PTO/AlA/15(03-13)
`Approved for use through 01/31/2014. OMB 0651—0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Pa erwork Reduction Act of 1995 no ersons are re-uired to resond to a collection of information unless it dis-la s a valid OMB control number
`
`
`
`UTILITY
`PATENT APPLICATION
`
`0645075014 ”52.0
`Stephen J Baker
`
`
`
`
`
`
`
`
`
`TRANSMITTAL
`BORON-CONTAINING SMALL MOLECULES
`
`(Onlyfornew nonprovisiona/ applications under 37 CFR l.53(b))
`Express MG” Labe/ No'_
`
`
`APPLICATION ELEMENTS
`Commissioner for Patents
`
`
`See MPEP chapter 600 concerning utility patent application contents.
`ADDRESS T0:
`P~0- BOX 1450
`
`
`
`Alexandria, VA 22313-1450
`Fee Transmittal Form
`
`(PTO/SB/17 or equivalent)
`ACCOMPANYING APPLICATION PAPERS
`
`
`2. (1 Applicant asserts small entity status.
`10- I: Assignment Papers
`See 37 CFR 1.27
`(cover sheet & document(s))
`Name of Assignee
` 3. (1 Applicant certifies micro entity status. See 37 CFR 1.29.
`
`
`Applicant must attach form PTO/SB/15A or B or equivalent.
`
`
`4. I Specification
`[Total Pages 316
`37 CFR 3.73(c) Statement
`(1 Power of Attorney
`Both the claims and abstract must start on a new page.
`(when there is an assignee)
`English Translation Document
`(See MPEP § 608.01la)for information on the preferred arrangement)
`(if applicable)
`5.. Drawing(s) (35 U.S.C. 113)
`[Toto/Sheets 53
`]
`6. Inventor's Oath or Declaration
`[Total Pages
`]
`Information Disclosure Statement
`(including substitute statements under 37 CFR 1.64 and assignments
`(PTO/SB/08 or PTO—1449)
`serving as an oath or declaration under 37 CFR 1.63(e))
`
`
`
`
`
`
`
`
`
`a. (:l Newly executed (original or copy)
`b. [j A copy from a prior application (37 CFR 1.63(d))
`Application Data Sheet
`"See note below.
`See 37 CFR 1.76 (PTO/AlA/14 or equivalent)
`CD-ROM or CD—R
`
`7.
`
`8.
`
`]
`
`EDD
`
`11.
`
`12
`
`13.
`
`._tP
`
`Dalia
`
`16.
`
`17
`
`(1 Copies of citations attached
`Preliminary Amendment
`Return Receipt Postcard
`(MPEP § 503) (Should be specifically itemized)
`Certified Copy of Priority Document(s)
`(ifforeign priority is claimed)
`Nonpublication Request
`Under 35 U.S.C. 122(b)(2)(B)(i). Applicant must attach form PTO/SB/35
`or equivalent.
`
`other: *Request To Use Computer Form of Sequence Listing
`
`From Another Application Under 37 C.F.R. § 1.821(e);
`
`*Requesi For Prioritized Examination
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`in duplicate, large table, or Computer Program (Appendix)
`(:I Landscape Table on CD
` 9. Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. — c. are required)
`
`
`
`
`
`
`
`
` *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 filed under 35 U.S.C. 111, the application must contain an ADS specifying the applicant ifthe applicant is an
`
`
`assignee, person to whom the inventor is under an obligation to assign, or person who otherwise shows sufficient proprietary
`
`
`
`interest in the matter. See 37 CFR 1.46(b).
`19. CORRESPONDENCE ADDRESS
`
`
`
`
`
` I: The address associated with Customer Number: 43850
`OR (: Correspondence address below
`
` Name
`
`Address
`
`
`18.
`
`I
`
`a. (3 Computer Readable Form (CRF)
`b.
`Specification Sequence Listing on:
`
`i. [1 CD-ROM or CD-R (2 copies); or
`ii.
`Paper
`Statements verifying identity of above copies
`
`c.
`
`City __— zipcode
`
`Country- Telephone—_
`
`
`
`
`
`Registration No.
`Name
`
`
`
`46,690
`Todd Esker
`(Print/Type)
`
`
`
`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 111 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, P.O. Box 1450, Alexandria, VA 22313—1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TO: Commissioner for Patents, P.0. Box 1450, Alexandria, VA 22313-1450.
`if you 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
`
`

