 have been fully considered but they are
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`not persuasive.
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`Applicant argues that the submitted Declaration from medical oncologist
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`Sandeep K. Reddy is directed to the improvements the instantly claimed method
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`comprises.
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`

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`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 11 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 11 of 13
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`Application/Control Number: 14/187,028
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`Page 9
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`Art Unit: 1631
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`At page 2 of the declaration, Dr. Sandeep Reddy states that he believes “that the
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`claimed invention provides a profound improvement in another technology or technical
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`field. Namely, the claims provide an improvement in the practice of medicine by
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`identifying therapeutic agents that are of likely benefit to an individual with uterine
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`cancer. Dr. Sandeep Reddy describes the Caris Molecular Intelligence service, which
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`has provided it to over 75,000 cancer patients, including thousands of uterine cancer
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`samples. Furthermore, Dr. Sandeep describes wherein physicians have used the
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`reports in the real world to assist in the treatment of their cancer patients.
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`The declaration is not found persuasive. The office is not arguing with the
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`application of the results of the reports being using by physicians who may have had
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`real world success with treating cancer patients, specifically uterine cancer patients.
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`The office's position is that the real world "improvement” does not directly fall out of the
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`claims nor do the steps of the claims produce said "improvement." The declaration is
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`essentially directed towards limitations not recited in the claims with regards to the
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`improvements. The result of said claims generate a report indicating a likely benefit of
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`the at least one therapeutic agent. The claims do not result in said report being applied
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`by physicians in the actual treatment of cancer patients which has produced an
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`improvement not otherwise realized in their treatment without said report. The claims
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`fall short of comprising any substantial practical application of the abstract idea by
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`ending at only a generation of said report. The claims appear to be analogous in fact
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`pattern to the claims in Mayo v Prometheus, wherein said claims resulted in indicating
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`the administered drug to be optimized based on the measured level of metabolites.
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`

`

`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 12 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 12 of 13
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`Application/Control Number: 14/187,028
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`Page 10
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`Art Unit: 1631
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`The courts found the claimed invention not to be patent eligible as it was focused on a
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`judicial exception without any substantial practical application. Similarly they
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`administered a drug, measured the metabolites and used that measurement to indicate
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`an optimization of treatment. The result of the instantly claimed method do not produce
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`a substantial practical application in addition to the abstract method steps and therefore,
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`remain drawn to patent ineligible subject matter.
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`No claim is allowed.
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`Conclusion
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
`policy as set forth in 37 CFR1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`MONTHS from the mailing date of this action.
`In the event a first reply is filed within
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`mailed until after the end of the THREE-MONTH shortened statutory period, then the
`shortened statutory period will expire on the date the advisory action is mailed, and any
`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
`the advisory action.
`In no event, however, will the statutory period for reply expire later
`than SIX MONTHS from the mailing date of this final action.
`
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Jason Sims, whose telephone number is (571 )-272—
`7540.
`
`If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s
`supervisor, Marjorie Moran can be reached via telephone (571)-272—0720.
`
`Papers related to this application may be submitted to Technical Center 1600 by
`facsimile transmission. Papers should be faxed to Technical Center 1600 via the
`
`

`

`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 13 of 13
`Case 1:17-cv-12194-MLW Document 24-2 Filed 01/16/18 Page 13 of 13
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`Application/Control Number: 14/187,028
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`Page 11
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`Art Unit: 1631
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`Central PTO Fax Center. The faxing of such papers must conform with the notices
`published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61
`(November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR §1.6(d)).
`The Central PTO Fax Center number is (571 )-273-8300.
`
`Information regarding the status of an application may be obtained from the
`Patent Application Information Retrieval (PAIR) system. Status information for
`published applications may be obtained from either Private PAIR or Public PAIR.
`Status information for unpublished applications is available through Private PAIR only.
`For more information about the PAIR system, see httpz/lpair—direct.usptogov. Should
`you have questions on access to the Private PAIR system, contact the Electronic
`Business Center (EBC) at 866-217-9197 (toll-free).
`
`/Jason Sims/
`
`Primary Examiner, Art Unit 1631
`
`