`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMNHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`11/505,591
`
`ISSUE DATE
`
`08/03/2010
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`7767657
`
`064507—5014USOl
`
`5739
`
`43850
`
`7590
`
`07/14/2010
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`One Market, Spear Street Tower, Suite 2800
`San Francisco, CA 94105
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 348 day(s). Any patent to issue from the above—identified application will
`include an indication of the adjustment on the front page.
`
`If a Continued Prosecution Application (CPA) was filed in the above—identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information
`Retrieval (PAIR) WEB site (http://pair.uspto. gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the
`Office of Patent Legal Administration at (571)—272—7702. Questions relating to issue and publication fee
`payments should be directed to the Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)-272-4200.
`
`APPLICANT(S) (Please see PAIR WEB site http://pair.uspto. gov for additional applicants):
`
`Stephen J. Baker, Mountain View, CA;
`Tsutomu Akama, Sunnyvale, CA;
`Vincent S. Hernandez, Watsonville, CA;
`Karin M. Hold, Belmont, CA;
`Jacob J. Plattner, Orinda, CA;
`Virginia Sanders, San Francisco, CA;
`Yong-Kang Zhang, San Jose, CA;
`Kirk R. Maples, San Jose, CA;
`Gregory T. Fieldson, Morgantown, WV;
`
`IR103 (Rev. 10/09)
`
`MYLAN - EX. 1016, p.1
`
`MYLAN - Ex. 1016, p. 1
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 223 1 3- 1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`One Market, Spear Street Tower, Suite 2800
`San Francisco, CA 94105
`
`SHIAO’REITSANG
`
`1626
`DATE MAILED: 08/07/2009
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`08/16/2006
`11/505,591
`TITLE OF INVENTION: BORON—CONTAINING SMALL MOLECULES
`
`Stephen J. Baker
`
`064507—5014US01
`
`5739
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`YES
`
`$755
`
`$300
`
`$0
`
`$1055
`
`11/09/2009
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION fl THE MERITS E CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATUTORY PERIOD CANNOT fl EXTENDED.
`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`I. Review the SMALL ENTITY status shown above.
`
`If the SMALL ENTITY is shown as YES, verify your current
`SMALL ENTITY status:
`
`If the SMALL ENTITY is shown as NO:
`
`A. If the status is the same, pay the TOTAL FEE(S) DUE shown
`above.
`
`A. Pay TOTAL FEE(S) DUE shown above, or
`
`B. If the status above is to be removed, check box 5b on Part B -
`Fee(s) Transmittal and pay the PUBLICATION FEE (if required)
`and twice the amount of the ISSUE FEE shown above, or
`
`B. If applicant claimed SMALL ENTITY status before, or is now
`claiming SMALL ENTITY status, check box 5a on Part B - Fee(s)
`Transmittal and pay the PUBLICATION FEE (if required) and 1/2
`the ISSUE FEE shown above.
`
`II. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a
`request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL—85 (Rev. 08/07) Approved for use through 08/31/2010.
`
`Page 1 of 3
`
`MYLAN - EX. 1016, p. 2
`
`MYLAN - Ex. 1016, p. 2
`
`
`
`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: M_ail Mail Stop ISSUE FEE
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`or m (571)-273-2885
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
`propriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`fpdicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS" for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change ofaddress)
`
`43850
`
`7590
`
`08/07/2009
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`‘
`One Market Spear Street Tower’ 811116 2800
`San Fran01sco, CA 94105
`
`Note: A certificate of mailin can only be used for domestic mailings of the
`Fee(()s)Transmittal. This certi icate cannot be used for any other accompanying
`papers. Each additional paper such as an assignment or formal drawing, must
`ave 1ts own certificate of mailing or transmission.
`
`Certificate of Mailing or Transmission
`I hereby cerltify that thisfllfee(fsf) Transmittal isf be§ng deiposited 1with the UIiited
`States Posta Service wi
`su icient postage or
`irst c ass mai
`in an enve ope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273—2885, on the date indicated below.
