PTO/AlA/lS (03-13)
`Approved for use 1h rough (1113112014. OMB 0651—0032
`U. S. Patent and Trademark Office 1
`‘i DEPARTMENT OF COMMERCE
`
`Under the Pa" erwork Reduction Act. of 19515; no ersons are rec uired to res wind to a collection of iniorrIzIation unless it mania s a valid OMB control number
`
`
`1111111111
`30115121511751114U818
`351313319” ~3- Baker
`F’mmme‘j’m’em‘”
`FATENT APPLECATlQN
`
`
`
`TRANEM EWAL
`BORON-CON TAlNlNG SMALL MOLECULES:
`
`Express Mail Label No
`(Onlyfc-r new nonprovisional appiicarions under 37 CFR 153113)}
`
`
`
`
`APPLECA‘E‘EQN ELEMEN'E'S
`See MPEP chapter 600 concerning utility patent application contents.
`
`ADDRESS T0:
`
`Commissioner for Patents
`9-01 333‘ 1450
`Alexandria, VA 22313—145111
`
`1Il:l Fee Transmittal mm
`(PTO/SW17 or equivalent)
`
`ACCGMPANYENG APPilCAliGN PAPERS
`
`2. [—1 Applicant asserts small entity status.
`""" See 37 cm 1,27
`
`10‘ 1
`
`Assignment i’apers
`(cover sheet is: documentijsfl
`
`
`3. D Applicant certifies micro entity status. See .37 cm 219,
`Applicant must. attachIoIm 1",10/5; 8/251313. or E101 equivalent.
`
`]
`
`[Total Pages 314
`4. [7] Specification
`Both the claims and abstract must start on a new page.
`(See MPEP 9' 603.01 {11),er information on the preferred arrangement)
`5. [Z] Drawingis) 1,35 use 1131
`{Total Sheets E?____________________1
`ES.
`inventor’s (3th or Declaration
`{Total Pages
`(including substitute statements 11nder37 CFR 1.64 and ass
`serving as an oath or r/eciamrion unde.'37 CFR 163(9),)
`a.
`mNewly executed!Ior1ginal orcopv)
`i A copy from a prior application (37 CFR 113303))
`Application Data Sheet
`* See note below.
`See 37 CFR 1.761'PTO/AlA/14 or equivalent)
`C9~RQM or CD41
`
`b.
`
`
`8.
`
`Name 0., Ass1gnee ---------------------------------------------------------
`_______________________________________________________________________________________
`
`37 CFR 3.73M Statement
`(when there is an aswgnee)
`
`E i’ower of Attorney
`
`11.
`
`1..
`
`1:11:111'1
`
`..11>
`1.. U1
`
`,
`
`15
`
`English Translation Document
`(ifapplicobie)
`13.
`information Disclosure Statement
` (PTO/SB/OS or PTO»1449}
`El Copies of citations attached
`'12] Preliminary Amendment
`Return Receipt Postcard
`-----1
`(MPEP § 503‘) (Should be specifically itemized)
`Certified Copy of Priority Documentisi
`.]foreign priority is claimed)
`
`17
`
`18.
`
`Nonpublication Request
`Under .35115.022111112113113. Applicant rriustattach foam 1910/38/35
`or equivalent.
`Other: "Roouest To Use Com uter Form of Seque
`
`
`From Another Applicauo
`n Unde1‘37 C.F.R.§1.821(e);
`
`*Requesi For Pi‘ioriiized Examination
`
`in duplicate, large table, or computer Program (Appendix)
`1 Landsca 2e Table on CD
`1"]
`9. Nucleotide and/or Amino Acid Sequence Submission
`(if applicable. items a.
`c. are required)
`a.i
`Computer Readable Form (CRF‘;
`I13
`bl Specificafion Sequence Listing on:
`iCD-ROMGICDR’7cr‘p1.3);or
`ll.l Paper
`'3
`
`-. m Statements venfying ident1ty of above cor. --
`111.1.
`*Note:
`)Benefit c'aims under 37 CFR 178. and foreign priority claims under 1 551111.151“ be included in an Application Data Sheet (ADS).
`(2
`)For applications filed untierES US C 111, the application must contain an ADS spe. .r.yirig the applicant if the applicant is an
`a.signee, peI‘son to whom the inventoriS under a1'oiigation to assign, or person who otherwise shows sufficient proprietary
`interest in the matter. See 37 CFR 1 46(1))
`19. CGRRESEGNDENCE ADDRESS
`
`..............................................................................................
`
`
`
`
`
`953 associated with Customer Number: 43850
`
`OR U Correspondence acidpress below
`
`
`
`“—
`—
`
`11111111 Eskerl
`
`March 11, 2131113
`
`"
`
`
`
`$553132: ””1, 46,691)
`“101111 Eaker
`
`
`ion oI iriforII
`than is me
`redby 37 CFR‘ .531",‘I The informatiori'iS requireo to obtain or retaina hen it by the public wh
`s to file (and by the USPTO
`This coile
`
`
`to processi an application. Confidential!
`governed'by 35 U. S. C. 122 and 37 CFR 1.1-1 andi1.4. This collection1: estimated to take 12 minutes to complete,
`including gathering, preparing, and subIIIittiIIgthe completed application for.m to the USPTO. Time will vary depending upon the individual c;se. Any comments on
`
`the amount of time you requi1e to complete this form and/or suggestions 1-3'1' reducing this burcl:11,shouid be sent to the Chief information Officer, US Patent and
`Trademark Office, U.S. Department of Commerce, PO. Box 1450,1’11exa11dr1a.\iA 22313-1450. DO NOT SEND FEES UPI COMPLETED FORMS T0 TliiS ADDRESS. SEND
`T0: Commissioner for Patents, 13.0. Eiox 14%, Alexandria, VA 22313-1450.
`lfyou need assistance in completing thefprm, call 1-800—1”T0—91 99 and select option 2.
`
`FIatWing Ex. 1002, p. 1
`
`FlatWing Ex. 1002, p. 1
`
`

