`064567-5014-US18
`stephen J. Baker
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`FlatWing Ex. 1002, p. 1
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`FlatWing Ex. 1002, p. 2
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`FlatWing Ex. 1002, p. 2
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`FlatWing Ex. 1002, p. 3
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`FlatWing Ex. 1002, p. 3
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`

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`
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`UNITED STATES DEPARTMENT OF COMMERCE
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`APPLICATION NO.
`
`
`
`
` FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATIONNO.
`
`15/068,352
`
`03/11/2016
`
`Stephen J. Baker
`
`064507-5014-US18
`
`3696
`
`MORGAN,LEWIS& BOCKIUS LLP (SE)
`MO USLLPPeBXAMINERWI:
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`One Market, Spear Street Tower, Suite 2800
`SHIAO,REI TSANG
`San Francisco, CA 94105
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`ART UNIT
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`PAPER NUMBER
`
`1628
`
`NOTIFICATION DATE
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`DELIVERY MODE
`
`07/06/2016
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
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`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)
`
`FlatWing Ex. 1002, p. 4
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`FlatWing Ex. 1002, p. 4
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`

`

`
`
`Applicant(s)
`Application No.
` 15/068,352 BAKER ETAL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`REI-TSANG SHIAO Na 1628
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
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`Status
`1)X] Responsive to communication(s)filed on 3/11/2016.
`LJ A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon__
`2a)L] This action is FINAL.
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`4)[] Since this application is in condition for allowance exceptfor formal matters, prosecution as to the merits is
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` Attachment(s)
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`Disposition of Claims*
`5)KX] Claim(s) 1-6 is/are pending in the application.
`
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`6)L] Claim(s)
`is/are allowed.
`7) Claim(s) 1-6 is/are rejected.
`8)L] Claim(s)____is/are objectedto.
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`Application Papers
`10)L] The specification is objected to by the Examiner.
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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:
`a)L] All
`b)[-] Some** c)L] None ofthe:
`1..] Certified copies of the priority documents have been received.
`2.L] Certified copies of the priority documents have been received in Application No.
`3.L] Copies of the certified copies of the priority documents have been receivedin this National Stage
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`““ See the attached detailed Office action for a list of the certified copies not received.
`
`3) CT] Interview Summary (PTO-413)
`1) X Notice of References Cited (PTO-892)
`Paper No(s)/Mail Date.
`:
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`4 Ol Other:
`2) X Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 3/77/16.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`:
`rp:
`FlatWi PrgoExe IQDatoGpsze
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`Office Action Summary
`
`FlatWing Ex. 1002, p. 5
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`

`

`Application/Control Number: 15/068,352
`Art Unit: 1628
`
`Page 2
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`The present application is being examined underthe pre-AlA first to invent
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`provisions.
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`DETAILED ACTION
`This application claims priority of the provisional application:
`
`1.
`
`60/654,060 withafiling 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 groundedin 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 /n 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 /n re Thorington,
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`418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timelyfiled terminal disclaimer in compliance with 37 CFR 1.321(c) may be
`
`used to overcome anactual or provisional rejection based on a nonstatutory double
`
`patenting ground providedthe conflicting application or patent is shown to be commonly
`
`ownedwith this application. See 37 CFR 1.130(b).
`
`Effective January 1, 1994, a registered attorney or agent of record may sign a
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`terminal disclaimer. A terminal disclaimer signed by the assignee mustfully comply with
`
`37 CFR 3.73(b).
`
`FlatWing Ex. 1002, p. 6
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`FlatWing Ex. 1002, p. 6
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`

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`Application/Control Number: 15/068,352
`Art Unit: 1628
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`Page 3
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`3.1.
`
`Claims 1-6 are rejected under the obviousness-type double patenting
`
`over claims 1 and 6-8 of Bakeret al. US 7,582,621, or over claims 35, 38-39 and 41-
`
`42 of Bakeret al. US 8,889,656 respectively.
`
`Applicants claims methods of usefor 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 furtherlimit the
`
`scope of methodsof use, i.e., the Tinea unguium infection is due to Trichophyton
`
`rubrum or Trichophyton mentagrophytes, see claims 2-6.
`
`Bakeret al. ‘621 claims methodsof usefor 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.
`
`Bakeret al. ‘656 claims methodsof usefor 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 etal. ‘621 or ‘656 is that
`
`Baker etal. ‘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 methodsof use of Bakeret 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
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`FlatWing Ex. 1002, p. 7
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`

