`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMlVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`11/357,687
`
`ISSUE DATE
`
`09/01/2009
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`7582621
`
`064507—5014US
`
`4964
`
`43850
`
`7590
`
`08/12/2009
`
`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 267 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 Customer Service Center of the Office of Patent Publication 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;
`Carolyn Bellinger-Kawahara, Redwood City, CA;
`Vincent S. Hernandez, Watsonville, CA;
`Karin M. Hold, Belmont, CA;
`James J. Leyden, Malvern, PA;
`Kirk R. Maples, San Jose, CA;
`Jacob J. Plattner, Berkeley, CA;
`Virginia Sanders, San Francisco, CA;
`Yong-Kang Zhang, San Jose, CA;
`
`IR103(Rev.11/05)
`
`FIatWing EX. 1013, p. 1
`
`FlatWing Ex. 1013, 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
`Alexandria1 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: 04/22/2009
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`02/16/2006
`11/357,687
`TITLE OF INVENTION: BORON—CONTAINING SMALL MOLECULES
`
`Stephen J. Baker
`
`064507—5014US
`
`4964
`
`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
`
`07/22/2009
`
`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
`
`FIatWing Ex. 1013, p. 2
`
`FlatWing Ex. 1013, p. 2
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail 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
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`in icated 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
`
`04/22/2009
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`‘
`One Market Spear Street Towel" Su1te 2800
`San Fran01sco, CA 94105
`
`Note: A certificate of _mai1iI_1 _ can only be used for domestic mailings of _the
`Fee(s) Transmlttal. Th1s cert1 1cate cannot be used for any other accompanylng
`fiapers. Each additional paper, such as an assignment or formal drawmg, must
`ave its own certificate of mailing or transmission.
`
`Certificate of Mailing or Transmission
`I hereby cerltify that thideee(fsf) Transmittal isf being deposited 1with the Uriited
`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.
`(Depositor's name)
`
`
`
`(Signature)
`
`(Date)
`
`02/16/2006
`11/357,687
`TITLE OF INVENTION: BORON—CONTAINING SMALL MOLECULES
`
`Stephen J. Baker
`
`064507—5014US
`
`4964
`
`APPLN. TYPE
`
`SMALL ENTITY
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`YES
`
`SHIAO, REI TSANG
`
`$755
`
`1626
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`3 Chan e of correspondence address (or Change of Correspondence
`Address orm 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
`Vumber is required.
`
`
`
`$300
`
`$0
`
`$1055
`
`07/22/2009
`
`514—064000
`
`2. For printing on the patent front page, list
`(1) the names of up to 3 registered patent attorneys
`1
`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 information is required by 37 CFR 1.311. The information is re uired to obtain or retain a benefit by the public which is to file (and by the USPTO to process)
`an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. T is collection is estimated to take 12 minutes to complete, including gathering, preparing, and
`submitting the completed application form to the USPTO. Time will v
`de endin 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 toaltffe C ief In ormation Officer, US. Patent and Trademark Office, US. Department of Commerce, PO.
`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
`
`FIatWin EX. 1013
`US. Patent and Trademark Of
`e; U.S. DEPARTM’EgT OF COMMERCE
`
`FlatWing Ex. 1013, 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
`Alexandria1 Virginia 223 1 3- 1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11/357,687
`
`02/16/2006
`
`Stephen J. Baker
`
`064507—5014Us
`
`4964
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`One Market, Spear Street Tower, Suite 2800
`San Francisco, CA 94105
`
`SHIAO’REITSANG
`
`1626
`DATE MAILED: 04/22/2009
`
`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 267 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 267 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
`
`FIatWing Ex. 1013, p. 4
`
`FlatWing Ex. 1013, p. 4
`
`

