PTO/AIA/15 (03-13)
`Approvedfor use through 01/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995 no persons are required to respondto a collection of information unlessit displays a valid OMB control number
`
`uTiury
`
`PATENT APPLICATION
`
`
`
`
`
`
`
`
`
`
`
`
`TRANSMITTAL
`
`[enressmantotetno|
`(Onlyfornewnonprovisionalapplications under37CFR 1.93(b))
`
`
`
`
`APPLICATION ELEMENTS
`Commissioner for Patents
`
`
`See MPEP chapter 600 concerningutility patent application contents.
`A DDRESS TO:
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`1.|_| Fee Transmittal Form
`ACCOMPANYING APPLICATION PAPERS
`
`(PTO/SB/17 or equivalent)
`
`
`2.|__| Applicant asserts smallentity status.
`10. | Assignment Papers
`
`
`See 37 CFR 1.27
`(cover sheet & document(s))
`
`Name of Assignee
`
`3,
`Applicantcertifies micro entity status. See 37 CFR 1.29.
`
`
`
`
`Applicant must attach form PTO/SB/15A or B or equivalent.
`
`
`
`
`4.|¥|Specification [Total Pages 316 ] 11.|__| 37 CFR 3.73(c) Statement [| Powerof Attorney
`
`
`
`
`Both the claims and abstract must start on a new page.
`(whenthere is an assignee)
`
`(See MPEP § 608.01(a)for information on the preferred arrangement)
`12
`English Translation Document
`
`
`
`
`5.|¥|Drawing(s) (35 U.S.C. 113) [Total Sheets 63 | (ifapplicable)
`
`
`
`
`
`
`6. Inventor's Oath or Declaration ]|13. |__| Information Disclosure Statement[Total Pages
`
`
`(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))
`
` [| Copiesof citations attached
`
`
`
`
`
`
`
`
`a.| | Newly executed(original or copy) 14. |v|Preliminary Amendment
`
`
`
`b.| | A copy fromaprior application (37 CFR 1.63(d)) 15.[__] Return Receipt Postcard
`
`7. [v] Application Data Sheet
`* See note below.
`(MPEP § 503) (Should be specifically itemized)
`
`
`See 37 CFR 1.76 (PTO/AIA/14 orequivalent)
`16.|__| Certified Copy of Priority Document(s)
`
`CD-ROM or CD-R
`(ifforeign priority is claimed)
`
`
`
`
`
`in duplicate, large table, or Computer Program (Appendix)
`17, [| Nonpublication Request
`L_| Landscape Table on CD
`Under 35 U.S.C. 122(b)(2}(B)(i). Applicant must attach form PTO/SB/35
`
`
`or equivalent.
`9. Nucleotide and/or Amino Acid Sequence Submission
`
`
`Other: “Request To Use Computer Readable Form of Sequence
`
`(if applicable, items a. —c. are required) 18.|v|
`
`
`Listing From Another Application Under 37 C.F.R. § 1.821(e);
`
`
`
`
`
`a.
`Computer Readable Form (CRF)
`
`b.[v]
`Specification SequenceListing on:
`RequestForPrioritized Examination.
`
`
`
`
`
`i. |_| CD-ROM or CD-R (2 copies); or
`
`
`|v|Paper
`
`
`c.| ¥|Statements verifying identity of above copies
`*Note:
`(1) Benefit claims under 37 CFR 1.78 and foreign priority claims under 1.55 must be includedin 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 theinventor is under an obligation to assign, or person who otherwise showssufficient proprietary
`interest in the matter. See 37 CFR 1.46(b).
`19. CORRESPONDENCE ADDRESS
`
`
`
`
`
`
`
`
`
`
`Address
`
`
`cy|—C~dYCState|
`| Telephone]
`Country
`
`
`ee
`Date
`Signature
`Fe b
`
`
`
`
`| 46:690
`(Print/Type) Todd Esker
`(Attorney/Agent)
`
`Name
`Registration No.
`
`
`
`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 whichis 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 amountof time you require to completethis form and/or suggestionsfor reducing this burden, should besent to the Chief information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce,P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMSTO THIS ADDRESS. SEND
`TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450,
`if you need assistance in completing the form, call 1-800-PTO-9199 andselect option 2.
`
`
`
`
`
`8.
`
`
`
`
`
`
`
`The address associated with Customer Number: 43850
`Name
`
`OR [| Correspondence address below
`
`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 REQUESTFOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`BORON-CONTAINING SMALL MOLECULES
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTSPRIORITIZED 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
`becausethat fee, set forth in 37 CFR 1.18(d), is currently $0. The basic filing fee, searchfee,
`and examination fee arefiled with the request or have been already been paid.
`| understand
`that any required excessclaims fees or application size fee must be paid for the application.
`| understand that the application may not contain, or be amendedto contain, more than four
`independentclaims, morethanthirty total claims, or any multiple dependentclaims, and that
`any request for an extension oftime will cause an outstanding Track | request to be dismissed.
`
`2.
`
`i.
`
`3. The applicable box is checked below:
`
`
`
`- Prioritized Examination under § 1.102(e)(1
`iqginal Application (Track One)
`(a) The application is an original nonprovisionalutility application filed under 35 U.S.C. 111(a).
`This certification and requestis being filed with theutility 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 beingfiled 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.
`Request for Continued Examination - Prioritized Examination under § 1.102(e)(2)
`ll.
`i. A request for continued examination has beenfiled with, or prior to, this form.
`ii.
`If the application is a utility application, this certification and requestis being filed via EFS-Web.
`iii. The application is an original nonprovisionalutility 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 requestis being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`v. No prior requestfor continued examination has been granted prioritized examination status
`under 37 CFR 1.102(e)(2).
`
`
`
`
`
`
`Signature js / £ ofOb en Date /€
`
`
`Name
`Practitioner
`Todd Esker
`46,690
`(Print/Typed)
`Registration Number
`Note:
`This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`Submit multiple formsif more than one signature is required.*
`[ *Total of
`
`forms are submitted.
`
`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.
`
`15/046,322
`
`02/17/2016
`
`Stephen J. BAKER
`
`064507-5014-US17
`
`1076
`
`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
`
`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 @ 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.
` 15/046,322 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 2/17/2016.
`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) Claim(s) 1-27 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) 1-27 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
`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 TOGDatppodoses
`
`Office Action Summary
`
`MYLAN - Ex. 1002, p. 4
`
`

