Under the Paperwork Reduction Act:of 1995 no
`UTI tiTY
`PATENT APPLICATION
`
`
`
`8.
`
`
`
`
`
`A.j ¥|Specification }444. [] 37 CFR'3.73(c) Statement[Total Puges 81? | Power of Attorney
`
`PTO/AIA/IS 108-13)
`Approved for use through 01/31/2014, OMB 0651-0032.
`U.S, Patentand Trademark Office; U.S, DEPARTMENT OF COMMERCE
`personsarerebuiredto respond to
`a callection of information unless it displays a validOMBcontrol number
`Attorney: Docket.No,
`064507-5014-US1 9
`
`First Named fnventor
`| Stephen J. Baker
`
`
`
`Express Mail Label No,
`
`
`
`
`TRANSMITTAL
`
`al applications under 37 SFR 4.53{b)}
`
`Cammissioner for Patents
`APPLICATION ELEMENTS
`P.O. Box 1450
`ADDRESS TO:
`Sée.MPEP chapter 600. concerning utility patent application contents,
`
`ponernnenenennnonne i. Alexandria, VA 22313-1450
`
`
`I) Fae Transmittal Form
`ACCOMPANYING APPLICATION PAPERS
`{P'TO/SB/1.7 of equivalent)
`| oenasereepreerenmecnin
`2, [ Applicant asserts smail-entity status.
`10, [| Assignment Papers
`
`See 37 CFR 127
`(cover sheet & document(s})
`Name of Assignee
`
` Applicant certifies micro entity status, See 37 CFR 1.29,
`Applicant must.attach form PTO/SB/15A orf of equivaient.
`po
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`
`
`
`
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`Goth the claims-and abstract must start on a new page.
`{when .there Is.aa assignee}
`¥
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`12, [| English Translation Document
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`5.4] nrawingts) G5 U.S.C.113)
`[Total Sheets 88]
`tifapplicable)
`
`G,. Inventor’s Oath ar Declaration
`[TetaiPagesdd 8 [| information Disclosure Statement
`{including substitute statemerits under 37 CER 1.64 and.assignments
`(PTO/SB/G8-or PTO-2449}
`serviag as.arroath or decoration under 37 CFR 2 63e))
`[] Copies of citations attached
`
`why
`red
`{
`inat
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`a. _| Newly executed (origina! or copy}
`14. iv Preliminary Amendment
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`‘
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`paar
`b. [| A-copy from a prior application (87 CFR 4.63{d)})
`15.
`Return Receipt Postcard
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`7.{¢] Application Data Sheet
`* Sea note below,
`(MPEP § 503) {Should be specifically. itemizea)
`
`See 37 CFR 1.76 (PTO/AIA/14orequivalent)
`16, |] Cartified Copy of Priority Bocument{s}
`
`CD-ROM or CD-R
`lifforeignpriority is claimed)
`
`me duplicate; largetable, or Computer Program (Appendix)
`ay, [| Nonpublication Request
`
`[| Landscape Table on CQ
`Under 35°U.5.C. 122(b2tB)G). Applicant must attach farm PTO/SB/35
`
`.
`>
`.
`set
`ivatent.
`
`9, Nucleotide and/or Amino Acid Sequence Submission
`orequivst
`lf applicable, items a. ~c. are required)
`18. [¢] Other:
`“Request To Use-Computer Form of Sequance Listing
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`inert
`a *
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`4
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`16
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`a. LJ Camputer Readable Forry (CRF)
`FromAnotherApplicationUnder37C.F.§1.82(e);_
`Beat
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`ninati
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`b,PriorttizedExaminationSpecification Sequence Listing on: “RequestFor
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`i. [| C0-ROMor CD-R {2 copies); or
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`
`id ¥| Paper
`eeteeenecteteneen
`
`Cc. [v] Statements verifying identity of above copies
`
`SrnaA
`Serr
`*Note: (1) Benefit claims under 37 CFR 1.78 and foreign priority claims under 1.55 must be Included in.an Application Data Sheet {ADS},
`(2) For applications fled under 35 U.S.C. 144, the application must contain an ADS specifying the applicant ifthe applicant is an
`assignee, person to. whom the inventorisunder an obligation to-assign, or persan who otherwise’showssufficient proprietary
`
`interest in the matter, See.37
`CFR 1.46{b}.
`
`19. CORRESPONDENCE ADDRESS
`
`iv| Theaddress associated with Customer Number: 43850
`OR [4 Correspondence address below
` egetrnIRIAA
`Name
`
`
`
`
`
`
`Address
`city
`Country
`
`Signature
`
`|
`
`
`SennennnnnenennnneeeeennnnnaeSaaeer
`
`
`.
`Narne
`Registration No.
`46,69
`
`
`(Print/Type} Todd Esker tAttorney/Agent} |
`This collection of information is required by 3? CER T.53{bh: The information is required to obtain or retain a benefit by the public whichis to fite{and-by the. USPTO.
`£0 process} an.application. Confidentiality is givernedby 35 U.S.C; 122.and 37- CFR 1.44 and 1.14, This collection is-estimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO, Time will vary depending upon the Individual-case, Any. comments.on
`the amaunt of time you require'te complete this farm and/or suggestions for reducing this burden, should be sent to the Chief information O#ficar, U.S. Patent and
`Trademark Office, U.S. Departrnant of Cominerce, P.O, fax 1450, Alexandria, VA22313-1450. DO NOT SEND-FRES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TQ: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`ifyau need assistance in completing the form, call 1-800-PTQ-9199 and select option2.
`
`MYLAN- Ex. 1002, p. 1
`
`MYLAN - Ex. 1002, p. 1
`
`

