|AttomeyDocketWo.|0G4507-5014-US18 ‘\
`
`PTO/AIA/15 {03-13}
`Approved for use through 01/31/2014. OMB 0651-0032
`US. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995 no persons are reguired to respond to a collection of information unless it displays a valid OMB control number
`
`
`
`
`UTILITY
`? First Named Inventor
`| Stephen J. Baker
`
`
`
` | Express Mail Label No.
`(Only for new nonprovisional applications under 37 CFR 1.53ib})}
`
`
`
`PATENT APPLICATION
`
`TRANSMITTAL
`
`Title
`
`BORON-CONTAINING SMALL MOLECULES
`
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`i
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`ACCOMPANYING APPLICATION PAPERS
`10. i| Assignment Papers
`(cover sheet & document(s}
`Name ofAssignee
`
`]
`
`37 CFR 3.73{c} Statement
`{when there is an assignee}
`
`[| Powerof Attorney
`
`11.
`
`DQ
`
`og
`
`13.
`
`1.[_] Fee Transmittal Form
`{PTO/SB/17 or equivalent}
`2. [| Applicant asserts small entity status.
`~~ See 37 CFR 1.27
`3. [| Applicant certifies micro entity status. See 37 CFR 1.29.
`
`Applicant must attach form PTO/SB/15A or B or equivalent.
`——
`4
`Specification
`[Total Pages 314
`Both the claims and abstract must start cn a new page.
`{See MPEP § 608.01 {a) for information on the preferred arrangement}
`English Transiation Document
`5.[¢] prawingls} (35 U.S.C. 113)
`{Total Sheets831
`Ufapplicable)
`6.
`inventor's Oath or Declaration
`{Total Pages __
`information Disclosure Statement
`
`
`
`(including substitute statements under 37 CFR 1.64 and ass+ OF.
`(PTO/SB/G8 ar PTO-1449}
`serving as an oath or declaration under 37 CFR 1.63{e}}
`[| Capies of citations attached
`a.
`
`[I 14. iy|Preliminary Amendment
`Newly executed (origina! or copy)
`| Acopyfrom a priar application {37 CFR 1.63(d})
`b.|
`ac | Return Receipt Postcard
`15.1
`a
`s
`
`Application Data Sheet
`* See note below.
`(MPEP § 503} (Should be specifically itemized)
`See 37 CFR 1.76 (PTO/AIA/14 or equivalent} 16.t| Certified Copy of Priority Document(s}
`
`CD-ROM or CD-R
`8.
`(ifforeign priority is claimed)
`in duplicate, large table, or Computer Program (Appendix)
`WV | Nonpubtication Request
`[i Landscape Table on CD
`Under 35 U.S.C. 122{b}2}(Biil. Applicant must attach form PTG/SB/35
`or equivalent.
`9. Nucleotide and/or Amino Acid Sequence Submission
`.
`|
`
`18. fv] Other: “Request To Use Computer Form of SequenceListing
`(if applicable, items a. ~ ¢. are required}
`
`a. r] Computer Readable Form {CRF}
`From Another Application Under 37 C.F.R. § 1.8271(6);
`
`b.[v] Specification SequenceListing on:
`“Request For Pioritized Examination
`i. [i CD-ROM or CO-R {2 copies}: or
`eeeeeeenenenneneneee
`
`ii
`Pape:
`c. [¥] Statements verifying identity of above copies
`
`ita
`*Note:
`(1) Benefit claims under 37 CFR 1.78 and foreign priority claims under 1.55 must be included in an Application Data Sneet (ADS).
`
`(2
`} For applications filed under 25 U.S.C, 114, the application must contain an ADS specifying the applicant if the applicant is an
`assignee, person to whomthe inventor is under an obligation to assign, or person who otherwise showssufficient proprietary
`interest in the matter. See 37 CFR 1.46({b}.
`19. CORRESPONDENCE ADDRESS
`
` The address associated with Customer Number; 45850
`
`oR [| Correspondence address below
`
`Name
`
`Address
`Ctystate|ZinCode|
`conty|StStS~*dSclepone |Sid
`
`Date
`March 11, 2016
`]
`
` {Attorney/Agent)
`
`Registration No. 46,690
`4
`
`
`
`
`
`Ss to file {and by the USPTO
`This collection of information is required by 37 CFR 1.53(b}. The informationis required to obtain or retain a benefit by the public wh
`
`
`te process) an application. Confidentiali
`governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collectionis estimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed apptication formto the USPTO. Time will vary depending uoon the individual case. Any comments on
`
`the amountcf time you require ta complete this form and/or suggestions far reducing this burden, should be sent tc the Chief Infcrmation Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TG: Commissioner for Patents, P.G. Box 1450, Alexandria, VA 22313-1450.
`ifyou need assistance in completing the form, cail 1-800-PTO-9199 and select optian 2.
`
`MYLAN- Ex. 1002, p. 1
`
`MYLAN - Ex. 1002, p. 1
`
`