`

`Application/Control Number: 15/046 ,322
`Art Unit: 1628
`
`Page 2
`
`The present application is being examined underthe pre-AlA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`1.
`
`Claims 1-27 are pending in the application.
`
`Election/Restriction
`
`2.
`
`The group setforth in the claims includes both independentanddistinct
`
`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 1-15, drawn to products, classified in classes 514/558, numerous
`
`subclasses.
`
`Il. Claims 16-27, 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: 15/046 ,322
`Art Unit: 1628
`
`Page 3
`
`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 diversethat 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-Il is required. Should applicant traverse
`
`on the ground that the compoundsarenot 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.
`
`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
`
`MYLAN- Ex. 1002, p. 6
`
`MYLAN - Ex. 1002, p. 6
`
`

`

`Application/Control Number: 15/046 ,322
`Art Unit: 1628
`
`Page 4
`
`application. Any amendmentof inventorship must be accompaniedby 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
`
`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
`
`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
`
`MYLAN- Ex. 1002, p. 7
`
`MYLAN - Ex. 1002, p. 7
`
`

`

`Application/Control Number: 15/046 ,322
`Art Unit: 1628
`
`Page 5
`
`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 moreof 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/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
`
`may betraversed (37 CFR 1.148) and(ii) identification of the claims encompassing
`
`the elected invention.
`
`MYLAN- Ex. 1002, p. 8
`
`MYLAN - Ex. 1002, p. 8
`
`

`

`Application/Control Number: 15/046 ,322
`Art Unit: 1628
`
`Page 6
`
`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 presentedat 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.
`
`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
`Art Unit: 1628
`
`Page 7
`
`the Patent Application Information Retrieval (PAIR) system. Status information
`
`for published applications may be obtained from either Private PAIR or Public
`
`PAIR. Status information for unpublished applications is available through
`
`Private PAIR only. For more information about the PAIR system, see http://pair-
`
`direct.uspto.gov. Should you have questions on accessto the Private PAIR system,
`
`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 25, 2016
`
`MYLAN - Ex. 1002, p. 10
`
`MYLAN - Ex. 1002, p. 10
`
`

