`Approved for use through 01/31/2014. OMB 0651-0032
`US. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Pa nerwork Reduction Act of 1995 no ersons are reuired to resend to a collection of information unless it disla s a valid OMB control number
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`TRANSMITI'AL
`BORON-CONTAINlNG SMALL MOLECULES
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`(Onlyfor new nonprovisional applications under37 CFR 1.53(b))
`Express M0” “be, NO'_
`
`
`
`
`
`APPLICATION ELEMENTS
`Commissioner for Patents
`See MPEP chapter 600 concerning utility patent application contents.
`A DDRESS TO
`P.O. BOX 1450
`
`Alexandria, VA 22313-1450
`
`
`
`1L Feei'ammim'imm
`ACCOMPANYING APPLICATION PAPERS
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`(PTO/SB/17 or equwalent)
`
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`
`2. L_ Applicant asserts small entity status.
`10- l: Assignment Papers
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`
`See 37 CFR 127
`(cover sheet & documentls))
`Name of Assignee
`
`Applicant certifies micro entity status. See 37 CFR 1.29.
`
`
`Applicant must attach form PTO/SB/15A or B or equivalent.
`4. L/_ Specification
`[Total Pages 316
`Both the claims and abstract must start on a new page.
`
`(See MPEP § 608.01(a)for information on the preferred arrangement)
`5.._/_ Drawing(s)(35 u.s.c.113)
`[Toto/Sheets 63
`i
`6. Inventor's Oath or Declaration
`[Total Pages
`]
`(including substitute statements under 37 CFR 1.64 and assignments
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`serwng as an oath or declaration under 37 CFR 1.63(e))
`
`
`a. L_ Newly executed (original or copy)
`b.|__ A copy from a prior application (37 CFR 1.63(d))
`7. [2 Application Data Sheet
`* See note below.
`See 37 CFR 1.76(PTO/A|A/14 or equ'valent)
`CD—ROM or CD-R
`
`In duplicate, large table, or Computer Program (Appendix)
`|__ Landscape Table on CD
`9. Nucleotide and/or Amino Acid Sequence Submission
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`Other: *Request To Use Computer Readable Form of Sequence
`(if applicable, items a. — c. are required)
`18. I_‘/_
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`Listing From Another Application Under 37 CFR. § 1.821(e);
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`a.
`Computer Readable Form (CRF)
`
`b. I
`Specification Sequence Listing on:
`Request For Prioritized Examination.
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`
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`i. L_ CD—ROM or CD—R (2 copies); or
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`ii.|_/_ Paper
`Statements verifying identity of above copies
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`l: Power of Attorney
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`17. L— Nonpublication Request
`Under 35 U.S.C. 122(b)(2)(B)(i). Applicant must attach form PTO/SB/35
`or equivalent.
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`UTILITY
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`PATENT APPLICATION
`
`064507-5014'U317
`
`Stephen J- Baker
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`12
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`11. L_ 37 CFR 3.73(C) Statement
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`(when there is an assignee)
`English Translation Document
`(ifapplicable)
`13. L_ information Disclosure Statement
`(PTO/SB/08 or PTO~1449)
`
`
` [: Copies of citations attached
`
`14. LV/_ Preliminary Amendment
`15‘ L— Return Receipt Postcard
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`(MPEP § 503) (Should be specifically itemized)
`16. L_ Certified Copy of Priority Document(s)
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`(ifforeign priority is claimed)
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`]
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`8.
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`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 filed under 35 U.S.C. 111, the application must contain an ADS specifying the applicant if the applicant is an
`assignee, person to whom the inventor is under an obligation to assign, or person who otherwise shows sufficient proprietary
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`interest in the matter. See 37 CFR 1.46lb).
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`19. CORRESPONDENCE ADDRESS
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`OR [: Correspondence address below
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`The address associated with Customer Number: 43850
`Name
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`Address
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`City —_—
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`Country
`Telephone—-
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`'
`*******
`7:
`Signature
`'
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`Name
`Registration No.
`(Print/Type) TOdd ESker
`(Attorney/Agent) l46a690
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`
`
`
`This collection of information is required by 37 CFR 1.53(b). The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO
`to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 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 amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief information Officer, US. Patent and
`Trademark Office, US. Department of Commerce, PO. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TO: Commissioner for Patents, PO. Box 1450, Alexandria, VA 22313-1450.
`Ifyou need assistance in completing the form, call 1-800—PTO-9199 and select option 2.