`

`Boo Code: TRACK”: .REQ
`
`Document Description: Tracane Request
`
`_.
`i3 i UNA/424 (04-14)
`
`CERTEFECATTQN AND REQUEST FGR PREQRETEZEE} EXAMENATTQN
`
`UMBER 3'? $FR1.102(e)(Paget or t)
`
`known):
`
`Nonprovisionai Appiication Number (if
`
`AP?LECANT HEREBY CERTEFEES THE FQLLDWENG ANS REQUESTS PREQRETEZEQ EXAMENATEQN FOR
`THE ABQVE—EDENTEFEEQ A53PLECATEQN.
`
`t. The processing tee set forth in 37’ CFR t.‘i7(i)(t) and the prioritized examination fee set forth in
`37 CPR t.t7(c) have been tiied with the request. The puhiioation tee requirement is met
`because that fee, set torth in 37 CFR 1.18(d), is ourrentiy $6. The basic tiiing tee, search tee,
`and examination tee are tiied with the request or have been aiready been paid.
`i understand
`that any required excess ciaims fees or appiication size fee must be paid for the appiication.
`
`2.
`
`i understand that the appiication may not contain, or he amended to contain, more than four
`independent oiaims. more than thirty totai oiairns, or any rnuitipie dependent oiairns, and that
`any request for an extension of time Wiii cause an outstanding Track i request to be dismissed.
`
`3. The appiicahie box is checked heiow:
`
`iii Qri
`
`
`inaiA tioation Track Cine —Prioritized Examination under
`
`
`
`i.
`
`(a) The appiication is an originai nonprovisionai utiiity appiication tiied under 35 USC. 111(8).
`This certification and request is being tiied with the utiiity appiication via EFS—Weh.
`moo"-
`
`(h) The appiication is an originai nonprovisionai piaht appiioation tiied under 35 USC. ’i‘it(a).
`This certification and request is being tiied with the piant appiication in paper.
`
`ii. An executed inventor’s oath or deciaration under 37 CFR 1.63 or 37 CFR 1.64 for each
`inventor, or the appiication data sheet meeting the conditions specified in 37 CPR ’i.53(t)(3)(i) is
`fiied with the appiication.
`
`3
`
`’
`
`
`it. w Reuest for Continued Examination _ Prioritized Examination under t.tt)2e2
`
`i. A request for continued examination has been tiied with. or prior to, this form.
`ii.
`if the appiication is a utiiity appiicatioh, this certification and request is being tiied via EFS—Wep.
`iii. The appiication is an originai nonprovisionai utiiity appiication tiied under 35 USC. ’itha), or is
`a nationai stage entry under 35 USO. 371.
`iv. This certification and request is being tiied prior to the maiiing of a first Office action responsive
`to the request for continued examination.
`v. No prior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.102(e)(2).
`
`Signagme iTodd Eskeri
`
`. ngd Egker
`Marne
`(Print/Typed)
`
`Dateiv’iarch “it, 2016
`
`Practitioner
`Registration Number
`
`463690
`
`This form must be signed in accordance with 37 CPR 1.33. See 37 CPR 1.4(0’) for signature requirements and certifications.
`iota:
`Submit inuitinie forms if more than one sir nature is required. *
`
`'
`
`forms are submitted.
`
`D *Totai of
`
`FIatWing Ex. 1002, p. 2
`
`FlatWing Ex. 1002, p. 2
`
`