`

`
`
`Notice of Allowability
`
`Application No.
`
`11/357,687
`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 1/23/2009.
`
`
`2. IZI The allowed claim(s) is/are 27-31 40 and 42-47 now are 1-12.
`
`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. 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)).
`
`* 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) I] including changes required by the Notice of Draftsperson’s Patent Drawing Review ( PTO-948) attached
`
`
`1) D hereto or 2) I] to Paper No./Mai| Date
`
`(b) I] 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/08),
`Paper No./Mai| Date
`4. I] Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`/REI-TSANG SHIAO/
`
`Primary Examiner, Art Unit 1626 U.S. Patent and Trademark Office
`
`5. El Notice of Informal Patent Application
`
`6. El Interview Summary (PTO-413),
`Paper No./Mai| Date
`.
`7. I] Examiner's Amendment/Comment
`
`8. X Examiner's Statement of Reasons for Allowance
`
`9. D Other
`
`PTOL-37 (Rev. 08-06)
`
`Notice of Allowability
`
`Part of Pafler No./Mai| Da5te 20090420
`FlatWing Ex. 013, p.
`
`
`
`FlatWing Ex. 1013, p. 5
`
`

`

`Application/Control Number: 11/357,687
`
`Page 2
`
`Art Unit: 1626
`
`DETAILED ACTION
`
`1.
`
`This application claims benefit of the provisional application:
`
`60/654,060 with a filing date 02/16/2005.
`
`2.
`
`Amendment of claims 27 and 40, cancellation of claims 1-26 and 32-39, 41, and
`
`addition of claims 43-47 in the amendment filed on January 23, 2009 is acknowledged.
`
`Claims 27-31, 40, and 42-47 are pending in the application. No new matter is found.
`
`Since the newly added claims 43-47 are commensurate with the scope of the invention,
`
`claims 27-31, 40, and 42-47 are prosecuted in the case.
`
`3.
`
`The rejection of claims 27-31, 40 and 42 under 35 U.S.C. 112, first paragraph
`
`Reasons for Allowance
`
`has been overcome in the amendment filed on January 23, 2009.
`
`4.
`
`Applicant's arguments regarding the rejection of claims 27-31, 40, and 42 under
`
`35 U.S.C. 103(a) over Austin et al. ‘024 in view of Answre.com filed on January 23,
`
`2009 have been fully considered and they are persuasive. Since Austin et al. ‘024 or
`
`Answre.com does not disclose the instant invention of methods of use for treating
`
`infection in an animal, therefor the instant invention is distinct from Austin et al. The
`
`rejection of claims 27-31, 40, and 42 under 35 U.S.C. 103(a) over Austin et al. ‘024 in
`
`view of Answre.com has been withdrawn herein. Since claim 41 has been canceled,
`
`the rejection of claim 41 under 35 U.S.C. 103(a) is obviated herein.
`
`5.
`
`Since claims 53-54 and 58 of Baker et al. co-pending application No. 11/505,591
`
`have been canceled, the provisional rejection of claims 27-31, 40, and 42 under the
`
`FlatWing Ex. 1013, p. 6
`
`FlatWing Ex. 1013, p. 6
`
`

`

`Application/Control Number: 11/357,687
`
`Page 3
`
`Art Unit: 1626
`
`obviousness-type double patenting over Baker et al. co-pending application No.
`
`11/505,591 has been withdrawn herein.
`
`6.
`
`Claims 27-31, 40, and 42-47 are neither anticipated nor rendered obvious over
`
`the art of record, and therefore are allowable. A suggestion for modification of above
`
`reference to obtain the instant methods of use has not been found. Claims 27-31, 40,
`
`and 42-47 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.
`
`FlatWing Ex. 1013, p. 7
`
`FlatWing Ex. 1013, p. 7
`
`

`

`Application/Control Number: 11/357,687
`
`Page 4
`
`Art Unit: 1626
`
`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
`
`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/
`
`Primary Examiner, Art Unit 1626
`
`April 20, 2009
`
`FlatWing Ex. 1013, p. 8
`
`FlatWing Ex. 1013, p. 8
`
`