`

`Doc Code: TRACK1.REQ
`
`Document Description: TrackOne Request
`
`PTO/AIA/424 (04-14)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(9) (Page 1 of 1)
`
`BORON-CONTAINING SMALL MOLECULES
`
`.
`
`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(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.
`
`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:
`
`Ori-inal A lication Track One - Prioritized Examination under ~ 1.102 e 1
`
`i.
`
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111( ).
`This certification and request is being filed with the utility application via EFS-Web.
`___QR___
`
`(b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111( ).
`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.
`
`ll.
`
`Request for Continued Examination - Prioritized Examination under § 1.1 029112)
`
`A request for continued examination has been filed with, or prior to, this form.
`lfthe application is a utility application, this certification and request is being filed via EFS—Web.
`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).
`
`Practitioner
`Reistration Number
`
`
`
`This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d)
`Note:
`
`Submit multile forms if more than one sinature is required. *
`
`for signature requirements and certifications.
`
`forms are submitted.
`
`MYLAN - Ex. 1002, p. 2
`
`MYLAN - Ex. 1002, p. 2
`
`

`

` vs! “111%
`\.\_:
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMNHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`15/134,286
`
`04/20/2016
`
`Stephen J. BAKER
`
`064507—5014—US20
`
`5251
`
`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.
` 15/134,286 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 4/20/2016.
`|:| 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
`
`; the restriction requirement and election have been incorporated into this action.
`
`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`
`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)IZI Claim(s) 1-29 is/are pending in the application.
`5a) Of the above cIaim(s)
`is/are withdrawn from consideration.
`
`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 -29 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
`
`.
`,
`.
`MYLANartoEaQer qmgatpeofiosm
`
`MYLAN - Ex. 1002, p. 4
`
`

`

`Application/Control Number: 15/134,286
`
`Page 2
`
`Art Unit: 1628
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`1.
`
`Claims 1-29 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
`
`inventions of a broad statutory category (e.g. Compounds, Methods of Use, Methods of
`
`Making, etc.):
`
`I. Claims 1-12, drawn to methods of use, classified in classes 514/558, numerous
`
`subclasses.
`
`ll. Claims 13-29, drawn to methods of use, classified in classes 514/558, numerous
`
`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
`
`

`

`Application/Control Number: 15/134,286
`
`Page 3
`
`Art Unit: 1628
`
`restriction of a Markush group is proper where the compounds within the group either
`
`(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
`
`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
`
`MYLAN - EX. 1002, p. 6
`
`MYLAN - Ex. 1002, p. 6
`
`

`

`Application/Control Number: 15/134,286
`
`Page 4
`
`Art Unit: 1628
`
`application. Any amendment of inventorship must be accompanied by a 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
`
`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
`
`MYLAN - Ex. 1002, p. 7
`
`

`

`Application/Control Number: 15/134,286
`
`Page 5
`
`Art Unit: 1628
`
`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
`
`

`

`Application/Control Number: 15/134,286
`
`Page 6
`
`Art Unit: 1628
`
`The election of an invention may be made with or without traverse. To reserve a
`
`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: 15/134,286
`
`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 23, 2016
`
`MYLAN - Ex. 1002, p. 10
`
`MYLAN - Ex. 1002, p. 10
`
`