`

`Privacy Act Statement
`
`The Privacy Act M1974 (PL. soars) requires that you be given certain information in connection with your
`submission otthe attached form reiated to a patent apptication or patent. Accordingiy, pursuant to the requirements ot
`the Act, piease he advised that: (1) the generat authority for the coitection otthis information is 35 USC. 2(b)(2); (2)
`turnishing of the information soiicited is vciuntary; and (3) the principat purpose for which the information is used by the
`US. Patent and Trademark Otfice is to process and/or examine your submission rotated to a patent appiication or
`patent.
`if you do not turnish the requested information, the US. Patent and Trademark Office may not be abte to
`process and/or examine your submission, which may resuit in termination of proceedings or abandonment otthe
`apptication or expiration ot'the patent.
`
`The information provided by you in this torm witi be subject to the totiowing routine uses:
`
`1 .
`
`'t'he int‘ormation on this t'orm wiii be treated contidentiaity to the extent attowed underthe Freedom ot‘
`information Act (5 USC. 552) and the Privacy Act (5 USC 552a). Records front this system of records may
`he disoiosed to the Department of Justice to determine whether disotosure otthese records is required by the
`Freedom of information Act.
`
`A record from this system of records may he disciosed, as a routine use, in the course of presenting evidence
`to a court, magistrate, or administrative tribunai, inciuding disciosures to opposing counset in the course of
`settiement negotiations.
`A record in this system of records may he disciosed, as a routine use, to a Member of Congress submitting a
`request invoiving an individuai, to whom the record pertains, when the individuat has requested assistance from
`the Member with respect to the subject matter otthe record.
`A record in this system of records may he disciosed, as a routine use, to a contractor ofthe Agency having
`need forthe information in order to perform a contract. Recipients ot information shaii be required to compty
`with the requirements otthe Privacy Act ot 1974-, as amended, pursuant to 5 USC. 55.12am).
`A record retated to an internationai Apptication fiied under the Patent Cooperation Treaty in this system of
`records may he disciosed, as a routine use, to the internationai Bureau otthe Wortd intettectuat Property
`Organization, pursuant to the Patent Cooperation Treaty.
`A record in this system of records may be disciosed, as a routine use, to another federai agency for purposes
`ot Nationai Security review (35 USC. 181) and for review pursuant to the Atomic Energy Act (42 USC.
`218(c)).
`A record from this system of records may be disciosed, as a routine use, to the Administrator, Generai
`Services, or his/her designee. during an inspection of records conducted by GSA as part cfthat agency’s
`responsibiiity to recommend improvements in records management practices and programs, under authority ot‘
`44 USC. 2904 and 2906. Such disciosure shatt be made in accordance with the GSA reguiations governing
`inspection of records forthis purpose, and any other retevant (re, GSA or Commerce) directive. Such
`disciosure shaii not he used to make determinations about individuais.
`
`A record from this system of records may be disciosed, as a routine use, to the puhtic after either pubiication of
`the apptication pursuant to 35 USC. 122th) or issuance of a patent pursuant to 35 USC. 151. Further, a
`record may he disciosed, subject to the iimitations of 37 CFR 1.14, as a routine use, to the puhtic tithe record
`was tiied in an appiication which became abandoned or in which the proceedings were terminated and which
`apptication is referenced by either a pubiished apptication, an apptication open to pubiic inspection or an issued
`patent.
`A record trom this system of records may be disciosed, as a routine use, to a Federai, State, or iocai iaw
`enforcement agency, it‘the USPTO becomes aware of a viotation or potentiai viotation ot‘ taw or reguiation.
`
`FIatWing Ex. 1002, p. 3
`
`FlatWing Ex. 1002, p. 3
`
`

