`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`I nited States Patent and Trademark Office
`Address: COMMISSIONER FOR PATFNTS
`P 0 Box 1450
`Alexandria. Virginia 22“ 3-1450
`www.mptogw
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`10/22/2012
`
`7590
`62965
`BAKER BOTIS L.L.P.
`30 ROCKEFELLER PLAZA
`mmnoor
`NEW YORK, NY 10112-4498
`
`EXAMINER
`POLANSKY. GREGG
`
`1629
`
`DATE MAILED: 10/22/2012
`
`APPLICATION NO.
`FILING DATE
`FIRST NAMED INVENTOR
`ATTORNEY DOCKET NO.
`CONFIRMATION NO.
`
`13/541524
`07/03/1011
`Priyanka Roychowdhury
`0773500355
`8238
`TITLE OF INVENTION: DEXMEDETOMIDINE PREMIX FORMULATION
`
`APPLN TYPE
`SMALL ENTITY
`ISSL'E FEE DUE
`PUBLICATION FEE DUE
`PREV. PAID ISSUE F133
`TOTAL FEE(S) DUE
`DATE DUE
`
`NO
`$300
`$0
`nonprovisional
`$1770
`$2070
`01/22/2013
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PB! 25E! .!IT!QN gm TH E. MERITS IS LLQSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`TIIIS APPLICATION IS SUBJECT TO WITIIDRAWAL FROM ISSUE AT TIIE INITIATIVE OF TIIE 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 MQNTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`W. 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.
`
`IIOW TO REPLY TO TIIIS NOTICE:
`
`1. 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 -
`Fcc(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 - Fec(s)
`'l'ransmittal and pay the PUBLICATION FEE (if required) and 1/2
`the ISSUE FEE shown above.
`
`11. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and retumed to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the feets) to your deposit account, section "4b"
`of Part B — Feets) 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.
`
`111. 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.
`
`HOE-85 (Rev. 02/11)
`
`Page 1 of 3
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLc — Exhibit 1056 — Page 1
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable l'ee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.0. 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 FF.F. and PUBLICATION FEF. (if required). Blocks 1
`ap ropriate. All further correspondence including the Patent. advance orders and notification of maintenance fees will be mailed to the current corres ondence address as
`in icated unless corrected below or directed otherwise in Block I. by (a) specifying a new correspondence address: and/or (b) indicating a separate " ‘
`'E ADDRESS" for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change el'addtess'
`
`62965
`
`7590
`
`1013212012
`
`‘
`.
`‘
`.
`30 ROCKEI‘ELLER PLAZA
`(1
`oor
`
`NEW YORK, NY 10112-4498
`
`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 its own certificate of mailing or transmisston.
`
`Certificate of Mailing or Transmission
`that this Fee(s) Transmittal is being deposited with the United
`l hereb -‘ certif
`States ostal . ervice with sufficient postage for first class mail in an envelope
`a
`resse
`to
`e
`at
`‘to
`‘
`a
`ress a Ve. or
`in
`acsrmi e
`dd
`d
`th M ’1 8
`ISSUE FEE dd
`bo
`be‘ g f
`’
`l
`transmitted to the I'SP’FO (- 71) 273—2885. on the date indicated below.
`
`
`
`chpositor's name}
`
`APPLICATION NO.
`FILING DATE
`FIRST NAMED INVENTOR
`ATTORNEY DOCKET NO.
`CONFIRMATION NO.
`
`07/03/2012
`13/541524
`0773500355
`8238
`Priyanka Roychowdhury
`TITLE OP INVENTION: DEXMEDETOMIDINE PREMIX FORMULATION
`
`APPLN. TYPE
`SMALL ENTITY
`ISSL'E FEE DUE
`PUBLICATION FEE DUE
`PREV. PAID ISSUE FEE
`TOTAL FEE(S) DUE
`DATE DUE
`
`NO
`3300
`$0
`$2070
`nonprovisional
`$1770
`01/22/2013
`
`EXAMINER
`ART UNIT
`CLASS-SI IBCIASS
`
`POLANS KY. GREGG
`1629
`514- 183000
`
`1. Change of conespondence address or indication of "Fee Address" (37
`CPR 1.363).
`'3 Change of correspondence address (or Change of Correspondence
`Address orm PTO/SB/ 12?.) attached.
`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
`l
`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.
`
`
`
`1
`'
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`
`PLEASE NOTE: Unless an assignee 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 forth in 37 CF 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) :
`
`D Individual D Corporation or other private group entity D Government
`
`4a. The following fee-(s) are submitted:
`D Issue Fee
`
`41). Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`D A check is enclosed.
`
`D Publication Fee (No small entity discount permitted)
`D Advance Order - # of Copies
`
`Cl Payment by credit card. Form PTO-2038 is attached.
`DThe 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)
`D b. Applicant is no longer claiming SMALL ENTITY status. Sec 37 CPR 1.27(g)(2).
`D a. Applicant claims SMALL ENTITY status. See 37 CFR 127.
`NOTE: The Issue Fee and Publication Tee (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
`
`
`
`Date
`
`Typed or printed name
`
`Registration No.
`
`This collection of information is required by 37 CPR 1.311. The information is ret uired to obtain or retain a benefit by the public which is to file (and by the USPTO to process)
`is collection is estimated to take 12 minutes to complete. including gathering. prepanng. and
`an application. Confidentiality is govemed'lw 35 U.S.C. 122 and 37 CFR 1.14.
`de. ndin upon the individual case. Any comments on the amount of time you require to com.lete
`submitting the completed application form to the USPTO. Time will va
`c C icf In ormation Officer, US. Patent and Trademark Office. US. Department of Commerce,
`.0.
`this form and/or su gcstions for reducing this burden, should be sent to
`Box 1450. Alexan rra. Virginia 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents. PO. Box 1450.
`Alexandria. Virginia 21313-1450.
`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.
`
`P’l‘OL-SS (Rev. 02/1 1) Approved for use through 08/31/2013.
`
`OMB 0651-0033
`
`L15. Patent and fistitianMinersmmmamm
`Amneal Pharmaceuticals LLc — Exhibit 1056 — Page 2
`
`