`

`CERTIFICATE OF ELECTRONIC TRANSMISSION
`
`PATENT
`Attorney Docket No.: 064507-5014-US17
`
`[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:Sung22,200_
`Signed:
`
`Peter Roidmaier
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`Confirmation No.: 1076
`
`Stephen Baker,efal.
`
`Examiner: SHIAO,Rei Tsang
`
`Application No.: 15/046,322
`
`Art Unit: 1628
`
`RESPONSE TO RESTRICTION
`REQUIREMENT
`
`Filed: February 17, 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 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 ofthis paper.
`
`Remarks are on page 9 ofthis paper.
`
`DB2/ 30337742.2
`
`Page 1 of 9
`
`MYLAN- Ex. 1002, p. 11
`
`MYLAN - Ex. 1002, p. 11
`
`

`

`U.S. Pat. App. No. 15/046,322
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2016
`
`PATENT
`
`Amendments tothe Specification:
`
`Please replace the first paragraph in the application with the following:
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`‘The present application is a continuation of U.S. Patent Application No. 14/537,771,
`[0001]
`tiled November10, 2014, whichis 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, whichis 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,ali 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, whichis a continuation of U.S. Patent Application No. 11/357,687, filed
`February 16, 2006, now U.S. Patent No. 7,582,621, which claimsthe 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
`
`

`

`USS. Pat. App. No. 15/046,322
`Response dated June 27, 2016
`Responseto 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. 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, whichis a
`
`continuation of U.S. Patent Application No. 12/629,753, filed December 2, 2009, now U.S.
`
`Patent No. 8,115,026, which is a divisional of U.S. Patent Application No. 11/505,591, filed
`
`August 16, 2006, now U.S. Patent No. 7,767,657, which claims the benefit of U.S. Provisional
`
`Patent Application No. 60/755,227, filed 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 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, whichis 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. 15/046,322
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2016
`
`PATENT
`
`Listing of Claims:
`
`(Original) A pharmaceutical formulation, comprising:
`1,
`1,3-dihydro-5-fluoro-1-hydroxy-2, 1-benzoxaborole, or a pharmaceutically acceptable salt
`
`a pharmaceutically acceptable topical carrier.
`
`2.
`
`(Original) The pharmaceutical formulation of claim 1, wherein the
`
`pharmaceutically acceptable topical carrier comprises one or more members selected from
`polymers, thickeners, buffers, neutralizers, chelating agents, preservatives, surfactants or
`
`emulsifiers, antioxidants, waxes or oils, emollients, sunscreens, and a solvent or mixed solvent
`
`system.
`
`3.
`(Original) The pharmaceutical formulation of claim 1, wherein the
`pharmaceutically acceptable topical carrier comprises a solvent system anda chelating agent;
`wherein the solvent system comprises ethanol and propylene glycol; and wherein
`the chelating agent is ethylene diamine tetraacetic acid (EDTA)or a pharmaceutically acceptable
`salt thereof.
`
`(Original) A pharmaceutical formulation, comprising:
`4.
`1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically acceptablesalt
`thereof;
`
`a solvent system and
`
`a chelating agent.
`
`5.
`
`(Original) The pharmaceutical formulation of claim 4, wherein the
`
`solvent system comprises ethanol.
`
`6.
`
`(Original) The pharmaceutical formulation of claim 4, wherein the
`
`N20ee
`
`Qn
`
`—nmBPWwNO=nmBeWNOeenmBPWYNH
`
`No
`
`Page 4 of 9
`
`MYLAN- Ex. 1002, p. 14
`
`MYLAN - Ex. 1002, p. 14
`
`