`

` vs! “111%
`\.\_:
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`15/068,352
`
`03/11/2016
`
`Stephen J. Baker
`
`064507—5014—US18
`
`3696
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`One Market, Spear Street Tower, Suite 2800
`San Francisco, CA 94105
`
`SHIAO’ RBI TSANG
`
`ART UNIT
`
`1628
`
`PAPER NUIVIBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`07/06/2016
`
`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):
`
`sfipdocketing @ morganlewis.com
`donald.mixon @ morganlewis.com
`
`PTOL—90A (Rev. 04/07)
`
`FIatWIng EX. 1002, p. 4
`
`FlatWing Ex. 1002, p. 4
`
`

`

`
`
`Applicant(s)
`Application No.
` 15/068,352 BAKER ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1628REI-TSANG SHIAO [SENS
`
`-- 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 CFR1. 136( a).
`after SIX () MONTHS from 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) 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).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`1)IZI Responsive to communication(s) filed on 3/11/2016.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|ZI This action is non-final.
`2a)|:l 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
`
`; 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 Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)IZI Claim(s) L6is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6)I:I Claim(s)
`7)|Z| Claim(s)_1-6is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
`
`
`are subject to restriction and/or election requirement.
`9)I:I Claim((s)
`* 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
`hit
`:/'I’vaIW.usnI‘.0. ovI’ atentS/init events/
`
`
`
`hI/index.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 3/11/2016is/are: a)lX| 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:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:l All
`
`b)|:l Some” c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l 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)
`
`3) D Interview Summary (PTO-413)
`1) E 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 3/11/16.
`US. Patent and Trademark Office
`
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`.
`,
`.
`Fl atWi figoEaper qmgatpeofinea
`
`FlatWing Ex. 1002, p. 5
`
`

`

`Application/Control Number: 15/068,352
`
`Page 2
`
`Art Unit: 1628
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`1.
`
`This application claims priority of the provisional application:
`
`DETAILED ACTION
`
`60/654,060 with a filing date 02/16/2005.
`
`2.
`
`Claims 1-6 are pending in the application.
`
`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. See 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); and 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) may be
`
`used to overcome an actual or provisional rejection based on a nonstatutory double
`
`patenting ground provided the conflicting application or patent is shown to be commonly
`
`owned with this application. See 37 CFR 1.130(b).
`
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`
`37 CFR 3.73(b).
`
`FlatWing Ex. 1002, p. 6
`
`FlatWing Ex. 1002, p. 6
`
`