`

`Doc Code: TRACK 1.REQ
`Document Description: TrackOne Request
`
`PTOMAIAM24 (04-14)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 27 CFR 1.102(e) (Page 1 of 1)
`
`t First Named
`|
`Inventor:
`
`t Title of
`i
`invention:
`
`i
`J
`
`"
`
`| Nonprovisional Application Number(if
`| known):
`
`.
`.
`]
`|To be assigned
`
`| 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 requirementis met
`because that fee, set forth in 37 CFR 1.18(d), is currently $0. The basic filing fee, searchfee,
`and examination fee are filed with the request or have been already been paid.
`| understand
`that any required excess claims fees or application size fee must be paid for the application.
`| understand that the application may not contain, ar be amended to contain, more than four
`independent claims, more than thirty total claims, or any multiple dependentclaims, 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:
`
`(Vl Orininal Application (Track One} - Prioritized Examination under
`
`i.
`
`(a) The application is an original nonprovisional utility application filed under 35 LLS.C. 174 {a).
`This certification and request is being filed with the utility application via EFS-Web.
`om QR~-=
`(o) The application is an original nonprovisional plant application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the plant application in paper.
`
`i [|
`
`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 TS30B)Q)is |
`filed with the application.
`[| Request for Continued Examination - Prioritized Examination under§ 1.102(e(2}
`A request for continued exarnination has beenfiled with, or priorto, this form.
`|
`(f the application is a utility application, this certification and request is being filed via EFS-Web.
`iii, The application is an original nonprovisionalutility application filed under 35 U.S.C. {iifa), oris |
`a national stage entry under 35 U.S.C. 371.
`iv. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`Noprior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.102(e)(2).
`
`eerationnumber‘6,690690 —
`Note: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d)
`for signature reguirements: and certifications.
`i Submit multipleformsif mare than one signature is required.”
`“Total ofwuforms.are submitted.
`
`Practitioner
`
`|
`
`MYLAN- Ex. 1002, p. 2
`
`MYLAN - Ex. 1002, p. 2
`
`

`

`
`
`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.
`
`15/091,394
`
`04/05/2016
`
`Stephen J. BAKER
`
`064507-5014-US19
`
`7426
`
`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
`
`05/20/2016
`
`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. 3
`
`MYLAN - Ex. 1002, p. 3
`
`

`

`
`
`Applicant(s)
`Application No.
` 15/091 ,394 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 2MONTHS 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 4/5/2016.
`LJ A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon__
`2a)L] This action is FINAL.
`2b)L] 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) 1-26 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)L] Claim(s)__ is/are rejected.
`8)L] Claim(s)____ is/are objectedto.
`
`9)X] Claim(s) 1-26 are subjectto 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)L] The drawing(s)filed on
`is/are: a)L_] 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)LJ] 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 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.
`
`3) CT] Interview Summary (PTO-413)
`1) Cc] Notice of References Cited (PTO-892)
`Paper No(s)/Mail Date.
`:
`.
`4 O Other:
`2) Cc] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`PTOL-326(Rev. 11-13)
`
`MYLANetoPaxer TOGLappdost 7
`
`Office Action Summary
`
`MYLAN - Ex. 1002, p. 4
`
`