`

`
`
`
`
`searCh Nate's
`
`
`
`
`
`
`
`Application/Control No.
`
`Applicant(s)lPatent under
`Reexamination
`
`11/357,687
`Examiner
`
`BAKER ET AL.
`Art Unit
`
`REI-TSANG SHIAO
`
`1626
`
`
`
`
`
`SEARCHED
`
`SEARCH NOTES
`
`(INCLUDING SEARCH STRATEGY)
`DATE
`
`EXMR
`
`4/20/2009
`EAST class/subclass
`
`4/20/2009
`
`4/20/2009
`
`
`
`
`
`4/20/2009
`
`
`
`
`INTERFERENCE SEARCHED
`
`288
`
`
`
`US. Patent and Trademark Office
`
`Part of Paper No. 20090420
`
`FIatWing Ex. 1013, p. 9
`
`
`
`FlatWing Ex. 1013, p. 9
`
`

`

`
`
`Issue Classification
`
`Qggyggnrtgélgfent under
`fifgiscfégglControl No.
`
`’
`BAKER ET AL.
`Examiner
`Art Unit
`
`
`
`REI-TSANG SHIAO
`
`1626
`
`ISSUE CLASSIFICATION
`
`
`
`SUBCLASS CLAIMED NON-CLAIMED
`
`
`
`
`
`/
`
`64
`
`A
`
`61
`
`K
`
`31
`
`/69
`
`I-_
`/
`
`
`
`Assistant Examiner
`
`/Rei-tsang Shiao/
`4/20/2009
`
`(Legal Instruments Examiner)
`
`(Date)
`
`(Primary Examiner)
`
`(Date)
`
`D Claims renumbered in the same order as presented by applicant
`
`O.G.
`Print Fig.
`
`NONE
`
`11:
`
`toN—\Original
`
`ginal
`Original
`3Original
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`FlatWing Ex. 1013, p. 10
`
`

`

`A
`
`
`
`. UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BIB DATA SHEET
`
`Page 1 of 1
`
`UNITED STATES DEPARTMENT OF COMB/[ERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`CONFIRMATION NO. 4964
`
`SERIAL NUMBER
`11/357,687
`
`FILINS‘AC'I'IE 371(6)
`02/16/2006
`
`GROUP ART UNIT ATTORNEg DOCKET
`064507-5014US
`
`RULE
`
`APPLICANTS
`
`Stephen J. Baker, Mountain View, CA;
`Tsutomu Akama, Sunnyvale, CA;
`Carolyn Bellinger-Kawahara, Redwood City, CA;
`Vincent S. Hernandez, Watsonville, CA;
`Karin M. Hold, Belmont, CA;
`James J. Leyden, Malvern, PA;
`Kirk R. Maples, San Jose, CA;
`Jacob J. Plattner, Berkeley, CA;
`Virginia Sanders, San Francisco, CA;
`Yong-Kang Zhang, San Jose, CA;
`** CONTINUING DATA *************************
`
`This appln claims benefit of 60/654,060 02/16/2005
`** FOREIGN APPLICATIONS *************************
`
`
`
`** IF REQUIRED, FOREIGN FILING LICENSE GRANTED ** ** SMALL ENTITY **
`03/30/2006
`
`
`
`—I Yes VJNO
`Foreign Priority Claimed
`
`
`35 USC 119(a—d) conditions met _I Yes JNO
`Verified and
`/RE|—TSANG SHIAO/
`Acknowledged
`Examiner's Signature
`
`Allowance
`[I Met after
`RS.
`Initials
`
`STATE OR
`COUNTRY
`
`SHEETS
`DRAWINGS
`
`CA
`
`I 2
`
`TOTAL
`CLAIMS
`‘\“\“““
`‘S§\“\“w
`
`INDEPENDENT
`CLAIMS
`
`3
`
`ADDRESS
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`One Market, Spear Street Tower, Suite 2800
`San Francisco, CA 94105
`UNITED STATES
`
`Boron-containing small molecules
`
`FEES: Authority has been given in Paper
`FILING FEE
`RECEIVED No.
`to charge/credit DEPOSIT ACCOUNT
`for following:
`
`-
`-
`3 1-17 Fees (Process'ng EXI- 0“ “me
`31.18 Fees (Issue)
`
`3 All Fees
`
`3 1.16 Fees (Filing)
`
`3 Other
`
`3 Credit
`
`BIB (Rev. 05/07).
`
`FIatWing Ex. 1013, p. 11
`
`FlatWing Ex. 1013, p. 11
`
`

