UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMNIERCE
`I nited States Patent and Trademark Office
`Address: COMMISSIONER FOR PATFNTS
`P 0 Box 1450
`Alcxartlria. \~"r
`inin ::\I 14450
`www.uspto.,»:
`=
`
`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: I0/02/2013
`
`APPLl('ATI().\I NO.
`FILING DATE
`FIRST NAMED INVENTOR
`ATTORNEY DOCKET N().
`CONFIRMATION NO.
`
`0-I/ll/1013
`I3/867.861
`Priyanka Roychowdhury
`0773500406
`436?.
`TITLE OF lNVll\ITION: Dexmedetomidine Premix Formulation
`
`APPLN. TYPE
`ENTITY STATES
`ISSUE FEE DUE
`PUBLICATION FEE DUE
`PREV. PAID ISSUE FEE
`TOTAL FEE(S) DUE
`DATE DUE
`
`$300
`$0
`nonprovisional
`UNDISCOI IN I El)
`$l780
`$2080
`0|/02/20]-I
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`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
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`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MQNTHS FROM THE
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`I’l‘OL-85 (Rev. 02/11)
`
`Page I of 4
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC — Exhibit 1060 — Page 1
`
`

`
`PART B - FEE(S) TRANSMITTAL
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`Complete and send this form, together with applicable l'ee(s), to: Mail Mail Stop ISSUE FEE
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`Certificate of Mailing or Transmission
`that this Fee(s) Transmittal is being deposited with the United
`I hereb -‘ ceitif
`Sttjadtes
`ojstal .ue;r\'i1c/E? vlvitsh
`first lL;‘l)¢’lSS mailbien an tt:'nV€.‘l0l’il€'
`e
`ai
`‘to
`‘
`a
`ress a
`ve. or
`ing acsimi e
`a
`resse
`to
`transmitted to the rsmo (_ 71; 273-2885. on the date indicated below.
`_
`
`V
`
`7590
`62965
`BAKER BOTTS L.L.P.
`«
`30 R0( KFIFFII -I -FIR Pl -A7‘/A
`44th Floor
`
`10/02/3013
`
`NEW YORK, NY 101124493
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`04/22/2013
`I3/867.861
`TITLE OF INVEVTION: Dexmedetomidine Premix Fomiulation
`
`Priyanka Roychowdhury
`
`0773500406
`
`436.7.
`
`AP'l’Ll\'. 'l'YP'E
`EN'I‘I'l‘Y S'I'A‘I'L'S
`ISSUE FEE DUE
`PUBLICA'I’I()N FEE DUE
`PREV. PAID ISSUE I"l;'E
`'l‘O'I'AL FEE(S) DUE
`DATE DUE
`
`$300
`$0
`$2080
`OI/OZ/Z014
`nonprovisional
`UNDISCOUNTED
`$1780
`
`EXAMINER
`ART UNIT
`CLASS-SUBCLASS
`
`POLANSKY. GREGG
`1629
`514-3960()0
`
`._
`).
`é.F(lT2hz]in1g(i):3ot‘ correspondence address or indication of "Fee Address" (37
`D Change of correspondence address (or Change of Correspondence
`Address orm PTO/SB/I22) attached.
`El "Fee Address" indication (or "liee Address" Indication fomi
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`2. For printing on the patent front page. list
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`l’I'OL-85 (Rev. 02/11)
`
`Page 2 of 4
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC — Exhibit 1060 — Page 2
`
`

`
`5. Change in Entity Status (from status indicated above)
`0 Applicant certifying micro entity status. See 37 CFR 1.29
`0 Applicant asserting small entity status. See 37 CFR 1.27
`0 Applicant changing to regular undiscounted fee status.
`
`NOTE: Absent a valid certification of Micro Entity Status (see form PTO/SB/15A and 15B), issue
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`interest as shown by the records of the United States Patent and Trademark Office.
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`Authorized Signature _______________________ _
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Page 3 of 4
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1060 – Page 3
`
`

`
`
`
`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~'
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`077.150.0406
`
`4362
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`13/867.861
`
`0-I/22/2013
`
`Priyanka Rnychowdhury
`
`BAKER BOTTS L.L.P.
`30 ROCKEFELLER PLAZA
`44mF1oor
`NEW YORK, NY 10112-4498
`
`POLANSKY. GREGG
`
`1539
`
`DATE MAILED: l0/02/2013
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(application filed on or after May 29, 2000)
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`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
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`If a Continued Prosecution Application (CPA) was filed in the above-identified application,
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`the filing date that
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`P'I‘OL-85 (Rev. 02/11)
`
`Page 4 of 4
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC — Exhibit 1060 — Page 4
`
`

`
`Privacy Act Statement
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`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1060 – Page 5
`
`