`

`Application/Control Number: 15/068,352
`Art Unit: 1628
`
`Page 4
`
`The motivation to make the claimed methods of use derived from the known
`
`methods of use of Bakeretal. ‘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 Bakeret al. co-pending applications
`
`number 15/046,322 respectively.
`
`Applicants claims methods of usefor 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. Dependentclaims 2-6 furtherlimit the
`
`scope of methodsof use, i.e., the Tinea unguium infection is due to Trichophyton
`
`rubrum or Trichophyton mentagrophytes, see claims 2-6.
`
`Bakeret al. ‘394 claims methodsof usefor 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 1-2.
`
`Bakeret al. ‘(052 claims methods of use for treating Trichophyton species
`
`infection of on nail in a human using a pharmaceutical composition comprising a
`
`compoundofformula (IIc), see claims 1, 4, 19, 25, 29-30 and 34-35.
`
`Bakeret al. ‘322 claims methods of usefor treating Trichophyton rubrum or
`
`Trichophyton mentagrophytes infection of on nail in a human using a pharmaceutical
`
`FlatWing Ex. 1002, p. 8
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`FlatWing Ex. 1002, p. 8
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`

`

`Application/Control Number: 15/068,352
`Art Unit: 1628
`
`Page 5
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`composition comprising a compound 1,3-dihydro-5-fluoro-1-hydroxy-2, 1-benzoxaborole,
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`see claims 1 and 16-17.
`
`The difference between the instant claims and Baker etal. ‘394, ‘052 or‘322 is
`
`that Bakeretal. ‘394, ‘052 or ‘322 methods of usefor treating fungus infection broadly.
`
`Bakeret 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 methodsof use of Bakeretal. ‘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
`
`methodsof use of Bakeret al. ‘394, ‘052 or ‘322 would possesssimilar activity to that
`
`which is claimed in the reference.
`
`This is a provisional obviousness-type double patenting rejection because the
`
`conflicting claims have notin fact been patented.
`
`Conclusion
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Rei-tsang Shiao whose telephone numberis (571) 272-
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`
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`
`Shen, can be reached on (571)272-3157. The fax phone numberfor the organization
`
`wherethis 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
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`

`

`Application/Control Number: 15/068,352
`Art Unit: 1628
`
`Page 6
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`the Patent Application Information Retrieval (PAIR) system. Status information
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`for published applications may be obtained from either Private PAIR or Public
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`PAIR. Status information for unpublished applications is available through
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`Private PAIR only. For more information about the PAIR system, see htip://pair-
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`direct.uspto.gov. Should you have questions on accessto the Private PAIR system,
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`1000.
`
`/REI-TSANG SHIAO/
`
`Rei-tsang Shiao, Ph.D.
`Primary Examiner
`Art Unit 1628
`
`June 22, 2016
`
`FlatWing Ex. 1002, p. 10
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`FlatWing Ex. 1002, p. 10
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`

`

`
`
`Index of Claims
`
`Application/Control No.
`
`15/068,352
`Examiner
`
`Applicant(s)/Patent under
`Reexamination
`
`BAKER ETAL.
`Art Unit
`
`oO
`
`
`o|e2oOO/O/O!O!O00/0000|CO|00|00|CoSII]NTSSININSIEToD/D|/M]HD!)aoaono]on}oryor]onoO™“OyBO}pyCOINOROPp]O/O|NOD]jyBRl@/rm]/-1oNIoyR/O]pyOOS]OD)or]Ri]
`
`
`
`
`
`:|Rejected - (Throughnumeral) N Non-Elected A, Appeal
`
`= Allowed
`A
`Restricted
`1}Interference 0 Objected
`
`REI-TSANG SHIAO
`
`1628
`
`a
`£
`a
`o
`
`=O
`
`—|
`@
`&
`uw
`
`|efsa7{||||TT
`
`[148]|||| |||{|
`149
`150
`
`a
`
`U.S. Patent and TrademarkOffice
`
`Part of Paper No. 20160622
`
`FlatWing Ex. 1002, p. 11
`
`FlatWing Ex. 1002, p. 11
`
`