`
`
`
`MYLAN - Ex. 1002, p. 1
`
`MYLAN - Ex. 1002, p. 1
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`
`
`Doc Code: TRACK1.REQ
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`Document Description: TrackOne Request
`
`PTO/AlA/424 (04-14)
`
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`BORON-CONTAINING SMALL MOLECULES
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`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
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`THE ABOVE—IDENTIFIED APPLICATION.
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`1. The processing fee set forth in 37 CFR 1.17(i)(1) and the prioritized examination fee set forth in
`37 CFR 1.17(c) have been filed 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 already been paid.
`i understand
`that any required excess claims fees or application size fee must be paid for the application.
`
`2.
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`i 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:
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`
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`'
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`inal A lication Track One - Prioritized Examination under ~ 1.102 e 1
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`
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`i.
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`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a).
`This certification and request is 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. 111(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, gr the application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is
`filed with the application.
`
`ll.
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`Reguest 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.
`ii.
`lfthe application is a utility application, this certification and request is being filed via EFS—Web.
`iii. The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a), or is
`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.
`v. No prior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.102(e)(2).
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`Sionature /(_I{’ /7 / f: .i/(fx/a) . Date
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`
`Name
`Practitioner
`Todd Esker
`‘
`467690
`(Print/Typed)
`Registration Number
`
`forms are submitted.
`
`This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`Note:
`Submit multiple forms if more than one signature is required.*
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`1:]
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`*Total of
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`MYLAN - Ex. 1002, p. 2
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`MYLAN - Ex. 1002, p. 2
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`
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` vs! “111%
`\.\_:
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`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
`
`
`
`
`
`15/046,322
`
`02/17/2016
`
`Stephen J. BAKER
`
`064507—5014—US17
`
`1076
`
`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
`
`06/07/2016
`
`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. 3
`
`MYLAN - Ex. 1002, p. 3
`
`
`
`
`
`Applicant(s)
`Application No.
` 15/046,322 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 2/17/2016.
`|:| A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|:I This action is non-final.
`2a)|:I This action is FINAL.
`3)|:| An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)IZI Claim(s) 1-27is/are pending in the application.
`5a) Of the above cIaim(s)
`is/are withdrawn from consideration.
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`is/are allowed.
`6)I:I Claim(s)
`7)|:| Claim(s)_ is/are rejected.
`8)|:| Claim(s)_ is/are objected to.
`
`9)IXI Claim((s) 1 -27 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
`htt
`:/'I’www.usoto. ovI’ atents/init events/
`
`
`
`h/index.‘s or send an inquiry to PPI-ifeedback-{cBusgtocov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on
`is/are: a)|:| 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)|:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:I All
`
`b)I:I Some** c)I:I None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.I: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) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) [I InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
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`.
`,
`.
`MYLANartoEaper qmgatpeofioszs
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`MYLAN - Ex. 1002, p. 4
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`
`
`Application/Control Number: 15/046,322
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`Page 2
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`Art Unit: 1628
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`The present application is being examined under the pre-AIA first to invent
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`provisions.
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`DETAILED ACTION
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`1.
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`Claims 1-27 are pending in the application.
`
`Election/Restriction
`
`2.
`
`The group set forth in the claims includes both independent and distinct
`
`inventions, and patentably distinct compounds (or species) within each invention.
`
`However, this application discloses and claims a plurality of patentably distinct
`
`inventions far too numerous to list individually. Moreover, each of these inventions
`
`contains a plurality of patentably distinct compounds, also far too numerous to list
`
`individually. For these reasons provided below, restriction to one of the following
`
`Groups is required under 35 U.S.C. 121, wherein an Group is a set of patentably distinct
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`inventions of a broad statutory category (e.g. Compounds, Methods of Use, Methods of
`
`Making, etc.):
`
`I. Claims 1-15, drawn to products, classified in classes 514/558, numerous
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`subclasses.
`
`ll. Claims 1627, drawn to methods of use, classified in classes 514/558, numerous
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`subclasses.
`
`In accordance with 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),
`
`MYLAN - EX. 1002, p. 5
`
`MYLAN - Ex. 1002, p. 5
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`
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`Application/Control Number: 15/046,322
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`Page 3
`
`Art Unit: 1628
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`restriction of a Markush group is proper where the compounds within the group either
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`(1) do not share a common utility, 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 independent and distinct inventions where two or more
`
`members are 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 Groups MI is required. Should applicant traverse
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`on the ground that the compounds are not patentably distinct, applicant should submit
`
`evidence or identify such evidence now of record showing the compounds to be obvious
`
`variants or clearly admit on the record that this is the case.
`
`In either instance, if the
`
`examiner finds one of the inventions unpatentable over the prior art, the evidence or
`
`admission may be used in a rejection under 35 U.S.C 103(a) of the other.