`

`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`l nited States Patent and Trademark Office
`Address: COMMISSIONER FOR PATFNTS
`P 0 Box 1450
`Alexandria. Virginia 23111-1450
`WWWJLSPIOVEUV
`
`0773500355
`
`8238
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`13/541524
`
`07/03/2012
`
`Priyanka Rnychowdhury
`
`BAKER BOTTS L.L.P.
`30 ROCKEFELLER PLAZA
`mm
`NEW YORK, NY 10112-4498
`
`POLANSKY. GREGG
`
`1629
`
`DATE MAILED: 10/22/2012
`
`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 Infonnation 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 l-(888)-786-0101 or (571)-272-4200.
`
`P’l‘OL—BS (Rev. 02/11)
`
`Page 3 of 3
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLc — Exhibit 1056 — Page 3
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with
`your submission of the attached form related to a patent application or patent. Accordingly, pursuant to
`the requirements of the Act, please be advised that: (1) the general authority for the collection of this
`information is 35 U.S.C. 2(b )(2); (2) furnishing of the information solicited is voluntary; and (3) the
`principal purpose for which the information is used by the U.S. Patent and Trademark Office is to process
`and/or examine your submission related to a patent application or patent. If you do not furnish the
`requested information, the U.S. Patent and Trademark Office may not be able to process and/or examine
`your submission, which may result in termination of proceedings or abandonment of the application or
`expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom
`of Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of
`records may be disclosed to the Department of Justice to determine whether disclosure of these
`records is required by the Freedom of Information Act.
`2. A record from this system of records may be disclosed, as a routine use, in the course of presenting
`evidence to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel
`in the course of settlement negotiations.
`3. A record in this system of records may be disclosed, as a routine use, to a Member of Congress
`submitting a request involving an individual, to whom the record pertains, when the individual has
`requested assistance from the Member with respect to the subject matter of the record.
`4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency
`having need for the information in order to perform a contract. Recipients of information shall be
`required to comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5
`U.S.C. 552a(m).
`5. A record related to an International Application filed under the Patent Cooperation Treaty in this
`system of records may be disclosed, as a routine use, to the International Bureau of the World
`Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for
`purposes of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy
`Act (42 U.S.C. 218(c)).
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator,
`General Services, or his/her designee, during an inspection of records conducted by GSA as part of
`that agency's responsibility to recommend improvements in records management practices and
`programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance
`with the GSA regulations governing inspection of records for this purpose, and any other relevant
`(i.e., GSA or Commerce) directive. Such disclosure shall not be used to make determinations about
`individuals.
`8. A record from this system of records may be disclosed, as a routine use, to the public after either
`publication of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35
`U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37 CPR 1.14, as a
`routine use, to the public if the record was filed in an application which became abandoned or in
`which the proceedings were terminated and which application is referenced by either a published
`application, an application open to public inspection or an issued patent.
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local
`law enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or
`regulation.
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1056 – Page 4
`
`