`

`CERTIFICATE OF ELECTRONIC TRANSMISSION
`
`PATENT
`
`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:
`
`O/V'V‘z 2? 20/6
`
`We"""""""
`Peter Roidmaier
`
`Attorney Docket No.: 064507—5014-US20
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`,
`
`Confirmation No.: 5251
`
`Stephen Baker, et al.
`
`Application No.: 15/134,286
`
`Filed: April 20, 2016
`
`For: BORON-CONTAINING SMALL
`MOLECULES
`
`
`
`Examiner: SHIAO, Rei Tsang
`
`Art Unit: 1628
`
`RESPONSE TO RESTRICTION
`
`REQUIREMENT
`
`Customer No.: 43850
`
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313 —1450
`
`Commissioner:
`
`In response to the restriction requirement dated June 7, 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 of this paper.
`
`Remarks are on page 8 of this paper.
`
`DB2/30337748.2
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`Page 1 0f8
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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. 15/134,286
`Response dated June 27, 2016
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`PATENT
`
`Amendments to the Specification:
`
`Please replace the first paragraph in the application with the following:
`
`CROSS—REFERENCE TO RELATED APPLICATIONS
`
`plicwtion is a continuwtion of JS. P..tentApp1111'1cation 110. 15/091,394,
`
`.1led April 5, 2016, which is a continuation of US. Patent Application No. 15/068,352, filed
`
`March1 12016 which1s a continuation of US Patent Application No. 15/046,322, filed on
`
`February 17, 2016, whichis a continuation of US. Patent Application No. 14/537,771, filed
`
`November 10, 2014, which is a continuation of US. Patent Application No. 14/201,459, 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
`
`continuation of US. Patent Application No. 12/6'2973,5 filed December 2, 2009, now U. S.
`
`Patent No. 8,115,026, which is a divisional of US. Patent Application No. 1 1/505,591, filed
`
`August 16, 2006, now US. Patent No. 7,767,657, which claims the benefit of US. Provisional
`
`Patent Application No. 60/755,227, filed December 30, 2005, and the benefit of US. Provisional
`
`Patent Application No. 60/746,361, filed May 3, 2006, all of which are incorporated by reference
`
`in their entirety for all purposes. US. Patent Application No. 11/505,591 is also a continuation—
`
`in—part of US. Patent Application No. 11/357,687, filed February 16, 2006, now US. Patent No.
`
`7,582,621, which claims the benefit ofU.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 US. Patent Application No. 13/874,329,
`
`filed April 30, 2013, now US. Patent No. 8,889,656, which is a continuation of US. Patent
`
`Application No. 13/224,252, filed September 1, 2011, now US. Patent No. 8,440,642, which is a
`
`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
`
`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.
`
`Page 2 of8
`
`MYLAN - Ex. 1002, p. 12
`
`MYLAN - Ex. 1002, p. 12
`
`

`

`U.S. Pat. App. No. 15/134,286
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2016
`
`PATENT
`
`Version showing changes made:
`
`CROSS—REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`The present application is a continuation of U.S. Patent Application No. 15/091,394,
`
`filed April 5, 2016, which is a continuation of U.S. Patent Application No. 15/068,3 52, 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
`
`November 10, 2014, whichiis 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. 1 1/505,591, filed
`
`August 16, 2006, now U.S. Patent No. 7,767,657, which claims the benefit of U.S. Provisional
`
`Patent Application No. 60/755,227, filed December 30, 2005, 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. 1 1/357,687, 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.
`
`Page 3 of8
`
`MYLAN - Ex. 1002, p. 13
`
`MYLAN - Ex. 1002, p. 13
`
`

`

`
`
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`
`US. Pat. App. No. 15/134,286
`Response dated June 27, 2016
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`Response to RCStilCLiUu L\CU1‘L111”0111€11L dated June I , 2uru
`
`PATENT
`
`Listing of Claims:
`
`1.
`
`(Original) A method of treating a human having onychomycosis of a
`
`toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes, the method
`
`topically administering to the toenail a pharmaceutical composition comprising an
`
`amount of 1,3-dihydro—5-‘1uoro-l -hydroxy—2,l-benzoxaborole or a pharmaceutically acceptable
`
`salt thereof, effective to inhibit an aminoacyl tRNA synthetase in the Trichophyton rubrum or
`
`Trichophyton mentagrophytes.
`
`2.
`
`(Original) The method of claim 1, wherein the pharmaceutical
`
`““J
`composition is in the form of a solution comprising 5% w/w of l,3-dihydroa5—fluorowlwhvdroxy-
`
`2,1-benzoxaborole or a phannaceutically acceptable sal‘ thereof.
`
`3.
`
`(Original) The method of claim 1, wherein the pharmaceutical
`
`composition further comprises ethanol and propylene glycol.
`
`4.
`
`(Original) The method of claim 1, wherein the aminoaeyl tRN
`
`A
`
`synthetase is leucyl tRNA synthetase.
`
`5.
`
`(Original) The method of claim 4, wherein the pharmaceutical
`
`composition is in the form of a solution comprising 5% w/w of 1,3—dihydro-5—fluoro-l ~hydroxy—
`
`2,1-benzoxaborole or a pharmaceutically acceptable salt thereof.
`
`6.
`
`(Original) The method of claim 5, wherein the pharmaceutical
`
`composition further comprises ethanol and propylene glycol.
`
`7.
`
`(Original) The method of claim 1, wherein the administering of the
`
`pharmaceutical composition occurs once a day.
`
`8.
`
`(Original)
`
`’1"
`1
`
`he method of claim 6, wherein the administering of the
`
`pharmaceutical composition occurs once a day.
`
`Page 4 of8
`
`MYLAN - Ex. 1002, p. 14
`
`MYLAN - Ex. 1002, p. 14
`
`

