UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`15/192,792
`
`06/24/2016
`
`Daniel D. V011 Hoff
`
`37901-715331
`
`3589
`
`WOMBLE BOND DICKINSON (US) LLP
`ATTN: IP Doeketing
`PO. BOX 7037
`
`Atlanta, GEORGIA 30537-7037
`UNITED STATES OF AMERICA
`
`LIN” JERRY
`
`1631
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/28/2018
`
`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):
`
`IPDoeketing @wbd-us.com
`patent@ earisls.eom
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Off/09 A0170” Summary
`
`Application No.
`15/192,792
`Examiner
`JERRY LIN
`
`Applicant(s)
`Von Hoff etal.
`Art Unit
`1631
`
`AIA Status
`No
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 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). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`|f 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 if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1). Responsive to communication(s) filed on 24 June 2016.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2a)D This action is FINAL.
`
`2b)
`
`This action is non-final.
`
`3)[:] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
`
`4)[:] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)
`Claim(s)
`
`1—17 is/are pending in the application.
`
`5a) Of the above claim(s)
`
`is/are withdrawn from consideration.
`
`E] Claim(s)
`
`is/are allowed.
`
`Claim(s) fl is/are rejected.
`
`[:1 Claim(s) _ is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
`
`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aflowabte. 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
`
`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10)[:] The specification is objected to by the Examiner.
`
`11)[:] The drawing(s) filed on
`
`is/are: a)D accepted or b)l:] objected to by the Examiner.
`
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12):] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)D All
`
`b)I:I Some”
`
`c)CI None of the:
`
`1.[:]
`
`Certified copies of the priority documents have been received.
`
`2.[:]
`
`Certified copies of the priority documents have been received in Application No.
`
`3.[:] Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`2) E] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) D Other-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20180623
`
`

`

`Application/Control Number: 15/192,792
`Art Unit: 1631
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AIA or AIA Status
`
`1.
`
`The present application is being examined under the pre-AIA first to invent provisions.
`
`Claims 1-17 are under examination.
`
`Status of the Claims
`
`2.
`
`35 U.S.C. 101 reads as follows:
`
`Claim Rejections - 35 USC § 101
`
`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.
`
`Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a
`
`judicial exception (Le, a law of nature, a natural phenomenon, or an abstract idea) without significantly
`
`more.
`
`Claims t-t T are directed ts metned identifying at teast ene therapeutic agent fer an indiviriiiai with
`
`U)
`cancer. As ee crieed in Aiice Corp, Pty. Ltd. V, (3213 Bank int’i, 573 U.S.__, 134 8. Cr. 5334?, no
`
`U.S.P.Q2d 1976 (20%), a two-step analysis is require-2i in considering the patent eiigihiiity cf the claimed
`
`subject matter. The first step requires deterntii'iii'ig it" the ctaime-ci subject matter is e‘irectet'.i te a judiciat
`
`exception, The instant claims require the assaying i'nctecuiai' targets, comparing mete-cuter ptet‘iie test
`
`values witi'i a reference value tc identityi a eieiegieal state identifying a therapeutic agent Where the
`
`hielegieal state artisatsc a tikely benefit from the therapeutic agent. and gei'ierating a teeert cf the
`
`bielegieal state.
`
`in the instant ease. the step ct ccrhpaiing nteiecutar pretile test vatues with a reference
`
`value to identihi a isieiegieal state is a naturai ccrrelatien between mete-cuter targets and a bicicgicai state.
`
`Thus, the instant claims are drawn te the judicial exeeptien ci a naturai ccnstaticn. Furthermore, the
`
`courts have teunci comparing data to aisc iz-e drawn is the judiciai exeeptien of an abstract idea. (See
`
`Ciassen immunciherapies inc. v, Biegen i550 1359 i936 105.1100 U.S.Pflfid ”5492 {Fed Cir. 201th.
`
`Thus, the instant claims are drawn te a jueieiai excepticn.
`
`