`(Depositors name)
`
`
`
`(Signature)
`
`(Date)
`
`08/16/2006
`11/505,591
`TITLE OF INVENTION: BORON—CONTAINING SMALL MOLECULES
`
`Stephen J. Baker
`
`064507-5014US01
`
`5739
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`SHIAO, REI TSANG
`
`$755
`
`1626
`
`$300
`
`514—064000
`
`$1055
`
`11/09/2009
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`3 Change of correspondence address (or Change of Correspondence
`
`Address rom PTO/SB/ 122) attached.
`3 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03—02 or more recent) attached. Use of a Customer
`Number is required.
`
`2. For printing on the patent front page, list
`(1) the names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`(2) the name of a single firm (having as a member a
`2
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`
`
`3
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`If an assignee is identified below, the document has been filed for
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) :
`
`'3 Individual
`
`'3 Corporation or other private group entity '3 Government
`
`4a. The following fee(s) are submitted:
`3 Issue Fee
`
`3 Publication Fee (No small entity discount permitted)
`3 Advance Order — # of Copies
`
`
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`
`3 Payment by credit card. Form PTO—2038 is attached.
`3 The Director is hereby authorized to charge the required fee(s), any deficiency, or credit any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`
`
`5. Change in Entity Status (from status indicated above)
`:I b. Applicant is no longer claiming SMALL ENTITY status. See 37 CFR 1.27(g)(2).
`:I a. Applicant claims SMALL ENTITY status. See 37 CFR 1.27.
`NOTE: The Issue Fee and Publication Fee (if required) will not be accepted from anyone other than the applicant; a registered attorney or agent; or the assignee or other party in
`interest as shown by the records of the United States Patent and Trademark Office.
`
`Authorized Signature
`
`Typed or printed name
`
`
`Date
`
`Registration No.
`
`This collection of information1s required by 37 CFR 1.311. The information1s re uired to obtain or retain a benefit by the public which1s to file (and by the USPTO to process)
`an application. Confidentiality1s governedby 35 U.S.C. 122 and 37 CFR 1d14. T is collection1s estimated to take 12 minutes to complete, including gathering, preparlng, and
`submitting the completed application form to the USPTO. Time will v
`eendin 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
`edC ief In ormation Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O.
`Box 1450, Alexandria, Virginia 22313—1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, PO. Box 1450,
`Alexandria, Virginia 22313—1450.
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`PTOL—85 (Rev. 08/07) Approved for use through 08/31/2010.
`
`OMB 0651—0033
`
`MYLAN- EX. 1016
`U.S. Patent and Trademark Office; U.S.DEPARTM’EPT=3OF CONIMERCE
`
`MYLAN - Ex. 1016, p. 3
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 223 1 3- 1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/505,591
`
`08/16/2006
`
`Stephen J. Baker
`
`064507—5014USOl
`
`5739
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`One Market, Spear Street Tower, Suite 2800
`San Francisco, CA 94105
`
`SHIAO’REITSANG
`
`1626
`DATE MAILED: 08/07/2009
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment to date is 179 day(s). If the issue fee is paid on the date that is three months after the
`mailing date of this notice and the patent issues on the Tuesday before the date that is 28 weeks (six and a half
`months) after the mailing date of this notice, the Patent Term Adjustment will be 179 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the above—identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information Retrieval
`(PAIR) WEB site (http://pair.uspto.gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)—272—7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of
`the Office of Patent Publication at
`1—(888)—786—0101
`or
`(571)-272-4200.
`
`PTOL—85 (Rev. 08/07) Approved for use through 08/31/2010.
`
`Page 3 of 3
`
`MYLAN - EX. 1016, p. 4
`
`MYLAN - Ex. 1016, p. 4
`
`
`
`
`
`Notice of Allowability
`
`Application No.
`
`11/505,591
`Examiner
`
`Applicant(s)
`
`BAKER ET AL.
`Art Unit
`
`REI-TSANG SHIAO
`
`1626
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application.
`If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1. IXI This communication is responsive to amendment filed on 7/28/2009.
`
`
`2. IXI The allowed claim(s) is/are 121 and 193-215 now are 1-24.