`

`US. Pat. App. No. 15/134,286
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2016
`
`PATENT
`
`9.
`
`(Original) The method of claim 1, wherein the method inhibits an
`
`aminoacyl tRNA synthetase in Trichophyton rubrum.
`
`10.
`
`(Original) The method of claim 1, wherein the method inhibits an
`
`aminoacyl tRNA synthetase in Trichophyton mentagrophytes.
`
`11.
`
`(Original) The method of claim 6, wherein the method inhibits leucyl
`
`tRNA synthetase in Trichophyton rubrum.
`
`12.
`
`(Original) The method of claim 6, wherein the method inhibits leucyl
`
`tRNA synthetase in Trichophyton mentagrophytes.
`
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`
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`
`13.
`
`(Original) A method of inhibiting an aminoacyl tRNA synthetase in
`
`Trichophyton rubrum or Trichophyton mentagrophytes, the method comprising:
`
`contacting the Trichophyton rubrum or Trichophyton mentagrophytes with an
`
`amount of 1,3-dihydro—5—fluoro—1-hydroxy-2,1‘-benzoxaborole or a pharmaceutically acceptable
`
`salt thereof effective to inhibit the aminoacyl tRNA synthetase in the Trichophyton rubrum or
`
`Trichophyton mentagrophytes,
`
`wherein the Trichophyton rubrum or Trichophyton mentagrophytes is in a human
`
`toenail unit.
`
`14.
`
`(Original) The method of claim 13, wherein the contacting is achieved by
`
`topically administering to the human toenail unit a pharmaceutical composition comprising
`
`ethanol, propylene glycol, and 1,3-dihydro-5—fluoro—1-hydroxy-2,1—benzoxaborole or a
`
`pharmaceutically acceptable salt thereof.
`
`15.
`
`(Original) The method of claim 14, wherein the pharmaceutical
`
`composition is in the form of a solution comprising 5% w/w of 1,3-dihydro—5—fluoro-1—hydroxy-
`
`2,1-benzoxaborole or a pharmaceutically acceptable salt thereof.
`
`Page 5 of8
`
`MYLAN - Ex. 1002, p. 15
`
`MYLAN - Ex. 1002, p. 15
`
`

`

`US. Pat= App. No. 15/134,286
`Response dated June 27, 2016
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`PATENT
`
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`
`16.
`
`(Original) The method of claim 13, wherein the aminoacyl tRNA
`
`synthetase is leucyl tRNA synthetase.
`
`17.
`
`(Original) The method of claim 13, wherein onychomycosis of the human
`
`toenail unit due to Trichophyton rubrum or Trichophyton mentagrophytes is treated.
`
`18.
`
`(Original) The method of claim 14, wherein onychomycosis of the human
`
`toenail unit due to Trichophyton rubrum or Trichophyton mentagrophytes is treated.
`
`19.
`
`(Original) The method of claim 14, wherein the topical administering of
`
`the pharmaceutical composition occurs once a day.
`
`20.,
`
`(Original) The method of claim 18, wherein the topical administering of
`
`the pharmaceutical composition occurs once a day.
`
`21.
`
`(Original) The method of claim 14, wherein the Trichophyton rubrum or
`
`Trichophyton mentagrophytes is in a nail plate of the human toenail unit.
`
`22.
`
`(Original) The method of claim 14, wherein the Trichophyton rubrum or
`
`Trichophyton mentagrophytes is in a nail bed of the human. toenail unit.
`
`23.
`
`(Original) The method of claim 14, wherein the 1,3»«dihydrow5mfluorowlm
`
`hydroxy—2,l-benzoxaborole or the pharmaceutically acceptable salt thereof is delivered into a
`
`nail plate of the human toenail unit.
`
`24.
`
`(