`

`Application/Control Number: 15/091 ,394
`Art Unit: 1628
`
`Page 2
`
`The present application is being examined underthe pre-AlA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`1.
`
`Claims 1-26 are pending in the application.
`
`Election/Restriction
`
`2.
`
`The Markush group setforth in the claims includes both independent and distinct
`
`inventions, and patentably distinct compounds(or species) within each invention.
`
`However,this application discloses and claimsa plurality of patentably distinct
`
`inventions far too numerous tolist individually. Moreover, each of these inventions
`
`contains a plurality of patentably distinct compounds, also far too numerous tolist
`
`individually. For these reasons provided below,restriction to one of the following
`
`Groupsis required under 35 U.S.C. 121, wherein an Group is a set of patentably distinct
`
`inventions of a broad statutory category (e.g. Compounds, Methods of Use, Methods of
`
`Making, etc.):
`
`|. Claims 1-13, drawn to methods of use, classified in classes 514/558, numerous
`
`subclasses.
`
`Il. Claims 14-19, drawn to methods of use, classified in classes 514/558, numerous
`
`subclasses.
`
`Ill. Claims 20-26, drawn to methods of use, classified in classes 514/558, numerous
`
`subclasses.
`
`MYLAN- Ex. 1002, p. 5
`
`MYLAN - Ex. 1002, p. 5
`
`

`

`Application/Control Number: 15/091 ,394
`Art Unit: 1628
`
`Page 3
`
`In accordancewith the decisions in In re Harnisch, 631 F.2d 716, 206 USPQ
`
`300 (CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984),
`
`restriction of a Markush group is proper where the compoundswithin the group either
`
`(1) do not share a commonutility, or (2) do not share a substantial structural feature
`
`disclosed as being essential to that utility.
`
`In addition, a Markush group may
`
`encompass a plurality of independentand distinct inventions where two or more
`
`membersare so unrelated and diverse that a prior art reference anticipating the claim
`
`with respect to one of the members would not render the other member(s) obvious
`
`under 35 U.S.C. 103.
`
`An election of any one of GroupsI-lIll is required. Should applicant traverse
`
`on the ground that the compoundsare not patentably distinct, applicant should submit
`
`evidenceor identify such evidence now of record showing the compoundsto be obvious
`
`variants or clearly admit on the record that this is the case.
`
`In either instance, if the
`
`examinerfinds one of the inventions unpatentable overthe prior art, the evidence or
`
`admission may be used in a rejection under 35 U.S.C 103(a) of the other.
`
`All compoundsfalling outside the class(es) and subclass(es) of the selected
`
`compound and any other subclass encompassedbythe election above will be directed
`
`to nonelected subject matter and will be withdrawn from consideration under 35 U.S.C.
`
`121 and 37 C.F.R. 1.142(b). Applicant may reservethe right to file divisional
`
`applications on the remaining subject matter. The provisions of 35 U.S.C. 121 apply
`
`with regard to double patenting covering divisional applications.
`
`MYLAN- Ex. 1002, p. 6
`
`MYLAN - Ex. 1002, p. 6
`
`

`

`Application/Control Number: 15/091 ,394
`Art Unit: 1628
`
`Page 4
`
`Applicant is reminded that upon cancellation of claims to a non-elected invention,
`
`the inventors must be amendedin compliance with 37C.F.R. 1.48(b) if one of the
`
`currently namedinventorsis no longer an inventor of at least one claim remaining in the
`
`application. Any amendmentof inventorship must be accompanied bya petition under
`
`37 C.F.R. 1.48(b) and by the fee required under 37CFR 1.17(i). If desired upon election
`
`of a single compound, applicants can review the claims and disclosure to determine the
`
`scopeof the invention and can set forth a group of compounds whichare so similar
`
`within the same inventive concept and reduction to practice. Markush claims must be
`
`provided with support in the disclosure for each memberof the Markush group. See
`
`MPEP 608.01(p). Applicant should exercise caution in making a selection of a single
`
`memberfor each substituent group on the base molecule to be consistent with the
`
`written description.
`
`Rationale Establishing Patentable Distinctiveness Within Each Group
`
`Eachinvention setlisted aboveis directed to or involves the use or making of
`
`compoundswhich are recognizedin the art as being distinct from one another because
`
`of their diverse chemical structure, their different chemical properties, modesof action,
`
`different effects and reactive conditions (MPEP 806.04, MPEP 808.01). Additionally,
`
`the level of skill in the art is not such that one invention would be obvious over either of
`
`the other inventions, i.e. they are patentable over each other. Chemical structures
`
`whichare similar are presumedto function similarly, whereas chemical structures that
`
`are not similar are not presumedto function similarly. The presumption even for similar
`
`MYLAN- Ex. 1002, p. 7
`
`MYLAN - Ex. 1002, p. 7
`
`