`
`3. El Acknowledgment is made ofa claim forforeign priority under 35 U.S.C. § 119(a)—(d) or (f).
`a) D All
`b) D Some*
`0) El None
`of the:
`
`1. El Certified copies of the priority documents have been received.
`
`2. El Certified copies of the priority documents have been received in Application No.
`
`3. D 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)).
`
`* Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE” of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`4. D A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER’S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO-152) which gives reason(s) why the oath or declaration is deficient.
`
`5. El CORRECTED DRAWINGS (as “replacement sheets”) must be submitted.
`(a) D including changes required by the Notice of Draftsperson’s Patent Drawing Review ( PTO-948) attached
`
`
`1) D hereto or 2) D to Paper No./Mai| Date
`
`(b) D including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`
`Paper No./Mai| Date
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the front (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6. El DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. El Notice of References Cited (PTO-892)
`
`2. El Notice of Draftperson's Patent Drawing Review (PTO-948)
`
`3. El Information Disclosure Statements (PTO/SB/O8),
`Paper No./Mai| Date
`4. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`5. El Notice of Informal Patent Application
`
`6. El Interview Summary (PTO-413),
`Paper No./Mai| Date
`.
`7. El Examiner's Amendment/Comment
`
`8. IX Examiner's Statement of Reasons for Allowance
`
`9. D Other
`
`IREI-TSANG SHIAO/
`
`Primary Examiner, Art Unit 1626
`
`
`
`U.S. Patent and Trademark Office
`
`PTOL-37 (Rev. 08-06)
`
`Notice of Allowability
`
`Part of Pa er No./Mai| Da5te 20090729
`MYLAN-Ex.1)016, p5
`
`
`
`MYLAN - Ex. 1016, p. 5
`
`
`
`Application/Control Number: 11/505,591
`
`Page 2
`
`Art Unit: 1626
`
`DETAILED ACTION
`
`1.
`
`This application claims benefit of the provisional application:
`
`60/755,227 with a filing date 12/30/2005; and 60/746,361 with a filing date 05/03/2006.
`
`2.
`
`Amendment of claim 195, cancellation of claims 1-120 and 122-192, addition of
`
`claim 215, and request for a corrected filing receipt in the amendment filed on July 28,
`
`2009 is acknowledged. Claims 121 and 193-215 are pending in the application. No new
`
`matter is found. Since the newly added claim 215 is commensurate with the scope of
`
`the invention, claims 121 and 193-215 are prosecuted in the case.
`
`Reasons for Allowance
`
`3.
`
`The rejection of claim 195 under 35 U.S.C. 112, first paragraph has been
`
`overcome in the amendment filed on 7/28/2009.
`
`4.
`
`Applicant's arguments regarding the rejection of claims 121 and 193-214 under
`
`35 U.S.C. 103(a) over Austin et al. ‘188 in view of Austin et al. ‘024 filed on May 18,
`
`2009 have been fully considered and they are persuasive. Since Austin et al. ‘188
`
`does not disclose the instant pharmaceutical composition, therefore Austin et al. ‘188 is
`
`distinct from the instant invention. The rejection of claims 121 and 193-214 under 35
`
`U.S.C. 103(a) over Austin et al. ‘188 in view of Austin et al. ‘024 has been withdrawn
`
`herein.
`
`5.
`
`Claims 121 and 193-215 are neither anticipated nor rendered obvious over the
`
`art of record, and therefore are allowable. A suggestion for modification of above
`
`MYLAN - EX. 1016, p. 6
`
`MYLAN - Ex. 1016, p. 6
`
`
`
`Application/Control Number: 11/505,591
`
`Page 3
`
`Art Unit: 1626
`
`reference to obtain the instant pharmaceutical compositions has not been found.
`
`Claims 121 and 193-215 are allowed.
`
`Any comments considered necessary by applicant must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled “Comments on
`
`Statement of Reasons for Allowance”.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`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, Joseph K. McKane can be reached on (571) 272-0699. 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
`
`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 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
`
`MYLAN - Ex. 1016, p. 7
`
`MYLAN - Ex. 1016, p. 7
`
`
`
`Application/Control Number: 11/505,591
`
`Page 4
`
`Art Unit: 1626
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272—1000.