`

`Application/Control Number: 15/192,792
`Art Unit: 1631
`
`Page 3
`
`the se21.11111 {33113-1.he analysis requires»; determining if the eieirrts inelu'e edditienaieierrtehts
`
`t1: et e1e3<auttiei-e115.
`
`tr3 311111111111 111 sighit 1121:11151y 111111e 5.119111 the judieiel exeeptien, The ir1ste11tciatri13 recite
`
`the additi1111eie:e5111ent3 eta1313331311 r111 meleeuiar 13143521313' cernputer11313113352. eregrarn cede. inputting
`
`values, generating a repert, Aceerdihg to the 3peeitieetien. 1:111 pages; 2041-13. aseaytng rheieeuier terget3 i3
`
`weti-knewn, ashventienai and r11u‘1ir1e.
`
`ih e11111tiei1smernputer 1131131113313, 1110912131 cede]:r113u55ti11g veiue3
`
`and generating a report, are weti-knewn, cerwentienai, and reuti 1e functions er cernpehents 1:11 a
`
`computer (See specifieetien, page 117., paragraphs 911187-00189: MPEP §§'2108 135(1:1), 21950511;- and
`
`2106.05tg)‘1. 111 addition, the recitation of the specific markers to be used in the abstract idea does net
`
`transform the ehstraet idea intce 11-1111abstraet idea 1:See but/SAFE, inc. 1/3Geegie inc 7131 5 F.3d 1350,
`
`112
`
`313.123.2135 109:3 1E-edf“ir 201415. Furthermeie, the e11—11nents teixen as 3 13011113511215: ten are eiso wett-
`
`knewn, cenventienel art-:1 reutine, since 51113 e:'en'ients :11'e rner1'-11'y specifying the types of data fer a data
`
`gathering step. Thus. the instant cieirns do not include edditienai eternente that are sufficient to emeuht 1-21
`
`significantty more than the judiciat exception.
`
`Dependent claims 2- 4 recite additional elements of a computer system. However, remotely
`
`inputting data, using an internet connection or presenting a report in an electronic or paper format are
`
`well-known, conventional, and routine functions of a generic computer. (See MPEP §§ 211315 .05 ((1),
`
`2108.051 :1 and 2106.0511111
`
`teciting 1'11e11-khewh, cenventiehai, and routine functions 01 a generic
`
`computer is not sufficient 1e transform a judieiei exeeptieh 1111.0 patent eiigible subject matter.
`
`Dependente ieimsS 14 and 17 recite eddit tonel elementseregardtngttedata used and the seurce
`
`of date. However, describing the e'eta and the seui‘ce of the date is sufficient to transform the judiciai
`
`exceptien-ir1te pe'tent eiig1111e 31111ject r11etter {ea1eemit/SAFE, inc. 1/ 1313119113, inc. 7155 15,311 1351), 112
`
`- 53.13.132.211tuQStFedfltrEGtaiygtvtPEP $106.05 (gt).
`
`Dependent cieirns 15 and 11:; 1e.,1i etpertieuier 333113.13. Hewever, these essays are weitAknevvn,
`
`eeriventiehai. and reutine date gathering preeees 3313113121111:31.ir3r1 pages 21)1113;11’ti3Ei—t $12: 1363. {)5 111;)
`
`Reeiting weii-khewn. eenvehtienai, and reutine detepethering prece33e3 is net euttir3ie115. te treneferrn e.
`
`iudietei except 11111 11110 eat5er:t e:'igit3ie 31;t3jeet matter.
`
`

`

`Application/Control Number: 15/192,792
`Art Unit: 1631
`
`Page 4
`
`Examiner’s Note:
`
`3.
`
`The closest prior art is Kallioniemi et al. (US. 2005/0244880) who teaches a method of assaying
`
`for molecular targets (paragraphs 0080-0010 and 086), comparing the profile to a normal reference
`
`(paragraphs 0008 and 0101), accessing a drug database for therapies for the targets (paragraph 0089),
`
`and generating a report (paragraphs 00889 and 0161). However, Kallioniemi et al. do not teach the
`
`molecular targets of AR, BRAF, CTNNB1, EGFR, ERRB2, ESR1, KIT, KRAS, MET, MLH1, PDGFRA,
`
`PDGFRB, PIK3CA (PI3K), PTEN, and TOP1 or that the report includes the efficacy of each drug.
`
`Contact Information
`
`Any inquiry concerning this communication or earlier communications from the examiner should
`
`be directed to JERRY LIN whose telephone number is (571 )272—2561. The examiner can normally be
`
`reached on M, Tu, Th, F, 5:30am-4pm.
`
`Examiner interviews are available via telephone, in-person, and video conferencing using a
`
`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
`
`the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`
`Peter Paras can be reached on (571) 272-4517. The fax phone number for the organization where this
`
`application or proceeding is assigned is 571 -273-8300.
`
`Information regarding the status of an application may be obtained from the Patent Application
`
`Information Retrieval (PAIR) system. Status information for published applications may be obtained from
`
`either Private PAIR or Public PAIR. Status information for unpublished applications is available through
`
`Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC)
`
`at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative
`
`

`

`Application/Control Number: 15/192,792
`Art Unit: 1631
`
`Page 5
`
`or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -272—
`
`1000.
`
`/JERRY LIN/
`
`Primary Examiner, Art Unit 1631
`
`

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