`

`‘30.
`
`2
`
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`(514/64)CCLs USPAT
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`4/ 20/ 2009 11:35:23 AM
`
`FIatWing Ex. 1013, p. 12
`file:///CI/Documents%20and%2OSettings/rshiao/My%20D0cum...357687/EASTSearchHist0ry.11357687_AccessibleVersion.htm4/20/2009 11:35 :25 AM
`
`FlatWing Ex. 1013, p. 12
`
`

`

`CERTIFICATE or 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
`Trademark Office's Patent Electronic Business Center on:
`Dated:
`' L3 /0
`Signed:
`0' Wit/6‘" “LII-em
`
`Attorney Docket No.: 0645 07-5014-US
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of:
`
`Confirmation No.: 4964
`
`Stephen J. BAKER, et a].
`
`Examiner: SHIAO, Rei Tsang
`
`Application No.:
`
`1 1/357,687
`
`Art Unit: 1626
`
`.
`
`Filed: February 16, 2006
`
`RESPONSE TO FIRST OFFICE ACTION
`
`For: BORON—CONTAINING SMALL
`MOLECULES
`
`Customer No.: 43850
`
`
`
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`In response to the First Office Action dated August 26, 2008, please enter the
`
`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 4 of this paper.
`
`Page 1 of7
`
`FIatWing EX. 1013, p. 13
`
`FlatWing Ex. 1013, p. 13
`
`

`

`Appl. No. 11/357,687
`Amendment dated January 23, 2009
`Response to Office Action dated August 26, 2008
`
`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. — 26.
`
`(Cancelled).
`
`,_.AWNH
`\OOO\IO'\UIJ>UJN
`UIAUJNn—Io
`
`I—lI—‘h—il—‘D—‘l—l
`
`27.
`
`(Currently amended) A method of treating err—preventing an infection in
`
`an animal, said method comprising administering to the animal a therapeutically effective
`
`amount of 1,3-dihydro-5-fluoro-l-hydroxy-2,l-benzoxaborole, or a pharmaceutically acceptable
`
`salt thereof er—a—predrug—thereof., sufficient to treat said infection.
`
`28.
`
`(Original) The method of claim 27, wherein said infection is a member
`
`selected from a systemic infection, a cutaneous infection, and an ungual or periungual infection.
`
`29.
`
`(Original) The method of claim 27, wherein said infection is a member
`
`selected from chloronychia, paronychias, erysipeloid, onychorrhexis, gonorrhea, swimming-pool
`
`granuloma, larva migrans, leprosy, Orf nodule, milkers' nodules, herpetic whitlow, acute
`
`bacterial perionyxis, chronic perionyxis, sporotrichosis, syphilis, tuberculosis verrucosa cutis,
`
`tularemia, tungiasis, peri- and subungual warts, zona, nail dystrophy (trachyonychia),
`
`dermatological diseases, psoriasis, pustular psoriasis, alopecia aerata, parakeratosis pustulosa,
`
`contact dermatosis, Reiter's syndrome, psoriasiform acral dermatitis, lichen planus, idiopathy
`
`atrophy in the nails, lichin nitidus, lichen striatus, inflammatory linear verrucous epidermal
`
`naevus (ILVEN), alopecia, pemphigus, bullous pemphigoid, acquired epiderrnolysis bullosa,
`
`Darier's disease, pityriasis rubra pilaris, palmoplantar keratoderma, contact eczema, polymorphic
`
`erythema, scabies, Bazex syndrome, systemic scleroderma, systemic lupus erythematosus,
`
`chronic lupus erythematosus, dermatomyositus, Sporotrichosis, Mycotic keratitis, Extension
`
`oculomycosis, Endogenous oculomycosis, Lobomycosis, Mycetoma, Piedra, Pityriasis
`
`versicolor, Tinea corporis, Tinea cruris, Tinea pedis, Tinea barbae, Tinea capitis, Tinea nigra,
`
`Otomycosis, Tinea favosa, Chromomycosis, and Tinea Imbricata.
`
`Page 2 of7
`
`FIatWing Ex. 1013, p. 14
`
`FlatWing Ex. 1013, p. 14
`
`