`
`/RE|—TSANG SHIAO/
`
`Primary Examiner, Art Unit 1626
`
`Julu 29, 2009
`
`MYLAN - EX. 1016, p. 8
`
`MYLAN - Ex. 1016, p. 8
`
`
`
`
`
`
`
`searCh Nate's
`
`
`
`Application/Control No.
`
`Applicant(s)lPatent under
`Reexamination
`
`11/505,591
`Examiner
`
`BAKER ET AL.
`Art Unit
`
`REI-TSANG SHIAO
`
`1626
`
`
`
`
`
`SEARCHED
`
`SEARCH NOTES
`
`(INCLUDING SEARCH STRATEGY)
`DATE
`
`EXMR
`
`7/29/2009
`EAST class/subclass
`
`7/29/2009
`
`7/29/2009
`
`
`
`
`
`7/29/2009
`
`
`
`
`INTERFERENCE SEARCHED
`
`288
`
`
`
`US. Patent and Trademark Office
`
`Part of Paper No. 20090729
`
`MYLAN - EX. 1016, p. 9
`
`
`
`MYLAN - Ex. 1016, p. 9
`
`
`
`EAST Search History
`
`EAST Search History
`
`EAST Search History (Prior Art)
`
`
`
`
`:DBs
`:Default
`" Ref Hits Search
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`:308 - :514/64
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`:2009/07/29
`
`
`:10:26
`
`7/ 29/ 2009 10:27:40 AM
`
`MYLAN - EX. 1016, p. 10
`file:///CI/Documents%20and%2OSettings/rshiao/My%20Docum...505591/EASTSearchHist0ry.11505591_AccessibleVersion.htm7/29/2009 10:27 :43 AM
`
`MYLAN - Ex. 1016, p. 10
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`Issue Classification
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`aggrggnagélgfent under
`A$r5|6c5atégqlControl No.
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`’
`BAKER ET AL.
`Examiner
`Art Unit
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`REI-TSANG SHIAO
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`1626
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`ISSUE CLASSIFICATION
`INTERNATIONAL CLASSIFICATION
`CLAIMED
`NON-CLAIMED
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`SUBCLASS
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`64
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`/69
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`IIIIIIIIIIIIIIIIIIIIIIm
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`IIIIIIIIIIIIIIIIIIIIIIW
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`Assistant Examiner
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`/Rei-tsang Shiao/
`7/29/09
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`(Legal Instruments Examiner)
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`(Date)
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`(Primary Examiner)
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`(Date)
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`0 G
`Print Fig.
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`NONE
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`El 30
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`4s \l
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`'
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`Original
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`I
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`Original
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`US. Patent and Trademark Office
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`MYLAN - Ex. 1016, p. 11
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`A
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`, UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BIB DATA SHEET
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`Page 1 of 2
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`www.u sptogov
`
`CONFIRMATION NO. 5739
`
`SERIAL NUMBER
`11/505591
`
`FILINSAC'I'IE 371(6)
`08/16/2006
`
`GROUP ART UNIT ATTORNEg DOCKET
`064507-5014USO1
`
`RULE
`
`APPLICANTS
`
`Stephen J. Baker, Mountain View, CA;
`Tsutomu Akama, Sunnyvale, CA;
`Michael Richard Kevin Alley, Santa Clara, CA;
`Steven J. Benkovic, State College, PA;
`Michael DiPierro, Wadsworth, IL;
`Vincent S. Hernandez, Watsonville, CA;
`Karin M. Hold, Belmont, CA;
`Isaac Kennedy, Bolingbrook, IL;
`Igor Likhotvorik, Naperville, IL;
`Weimin Mao, Sunnyvale, CA;
`Kirk R. Maples, San Jose, CA;
`Jacob J. Plattner, Berkeley, CA;
`Fernando Rock, Los Altos, CA;
`Virginia Sanders, San Francisco, CA;
`Aaron M. Stemphoski, Florence, SC;
`George Petros Yiannikouros, Florence, SC;
`Siead Zegar, Orland Park, IL;
`Yong-Kang Zhang, San Jose, CA;
`Huchen Zhou, Shanghai, CHINA;
`** CONTINUING DATA *************************
`
`This appln claims benefit of 60/755,227 12/30/2005
`and claims benefit of 60/746,361 05/03/2006
`and iS a CIP Of 11/357,687 02/16/2006 and Claims benefit of EEO/654,060 02/16/2005. R.8.
