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`
` liTlLlT‘i’
`
`
`
`Stephan J_ Baker
`Firstl‘iiomealnventor
`PATENT APPLECATEGN
`
`
`BORON--CONTAlNlNG SMALL MOLECULES
`""‘le
`
`TRANSMEWAL
`
`Express Mail Label No.
`(Onlyfc-r new nonprovisionol applications under 37 CFR 1.53:1)”
`
`
`
`054507—501 44181 8
`
`"
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`[Total Pages 314
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`(st-1'
`In
`I.—‘
`'
`’V"f‘E"l
`3/
`,4
`-mwng as an oar” circa/oration unuersx c. K 1.641(9))
`a.
`TIi Newl executed lori inalorcoov
`-
`‘l
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`g
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`i A copy from a prior application (37 CFR 1.63(d))
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`1’,‘
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`18.
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`Name oi Assigriee ---------------------------------------------------------
`_______________________________________________________________________________________
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`interest in the matter. See 37 CFR 1.46lb).
`19. CORRESPONDENCE ADDRESS
`
`
`
`
`0R U Correspondence address below
`
`s——‘
`.
`W— -1001m0.e 31-—
`l‘i'odd Eskeri
`
`March 11, 2016
`
`"
`
`
`
`ffgijffigfifiigffi, 46,690
`Todd Esker
`
`
`ion of inforn 'tlon is red red by 37 CFR 1.53l yl. The information is required to obtain or retain a hen it by the pubilr. wh
`s to file (and by the USPTO
`This coile
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`TC): Commissioner for Patents, PIE. Eiox 14539, Alexandria, VA 22313-1450.
`ifyou need assistance in completing theform, mill-800471349199 and select option 2.
`
`MYLAN - EX. 1002, p. 1
`
`MYLAN - Ex. 1002, p. 1
`
`

`

`Doc Code: TRACK1.REQ
`
`Document Description: Tracane Request
`
`__P T O/AiA/424 (04-14)
`
`CERTEFiCATiC‘iN AND REQUEST FCR PREQRETEZEE} EXAMiNATiQN
`
`UMBER 37 CFR 1.102(e) (Page i of 1)
`
`known):
`
`Nonprovisionai Appiication Number (if
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`APPLECANT HEREBY CERTEFEES THE FOLLOWENG AND REQUESTS PREORETEZED EXAMENATEQN FOR
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`i understand that the appiication may not contain, or be amended to contain, more than four
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`any request for an extension of time wiii cause an outstanding Track i request to be dismissed.
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`3. The abpiicabie box is checked beiow:
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`iii Ori
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`inaiA iication Track One —Prioritized Examination under
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`
`
`i.
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`(a) The appiication is an originai nonprovisionai utiiity appiication fiied under 35 U.S.C. 111(a).
`This certification and request is being fiied with the utiiity appiication via EFS—Web.
`more"-
`
`(b) The appiication is an originai nonprovisionai piant appiication fiied under 35 USC. 111(a).
`This certification and request is being fiied 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, 95 the apoiication data sheet meeting the conditions specified in 37’ CFR 1.53(f)(3)(i) is
`fiied with the appiication.
`
`3
`
`’
`
`
`ii. _ Reuest for Continued Examination _ Prioritized Examination under 1.102e2
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`i. A request for continued examination has been fiied with! or prior to, this form.
`ii.
`if the appiication is a utiiity apoiication, this certification and request is being fiied via EFS—Web.
`iii. The appiication is an originai nonprovisionai utiiity appiication fiied under 35 USC. 111(a), or is
`a nationai stage entry under 35 U.S.C. 371.
`iv. This certification and request is being fiied 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 t.1D2(e)(2).
`
`Signawre iTodd Eskerl
`
`. ngd Egker
`Name
`(Print/Types)
`
`Datetiiarch “it, was
`
`Practitioner
`Registration Number
`
`463690
`
`m: This form must be signed in accordance with 37 CFR 1.33. See 3.7 CFR 1.4(0’) for signature requirements and certifications.
`Submit inuitinie forms if more than one sir nature is required. "
`
`'
`
`forms are submitted.
`
`D *Totai of
`
`MYLAN - EX. 1002, p. 2
`
`MYLAN - Ex. 1002, p. 2
`
`

`

`Privacy Act Statement
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`enforcement agency, ii‘the USPTO becomes aware of a vioiation or potentiai vioiation oi iaw or reguiation.
`
`MYLAN - EX. 1002, p. 3
`
`MYLAN - Ex. 1002, p. 3
`
`