`

`Application/Control Number: 15/068,352
`
`Page 3
`
`Art Unit: 1628
`
`3.1
`
`Claims 1-6 are rejected under the obviousness-type double patenting
`
`over claims 1 and 6-8 of Baker et al. US 7,582,621, or over claims 35, 38-39 and 41 -
`
`42 of Baker et al. US 8,889,656 respectively.
`
`Applicants claims methods of use for treating Tinea unguium infection of a toenail
`
`in a human using a pharmaceutical composition comprising a compound 1,3-dihydro-5-
`
`fluoro-1-hydroxy-2,1-benzoxaborole, see claim 1. Dependent claims 2-6 further limit the
`
`scope of methods of use, i.e., the Tinea unguium infection is due to Trichophyton
`
`rubrum or Trichophyton mentagrophytes, see claims 2-6.
`
`Baker et al. ‘621 claims methods of use for treating Tinea unguium infection of on
`
`nail in a human using a pharmaceutical composition comprising a compound 1,3-
`
`dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, see columns 67-68.
`
`Baker et al. ‘656 claims methods of use for treating Tinea unguium infection of on
`
`nail in a human using a pharmaceutical composition comprising a compound 1,3-
`
`dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, see columns 69-70.
`
`The difference between the instant claims and Baker et al. ‘621 or ‘656 is that
`
`Baker et al. ‘621 or ‘656 methods of use for treating fungus infection broadly. Baker et
`
`al. ‘621 or ‘656 methods of use overlap with the instant invention.
`
`One having ordinary skill in the art would find the claims 1-6 prima facie obvious
`
`because one would be motivated to employ the methods of use of Baker et al. ‘621 or
`
`‘656 to obtain instant invention. Dependent claims 2-6 are also rejected along with claim
`
`1 under the obviousness-type double patenting.
`
`FlatWing Ex. 1002, p. 7
`
`FlatWing Ex. 1002, p. 7
`
`

`

`Application/Control Number: 15/068,352
`
`Page 4
`
`Art Unit: 1628
`
`The motivation to make the claimed methods of use derived from the known
`
`methods of use of Baker et al. ‘621 or ‘656 would possess similar activity to that which
`
`is claimed in the reference.
`
`3.2
`
`Claims 1-6 are provisionally rejected under the obviousness-type double
`
`patenting over claims 1-2 of Baker et al. co-pending applications number 15/091 ,394,
`
`or over claims 1, 4, 19, 25, 29-30 and 34-35 of Baker et al. co-pending applications
`
`number 14/977,052, or over claims 1 and 16—17 of Baker et al. co-pending applications
`
`number 15/046,322 respectively.
`
`Applicants claims methods of use for treating Tinea unguium infection of a toenail
`
`in a human using a pharmaceutical composition comprising a compound 1,3-dihydro-5-
`
`fluoro-1-hydroxy-2,1-benzoxaborole, see claim 1. Dependent claims 2-6 further limit the
`
`scope of methods of use, i.e., the Tinea unguium infection is due to Trichophyton
`
`rubrum or Trichophyton mentagrophytes, see claims 2-6.
`
`Baker et al. ‘394 claims methods of use for treating Trichophyton rubrum or
`
`Trichophyton mentagrophytes infection of on nail in a human using a pharmaceutical
`
`composition comprising a compound 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole,
`
`see claims 12
`
`Baker et al. ‘052 claims methods of use for treating Trichophyton species
`
`infection of on nail in a human using a pharmaceutical composition comprising a
`
`compound of formula (llc), see claims 1, 4, 19, 25, 29-30 and 34-35.
`
`Baker et al. ‘322 claims methods of use for treating Trichophyton rubrum or
`
`Trichophyton mentagrophytes infection of on nail in a human using a pharmaceutical
`
`FlatWing Ex. 1002, p. 8
`
`FlatWing Ex. 1002, p. 8
`
`

`

`Application/Control Number: 15/068,352
`
`Page 5
`
`Art Unit: 1628
`
`composition comprising a compound 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole,
`
`see claims 1 and 16-17.
`
`The difference between the instant claims and Baker et al. ‘394, ‘052 or ‘322 is
`
`that Baker et al. ‘394, ‘052 or ‘322 methods of use for treating fungus infection broadly.
`
`Baker et al. ‘394, ‘052 or ‘322 methods of use overlap with the instant invention.
`
`One having ordinary skill in the art would find the claims 1-6 prima facie obvious
`
`because one would be motivated to employ the methods of use of Baker et al. ‘394, ‘052
`
`or ‘322 to obtain instant invention. Dependent claims 2-6 are also provisionally rejected
`
`along with claim 1 under the obviousness-type double patenting.
`
`The motivation to make the claimed methods of use derived from the known
`
`methods of use of Baker et al. ‘394, ‘052 or ‘322 would possess similar activity to that
`
`which is claimed in the reference.
`
`This is a provisional obviousness-type double patenting rejection because the
`
`conflicting claims have not in fact been patented.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Rei-tsang Shiao whose telephone number is (571) 272-
`
`0707. The examiner can normally be reached on 8:30 AM - 5:00 PM.
`
`If attempts to
`
`reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston
`
`Shen, can be reached on (571)272-3157. 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
`
`FlatWing Ex. 1002, p. 9
`
`FlatWing Ex. 1002, p. 9
`
`

