`
`UNITED STATES DEPARTMENT OF COMIVIERCE
`L nited States Patent and Trademark Office
`Address: COMMISSIONER FOR PATFNTS
`P 0 Box 1450
`Alcxartlria. \~"r
`inin ::\I 14450
`www.nspto.,»:
`=
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`BAKER BOTFS L_L_P_
`30 ROCKEFELLER PLAZA
`44th Floor
`NEW YORK, NY 10112-4498
`
`EXAMINER
`
`POLANSKY. GREGG
`
`1539
`
`DATE MAILED: OI/l I/2013
`
`
`I3/678.1-I8
`I 1/15/10] .7.
`Priyanka Roychowdhury
`077350.035‘)
`9687
`TITLE OF INVl1\ITION: METHODS OF TREATMENT USING A DEXMEDETOMIDINE PREMIX FORMULATION
`
`APPLN. TYPE
`SMALL ENTITY
`ISSUE FEE DUE
`PUBLICATION FEE DUE
`PREV. PAID ISSUE F133
`TOTAL FEE(S) DUE
`DATE DUE
`
`NO
`$30()
`$0
`nonprovisional
`S I 770
`$2070
`04/] 1/20] 3
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
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`I’l‘OL-85 (Rev. 02/11)
`
`Page I of 3
`
`Petition for Inter Partes Review of US 8,455,527
`Amneal Pharmaceuticals LLC — Exhibit 1055 — Page 1
`
`
`
`PART B - FEE(S) TRANSMITTAL
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`CURRENT ('0RRE5P0NDEN('E ADDRESS (NOW U-WBIOCR 1
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`‘"01’ 1"¥¢hmIs=o1'a<1dIess'
`
`62965
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`7590
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`01/] lI‘2DI3
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`BAKER BOTFS L'L.P'
`‘
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`
`‘h th U ' d
`rt'f hfefiiirlfatf lJt'l'Mai|ilitg ‘Ir'Ttr>a'n§m<issimi d
`b
`Ih
`ere
`-‘ce I
`t
`21
`I
`IS
`ee ‘s_' _ransmi ta IS‘
`ei_ng eposite _wit
`e
`nite
`States ostal . ervice with sullicrent postage for lirst class mail in an envelope
`addressed to the Mail Sto
`ISSUE FEE address above. or being facsimile
`transmitted to the ['Sl"I‘0 (- 71) 273-2885. on the date indicated below.
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`t'Dcpositor's name}
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`APPLICATION NO.
`FILING DATE
`FIRST NAMED INVENTOR
`ATTORNEY DOCKET NO.
`CONFIRMATION NO.
`
`9687
`I3/678.1-I8
`I 1/15/2012
`Priyanka Roychowdhury
`077350.035‘)
`TITLE OF INVENTION: METHODS OF
`USING A DEXMEDETOMIDINE PREMIX FORMULATION
`
`APPLN. TYPE
`SMALL ENTITY
`ISSUE FEE DUE
`PUBLICATION FEE DUE
`PREV. PAID ISSUE FEE
`TOTAL FEE(S) DUE
`DATE DUE
`
`NO
`3300
`$0
`nonprovisional
`S I 770
`$2070
`(H11 H20] 3
`
`UNIT
`
`EXAMINER
`cr.Ass-srrncmss
`POLANS KY. GREGG
`I 629
`5 I 4-396000
`
`1. Change of conespondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`D Chan e of correspondence address (or Change of Correspondence
`Address oriri PTO/SB/ 122) attached.
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`D "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
`(I) the names of up to 3 registered patent attorneys
`or agents OR. altematively.
`(2) the name ofa single firm (having as a member a
`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.
`
`I
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`1
`'
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`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
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`PLEASE NOTE: Unless an assilgnee is identified below. no assignee data will appear on the patent.
`If an assignee is identified below. the document has been filed for
`recordation as set lorth in 37 Cr’
`3.11. Completion of this form is NOT a substitute lor filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESlDI:'NCE: (CITY and S'l‘A'l'E OR (_"OUN'l'RY)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) : 0 Individual D Corporation or other private group entity D Government
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`D 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
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`Date
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`Registration No.
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`This collection of information is required by 37 (‘FR 1.311. The information is rer uired to obtain or retain a benefit by the public which is to file (and by the USPTO to process)
`an application. Confidentiality is govemed by 35 Il.S.C. I22 and 37 CFR 1.14.
`is collection is estimated to take I2 minutes to complete, including gathering. prepanng. and
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`c C icf In ormation Officer, US. Patent and Trademark Office. L'.S. Department of Commerce,
`.0.
`Box 1450. Alexan ria. Virginia 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents. P.O. Box 1450.
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`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. 02/1 I ; Approved for use through 08/31/2013.
`
`OMB 0651-0033
`
`Lzs. Patent and IISIIIIBII &filH%Ts%fi%2%fl9WM 27
`Amneal Pharmaceuticals LLC — Exhibit 1055 — Page 2
`
`
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`I nited States Patent and Trademark Office
`Address: COMMISSIONER FOR PATFNTS
`P 0 Box 1450
`Alcxattiria. Virginia 231] 1- I 450
`www.uspIo.,~:m~'
`
`077350.035‘)
`
`9687
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`I3/678.148
`
`l I/I5/2012
`
`Priyanka Rnychowdhury
`
`BAKER BOTTS L.L.P.