`

`Notice of Allowability
`
`13/541,524
`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. [8] This communication is responsive to Applicants' response to the Office action mailed 811712012.
`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. [8] The allowed claim(s) is/are J.2.
`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. 0 A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER'S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PT0-152) which gives reason(s) why the oath or declaration is deficient.
`6. D CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`(a) D including changes required by the Notice of Draftsperson's Patent Drawing Review ( PT0-948) attached
`1) D hereto or 2) D to Paper No./Mail Date __ .
`(b) 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).
`7. 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. [8] Notice of References Cited (PT0-892)
`2. D Notice of Draftperson's Patent Drawing Review (PT0-948)
`
`3. [8] Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date 9/17/2012
`4. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`5. D Notice of Informal Patent Application
`6. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`7. D Examiner's Amendment/Comment
`
`8. [8] Examiner's Statement of Reasons for Allowance
`9. D Other __ .
`
`/JEFFREYS. LUNDGREN/
`Supervisory Patent Examiner, Art Unit 1629
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 03·11)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20121003-A
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1056 – Page 5
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 2
`
`DETAILED ACTION
`
`Information Disclosure Statement
`
`1.
`
`Applicants' Information Disclosure Statements filed on 9/17/2012 and
`
`10/04/2012 are acknowledged and have been reviewed.
`
`Terminal Disclaimer
`
`2.
`
`The terminal disclaimer filed on 9/17/2012 disclaiming the terminal portion
`
`of any patent granted on this application which would extend beyond the
`
`expiration date of U.S. Patent No. 8,242, 158 has been reviewed and is accepted.
`
`The terminal disclaimer has been recorded. Accordingly, the rejection of record
`
`of Claims 1-7 on the ground of nonstatutory obviousness-type double patenting is
`
`withdrawn.
`
`Reasons for Allowance
`
`3.
`
`The following is an examiner's statement of reasons for allowance:
`
`Applicants argue that "practicing the claims results in surprising and unexpected
`
`advantages with regard to stability of the claimed composition over the prior art
`
`which is indisputable evidence of the non-obviousness of the claims over the
`
`cited references." Applicants point to the Specification (page 8, paragraph
`
`[0038]) teaching that that the claimed formulation "can be stable under the
`
`conditions of manufacture and storage and can be preserved against the
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1056 – Page 6
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 3
`
`contaminating action of microorganisms such as bacteria and fungi." Applicants
`
`assert that Example 1 of the Specification demonstrates that a dexmedetomidine
`
`(4 µg/ml) formulation "stored in glass vials and ampoules maintained a higher
`
`level of potency after a 5 month storage period compared to storage in plastic,
`
`CR3 or PVC containers" (i.e., over 98% potency after 5 months vs. as much as a
`
`20% reduction in potency when stored in plastic or PVC containers after a two-
`
`week storage period). The Precedex® Package Insert (cited in the art rejections
`
`of the previous Office action) discloses that the 100 µg/ml dexmedetomidine
`
`concentrate is suitable for storage, but once diluted for use it is not suitable for
`
`storage. Furthermore, the Declaration of Huailiang Wu provided by Applicants
`
`provides further evidence of the surprising increase in stability of
`
`dexmedetomidine compositions (1, 10, 15 and 50 µg/ml) stored in sealed glass
`
`containers compared to storage in PVC bags.
`
`Although the prior art (not previously cited) teaches the adsorption to
`
`plastic of solutions of certain pharmaceutical agents (resulting in a decreased
`
`concentration of the agent), the art does not teach such for dexmedetomidine.
`
`For example, see Unger et al., Biomaterials, Vol. 22, 2001, pages 2031-2037,
`
`attached herewith.
`
`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."
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1056 – Page 7
`
`

`

`Application/Control Number: 13/541,524
`Art Unit: 1629
`
`Page 4
`
`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 9:30 A.M. -
`
`7:00 P.M. EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the
`
`examiner's supervisor, Jeffrey S. Lundgren can be reached on (571) 272-5541.
`
`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 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 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1056 – Page 8
`
`