`

`Doc Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`.PTO/AIA/424 (04-14)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`
`:
`known. ional
`Application
`Number(i
`|To be assigned
`
`N
`
`fisional Application
`
`Number
`
`(if
`
`.
`
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17()(1) and the prioritized examination fee set forth in
`37 CFR 1.17(c) have beenfiled with the request. The publication fee requirement is met
`because that fee, set forth in 37 CFR 1.18(d), is currently $0. The basic filing fee, search fee,
`and examination fee are filed with the request or have been aiready been paid.
`| understand
`that any required excess claims fees or application size fee must be paid for the application.
`
`2.
`
`{| understand that the application may not contain, or be amended to contain, more than four
`independent claims, more than thirty total claims, or any multiple dependent claims, and that
`any request for an extension of time will cause an outstanding Track | request to be dismissed.
`
`3. The applicable box is checked below:
`
`i.
`
`‘vi Original Application (Track One)
`
`
`- Prioritized Examination under
`
`
`
`i.
`
`(a) The application is an original nonprovisionai utility application filed under 35 U.S.C. 117(a).
`This certification and requestis being filed with the utility application via EFS-Web.
`---OR---
`(b) The application is an original nonprovisional plant application filed under 35 U.S.C. 117(a).
`This certification and request is being filed with the plant application in paper.
`
`ii. An executed inventor's oath or declaration under 37 CFR 1.63 or 37 CFR 1.64 for each
`inventor, or the application data sheet meeting the conditions specified in 37 CFR 1.53(f}\(3)(i) is
`filed with the application.
`
`|
`
`i.
`
`|| Request for Continued Examination - Prioritized Examination under § 1.102(e}(2}
`
`i. A request for continued examination has been filed with, or prior to, this form.
`li.
`ff the application is a utility application, this certification and request is being filed via EFS-Web.
`ii, The application is an original nenprovisional utility application filed under 35 U.S.C. 111(a), or is
`a national stage entry under 35 U.S.C. 3771.
`iv. This certification and requestis being filed prior to the mailing 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).
`
`| sicnature / |OUd Esker/
`Name
`| Todd Esker
`
`(Print/Typed)}
`
`forms are submitted.
`
`f
`
`: nate March 11, 2016
`| Practitioner
`46,690
`
`Registration Number
`
`This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 7.4(d) for signature requirements and certifications.
`| Nofe:
`j submit muitipie forms if more than one signatureis required*
`
`}
`5
`
`[|
`
`*Total of
`
`MYLAN- Ex. 1002, p. 2
`
`MYLAN - Ex. 1002, p. 2
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-575) requires that you be given certain information in connection with your
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`ff you do not furnish the requested information, the U.S. Patent and Trademark Office may not be abie to
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`The information provided by you in this form will be subject to the following routine uses:
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`1. The information on this form will be treated confidentially to the extent allowed under the Freedomof
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`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
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`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
`the application pursuant to 35 U.S.C. 122(b} or issuance of a patent pursuant to 35 U.S.C. 151. Further, a
`record may be disclosed, subject ic the limitations of 37 CFR 1.14, as a routine use, to the public if the record
`was filed in an application which became abandonedor in which the proceedings were terminated and which
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`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local jaw
`enforcement agency, ifthe USPTO becomes aware of a violation or potential violation of law or regulation.
`
`MYLAN- Ex. 1002, p. 3
`
`MYLAN - Ex. 1002, p. 3
`
`

`

`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
`
`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 USLLPPeEXAMINERWI:
`
`
`One Market, Spear Street Tower, Suite 2800
`SHIAO,REI TSANG
`San Francisco, CA 94105
`
`ART UNIT
`
`PAPER NUMBER
`
`1628
`
`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)
`
`MYLAN- Ex. 1002, p. 4
`
`MYLAN - Ex. 1002, p. 4
`
`