`
`** FOREIGN APPLICATIONS *************************
`UNITED STATES OF AMERICA PCT/U806/05542 02/16/2006
`
`** IF REQUIRED, FOREIGN FILING LICENSE GRANTED ** ** SMALL ENTITY **
`10/03/2006
`
`
`
`
`STATE OR
`COUNTRY
`
`SHEETS
`DRAWINGS
`
`TOTAL
`CLAIMS
`
`CA
`
`63 W
`
`INDEPENDENT
`CLAIMS
`21
`
`
`—I No
`Foreign Priority Claimed
`
`_I No
`35 USC 119(a—d) conditions met
`Verified and
`/REI-TSANG SHIAO/
`Acknowledged
`Examlner's Slgnature
`
`LI Mfgfigfige
`RS
`nItIa 8
`
`ADDRESS
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`One Market, Spear Street Tower, Suite 2800
`San Francisco, CA 94105
`UNITED STATES
`
`TITLE
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`Boron-containing small molecules
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`-— DA” Fees
`
`BIB (Rev. 05/07).
`
`MYLAN - EX. 1016, p. 12
`
`MYLAN - Ex. 1016, p. 12
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`
`
`FILING FEE FEES: Authority has been given in Paper
`RECE'VED No.
`to Charge/credit DEPOSIT ACCOUNT
`7845
`No.
`for following:
`
`31'16 Fees (ang)
`3 1.17 Fees (Processing Ext. of time)
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`Page 2 of 2
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`3 Credit
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`31.18 Fees (Issue)
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`3 Other
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`
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`BIB (Rev. 05/07).
`
`MYLAN - EX. 1016, p. 13
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`MYLAN - Ex. 1016, p. 13
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`
`
`Appl. No. 11/505,591
`Supplemental Response to Office Action dated January 27, 2009
`Response dated July 28, 2009
`
`PATENT
`
`Amendments to the Specification:
`
`Applicants respectfully request the first paragraph on page 1 of the application be
`
`replaced by the following paragraph which encompasses the information from the specification
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`filed on August 16, 2006, with the two priority applications claimed in the accepted Petition of
`
`March 5, 2007.
`
`[0001] The present application is a continuation-in-part of US. Patent
`Application 11/357,687 filed February 16, 2006, which claims the benefit of
`US. Provisional Patent Application 60/654,060 filed February 16, 2005, which
`is incorporated by reference in its entirety for all purposes. The present
`application claims the benefit of US. Provisional Patent Application 60/755,227
`filed December 30, 2005. The present application claims the benefit of US.
`Provisional Patent Application 60/746,361 filed May 3, 2006.
`
`,I’Rei Tsang Shiao/
`
`Entered
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`7/ 2 9/ O9
`
`Page2of10
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`_
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`MYLAN - EX. 1016, p. 14
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`MYLAN - Ex. 1016, p. 14
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`
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`CERTIFICATE OF ELECTRONIC TRANSMISSION
`
`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
`
`TrademarkOffice‘s Pate]Electr7nicBusinessCenteron:
`D...
`5 (6 I €
`Signed:
`lMMMI/fi ‘ @WL
`
`Candida Rubalcaba—Rivera
`
`Attorney Docket No.2 064507—5014—USOl
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`Confirmation No.: 5739
`
`Stephen J. BAKER, et al.
`
`Examiner: SHIAO, Rei Tsang
`
`Application No.: 11/505,591
`
`Art Unit: 1626
`
`Filed: August 16, 2006
`
`RESPONSE TO OFFICE ACTION
`
`For: BORON—CONTAINING SMALL
`MOLECULES
`
`Customer No.: 43850
`
`
`
`Commissioner for PatentS
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Madam:
`
`In reSponse to the Office Action dated January 27, 2009, please enter the
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`following amendments and remarkS.