`

`CERTIFICATE OP ELECTRONIC TRANSMISSION
`
`Thereby certify that this. correspondence, including listed enclosures is
`being electronicallytransmitted in Portable Document Form (PDF) through
`EPS-Web via Hyper Text Transfer Protocol to the United States Patent and
`Trademark Office's Patent Electronic Business Center om:
`‘
`
`
`
`PATENT
`Attorney Docket No.: 064507-5014-US18
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Confirmation No.: 3696
`
`Examiner: SHIAQ, Rei Tsang
`
`Art Unit: 1628
`
`RESPONSETO OFFICEACTION
`
`In re application of:
`
`Stephen Baker, ef al.
`
`Application No.: 15/068,352
`
`Filed: March 11, 2016
`For: BORON-CONTAINING SMALL
`MOLECULES
`
`Customer No.: 43850
`
`
`
`|
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Connnissioner:
`
`In response to the office action dated July 6, 2016, please enter the following
`
`amendments and remarks.
`
`Amendments to the specification begin on page 2 of this paper.
`
`A listing ofclaims begins on page 4 ofthis paper.
`
`Remarks begin onpage 5 of this paper.
`
`DB2/ 30432452.1
`
`Page i of 8
`
`FlatWing Ex. 1002, p. 12
`
`FlatWing Ex. 1002, p. 12
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`

`

`US. 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
`
`The present application is a continuation of U.S. Patent Application No. 15/046,322,
`[0001]
`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. 13/356,488, 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, whichis a divisional of U.S. Patent Application No.1 1/505,591, 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, andthe 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. 12/507,010,filed July 21,
`2009, now U.S. Patent No. 8,039,451, whichis 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 2 of 8
`
`FlatWing Ex. 1002, p. 13
`
`FlatWing 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 USS. Patent
`Application No. 13/356,488, filed January 23, 2012, now U.S. Patent No. 8,722,917, whichis 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 byreference in their entirety for all purposes.
`
`The-presentappleationU.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,
`whichis a continuation of U.S. Patent Application No. 13/224,252, filed September1, 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
`claimsthe benefit of 60/654,060, filed February 16, 2005, all of which are incorporated by
`
`reference in their entirety for all purposes.
`
`Page 3 of 8
`
`;
`FlatWing Ex. 1002, p. 14
`
`FlatWing Ex. 1002, p. 14
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`

`

`U.S. Pat. App. No. 15/068,352
`Response dated July 22, 2016
`Response to Office Action dated July 6, 2016
`
`Listing of Claims:
`
`PATENT
`
`nA&eWWN
`
`ek
`
`BeWwWNO
`
`—
`
`1.
`
`(Original) A methodoftreating 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 amountsufficient to treat the infection.
`
`2.
`
`(Original) The method of claim 1, wherein the Tinea unguium infection is
`
`due to Trichophyton rubrum or Trichophyton mentagrophytes.
`
`(Original) The method of claim 1, wherein the pharmaceutical
`3.
`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.
`
`(Original) The method ofclaim 1, wherein the Tinea unguium infection is
`5.
`due to Trichophyton rubrum or Trichophyton mentagrophytes, and wherein the pharmaceutical
`compositionis in the form of a solution comprising 5% w/w of 1,3-dihydro-5-fluoro-1-hydroxy-
`
`2,1-benzoxaborole.
`
`(Original) The method of claim 5, wherein the pharmaceutical
`6.
`composition further comprises ethanol and propylene glycol.
`
`Page 4 of 8
`
`.
`FlatWing Ex. 1002, p. 15
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`FlatWing Ex. 1002, p. 15
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`

`

`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
`
`I. Response to the Rejections
`Obviousness-type double patenting over claims ] and 6-8 of Baker et al. US 7,582,621
`Claims 1-6 are rejected on the ground of obviousness-type double patenting over claims1
`and 6-8 of Bakeret al. US 7,582,621 (“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 a rejection based on non-statutory double
`patenting is not an admission ofthe propriety of the rejection. Quad Environmental
`Technologies Corp. v. Union Sanitary District, 946 F.2d 870 (Fed. Cir. 1991). The filing ofa
`terminal disclaimer serves the statutory function of removing the rejection of double patenting,
`and raises neither a presumption nor estopp