`

`Application/Control Number: 15/068,352
`
`Page 6
`
`Art Unit: 1628
`
`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 or access to the
`
`automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-
`
`1000.
`
`/RE|—TSANG SHIAO/
`
`Rei-tsang Shiao, Ph.D.
`Primary Examiner
`Art Unit 1628
`
`June 22, 2016
`
`FIatWing EX. 1002, p. 10
`
`FlatWing Ex. 1002, p. 10
`
`

`

`
`
`Index of Claims
`
`Application/Control No.
`
`Applicant(s)/Patent under
`Reexamination
`
`15/068,352
`Examiner
`
`BAKER ET AL.
`Art Unit
`
`REI-TSANG SHIAO
`
`1628
`
`Rejected
`
`(Through numeral)
`Cancelled
`
`I
`
`Restricted
`
`n-
`l-
`
`! Appeal
`a Objected
`
`
`800©000000000000000000\l\l\l\l\l\l\l\l\l\l0)030303030)(NUILHUIUIUIUIUIUI"00\lU‘lhODN—l00\l£000\IO)U‘IJ>ODI\J—l U‘l-hODN—lOOOVOLH-th—lo\lU‘lhODN—l
`_L .1;O_L_L_L_L_L_L'hhhhhhO)01h00N—l
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Original
`
`_L_L_LOOO(JON—l
`
`_L O.1;
`
`_L_L 000301
`_L O \l
`
`_L_L_L—lOO0000
`
`_L _L
`
`_L
`
`_L _L 00
`
`_L_L_L_L_L_L
`_L_L_L_L_L_L_L_L_L_L
`
`_L_L_L_L_L_L
`NNNNNNNNN—l
`
`\IO‘JU‘IhODN
`00\IO)U‘I-h00l\)—lO£0
`
`_L NO
`
`_L_L_L
`
`000000N—lO
`
`_L 0000
`
`_L_L 000001-h
`_L 00O)
`
`_L_L_L
`
`000000©00\l
`
`-----------
`--------III
`149
`150
`
`US Patent and Trademark Office
`
`Part of Paper No. 20160622
`
`FIatWing Ex. 1002, p. 11
`
`FlatWing Ex. 1002, p. 11
`
`

`

`
`CER’I'IFICA'I‘E OF ELECTRONIC. TRANSMIESEEQN.
`
`I hereby (zersify that this correspondence, including listed enclosures is
`being electronically transmitted in Portable Document F0111) (PD?) through
`BPS-Web via Hyper Text Transfer Protocol to the United Siates Patent and
`’l'rademark Office’s Patent Electronic Business Center on:
`I
`
`
`
`PATEEI:
`Attorney Docket No: 064507601 44.181 8
`
`IN THE UNITED STATES PA'E‘EN'I‘ AND 'i‘li/XDEMARK OFFICE
`
`In re application of:
`
`Confirmation No: 3696
`
`Examiner: SlililiAO, Rei Tsang
`
`Art Unit: 1628
`
`RESPONSE T0 @EFEEBACHMQN
`
`Stephen Baker, et a].
`
`Application No.: 15/068352
`
`Filed: March ll, 2016
`
`For: BORON—CONTAINING SMALL
`MOLECULES
`
`Customer No.2 43850
`
`
`
`Commissioner for Patents
`PIT). Be): MSG
`
`Alexandria, VA 223134450
`
`Commissioner:
`
`In response to the office action dated July 6, 2016, please einer the following
`
`amendments and remarks.
`
`Amendments to the specification begin on page 2; of this paper.
`
`A listing of claims begins on page 4 of'this paper.
`
`Remarks begin on page 5 of'this paper.
`
`032/ 30432452.}.
`
`Page 1 0th
`
`FIatWing Ex. 1002, p. 12
`
`FlatWing Ex. 1002, p. 12
`
`