`

` vs! “111%
`\.\_:
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMNHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, 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 NUlVIBER
`
`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 @ morganlewiscom
`donald.mixon @ morganlewiscom
`
`PTOL—90A (Rev. 04/07)
`
`MYLAN ' EX. 1002, p. 4
`
`MYLAN - 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.
`I:I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|ZI This action is non-final.
`2a)|:| This action is FINAL.
`3)|: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 cIaim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6)|: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 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
`htt
`:/'I’www.usoto. ovI’ atents/init events/
`
`
`
`h/index.‘s or send an inquiry to PPI-ifeedback-{cBusgtocov.
`
`Application Papers
`
`10)|:I The specification is objected to by the Examiner.
`11)IZI The drawing(s) filed on 3/11/2016is/are: a)|ZI 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)|:l All
`
`b)|:l Some** c)|:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|: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
`
`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
`
`.
`,
`.
`MYLANartoEaQer flmgatpm‘50622
`
`MYLAN - 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).
`
`MYLAN - EX. 1002, p. 6
`
`MYLAN - 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.
`
`MYLAN - EX. 1002, p. 7
`
`MYLAN - 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
`
`MYLAN - EX. 1002, p. 8
`
`MYLAN - 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
`
`MYLAN - Ex. 1002, p. 9
`
`MYLAN - 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
`
`MYLAN - Ex. 1002, p. 10
`
`MYLAN - 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
`
`l-
`l-
`
`! Appeal
`a Objected
`
`Original
`
`_L_L_LOOO(JON—l
`
`_L O.1;
`
`.11.; 000301
`_L O \l
`
`_L_L_L—lOO000)
`
`_L _L
`
`_L
`
`
`
`_L _L 0)
`
`_L_L_L_L_L_L
`_L_L_L_L_L_L_L_L_L_L
`
`_L_L_L_L_L_L
`NNNNNNNNN—l
`
`Nam->00“)
`OJVGU‘I-hOON—loto
`
`
`
`
`
`
`80(0(00000(1303030303030)\l\l\l\l\l\l\l\l\l\l0)030303030)(IIUIUIUIU‘IU‘IU‘IU‘IU‘I"00\lmhcom—L03VLn-hooN—lQOJVGU‘I-hOON—l QOJVGU‘I-hOON—lo\lmhcom—L
`_L .1;O_L_L_L_L_L_L'hhhhhh0)01h0)N—l
`
`
`
`
`
`
`_L N(O
`
`_L_L_L
`
`000001)N—lO
`
`_L 0)0)
`
`(.00)01-h
`.11.;
`_L 0)O)
`
`_L_L_L
`
`000001)(003V
`
`-----------
`--------III
`149
`150
`
`US Patent and Trademark Office
`
`Part of Paper No. 20160622
`
`MYLAN - Ex. 1002, p. 11
`
`MYLAN - Ex. 1002, p. 11
`
`

`

`
`CER’I'lFICA'l‘E OF ELECTRONIC TRAnssnssiQn
`
`l hereby (zersify the: this correspondence, including listed enclosures is
`being electronically transmitted in Portable Document Fonn (PDF) through
`BPS-Web via Hyper Text Transfer Protocol to the United Siates Patent and
`’l'rademark Office’s Patent Electronic Business Center on:
`I
`
`
`
`PATEHE
`Attorney Docket No.: 06450760 l 4~US l 8
`
`IN THE UNITED STATES PA’I’EN’I‘ AND 'l‘liiADEMARK OFFICE
`
`In to application of:
`
`Confirmation No: 3696
`
`Examiner: Sill/i0, Rei Tsang
`
`Art Unit: 1628
`
`RESPONSE T0 GFFECBACEEQN
`
`Stephen Baker, et a].
`
`Application No.: 15/068352
`
`Filed: March ll, 2016
`
`For: nonon—eonminmo SMALL
`MOLECULES
`
`Customer No: 43850
`
`
`
`’
`
`Commissioner for Patents
`PO. Box l450
`
`Alexandria, VA 223134450
`
`Connoissioner:
`
`In response to the office action dated July 6, 2016, please emei' the following
`
`amendments and remarks.
`
`Amendments to {the specification begin on page 2; of this paper.
`
`A listing ofelaims begins on page 4 of'this paper.
`
`Remarks begin on page 5 of this paper.
`
`DBZ/ 304324521
`
`Page 1 oi 8
`
`MYLAN - Ex. 1002, p. 12
`
`MYLAN - 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. 14/201,45 9,
`
`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. 11/5 05,591 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. 7,5 82,621, 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 2 of8
`
`MYLAN - Ex. 1002, p. 13
`
`MYLAN - Ex. 1002, p. 13
`
`

`

`U.S. 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 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 US Patent
`
`Application No. 13/356,488, 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.
`
`¥he—present—applieationU.S. Patent Apflmtion 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. 12/507,010,
`
`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.
`
`Page 3 of8
`
`MYLAN - Ex. 1002, p. 14
`
`MYLAN - 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
`
`{11-wa
`
`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 Trichophyton mentagrophytes, 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.
`
`6.
`
`(Original) The method of claim 5, wherein the pharmaceutical
`
`composition further comprises ethanol and propylene glycol.
`
`Page 4 of8
`
`MYLAN - Ex. 1002, p. 15
`
`MYLAN - 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 0 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 appropriate fee.
`
`The filing of a terminal disclaimer to obviate