`

`Appl. No. 11/357,687
`Amendment dated January 23, 2009
`Response to Office Action dated August 26, 2008
`
`PATENT
`
`30.
`
`(Original) The method of claim 27, wherein said infection is
`
`onychomycosis.
`
`31.
`
`(Original) The method of claim 27, wherein said animal is a member
`
`selected from a human, cattle, goat, pig, sheep, horse, cow, bull, dog, guinea pig, gerbil, rabbit,
`
`cat, chicken and turkey.
`
`32. — 39.
`
`(Cancelled).
`
`40.
`
`(Currently amended) The method of claim 30, wherein said
`
`onychomycosis is #eea—w‘zgwium tinea unguium.
`
`41.
`
`(Cancelled).
`
`42.
`
`(Previously presented) The method of claim 27, wherein said animal is a
`
`human.
`
`43.
`
`(New) The method of claim 27, wherein the administering is at a site
`
`which is a member selected from the skin, nail, hair, hoof and claw.
`
`44.
`
`(New) The method of claim 43, wherein said skin is the skin surrounding
`
`the nail, hair, hoof or claw.
`
`45.
`
`(New) The method of claim 27, wherein said infection is a fungal
`
`infection.
`
`46.
`
`(New) A method of treating onychomycosis in a human, said method
`
`comprising administering to the human a therapeutically effective amount of 1,3-dihydro-5-
`
`fluoro—l -hydroxy-2, 1 -benzoxaborole, or a pharmaceutically acceptable salt thereof, sufficient to
`
`treat said onychomycosis.
`
`47.
`
`(New) A method of inhibiting the growth of a fungus in a human, said
`
`method comprising administering to the human a therapeutically effective amount of 1,3-
`
`dihydro-S-fluoro—l-hydroxy—2,1-benzoxaborole, or a pharrnaceutically acceptable salt thereof.
`
`Page 3 of7
`
`-
`FIatWing Ex. 1013, p. 15
`
`FlatWing Ex. 1013, p. 15
`
`

`

`Appl. No. 11/357,687
`Amendment dated January 23, 2009
`Response to Office Action dated August 26, 2008
`
`PATENT
`
`REMARKS/ARGUMENTS
`
`I. Status 01 the Claims
`
`After entry of this Response, claims 27-31, 40 and 42—47 are pending. Claims 1-
`
`26, 32-39 and 41 are cancelled without prejudice. Claims 43-47 are new. Claims 27-31 and 40
`
`and 42-47 are currently presented. Claim 27 is amended. No new matter has been added.
`
`II. Suggort [or the amended claims and new claims
`
`Claim 27 is amended to add the phrase “sufficient to treat said infection”.
`
`Support for this amendment is provided in paragraph 108.
`
`Support for new claim 43 is provided in paragraphs 108 and 109.
`
`Support for new claim 44 is provided in paragraph 109.
`
`Support for new claim 45 is provided in paragraphs 102, 103 and 108-116 and
`
`Fig. 2.
`
`Support for new claim 46 is provided in paragraphs 108, 109 and 258.
`
`Support for new claim 47 is provided in paragraphs 102, 103, 317, 320—323, 324-
`
`334, 335-371, 372-381.
`
`No new matter has been added.
`
`III. Response to the reiections
`
`35 US. C. § 112, first paragraph, enablement (5.1)
`
`Claims 27-31 and 40-42 are rejected for lacking enablement because the
`
`specification, while being enabling for using the compounds of claim 27 for treating fungal
`
`infections, allegedly does not reasonably provide enablement for using the compounds of claim
`
`27 for preventing infection.
`
`Solely to expedite prosecution, Applicants have amended claim 27 to remove the
`
`phrase ‘or preventing’. Applicants reserve the right to pursue this subject matter in another
`
`application, such as a continuation or a divisional.
`
`In light of this amendment, Applicants respectfully request withdrawal of the
`
`rejection.
`
`Page4of7
`
`FIatWing EX. 1013, p. 16
`
`FlatWing Ex. 1013, p. 16
`
`