`

`Application/Control Number: 15/091 ,394
`Art Unit: 1628
`
`Page 5
`
`chemical structures though is notirrebuttable, but may be overcome byscientific
`
`reasoning or evidence showing that the structure of the prior art would not have been
`
`expected to function as the structure of the claimed invention. Note that in accordance
`
`with the holdings of Application of Papesch, 50 CCPA 1084, 315 F.2d 381, 137 USPQ
`
`43 (CCPA 1963) and In re Lalu, 223 USPQ 1257 (Fed. Cir. 1984), chemical structures
`
`are patentably distinct where the structures are either not structurally similar, or the prior
`
`art fails to suggest a function of a claimed compound would have been expected from a
`
`similar structure.
`
`The above Groupsrepresent general areas wherein the inventions are
`
`independentand distinct, each from the other becauseof the following reasons:
`
`Restriction for examination purposes asindicated is proper becauseall these
`
`inventions listed in this action are independentor distinct for the reasons given above
`
`and there would be a serious search and examination burdenif restriction were not
`
`required because one or moreofthe following reasons apply:
`
`(a) the inventions have acquired a separate status in the art in view of their different classification;
`
`(b) the inventions have acquired a separate status in the art due to their recognized divergent
`
`subject matter;
`
`(c) the inventions require a different field of search (for example, searching different
`
`classes/subclassesor electronic resources, or employing different search queries);
`
`(d) the prior art applicable to one invention would notlikely be applicable to another invention;
`
`(e) the inventionsarelikely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35
`
`U.S.C. 112, first paragraph.
`
`Applicant is advised that the reply to this requirement to be complete must
`
`include(i) an election of a invention to be examined even though the requirement
`
`MYLAN- Ex. 1002, p. 8
`
`MYLAN - Ex. 1002, p. 8
`
`

`

`Application/Control Number: 15/091 ,394
`Art Unit: 1628
`
`Page 6
`
`may betraversed (37 CFR 1.148) and(ii) identification of the claims encompassing
`
`the elected invention.
`
`The election of an invention may be made with or without traverse. To reserve a
`
`right to petition, the election must be madewith traverse. If the reply does notdistinctly
`
`and specifically point out supposederrorsin the restriction requirement, the election
`
`shall be treated as an election without traverse. Traversal must be presented at the time
`
`of election in order to be considered timely. Failure to timely traverse the requirement
`
`will result in the loss of right to petition under 37 CFR 1.144. If claims are addedafter
`
`the election, applicant must indicate which of these claims are readable on the elected
`
`invention. If claims are added after the election, applicant must indicate which of these
`
`claims are readable upon the elected invention. Should applicant traverse on the ground
`
`that the inventions are not patentably distinct, applicant should submit evidence or
`
`identify such evidence now of record showing the inventions to be obvious variants or
`
`clearly admit on the record thatthis is the case. In either instance, if the examinerfinds
`
`one of the inventions unpatentable overthe prior art, the evidence or admission may be
`
`used in a rejection under 35 U.S.C. 103(a) of the other invention.
`
`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.
`
`MYLAN- Ex. 1002, p. 9
`
`MYLAN - Ex. 1002, p. 9
`
`

`

`Application/Control Number: 15/091 ,394
`Art Unit: 1628
`
`Page 7
`
`Information regarding the status of an application may be obtained from
`
`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, seehttp://pair-
`
`direct.uspto.gov. Should you have questions on accessto 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 accessto the
`
`automatedinformation system, call 800-786-9199 (IN USA OR CANADA)or 571-272-
`
`1000.
`
`/REI-TSANG SHIAOQ/
`
`Rei-tsang Shiao, Ph.D.
`Primary Examiner
`Art Unit 1628
`
`May 17, 2016
`
`MYLAN - Ex. 1002, p. 10
`
`MYLAN - Ex. 1002, p. 10
`
`