`
`All compounds falling outside the class(es) and subclass(es) of the selected
`
`compound and any other subclass encompassed by the 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 reserve the 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.
`
`Applicant is reminded that upon cancellation of claims to a non-elected invention,
`
`the inventors must be amended in compliance with 37C.F.R. 1.48(b) if one of the
`
`currently named inventors is no longer an inventor of at least one claim remaining in the
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`MYLAN - EX. 1002, p. 6
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`MYLAN - Ex. 1002, p. 6
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`
`
`Application/Control Number: 15/046,322
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`Page 4
`
`Art Unit: 1628
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`application. Any amendment of inventorship must be accompanied by a petition under
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`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
`
`scope of the invention and can set forth a group of compounds which are so similar
`
`within the same inventive concept and reduction to practice. Markush claims must be
`
`provided with support in the disclosure for each member of the Markush group. See
`
`MPEP 608.01 (p). Applicant should exercise caution in making a selection of a single
`
`member for each substituent group on the base molecule to be consistent with the
`
`written description.
`
`Rationale Establishing Patentable Distinctiveness Within Each Group
`
`Each invention set listed above is directed to or involves the use or making of
`
`compounds which are recognized in the art as being distinct from one another because
`
`of their diverse chemical structure, their different chemical properties, modes of 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
`
`which are similar are presumed to function similarly, whereas chemical structures that
`
`are not similar are not presumed to function similarly. The presumption even for similar
`
`chemical structures though is not irrebuttable, but may be overcome by scientific
`
`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
`
`MYLAN - EX. 1002, p. 7
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`MYLAN - Ex. 1002, p. 7
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`
`
`Application/Control Number: 15/046,322
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`Page 5
`
`Art Unit: 1628
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`with the holdings of Application of Papesch, 5O 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 Groups represent general areas wherein the inventions are
`
`independent and distinct, each from the other because of the following reasons:
`
`Restriction for examination purposes as indicated is proper because all these
`
`inventions listed in this action are independent or distinct for the reasons given above
`
`and there would be a serious search and examination burden if restriction were not
`
`required because one or more of the 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/subclasses or electronic resources, or employing different search queries);
`
`(d) the prior art applicable to one invention would not likely be applicable to another invention;
`
`(e) the inventions are likely 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
`
`may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
`
`the elected invention.
`
`MYLAN - Ex. 1002, p. 8
`
`MYLAN - Ex. 1002, p. 8
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`
`
`Application/Control Number: 15/046,322
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`Page 6
`
`Art Unit: 1628
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`The election of an invention may be made with or without traverse. To reserve a
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`right to petition, the election must be made with traverse. If the reply does not distinctly
`
`and specifically point out supposed errors in 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. lf claims are added after
`
`the election, applicant must indicate which of these claims are readable on the elected
`
`invention. lf 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 that this is the case. In either instance, if the examiner finds
`
`one of the inventions unpatentable over the prior art, the evidence or admission may be
`
`used in a rejection under 35 U.S.C. 103(a) of the other invention.
`
`Any inquiry concerning this communication or earlier communications from the
`
`Conclusion
`
`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: 15/046,322
`
`Page 7
`
`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 ht'gy’lpair-
`
`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.
`
`/REI-TSANG SHIAO/
`
`Rei-tsang Shiao, Ph.D.
`Primary Examiner
`Art Unit 1628
`
`May 25, 2016
`
`MYLAN - Ex. 1002, p. 10
`
`MYLAN - Ex. 1002, p. 10
`
`
`
`CERTIFICATE OF ELECTRONIC TRANSMISSION
`
`PATENT
`
`Attorney Docket No.: 064507—5014-US 17
`
`I hereby certify that this correspondence, including listed enclosures is
`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: MM
`Signed: fig 2%‘i‘7
`Peter Roidmaier
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In re application of:
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`Confirmation No.2 1076
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`Stephen Baker, et al.
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`Examiner: SHIAO, Rei Tsang
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`Application No.: 15/046,322
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`Art Unit: 1628
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`RESPONSE TO RESTRICTION
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`REQUIREMENT
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`Filed: February 17, 2016
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`For: BORON-CONTAINING SMALL
`MOLECULES
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`Customer No.: 43850
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`
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`Commissioner for Patents
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`PO. Box 1450
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`Alexandria, VA 22313-1450
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`Commissioner:
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`In response to the restriction requirement dated June 7, 2016, please enter the following
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`amendments and remarks.
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`Amendments to the specification begin on page 2 of this paper.
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`A listing of claims begins on page 4 of this paper.