`
`Amendments to the Claims are reflected in the listing of claimS which begins on page 2 of this
`paper.
`
`Remarks/Arguments begin on page 7 of this paper.
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`Page 1 of 12
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`MYLAN - EX. 1016, p. 15
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`MYLAN - Ex. 1016, p. 15
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`
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`Appl. No. 11/505,591
`Response to Office Action dated January 27, 2009
`Response dated May 14, 2009
`
`PATENT
`
`Amendments to the Claims:
`
`This listing of claims will replace all prior versions, and listings of claims in the application.
`
`Listing of Claims:
`
`1.-120. (Cancelled)
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`121.
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`(Previously presented) A pharmaceutical formulation, comprising:
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`(a) 1,3-dihydro-5-flu0ro-1-hydr0xy-2,1-benzoxab0role, or a salt thereof; and
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`(b) a pharmaceutically acceptable excipient
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`wherein said pharmaceutical formulation is for topical administration to an animal
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`suffering from an infection by a microorganism.
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`122. — 192. (Cancelled).
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`193. (Previously presented) The formulation of claim 121, wherein said
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`formulation is a member selected from a lacquer, lotion, cream, gel, ointment and spray.
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`194. (Previously presented) The formulation of claim 121, wherein said
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`formulation is a lacquer.
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`195. (Previously presented) The formulation of claim 121, wherein said
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`formulation further comprises one or more members selected from an emulsifier, emollient,
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`antioxidant, perservative, chelating agent, neutralizing agent, viscosity increasing agent, nail
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`penetration enhancer, anti-inflammatory agent, vitamin, anti-aging agent, sunscreen and acne-
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`treating agent.
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`196. (Previously presented) The formulation of claim 121, wherein said
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`formulation comprises one or more members selected from ethanol and propylene glycol.
`
`1
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`1
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`2
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`3
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`4
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`5
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`1
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`1
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`2
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`1
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`2
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`1
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`2
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`3
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`4
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`5
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`1
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`2
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`Page20f12
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`MYLAN - EX. 1016, p. 16
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`MYLAN - Ex. 1016, p. 16
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`
`
`Appl. No. 11/505,591
`Response to Office Action dated January 27, 2009
`Response dated May 14, 2009
`
`PATENT
`
`197. (Previously presented) The formulation of claim 121, comprising: about
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`propylene glycolzethanol in a ratio of about 1:4, and about 1:10 W volume of said 1,3-dihydro-
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`5-fluoro-1-hydroxy-2,1-benzoxaborole.
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`198. (Previously presented) The formulation of claim 121, comprising: about
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`70% ethanol; about 20% poly(vinyl methyl ether-alt-maleic acid monobutyl ester) and about
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`10% of said 1,3—dihydro—5—fluoro-1—hydroxy-2,1—benzoxaborole.
`
`199. (Previously presented) The formulation of claim 121, comprising: about
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`56% ethanol; about 14% water; about 15% poly(2-hydroxyethyl methacrylate); about 5% dibutyl
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`sebacate and about 10% of said 1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole.
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`200. (Previously presented) The formulation of claim 121, comprising: about
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`55% ethanol; about 15% ethyl acetate; about 15% poly(vinyl acetate); about 5% dibutyl sebacate
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`and about 10% 1,3—dihydro-5-fluoro—1—hydroxy—2,1-benzoxaborole.
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`201. (Previously presented) The formulation of claim 121, wherein said 1,3—
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`dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole is present in said formulation in a concentration
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`from about 0.5% to about 15% w/v.
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`hUJNo—t
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`202. (Previously presented) The formulation of claim 121, wherein said 1,3-
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`dihydro—5—fluoro—1-hydroxy—2,1—benzoxaborole, or salt thereof, is present in a form which is a
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`member selected from a hydrate with water, a solvate with an alcohol, an adduct with an amino
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`compound, and an adduct with an acid.
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`203. (Previously presented) The formulation of claim 121, wherein said
`
`formulation is in a cosmetically effective amount.