`

`U.S. Pat. App. No. 15/068,352
`Response dated July 22, 2016
`Response to Office Action dated July 6, 2016
`
`,
`
`PATENT
`
`Amendments to the Specification:
`
`Please replace the first paragraph in the application with the following:
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`The present application is a continuation of U.S. Patent Application No. 15/046,322,
`
`filed on February 17, 2016, which is a continuation of U.S. Patent Application No. 14/537,771,
`filed November 10, 2014, which is a continuation of U.S. Patent Application No. 14/201,459,
`
`filed March 7, 2014, now U.S. Patent No. 9,353,133, which is a continuation of U.S. Patent
`
`Application No. 13/3 56,488, filed January 23, 2012, now U.S. Patent No. 8,722,917, which is a
`
`continuation of U.S. Patent Application No. 12/629,753, filed December 2, 2009, now U.S.
`
`Patent No. 8,115,026, which is a divisional of U.S. Patent Application No. 11/505,591, filed
`
`August 16, 2006, now U.S. Patent No. 7,767,657, which claims the benefit of U.S. ProviSional
`
`Patent Application No. 60/755,227, filed December 30, 2005, and the benefit of U.S. Provisional
`
`Patent Application No. 60/746,361, filed May 3, 2006, all of which are incorporated by reference
`
`in their entirety for all purposes. U.S. Patent Application No. 11/505,591 is also a continuation-
`
`in—part of U.S. Patent Application No. 11/357,687, filed February 16, 2006, now U.S. Patent No.
`
`7,582,621, which claims the benefit of U.S. Provisional Patent Application No. 60/654,060, filed
`
`February 16, 2005, all of which are incorporated by reference in their entirety for all purposes.
`
`U.S. Patent Application No. 14/537,771 is also a continuation-in-part of U.S. Patent Application
`No. 13/874,329, filed April 30, 2013, now U.S. Patent No. 8,889,656, which is a continuation of
`
`U.S. Patent Application No. 13/224,252, filed September 1, 2011, now U.S. Patent No.
`
`8,440,642, which is a continuation of U.S. Patent Application No. l2/507,010, filed July 21,
`
`2009, now U.S. Patent No. 8,039,451, which is a continuation of U.S. Patent Application No.
`
`11/357,687, filed February 16, 2006, now U.S. Patent No. 7,582,621, which claims the benefit of
`
`60/654,060, filed February 16, 2005, all of which are incorporated by reference in their entirety
`
`for all purposes.
`
`Page2 of8
`
`_
`FIatWIng Ex. 1002, p. 13
`
`FlatWing Ex. 1002, p. 13
`
`