`30 ROCKEFELLER PLAZA
`44mF1oor
`NEW YORK, NY 10112-4498
`
`POLANSKY. GREGG
`
`1539
`
`DATE MAILED: Ol/l l/2013
`
`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 0 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 Tenn Adjustment will be 0 day(s).
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application,
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`the filing date that
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information Retrieval
`(PAIR) WEB site (http://pair.uspto.gov).
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`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
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`
`P'I‘OL-85 (Rev. 02/11)
`
`Page 3 of 3
`
`Petition for Inter Partes Review of US 8,455,527
`Amneal Pharmaceuticals LLC — Exhibit 1055 — Page 3
`
`
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with
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`The information provided by you in this form will be subject to the following routine uses:
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`1. The information on this form will be treated confidentially to the extent allowed under the Freedom
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`
`Petition for Inter Partes Review of US 8,455,527
`Amneal Pharmaceuticals LLC – Exhibit 1055 – Page 4
`
`
`
`Notice of Allowability
`
`13/678, 148
`Examiner
`
`ROYCHOWDHURY ET AL.
`Art Unit
`
`Application No.
`
`Applicant(s)
`
`Gregg Polansky
`
`1629
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`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. [8J This communication is responsive to the 1212012012 telephone interview and the filing of Terminal Disclaimers.
`2. D An election was made by the applicant in response to a restriction requirement set forth during the interview on __ ;the restriction
`requirement and election have been incorporated into this action.
`3. [8J The allowed claim(s) is/are 1-15. As a result of the allowed claim(s), 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
`http://www.uspto.gov/patents/init events/pph/index.isp or send an inquiry to PPHfeedback@uspto.gov .
`4. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a) D All
`b) D Some*
`c) D None
`of the:
`1. D Certified copies of the priority documents have been received.
`2. D 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.
`5. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`D including changes required by the attached Examiner's Amendment I Comment or in the Office action of
`Paper No./Mail 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. 0 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. D Notice of References Cited (PT0-892)
`2. [8J Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date 11/15/2012
`3. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. [8J Interview Summary (PT0-413),
`Paper No./Mail Date 20121221 .
`
`/Gregg Polansky/
`Examiner, Art Unit 1629
`
`5. D Examiner's Amendment/Comment
`6. [8J Examiner's Statement of Reasons for Allowance
`
`7. D Other __ .
`
`/JEFFREYS. LUNDGREN/
`Supervisory Patent Examiner, Art Unit 1629
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 09-12)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20121221
`
`Petition for Inter Partes Review of US 8,455,527
`Amneal Pharmaceuticals LLC – Exhibit 1055 – Page 5
`
`
`
`Application/Control Number: 13/678, 148
`Art Unit: 1629
`
`Page 2
`
`DETAILED ACTION
`
`Information Disclosure Statement
`
`1.
`
`Applicants' Information Disclosure Statement, filed 11 /15/201, is acknowledged
`
`and has been reviewed.
`
`Terminal Disclaimer
`
`2.
`
`The terminal disclaimer filed on 12/20/2012 disclaiming the terminal portion of
`
`any patent granted on this application which would extend beyond the expiration date of
`
`Patent Nos. 8,242, 158 and 8,338,470, and on any patent granted on Application No.
`
`13/678,260 has been reviewed and is accepted. The terminal disclaimers have been
`
`recorded.
`
`Reasons for Allowance
`
`3.
`
`The following is an examiner's statement of reasons for allowance: Although the
`
`prior art teaches providing sedation and analgesia to a patient in need thereof, and
`
`treating hypertension or anxiety, comprising administration to the patient an effective
`
`amount of a composition comprising dexmedetomidine or a pharmaceutically
`
`acceptable salt thereof, the prior art does not teach or reasonably suggest the use of
`
`dexmedetomidine disposed within a sealed glass container as a ready to use
`
`formulation for parenteral use at the instantly claimed concentrations. Additionally, the
`
`Petition for Inter Partes Review of US 8,455,527
`Amneal Pharmaceuticals LLC – Exhibit 1055 – Page 6
`
`
`
`Application/Control Number: 13/678, 148
`Art Unit: 1629
`
`Page 3
`
`Examiner concurs with Applicants' detailed explanation of patentability as set forth at
`
`pages 44-73 of the Examination Support Document filed by Applicants on 11/15/2008.
`
`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."
`
`4.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Gregg Polansky whose telephone number is (571 )272-
`
`9070. The examiner can normally be reached on Mon-Thur 10:00 A.M. - 8:00 P.M.
`
`EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Melenie L. McCormick can be reached on (571) 272-8037. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`Petition for Inter Partes Review of US 8,455,527
`Amneal Pharmaceuticals LLC – Exhibit 1055 – Page 7
`
`
`
`Application/Control Number: 13/678, 148
`Art Unit: 1629
`
`Page 4
`
`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
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`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Gregg Polansky/
`Examiner, Art Unit 1629
`
`/JEFFREYS. LUNDGREN/
`Supervisory Patent Examiner, Art Unit 1629
`
`Petition for Inter Partes Review of US 8,455,527
`Amneal Pharmaceuticals LLC – Exhibit 1055 – Page 8