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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
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`15/192,792
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`06/24/2016
`
`Daniel D. V011 Hoff
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`37901-715331
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`3589
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`WOMBLE BOND DICKINSON (US) LLP
`ATTN: IP Doeketing
`PO. BOX 7037
`
`Atlanta, GEORGIA 30537-7037
`UNITED STATES OF AMERICA
`
`LIN” JERRY
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`1631
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`06/28/2018
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
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`IPDoeketing @wbd-us.com
`patent@ earisls.eom
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`PTOL-90A (Rev. 04/07)
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`
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`Off/09 A0170” Summary
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`Application No.
`15/192,792
`Examiner
`JERRY LIN
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`Applicant(s)
`Von Hoff etal.
`Art Unit
`1631
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`AIA Status
`No
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`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`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).
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`Status
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`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
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`2a)D This action is FINAL.
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`2b)
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`This action is non-final.
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`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.
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`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.
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`Disposition of Claims*
`5)
`Claim(s)
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`1—17 is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) fl is/are rejected.
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`[:1 Claim(s) _ is/are objected to.
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`) ) ) )
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`6 7
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`8
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`
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`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
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
`10)[:] The specification is objected to by the Examiner.
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`11)[:] The drawing(s) filed on
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`is/are: a)D accepted or b)l:] objected to by the Examiner.
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`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).
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`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:
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`a)D All
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`b)I:I Some”
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`c)CI None of the:
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`1.[:]
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`Certified copies of the priority documents have been received.
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`2.[:]
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`Certified copies of the priority documents have been received in Application No.
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`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)).
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`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1)
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`Notice of References Cited (PTO-892)
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`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
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`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) D Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20180623
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`
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`Application/Control Number: 15/192,792
`Art Unit: 1631
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`Page 2
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`DETAILED ACTION
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`Notice of Pre-AIA or AIA Status
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`1.
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`The present application is being examined under the pre-AIA first to invent provisions.
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`Claims 1-17 are under examination.
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`Status of the Claims
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`2.
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`35 U.S.C. 101 reads as follows:
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`Claim Rejections - 35 USC § 101
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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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a
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`judicial exception (Le, a law of nature, a natural phenomenon, or an abstract idea) without significantly
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`more.
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`Claims t-t T are directed ts metned identifying at teast ene therapeutic agent fer an indiviriiiai with
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`U)
`cancer. As ee crieed in Aiice Corp, Pty. Ltd. V, (3213 Bank int’i, 573 U.S.__, 134 8. Cr. 5334?, no
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`U.S.P.Q2d 1976 (20%), a two-step analysis is require-2i in considering the patent eiigihiiity cf the claimed
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`subject matter. The first step requires deterntii'iii'ig it" the ctaime-ci subject matter is e‘irectet'.i te a judiciat
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`exception, The instant claims require the assaying i'nctecuiai' targets, comparing mete-cuter ptet‘iie test
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`values witi'i a reference value tc identityi a eieiegieal state identifying a therapeutic agent Where the
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`hielegieal state artisatsc a tikely benefit from the therapeutic agent. and gei'ierating a teeert cf the
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`bielegieal state.
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`in the instant ease. the step ct ccrhpaiing nteiecutar pretile test vatues with a reference
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`value to identihi a isieiegieal state is a naturai ccrrelatien between mete-cuter targets and a bicicgicai state.
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`Thus, the instant claims are drawn te the judicial exeeptien ci a naturai ccnstaticn. Furthermore, the
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`courts have teunci comparing data to aisc iz-e drawn is the judiciai exeeptien of an abstract idea. (See
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`Ciassen immunciherapies inc. v, Biegen i550 1359 i936 105.1100 U.S.Pflfid ”5492 {Fed Cir. 201th.
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`Thus, the instant claims are drawn te a jueieiai excepticn.
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`
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`Application/Control Number: 15/192,792
`Art Unit: 1631
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`Page 3
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`the se21.11111 {33113-1.he analysis requires»; determining if the eieirrts inelu'e edditienaieierrtehts
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`t1: et e1e3<auttiei-e115.
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`tr3 311111111111 111 sighit 1121:11151y 111111e 5.119111 the judieiel exeeptien, The ir1ste11tciatri13 recite
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`the additi1111eie:e5111ent3 eta1313331311 r111 meleeuiar 13143521313' cernputer11313113352. eregrarn cede. inputting
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`values, generating a repert, Aceerdihg to the 3peeitieetien. 1:111 pages; 2041-13. aseaytng rheieeuier terget3 i3
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`weti-knewn, ashventienai and r11u‘1ir1e.
