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`Applicant(s)
`Application No.
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`DUNCAN ET AL.
`12/971,084
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`Art Unit
`AIA (First Inventor to
`Examiner
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`
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`Notice of Allowability
`LYNDSEY BECKHARDT
`1613
`Fi'e) Stan‘s
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`No
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`-- 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 app ication.
`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.
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`IXI This communication is responsive to arguments and amendments filed 2/28/2013.
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`1.
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`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2. [I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
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`; the restriction
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`3. IX The allowed claim(s) is/are 40-67. 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
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`htt' :i/wwwus Ito. ov/natents/Init events/
`h/indax.‘s or send an inquiry to PPeradback' us tooov .
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`4. El Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`*0) El None of the:
`a) [I All
`b) [I Some
`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. El 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:
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`Interim copies:
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`a) D A“
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`b) El Some
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`0) El None of the:
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`Interim copies of the priority documents have been received.
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`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.
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`5. I] CORRECTED DRAWINGS (as “replacement sheets") must be submitted.
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`El
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`including changes required by the attached Examiner's Amendment / Comment or in the Office action of
`Paper No./Mai| Date
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`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).
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`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.
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`Attachment(s)
`1. El Notice of References Cited (PTO-892)
`2. E Information Disclosure Statements (PTO/SB/OS),
`Paper No./Mai| Date 02/28/2013
`3. El Examiner‘s Comment Regarding Requirement for Deposit
`of Biological Material
`4. IZI Interview Summary (PTO-413),
`Paper No./Mai| Date attached.
`/SCOTT LONG/
`
`Primary Examiner, Art Unit 1633
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`5. IXI Examiner's Amendment/Comment
`6. [Z Examiner‘s Statement of Reasons for Allowance
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`7. IZI Other See Continuation Sheet.
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`
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`U 8 Patent and Trademark Office
`PTOL-37 (Rev. 03-13)
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`Notice of Allowability
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`Part of Paper No./Mai| Date 20130404
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`Sandoz
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`Exhibit1014
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`Page1
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`Sandoz Exhibit 1014 Page 1
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`

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`Continuation Sheet (PTOL-37)
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`Application No. 12/971,084
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`Continuation of Attachment(s) 7. Other: search notes, index of Claims: search notes.
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`Sandoz
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`Exhibit1014
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`Page2
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`Sandoz Exhibit 1014 Page 2
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`

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`Application/Control Number: 12/971,084
`Art Unit: 1613
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`Page 2
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`EXAMINER’S AMENDMENT
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`Response to Amendment
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`The declaration under 37 CFR 1.132 filed 02/28/2013 is sufficient to overcome
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`the rejection of claim 49 based upon Baaske in view of Hersey, Varon and Zeidler.
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`Terminal Disclaimer
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`The terminal disclaimer filed on 04/02/2013 disclaiming the terminal portion of
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`any patent granted on this application which would extend beyond the expiration date of
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`7,659,291 has been reviewed and is accepted. The terminal disclaimer has been
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`recorded.
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`Information Disclosure Statement
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`Applicant’s Informational Disclosure Statement, filed on 02/28/2013 has been
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`considered. Please refer to Applicant‘s copy of the 1449 submitted herein.
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`Examiner‘s Amendment
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`An examiner’s amendment to the record appears below. Should the changes
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`and/or additions be unacceptable to applicant. an amendment may be filed as provided
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`by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be
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`submitted no later than the payment of the issue fee.
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`Authorization for this examiner’s amendment was given in a telephone interview
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`with Robert Paradiso on 04/03/2013.
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`The application has been amended as follows:
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`Claim 62. The method of claim 40, further comprising from abeut 0 mg/mL to
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`about 4 mg/mL sorbitol.
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`Sandoz
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`Exhibit1014
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`Page3
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`Sandoz Exhibit 1014 Page 3
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`

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`Application/Control Number: 12/971,084
`Art Unit: 1613
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`Page 3
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`Claim 63. The method of claim 41, further comprising from abeut 0 mg/mL to
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`about 4 mg/mL sorbitol.
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`Claim 64. The method of claim 42, further comprising from abeut 0 mg/mL to
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`about 4 mg/mL sorbitol.
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`Claim 65. The method of claim 47, further comprising from abeut 0 mg/mL to
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`about 4 mg/mL sorbitol.
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`Claim 68. Cancelled.
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`Claim 69. Cancelled.
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`Reasons for Allowance
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`The following is an examiner’s statement of reasons for allowance:
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`Applicant has amended the claims to overcome the 102(b) rejection of Baaske by
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`amending the instant claims to limit the storage of the composition to be in contact with
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`non-polar polymers, excluding the Baaske reference’s glass containment (abstract).
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`The Baaske references teaches storage of a dilute nicardipine solution in a glass
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`container wherein the composition is stable up to 7 days (abstract). Zeidler teaches
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`stability tests of a number of drugs wherein glass and polyethylene containers are
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`taught to be equivalent in terms of stability wherein stability was tested up to 24 hours
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`(abstract, conclusion). The ‘405 patent teaches storage in ampules (column 6, lines 45-
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`63, column 9, lines 1-7) wherein the dilute formed is in PVC bags and experiences
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`degradation (column 9, lines 15-25).
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`Applicant submitted a declaration under 37 C.F.R. 1.132 (02/28/2013) presenting
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`evidence for the advantageous stable form of a low concentration drug with a tonicity
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`Sandoz
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`Exhibit1014
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`Page4
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`Sandoz Exhibit 1014 Page 4
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`Application/Control Number: 12/971,084
`Art Unit: 1613
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`Page 4
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`agent, a buffer to maintain pH from about 3.6 to about 4.7 and storage in a non-polar
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`bag wherein stability data is presented for three months.
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`In view of the prior art and the declaration present, the prior art does not render
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`obvious the diluted nicardipine hydrochloride with tonicity agent, claimed pH range
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`stored in contact with non-polar polymers wherein the stability is maintain for at least
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`three months.
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`Therefore, the claimed invention is novel and patentably distinct over the prior art
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`of record.
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`Any comments considered necessary by applicant must be submitted no later
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`than the payment of the issue fee and, to avoid processing delays, should preferably
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`accompany the issue fee. Such submissions should be clearly labeled “Comments on
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`Statement of Reasons for Allowance.”
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`Sandoz
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`Exhibit1014
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`Page5
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`Sandoz Exhibit 1014 Page 5
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`

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`Application/Control Number: 12/971,084
`Art Unit: 1613
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`Page 5
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`Conclusion
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`Claims 40-67 are allowed.
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`Examiner Contact Information
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to LYNDSEY BECKHARDT whose telephone number is
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`(571)270-7676. The examiner can normally be reached on Monday thru Thursday 7:00
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`am to 4:00 pm.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Brian Kwon can be reached on (571) 272-0581. The fax phone number for
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`the organization where this application or proceeding is assigned is 571 -273-8300.
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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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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272—1000.
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`/LYNDSEY BECKHARDT/
`
`Examiner, Art Unit 1613
`/SCOTT LONG/
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`Primary Examiner, Art Unit 1633
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`Sandoz
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`Exhibit1014
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`Page6
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`Sandoz Exhibit 1014 Page 6
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