`

`US. Pat. App. No. 15/068,352
`Response dated July 22, 2016
`Response to Office Action dated July 6, 2016
`
`Version showing changes made:
`
`PATENT
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001] The present application is a continuation of US. Patent Application No. 15/046,322,
`
`filed on February 17, 2016, which is a continuation of US. Patent Application No. 14/537,771,
`
`filed November 10, 2014, which is a continuation of US. Patent Application No. 14/201,459,
`filed March 7, 2014, now US. Patent No. 9,353,133, which is a continuation of US. Patent
`
`Application No. 13/356,488, filed January 23, 2012, now US. Patent No. 8,722,917, which is a
`
`continuation of US. Patent Application No. 12/629,753, filed December 2, 2009, now US.
`
`Patent No. 8,115,026, which is a divisional of US. Patent Application No. 11/505,591, filed
`
`August 16, 2006, now US. Patent No. 7,767,657, which claims the benefit of US. Provisional
`
`Patent Application No. 60/755,227, filed December 30, 2005, and the benefit of US. Provisional
`
`Patent Application No. 60/746,361, filed May 3, 2006, all of which are incorporated by reference
`
`in their entirety for all purposes. US. Patent Application No. 11/505,591 is also a continuation-
`
`in-part of US. Patent Application No. 11/357,687, filed February 16, 2006, now US. Patent No.
`
`7,582,621, which claims the benefit of US. Provisional Patent Application No. 60/654,060, filed
`
`February 16, 2005, all of which are incorporated by reference in their entirety for all purposes.
`
`¥he—present—applieatienU.S. Patent Apriication No. 14/537,771 is also a continuation-in-part of
`
`US. Patent Application No. 13/874,329, filed April 30, 2013, now US. Patent No. 8,889,656,
`
`which is a continuation of US. Patent Application No. 13/224,252, filed September 1, 2011, now
`
`US. Patent No. 8,440,642, which is a continuation of US. Patent Application No. 12/507,010,
`
`filed July 21, 2009, now US. Patent No. 8,039,451, which is a continuation of US. Patent
`
`Application No. 11/357,687, filed February 16, 2006, now US. Patent No. 7,582,621, which
`
`claims the benefit of 60/654,060, filed February 16, 2005, all of which are incorporated by
`
`reference in their entirety for all purposes.
`
`Page 3 of8
`
`_
`FIatWIng Ex. 1002, p. 14
`
`FlatWing Ex. 1002, p. 14
`
`

`

`US. Pat. App. No. 15/068,352
`Response dated July 22, 2016
`Response to Office Action dated July 6, 2016
`
`PATENT
`
`‘
`
`Listing of Claims:
`
`1.
`
`(Original) A method of treating a Tinea unguium infection of a toenail of
`
`a human, the method comprising:
`
`topically administering to the toenail of the human a pharmaceutical composition
`
`comprising 1,3—dihydro-5-fluoro—1-hydroxy—2,1-benzoxaborole or a pharmaceutically acceptable
`
`salt thereof in an amount sufficient to treat the infection.
`
`2.
`
`(Original) The method of claim 1, wherein the Tinea unguium infection is
`
`due to Trichophyton rubrum or Trichophyton mentagrophytes.
`
`3.
`
`(Original) The method of claim 1, wherein the pharmaceutical
`
`composition is in the form of a solution comprising 5% w/w of 1,3-dihydro-5-fluoro-1-hydroxy-
`
`2,1—benzoxaborole.
`
`4.
`
`(Original) The method of claim 1, wherein the pharmaceutical
`
`composition further comprises ethanol and propylene glycol.
`
`5.
`
`(Original) The method of claim 1, wherein the Tinea unguium infection is
`
`due to Trichophyton rubrum or Trichophyz‘on mentagrophyz‘es, and wherein the pharmaceutical
`
`composition is in the form of a solution comprising 5% w/w of 1,3-dihydro-5-fluoro-1-hydroxy-
`
`2,1 -benzoxaborole.
`
`£11th
`
`LUJNt—A
`
`6.
`
`(Original) The method of claim 5, wherein the pharmaceutical
`
`composition further comprises ethanol and propylene glycol.
`
`Page 4 of8
`
`.
`FIatWIng Ex. 1002, p. 15
`
`FlatWing Ex. 1002, p. 15
`
`

`

`U.S. Pat. App. No. 15/068,352
`Response dated July 22, 2016
`Response to Office Action dated July 6, 2016
`
`PATENT
`'
`
`I. Status of the Claims
`
`Claims 1-6 are pending in this application.
`
`REMARKS
`
`II. Response to the Rejections
`
`Obviousness-tvpe double patenting over claims I and 6-8 ‘0: Baker et al. US 7, 5821 621
`
`Claims 1—6 are rejected on the ground of obviousness—type double patenting over claims 1
`
`and 6-8 of Baker et al. US 7,5 82,621 (“the ‘621 patent”). This rejection is respectfully traversed.
`
`The present application and US 7,582,621 are each owned by Anacor Pharmaceuticals,
`
`Inc. Without conceding the propriety of the double patenting rejection, and in order to expedite
`
`prosecution of the present application, Applicant submits herewith a Terminal Disclaimer
`
`over US 7,582,621, along with the