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`ih e11111tiei1smernputer 1131131113313, 1110912131 cede]:r113u55ti11g veiue3
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`and generating a report, are weti-knewn, cerwentienai, and reuti 1e functions er cernpehents 1:11 a
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`computer (See specifieetien, page 117., paragraphs 911187-00189: MPEP §§'2108 135(1:1), 21950511;- and
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`2106.05tg)‘1. 111 addition, the recitation of the specific markers to be used in the abstract idea does net
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`transform the ehstraet idea intce 11-1111abstraet idea 1:See but/SAFE, inc. 1/3Geegie inc 7131 5 F.3d 1350,
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`112
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`313.123.2135 109:3 1E-edf“ir 201415. Furthermeie, the e11—11nents teixen as 3 13011113511215: ten are eiso wett-
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`knewn, cenventienel art-:1 reutine, since 51113 e:'en'ients :11'e rner1'-11'y specifying the types of data fer a data
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`gathering step. Thus. the instant cieirns do not include edditienai eternente that are sufficient to emeuht 1-21
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`significantty more than the judiciat exception.
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`Dependent claims 2- 4 recite additional elements of a computer system. However, remotely
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`inputting data, using an internet connection or presenting a report in an electronic or paper format are
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`well-known, conventional, and routine functions of a generic computer. (See MPEP §§ 211315 .05 ((1),
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`2108.051 :1 and 2106.0511111
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`teciting 1'11e11-khewh, cenventiehai, and routine functions 01 a generic
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`computer is not sufficient 1e transform a judieiei exeeptieh 1111.0 patent eiigible subject matter.
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`Dependente ieimsS 14 and 17 recite eddit tonel elementseregardtngttedata used and the seurce
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`of date. However, describing the e'eta and the seui‘ce of the date is sufficient to transform the judiciai
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`exceptien-ir1te pe'tent eiig1111e 31111ject r11etter {ea1eemit/SAFE, inc. 1/ 1313119113, inc. 7155 15,311 1351), 112
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`- 53.13.132.211tuQStFedfltrEGtaiygtvtPEP $106.05 (gt).
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`Dependent cieirns 15 and 11:; 1e.,1i etpertieuier 333113.13. Hewever, these essays are weitAknevvn,
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`eeriventiehai. and reutine date gathering preeees 3313113121111:31.ir3r1 pages 21)1113;11’ti3Ei—t $12: 1363. {)5 111;)
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`Reeiting weii-khewn. eenvehtienai, and reutine detepethering prece33e3 is net euttir3ie115. te treneferrn e.
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`iudietei except 11111 11110 eat5er:t e:'igit3ie 31;t3jeet matter.
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`Application/Control Number: 15/192,792
`Art Unit: 1631
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`Page 4
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`Examiner’s Note:
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`3.
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`The closest prior art is Kallioniemi et al. (US. 2005/0244880) who teaches a method of assaying
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`for molecular targets (paragraphs 0080-0010 and 086), comparing the profile to a normal reference
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`(paragraphs 0008 and 0101), accessing a drug database for therapies for the targets (paragraph 0089),
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`and generating a report (paragraphs 00889 and 0161). However, Kallioniemi et al. do not teach the
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`molecular targets of AR, BRAF, CTNNB1, EGFR, ERRB2, ESR1, KIT, KRAS, MET, MLH1, PDGFRA,
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`PDGFRB, PIK3CA (PI3K), PTEN, and TOP1 or that the report includes the efficacy of each drug.
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`Contact Information
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`Any inquiry concerning this communication or earlier communications from the examiner should
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`be directed to JERRY LIN whose telephone number is (571 )272—2561. The examiner can normally be
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`reached on M, Tu, Th, F, 5:30am-4pm.
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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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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Peter Paras can be reached on (571) 272-4517. The fax phone number for the organization where this
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`application or proceeding is assigned is 571 -273-8300.
`
`Information regarding the status of an application may be obtained from the Patent Application
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`either Private PAIR or Public PAIR. Status information for unpublished applications is available through
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`Application/Control Number: 15/192,792
`Art Unit: 1631
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`Page 5
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`or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -272—
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`1000.
`
`/JERRY LIN/
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`Primary Examiner, Art Unit 1631
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`