Notice of Allowability
`
`Application No.
`
`Applicant(s)
`
`11/788,076
`Examiner
`
`DUNCAN ET AL.
`Art Unit
`
`LYNDSEY BECKHARDT
`
`1615
`
`-- The MAILING DATE 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 ALLOW ABILITY 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. 1Zl This communication is responsive to 07/06/2009.
`2. 1Zl The allowed claim(s) is/are 40-54.
`3. 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.
`4. 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.
`5. 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).
`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. D Notice of Draftperson's Patent Drawing Review (PT0-948)
`3. D Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date __
`4. D Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`
`/L YNDSEY BECKHARDT/
`Examiner, Art Unit 1615
`
`5. D Notice of Informal Patent Application
`6. D Interview Summary (PT0-413),
`Paper No./Mail Date __ .
`7. D Examiner's AmendmenUComment
`
`8. [8] Examiner's Statement of Reasons for Allowance
`
`9. [8] Other Index of Claims, Search Notes and Search Historv.
`
`U.S. Patent and Trademark Off1ce
`PTOL-37 (Rev. 08-06)
`
`Notice of Allowability
`
`Part of Paper No./Mail Date 20090908
`
`Sandoz Exhibit 1014 Page 1
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`

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`Continuation Sheet (PTOL-37)
`
`Application No.
`
`2
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`Sandoz Exhibit 1014 Page 2
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`

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`Application/Control Number: 11/788,076
`Art Unit: 1615
`
`Page 2
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`Reasons for Allowance
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`The following is an examiner's statement of reasons for allowance: Applicant
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`submitted declarations under 37 C.F.R § 1.132 (07/06/2009) presenting evidence for
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`the advantageous stable form of a low concentration drug only with the particular
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`combination of dextrose or sodium chlorides, a buffer to maintain pH from about 3.6 to
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`about 4.7 and storage in a non polar bag. The combination of prior art references
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`Mcfarlane (5, 164,405), Gayed (WO 01/07086), Kaiser (Solutions to Health Care Waste:
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`Life-Cycle Thinking and "Green" Purchasing) and Ogawa (4,880,823) does not render
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`obvious the stable dilute formulation of nicardipine hydrochloride with tonicity agent,
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`specified pH and containment without contact with polar polymers.
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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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`Conclusion
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`Claims 40-54 are allowed.
`
`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to L YNDSEY BECKHARDT whose telephone number is
`
`(571 )270-7676. The examiner can normally be reached on Monday thru Thursday 7:00
`
`am to 4:00pm.
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`Sandoz Exhibit 1014 Page 3
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`

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`Application/Control Number: 11/788,076
`Art Unit: 1615
`
`Page 3
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Michael Woodward can be reached on (571 )272-8373. The fax phone
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
`
`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.
`
`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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`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.
`
`/L YNDSEY BECKHARDT/
`Examiner, Art Unit 1615
`
`/MP WOODWARD/
`Supervisory Patent Examiner, Art Unit 1615
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`Sandoz Exhibit 1014 Page 4
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`