`

`CERTIFICATE OF ELECTRONIC TRANSMISSION
`
`I herebycertify that this correspondence, includinglisted enclosuresis
`being electronically transmitted in Portable Document Form (PDF) through
`EFS-Web via Hyper Text Transfer Protocol to the United States Patent and
`Trademark Office's Patent Electronic Business Center on:
`Dated: Sune 27, 2alb
`st
`heabt—
`
`Peter Roidmaier
`
`PATENT
`Attorney Docket No.: 064507-5014-US19
`
`IN THE UNITED STATES PATENT AND TRADEMARKOFFICE |
`
`In re application of:
`
`Confirmation No.: 7426
`
`Stephen Baker,ef al.
`
`Examiner: SHIAO,Rei Tsang
`
`Application No.: 15/091,394
`
`Art Unit: 1628
`
`RESPONSE TO RESTRICTION
`REQUIREMENT
`
`Filed: April 5, 2016
`
`For: BORON-CONTAINING SMALL
`MOLECULES
`
`Customer No.: 43850
`
`
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`In responseto the restriction requirement dated May 20, 2016, please enter the following
`
`amendments and remarks.
`
`Amendments to the specification begin on page 2 of this paper.
`
`A listing of claims begins on page 4 ofthis paper.
`
`Remarks begin on page 8 ofthis paper.
`
`DB2/30337746.2
`
`Page 1 of 9
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`MYLAN- Ex. 1002, p. 11
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`MYLAN - Ex. 1002, p. 11
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`

`

`U.S. Pat. App. No. 15/091,394
`Response dated June 27, 2016
`If
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`Response to Restriction Requirement dated May 20, 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
`
`U.
`
`filed March 11, 2016, whichis 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. 13/356,488,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 December30, 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 referencein their entirety for all purposes.
`
`The present application 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 referencein their entirety for all purposes.
`
`Page 2 of 9
`
`MYLAN - Ex. 1002, p. 12
`
`MYLAN - Ex. 1002, p. 12
`
`

`

`U.S. Pat. App. No. 15/091,394
`Responsedated June 27, 2016
`Responseto Restriction Requirement dated May 20, 2016
`
`PATENT
`
`Version showing changes made:
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`The present application is a continuation of U.S. Patent Application No. 15/068,352,
`
`filed March 11, 2016, which 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
`
`' November10, 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 claimsthe 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.
`
`The present application 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 of 9
`
`MYLAN- Ex. 1002, p. 13
`
`MYLAN - Ex. 1002, p. 13
`
`

`

`U.S. Pat. App. No. 15/091,394
`Responsedated June 27, 2016
`Response to Restriction Requirement dated May 20, 2016
`
`PATENT
`
`Listing of Claims:
`
`Gobo—
`Nourof
`
`bmWw
`
`Lor
`
`1.
`(Original) A methodofinhibiting the growth of Trichophyton rubrum or
`Trichophyton mentagrophytes present in a nail unit of a human, the method comprising:
`delivering into the nail unit an amountof 1,3-dihydro-5-fluoro-i-hydroxy-2,i-
`benzoxaborole or a pharmaceutically acceptable salt thereof effective to inhibit the growth ofthe
`Trichophyion rubrum ox Trichophyton mentagrophytes.
`
`(Original) The method of claim 1, wherein the amount ofthe 1,3-dihydro-
`2.
`5-fluoro-1-hydroxy-2,1-benzoxaborole or the pharmaceutically acceptable salt thereofis
`
`delivered into the nail unit by topically administering to the nail unit a pharmaceutical
`
`and 1,3-dihydro-5-fluoro-1-hydroxy-2,1-
`
`benzoxaborole or a pharmaceutically acceptable sait thereof.
`
`3.
`
`(Original) The method of claim 1, wherein the 1,3-dihydro-5-fluoro-1-
`
`hydroxy-2,1-benzoxaborole or the pharmaceutically acceptable salt thereof is delivered into a
`
`nail plate of the nail unit.
`
`4.
`
`(Original) The method of claim 1, wherein the 1,3-dihydro-5-fluoro-1-
`
`hydroxy-2,i-benzoxaborole or the pharmaceutically acceptabie sait thereof is delivered into a
`
`nail bed of the nail unit.
`
`5.
`
`(Original) The method of claim 1, wherein the amount of the 1,3-dihydro-
`
`5-fluoro-1-hydroxy-2,1-benzoxaborole or the pharmaceutically acceptable salt thereofis
`
`delivered into the nail unit once a day.
`
`6.
`
`(Original) The method ofclaim 1, wherein the method inhibits the growth
`
`of Trichophyton rubrum.
`
`7.
`
`(Original) The method of claim 1, wherein the method inhibits the growth
`
`of Trichophyton mentagrophytes.
`
`Page 4 of 9
`
`MYLAN- Ex. 1002, p. 14
`
`MYLAN - Ex. 1002, p. 14
`
`