`

`Appl. No. 11/357,687
`Amendment dated January 23, 2009
`Response to Office Action dated August 26, 2008
`
`’
`
`'
`
`35 US. C.
`
`112 zrst ara a h enablement 5.2
`
`PATENT
`
`Claims 27-31 and 40-42 are rejected for lacking enablement because the
`
`specification, while being enabling for pharmaceutically acceptable salts of the compounds of
`
`claim 27, allegedly does not reasonably provide enablement for prodrugs of the compounds of
`
`claim 27.
`
`$01er to expedite prosecution, Applicants have amended claim 27 to remove the
`
`term ‘or a prodrug thereof’ . Applicants reserve the right to pursue this subject matter in another
`
`application, such as a continuation or a divisional.
`
`In light of this amendment, Applicants respectfully request withdrawal of the
`
`rejection.
`
`35 US. C.
`
`103 a
`
`Over Austin in view 01 Answers. com
`
`Claims 27-31 and 40-42 are rejected under 35 U.S.C. § 103(a) as allegedly being
`
`unpatentable over Austin et al., CAPlus Document No. 124:234024 (Accession No.
`
`1996: 181598) or US Patent 5,880,188 (“Austin”) in view of “Fungicide,” Answers.com.
`
`Reference to “Answers.com” herein refers to Exhibit A, showng the record accessed December
`
`17, 2008, for “fungicide” on Answers.com.
`
`Austin in view of Answers.com does not teach or suggest the invention as
`
`claimed. Austin states that “The present invention relates to the use of oxaboroles and salts
`
`thereof as industrial biocides. . .” Col. 1, lines 6-8. A previous citation in the literature (FR
`
`73293 70) “discloses that an oxaborole is .
`
`.
`
`. useful in inhibiting the growth of micro organisms
`
`in aviation fuels.” Col. 1, lines 39-45. Austin suggests that the disclosed compounds
`
`“containing an oxaborole ring are particularly effective against .
`
`.
`
`. fimgi, especially fungi which
`
`cause degradation of plastics materials.” Col. 1, lines 46-50.
`
`Austin contemplates using oxaboroles for “the protection of a medium susceptible
`
`to microbial attack.” Col. 1, lines 54 & 55. Examples of a “medium” according to Austin
`
`include “solvent-based paint”, col. 5, line 8; “a plastics material”, col. 5, line 11; “an aqueous
`
`medium” col. 5, line 15. Austin suggests use of oxaboroles in systems such as
`
`liquid, particularly aqueous, systems such as cooling water liquors,
`paper mill liquors, metal working fluids, geological drilling
`
`Page 5 of7
`
`FIatWing Ex. 1013, p. 17
`
`FlatWing Ex. 1013, p. 17
`
`

`

`Appl. No. 11/357,687
`Amendment dated January 23, 2009
`Response to Office Action dated August 26, 2008
`
`PATENT
`
`lubricants, polymer em