`

`
`
`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 --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) 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).
`Anyreply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply betimely filed
`
`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.
`2b)X] This action is non-final.
`3)L] An election was made bythe applicant in responsetoarestriction requirementset forth during the interview on
`
`; the restriction requirement and election have been incorporatedinto this action.
`4)[] Since this application is in condition for allowance exceptfor formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
` Attachment(s)
`
`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.
`
`9)L] Claim(s)
`are subject to restriction and/or election requirement.
`* 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
`or send an inquiry to PPHfeedback@uspto.qgov.
`
`Application Papers
`10)L] The specification is objected to by the Examiner.
`11) The drawing(s)filed on 3/11/2016 is/are: a)IX] accepted or b)_] 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)[_] 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
`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.
`
`3) | Interview Summary (PTO-413)
`1) x Notice of References Cited (PTO-892)
`Paper No(s)/Mail Date.
`:
`.
`4 O 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)
`
`MYLANetoPaxer TOGDatppoSpee
`
`Office Action Summary
`
`MYLAN - Ex. 1002, p. 5
`
`

`

`Application/Control Number: 15/068,352
`Art Unit: 1628
`
`Page 2
`
`The present application is being examined underthe pre-AlA first to invent
`
`provisions.
`
`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,
`
`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
`
`terminal disclaimer. A terminal disclaimer signed by the assignee mustfully comply with
`
`37 CFR 3.73(b).
`
`MYLAN- Ex. 1002, p. 6
`
`MYLAN - Ex. 1002, p. 6
`
`

`

`Application/Control Number: 15/068,352
`Art Unit: 1628
`
`Page 3
`
`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 et al. ‘621 or ‘656 methods of usefor 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.
`
`MYLAN- Ex. 1002, p. 7
`
`MYLAN - Ex. 1002, p. 7
`
`

`

`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 usefor 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 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
`Art Unit: 1628
`
`Page 5
`
`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 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 methods of use of Bakeret 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
`
`methodsof use of Bakeret 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 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-
`
`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 numberfor the organization
`
`wherethis 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
`Art Unit: 1628
`
`Page 6
`
`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 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
`
`MYLAN - Ex. 1002, p. 10
`
`MYLAN - Ex. 1002, p. 10
`
`

`

`
`
`Index of Claims
`
`Application/Control No.
`
`15/068,352
`Examiner
`
`Applicant(s)/Patent under
`Reexamination
`
`BAKER ETAL.
`Art Unit
`
`oO
`
`
`
`
`
`
`o|2oO/O/O!O!O0/0|GO|00/00/CoSI]NTSNINSIoD/D/MD]MD!ayaaayoi|anyonoONOyBop}CINOROp]—O/O|INOD]ayRl@/rm]/-1oNoyB/a]py
`O/OIN|O/C]B/G]
`
`
`
`
`+|Rejected - (Throughnumeral) N Non-Elected A, Appeal
`
`= Allowed
`A
`Restricted
`1}Interference 0 Objected
`
`REI-TSANG SHIAO
`
`1628
`
`—|@a
`@
`£
`&
`a
`uw
`o
`
`_O
`
`|sa7{||||TTtT
`||[148]||||||tt
`
`
`149
`150
`
`a
`
`U.S. Patent and TrademarkOffice
`
`Part of Paper No. 20160622
`
`MYLAN- Ex. 1002, p. 11
`
`MYLAN - Ex. 1002, p. 11
`
`

`

`CERTIFICATE OP ELECTRONIC TRANSMISSION
`
`{hereby certify that this. correspondence, including fisted enclosures is
`being electronically transmitted in Portable Document Form (PDF) through
`EFS-Web via Llyper Text Transfer Protocol to the United States Patent and
`Trademark Office's Patent Electroni¢ 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
`
`RESPONSE TO 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
`
`Commissioner:
`
`In response tethe 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 L of 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
`
`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. 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 whichare 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, whichis 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 2 of 8
`
`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
`
`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. 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 whichare incorporated by reference 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,
`which is 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
`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 of 8
`
`MYLAN - Ex. 1002, p. 14
`
`MYLAN - Ex. 1002, p. 14
`
`

`

`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
`
`nAFeWWN
`
`—
`
`BmWwNO
`
`—
`
`1.
`
`(Original) A methodoftreating a Tinea unguium infection ofa 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.
`compositionis 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
`
`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 of
`
`the Claims
`
`Claims 1-6 are pending in this application.
`
`REMARKS
`
`Il. Response to the Rejections
`Obviousness-type double patenting over claims ] and 6-8 of Bakeret al. US 7,582,621
`Claims 1-6 are rejected on the ground of obviousness-type double patenting over claims |
`and 6-8 of Baker et 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.
`
`Thefiling of a terminal disclaimer to obviate a rejection based on non-statutory double
`patenting is not an admissionof the 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 estoppel on the merits of the rejection. Jd.; M.P.E.P. §
`804.02. With the filing of the Terminal Disclaimer and accompanying fee, Applicant
`respectfully submits that the obviousness-type double