`

`U.S. Pat. App. No. 15/091,394
`Responsedated June 27, 2016
`Response to RestrictionRequirement dated May20, 2016
`
`PATENT
`
`NHAFSFWN
`
`—_—
`
`SINAFBRWNY
`
`8.
`
`(Original) A method of inhibiting the growth of Trichophyton rubrum or
`
`Trichophyton mentagrophytes present in a nail unit of a human, the method comprising:
`
`contacting a dorsal layer of a nail plate of the nail unit with a topical solution comprising
`
`a compound that penetrates the nail plate to inhibit the growth of Trichophyton rubrum or
`
`Trichophyton mentagrophytes, the compoundbeing 1 ,3-dihydro-5-fluoro-1-hydroxy-2, 1 -
`
`benzoxaborole or a pharmaceutically acceptable salt thereof.
`
`9.
`
`(Original) The method of claim 8, wherein the topical solution comprises
`
`5% w/w of 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, and wherein the topical solution
`
`further comprises ethanol and propylene glycol.
`
`10.
`
`(Original) The method of claim 8, wherein the topical solution further
`
`comprises ethanol and propylene glycol.
`
`11.
`
`(Original) The method of claim 8, wherein the contacting of the dorsal
`
`layer of the nail plate of the nail unit with the topical solution occurs once a day.
`
`12.
`
`(Original) The method of claim 8, wherein the method inhibits the growth
`
`of Trichophyton rubrum.
`
`13.
`
`(Original) The method of claim 8, wherein the method inhibits the growth
`
`of Trichophyton mentagrophytes.
`
`14,
`
`(Original) A method of delivering a compound, in a human, from a dorsal
`
`layer of a nail plate to a nail bed to treat onychomycosis caused by Trichophyton rubrum or
`
`Trichophyton mentagrophytes, the method comprising:
`
`contacting the dorsal layer of the nail plate with a pharmaceutical composition
`
`comprising a compoundthat penetrates the nail plate, the compound being 1,3-dihydro-5-fluoro-
`
`1-hydroxy-2,1-benzoxaborole or a pharmaceutically acceptable salt thereof, thereby treating
`
`onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes.
`
`Page 5 of 9
`
`MYLAN- Ex. 1002, p. 15
`
`MYLAN - Ex. 1002, p. 15
`
`

`

`U.S. Pat. App. No. 15/091,394
`Response dated June 27, 2016
`Response to Restriction Requirement dated May 20, 2016
`
`PATENT
`
`GoNOpet
`
`fa
`
`aABPWYNHNeH
`AFBWwWNO
`
`(Original) The method of claim 14, wherein the pharmaceutical
`15.
`composition is in the form of a topical solution comprising 5% w/w of 1,3-dihydro-5-fluoro-1-
`hydroxy-2,1-benzoxaborole, and wherein the pharmaceutical composition further comprises
`athe nee nd need eqerincslane qhunal
`CuUldibOE GWG Propylene PIyCOl,
`
`16.
`
`(Original) The method ofclaim 14, wherein the pharmaceutical
`
`composition further comprises ethanol and propylene glycol.
`
`(Original) The method of claim 14, wherein the contacting of the dorsal
`17.
`layerofthe nail plate with the pharmaceutical composition occurs once a day.
`
`is.
`
`(Original) The method of claim 14, whereina cause of the
`
`onychomycosis is due to Trichophyton rubrum.
`
`19.
`
`(Original) The methodof claim 14, wherein a cause of the
`
`onychomycosis is due to Trichophyton mentagrophytes.
`
`(Original) A methodof killing Trichophyton rubrum or Trichophyton
`20.
`mentagrophytes present in a nail unit of a human, the method comprising:
`
`delivering into the nail unit an amountof 1,3-dihydro-