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`204. (Previously presented) The formulation of claim 121, wherein a site of said
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`topical administration is skin or nail or hair or skin surrounding the nail or skin surrounding the
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`hair.
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`Page 3 of 12
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`MYLAN - EX. 1016, p. 17
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`MYLAN - Ex. 1016, p. 17
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`
`
`Appl. No. 11/505,591
`Response to Office Action dated January 27, 2009
`Response dated May 14, 2009
`
`PATENT
`
`
`
`\IONUIAUJN\IONUIAUJNH
`
`UIAUJN
`
`205. (Previously presented) The formulation of claim 121, wherein the
`
`microorganism is a fungus or a yeast.
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`206. (Previously presented) The formulation of claim 205, wherein said fungus
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`or yeast is a member selected from Candida species, Trichophyton species, Microsporium
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`species, Aspergillus species, Cryptococcus species, Blastomyces species, Cocciodiodes species,
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`Histoplasma species, Paracoccidiodes species, Phycomycetes species, Malassezia species,
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`Fusarium species, Epidermophyton species, Scytalidium species, Scopulariopsis species,
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`Alternaria species, Penicillium species, Phialophora species, Rhizopus species, Scedosporium
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`species and Zygomycetes species.
`
`207. (Previously presented) The formulation of claim 205, wherein said fungus
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`or yeast is a member selected from Aspergilusfumigatus, Blastomyces dermatitidis, Candida
`
`albicans, Candida glabrata, Candida krusei, Cryptococcus neoformans, Candida parapsilosis,
`
`Candida tropicalis, Cocciodiodes immitis, Epidermophytonfloccosum, Fusarium solani,
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`Histoplasma capsulatum, Malasseziafurfur, Malassezia pachydermatis, Malassezia sympodialis,
`
`Microsporum audouinii, Microsporum canis, Microsporum gypseum, Paracoccidiodes
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`brasiliensis, Trichophyton mentagrophytes, Trichophyton rubrum and Trichophyton tonsurans.
`
`208. (Previously presented) The formulation of claim 205, wherein said fiJngus
`
`or yeast is a member selected from Trichophyton concentricum, Trichophyton violaceum,
`
`Trichophyton schoenleinii, Trichophyton verrucosum, Trichophyton soudanense, Microsporum
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`gypseum, Microsporum equinum, Candida guilliermondii, Malassezia globosa, Malassezia
`
`obtuse, Malassezia restricta, Malassezia sloofliae and A spergillusflavus.
`
`209. (Previously presented) The formulation of claim 205, wherein said fungus
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`or yeast is a dermatophyte.
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`210. (Previously presented) The formulation of claim 205, wherein said fungus
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`or yeast is a member selected from Tinea unguium, Trichophyton rubrum and Trichophyton
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`mentagrophytes.
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`Page4of12
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`MYLAN - EX. 1016, p. 18
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`MYLAN - Ex. 1016, p. 18
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`
`
`Appl. No. 11/505,591
`Response to Office Action dated January 27, 2009
`Response dated May 14, 2009
`
`PATENT
`
`211. (Previously presented) The formulation of claim 121, wherein the infection
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`is a cutaneous infection.
`
`212. (Previously presented) The formulation of claim 121, wherein the infection
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`is a member selected from an ungual, periungual and subungual infection.
`
`213. (Previously presented) The formulation of claim 121, wherein the infection
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`is onychomycosis.
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`214. (Previously presented) The formulation of claim 121, wherein the animal is
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`a human.
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`Page 5 of 12
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`MYLAN - EX. 1016, p. ’19
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`MYLAN - Ex. 1016, p. 19
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`
`
`Appl. No. 11/505,591
`Response to Office Action dated January 27, 2009
`Response dated May 14, 2009
`
`PATENT
`
`REMARKS/ARGUMENTS
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`I. Status at the Claims
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`Claims 121 and 193-214 are pending.
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`11. Resgonse to the Reiections
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`35 USC § 112,first paragraph
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`Claim 195 is rejected under 35 USC § 1 12, first paragraph, because the Examiner alleges
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`that while the specification enables a