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`Remarks are on page 9 of this paper.
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`1332/ 303377422
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`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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`
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`US. Pat. App. No. 15/046,322
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2 16
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`PATENT
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`Amendments tgtlre Specification:
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`Please replace the first paragraph in the application with the following:
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`CROSS-REFERENCE TO RELATED APPLKCATIONS
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`[0001]
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`The present application is a continuation of US. Patent Application No. 14/537,771,
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`filed November 10, 2014, which is a continuation of US. Patent Application No. 14/201,459,
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`filed March 7, 2014, now US. Patent No. 9,353,133, which is a continuation of US. Patent
`
`Application No. 13/356,488, filed January 23, 2012, now US. Patent No. 8,722,917, which is a
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`continuation of US Patent Application No. 12/629,753, filed December 2, 2009, now US.
`
`Patent No. 8,115,026, which is a divisional of US, Patent Application No. 11/505,591, filed
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`August 16, 2006, now US Patent No. 7,767,657, which claims the benefit of US. Provisional
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`Patent Application No. 60/755,227, filed December 30, 2005, and. the benefit of US. Provisional
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`Patent Application No. 60/746,361, filed May 3, 2006, all of which are incorporated by reference
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`in their entirety for all purposes. US. Patent Application No. 11/505,591 is also a continuation-
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`in-part of US. Patent Application No. 1 1/3 57,687, filed February 16, 2006, now US. Patent No.
`
`7,582,621, which claims the benefit of US. Provisional Patent Application No. 60/654,060, filed
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`February 16, 2005, all of which are incorporated by reference in their entirety for all purposes.
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`The present application is also a continuation-in-part of US. Patent Application No. 13/874,329,
`
`filed April 30, 2013, now US, Patent No, 8,889,656, which is .. continuation of US. Patent
`
`Application No. 13/224,252, filed September 1, 2011, now US. Patent No. 8,440,642, which is a
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`continuation of US. Patent Application No. 12/507,010, filed July 21, 2009, now US. Patent
`
`No. 8,039,451, which is a continuation of US. Patent Application No. 11/357,687, filed
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`February 16, 2006, now US. Patent No. 7,582,621, which claims the benefit of 60/654,060, filed
`
`February 16, 2005, all of which are incorporated by reference in their entirety for all purposes.
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`Page 2 of9
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`MYLAN - Ex. 1002, p. 12
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`MYLAN - Ex. 1002, p. 12
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`
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`U.S. Pat. App. No. 15/046,322
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2016
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`PATENT
`
`Version showing changes made:
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`The present application is a continuation of U.S. Patent Application No. 14/537,771,
`
`filed November 10, 2014, which is a continuation of U.S. Patent Application No. 14/201,459,
`
`
`filed March 7, 2014, now U.S. Patent No. 9 353 133 which is a continuation of U.S. Patent
`
`Application No. 13/3 56,488, filed January 23, 2012, now U.S. Patent No. 8,722,917, which is a
`
`continuation of U.S. Patent Application No. 12/629,753, filed December 2, 2009, now U.S.
`
`Patent No. 8,115,026, which is a divisional of U.S. Patent Application No. 11/505,591 , filed
`
`August 16, 2006, now U.S. Patent No. 7,767,657, which claims the benefit of U.S. Provisional
`
`Patent Application No. 60/755,227, filed December 30, 2005, and the benefit of U.S. Provisional
`
`Patent Application No. 60/746,361, filed May 3, 2006, all of which are incorporated by reference
`
`in their entirety for all purposes. U.S. Patent Application No. 1 1/505,591 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.
`
`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.
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`Page 3 of9
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`MYLAN - Ex. 1002, p. 13
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`MYLAN - Ex. 1002, p. 13
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`
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`US. Pat. App, No. 15/046,322
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2016
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`PATENT
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`Listing of Claims:
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`1.
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`(Original) A pharmaceutical formulation, comprising:
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`1,3-dihydro—5-fluoro-l-hydroxy-2,l—benzoxaborole, or a pharmaceutically acceptable salt
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`a pharmaceutically acceptable topical carrier.
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`2.
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`(Original) The pharmaceutical formulation of claim 1, wherein the
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`pharmaceutically acceptable topical carrier comprises one or more members selected from
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`polymers, thickeners, buffers, neutralizers, chelating agents, preservatives, surfactants or
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`emulsifiers, antioxidants, waxes or oils, emollients, sunscreens, and a solvent or mixed solvent
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`system.
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`3.