`
`Examiner-Initiated Interview Summary
`
`Application No.
`
`Applicant(s)
`
`13/867,861
`
`Examiner
`
`Gregg Polansky
`
`ROYCHOWDHURY ET AL.
`
`Art Unit
`
`1629
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) Gregg Polanskv.
`
`(2) Dennis Bissonnette.
`
`(3) __ .
`
`(4) __ .
`
`Type:
`
`Date of Interview: 17 September 2013.
`IZI Telephonic 0 Video Conference
`0 Personal [copy given to: 0 applicant
`Exhibit shown or demonstration conducted: 0 Yes
`If Yes, brief description: __ .
`
`0 applicant's representative]
`IZI No.
`
`Issues Discussed 0101 0112 0102 0103 IZ!Others
`(For each of the checked box( es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: __ .
`
`Identification of prior art discussed: __ .
`
`Substance of Interview
`(For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a
`reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc ... )
`
`Applicants' representative was contacted to inform him that the Application would be in a condition for allowance if
`terminal disclaimers were filed for patent numbers 8242158. 8338470. 8455527 and 8436033. After consulting with
`Applicants. Mr. Bissonnette called the Examiner on 912012013 to inform him that Applicants approved filing terminal
`disclaims for the above patents. An electronic terminal disclaimer for the above patents was filed and approved on
`912012013.
`
`Applicant recordation instructions: It is not necessary for applicant to provide a separate record of the substance of interview.
`
`Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of
`the substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the
`general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the
`general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.
`
`IZI Attachment
`/Gregg Polansky/
`Examiner, Art Unit 1629
`
`U.S. Patent and Trademark Office
`PTOL-4138 (Rev. 8/11/2010)
`
`Interview Summary
`
`PaperNo.20130923
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1060 – Page 6
`
`

`
`Notice of Allowability
`
`Application No.
`13/867,861
`Examiner
`Gregg Polansky
`
`Applicant(s)
`ROYCHOWDHURY ET AL.
`AIA (First Inventor to
`Art Unit
`File) Status
`1629
`No
`
`-- 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. [gl This communication is responsive to papers filed 412212013 and Terminal Disclaimers filed 912012013.
`DA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on ___ .
`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. [gl The allowed claim(s) is/are 1-9. 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
`~1tl;Q://v1rNw.us2to.gov/gatents/init events/Qgh/indexjs.Q or send an inquiry to PPHfeedback@uS(Qto.aov .
`4. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`*c) D None of the:
`a) D All
`b) D Some
`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. [gl Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date 9/20/2013
`3. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. [gl Interview Summary (PT0-413),
`Paper No./Mail Date 20130923.
`
`/SA VITHA RAO/
`Primary Examiner, Art Unit 1629
`
`5. D Examiner's Amendment/Comment
`6. [gl Examiner's Statement of Reasons for Allowance
`7. D Other __ .
`
`/Gregg Polansky/
`Examiner, Art Unit 1629
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20130923
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1060 – Page 7
`
`

`
`Application/Control Number: 13/867,861
`Art Unit: 1629
`
`Page 2
`
`REASONS FOR ALLOWANCE
`
`1.
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`2.
`
`Applicants' Information Disclosure Statement filed 9/20/2013 is acknowledged
`
`and has been considered.
`
`3.
`
`The following is an Examiner's statement of reasons for allowance:
`
`The Specification (page 8, paragraph [0038]) teaches that that the disclosed
`
`formulations "can be stable under the conditions of manufacture and storage and can
`
`be preserved against the contaminating action of microorganisms such as bacteria and
`
`fungi." 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 on the PT0-1449 filed by Applicants) 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 (9/17/2012) during the prosecution of Application 13/542,524 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.
`
`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1060 – Page 8
`
`

`
`Application/Control Number: 13/867,861
`Art Unit: 1629
`
`Page 3
`
`Although the prior art 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 (cited on the PT0-1449 filed by Applicants).
`
`Any comments considered necessary by Applicants 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.
`
`The terminal disclaimer filed on 9/20/2013 disclaiming the terminal portion of any
`
`patent granted on this application which would extend beyond the expiration date of
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`patent numbers 8436033, 8455527, 8338470, and 8242158 has been reviewed and is
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`accepted. The terminal disclaimer has been recorded.
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`5.
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`Claims 1-9 are pending and are allowed.
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`6.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Gregg Polansky whose telephone number is (571 )272-
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`9070. The examiner can normally be reached on Mon-Thur 10:00 A.M. - 8:00 P.M.
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`EST.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Melenie L. McCormick can be reached on (571) 272-8037. The fax phone
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`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1060 – Page 9
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`

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`Application/Control Number: 13/867,861
`Art Unit: 1629
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`Page 4
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`/Gregg Polansky/
`Examiner, Art Unit 1629
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`/SA VITHA RAO/
`Primary Examiner, Art Unit 1629
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`Petition for Inter Partes Review of US 8,648,106
`Amneal Pharmaceuticals LLC – Exhibit 1060 – Page 10