`

`U.S. Pat. App. No. 15/046,322
`Response dated June 27, 2016
`Response to Restriction Requirement dated June 7, 2016
`
`PATENT
`
`7.
`
`(Original) The pharmaceutical formulation of claim 4, wherein the
`
`solvent system comprises ethanol and propylene glycol.
`
`8.
`
`(Original) The pharmaceutical formulation of claim 4, wherein the
`
`chelating agent is ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt
`
`thereof.
`
`9.
`
`(Original) The pharmaceutical formulation of claim 8, wherein the
`
`ethylene diamine tetraacetic acid (EDTA)or a pharmaceutically acceptable salt thereof, is
`
`present in a concentration of from about 0.005% to about 2.0% w/w.
`
`10.
`
`(Original) The pharmaceutical formulation of claim 4, wherein the 1,3-
`
`dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically acceptable salt thereof, is
`
`present in a concentration of about 5% w/w.
`
`11.
`
`(Original) The pharmaceutical formulation of claim 4, wherein the
`
`formulation is suitable for the treatment of onychomycosis of a toenail due to Trichophyton
`rubrum or Trichophyton mentagrophytes by topical application of the formulation to the toenail.
`
`12.
`
`(Original) A pharmaceutical formulation, comprising:
`
`about 5% w/w 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole, or a pharmaceutically
`
`acceptable salt thereof;
`
`propylene glycol;
`
`ethanol; and
`
`ethylene diamine tetraacetic acid (EDTA) or a pharmaceutically acceptable salt thereof.
`
`13.
`
`(Original) The pharmaceutical formulation of claim 12, wherein the
`
`formulation is suitable for the treatment of onychomycosis of a toenail due to Trichophyton
`
`rubrum ot Trichophyton mentagrophytes by topical application of the formulation to the toenail.
`
`NnAFBWNY
`
`—
`
`Page 5 of 9
`
`MYLAN- Ex. 1002, p. 15
`
`MYLAN - Ex. 1002, p. 15
`
`

`

`U.S. Pat. App. No. 15/046,322
`Response dated June 27, 2016
`ated att
`Response to Restriction Requirernent dated June 7, 2016
`
`PATENT
`
`14.
`
`(Original) The pharmaceutical formulation of claim 12, wherein the
`
`ethylene diamine tetraacetic acid (EDTA)or a pharmaceutically acceptable salt thereof,is
`
`present in a concentration of from about 0.005% to about 2.0% w/w.
`
`43.
`
`(Original) The pharmaceutical formulation of claim 14, wherein the
`
`formulation is suitable for the treatment of onychomycosisof a toenail due to Trichophyton
`rubrum or Trichophyton mentagrophytes by topical application of the formulation to the toenail.
`
`16.
`
`(Original) A method oftreating a human having onychomycosis of a
`
`toenail due to Trichophyton rubrum,
`
`said method comprising topically administering a therapeutically effective amount ofthe
`
`pharmaceutical formulation of claim 1 to the toenail.
`
`(Original) A method of treating a human having onychomycosis of a
`17.
`toenail due to Trichophyton mentagrophytes,
`
`said method comprising topically administering a therapeutically effective amountof the
`
`pharmaceutical formulation of claim 1 to the toenail.
`
`(Original) A method oftreating a human having onychomycosis of a
`18.
`toenail due to Trichophyton rubrum or Trichophyton mentagrophytes,
`
`said method comprising topically administering a therapeutically effective amount of the
`
`pharmaceutical formulation of claim 1 to the toenail.
`
`19.
`
`(Original) A method oftreating a human having onychomycosis of a
`
`toenail due to Trichophyton rubrum,
`
`said method comprising topically administering a therapeutically effective amountof the
`
`pharmaceutical formulation of claim 4 to the toenail.
`
`NoreWwWBLreWwWNY
`
`SeWw
`
`BhWwWN
`
`Page 6 of 9
`
`MYLAN- Ex. 1002, p. 16
`
`MYLAN - Ex. 1002, p. 16
`
`

`

`USS. Pat. App. No. 15/046,322
`Response dated June 27, 2016
`Responseto Restriction Requirement dated June 7, 2016
`
`PATENT
`
`20.
`
`(Original) A method oftreating a human having onychomycosis of a
`
`toenail due to Trichophyton mentagrophytes,
`
`said method comprising topically administering a therapeutically effective amountof the
`
`pharmaceutical formulation of claim 4 to the toenail.
`
`21.
`
`(Ori