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`(Original) The pharmaceutical formulation of claim 1, wherein the
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`pharmaceutically acceptable topical carrier comprises a solvent system and a chelating agent;
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`wherein the solvent system comprises ethanol and propylene glycol; and wherein
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`the chelating agent is ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable
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`salt thereof.
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`4.
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`(Original) A pharmaceutical formulation, comprising:
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`1,3udihydro—5—fluoro-l-hydroxy-2,1—benzoxaborole, or a pharmaceutically acceptable salt
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`thereof;
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`a solvent system and
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`a chelating agent.
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`5.
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`(Original) The pharmaceutical formulation of claim 4, wherein the
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`solvent system comprises ethanol.
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`6.
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`(Original) The pharmaceutical formulation of claim 4, wherein the
`
`l\)
`
`U]4;b.)[\JU]4hU.)[\DD—‘Lu
`
`)_.u
`
`MJ>WN
`
`2
`
`Ix.)
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`Page 4 of9
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`MYLAN - Ex. 1002, p. 14
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`MYLAN - Ex. 1002, p. 14
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`
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`US. Pat. App. No. 15/046,322
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2016
`
`PATENT
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`7.
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`(Original) The pharmaceutical formulation of claim 4, wherein the
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`solvent system comprises ethanol and propylene glycol.
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`8.
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`(Original) The pharmaceutical formulation of claim 4, wherein the
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`chelating agent is ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt
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`thereof.
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`9.
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`(Original) The pharmaceutical formulation of claim 8, wherein the
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`ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof, is
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`present in a concentration of from about 0.005% to about 2.0% w/w.
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`10.
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`(Original) The pharmaceutical formulation of claim 4, wherein the 1,3-
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`dihydro—5-fluoro—1-hydroxy—2,1-benzoxaborole, or a pharmaceutically acceptable salt thereof, is
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`present in a concentration of about 5% w/w.
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`11.
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`(Original) The pharmaceutical formulation of claim 4, wherein the
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`formulation is suitable for the treatment of onychomycosis of a toenail due to Trichophyton
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`rubrum or Trichophyton mentagrophytes by topical application of the formulation to the toenail.
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`12.
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`(Original) A pharmaceutical formulation, comprising:
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`about 5% w/w 1,3—dihydro—5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically
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`acceptable salt thereof;
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`propylene glycol;
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`ethanol; and
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`ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof.
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`13.
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`(Original) The pharmaceutical formulation of claim 12, wherein the
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`formulation is suitable for the treatment of onychomycosis of a toenail due to Trichophyton
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`rubrum or Trichophyton mentagrophytes by topical application of the formulation to the toenail.
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`ONU‘I-PUJNH
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`Page 5 of9
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`MYLAN - Ex. 1002, p. 15
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`MYLAN - Ex. 1002, p. 15
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`
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`US. Pat. App. No. 15/046,322
`Response dated June 27. 2016
`Response to Restriction Requirement dated June 7, 20l6
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`PATENT
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`14.
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`(Original) The phannaceutical formulation of claim 123 wherein the
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`ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof, is
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`present in a concentration of from about 0.005% to about 2.0% w/w.
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`1.5.
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`(Original) The pharmaceutical formulation of claim 14, wherein the
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`formulation is suitable for the treatment of onychomycosis of a toenail due to Trichophyton
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`rubrum or Trichophyton mentagrophytes by topical application of the formulation to the toenail.
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`16.
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`(Original) A method of treating a human having onychomycosis of a
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`toenail due to Trichophyton rubrum,
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`said method comprising topically administering a therapeutically effective amount of the
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`pharmaceutical formulation of claim 1 to the toenail.
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`17.
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`(Original) A method of treating a human having onychomycosis of a
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`toenail due to Trichophyton mentagrophytes,
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`said method comprising topically administering a therapeutically effective amount of the
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`pharmaceutical formulation of claim 1 to the toenail.
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`18.
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`(Original) A method of treating a human having onychomycosis of a
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`toenail due to Trichophyton rubrum or Trichophyton mentagrophytes,
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`said method comprising topically administering a therapeutically effective amount of the
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`pharmaceutical formulation of claim 1 to the toenail.
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`19.
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`(Original) A method of treating a human having onychomycosis of a
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`toenail due to Trichophylon rubrumi
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`said method comprising topically administering a therapeutically effective amount of the
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`pharmaceutical formulation of claim 4 to the toenail.
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`NHAWNAWN
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`b93
`
`#WNH
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`Page 6 of9
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`MYLAN - Ex. 1002, p. 16
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`MYLAN - Ex. 1002, p. 16
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`
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`US. Pat. App. No. 15/046,322
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2016
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`PATENT
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`20.
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`(Origina