KENDRA D. CARTER
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`1627
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`-- The MAILING DATE 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 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.
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`1. IX This communication is responsive to 9/6/12.
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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
`the restriction requirement and election have been incorporated into this action.
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`3
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`3. IE The allowed claim(s) Is/are 12,5,6,9,10,13,14,17 18,21 and 22 (renumbered 1-122.
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`4. I] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`a) I] All
`b) I:I Some*
`0) El None
`of the:
`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.
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`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)).
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`* Certified copies not 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.
`
`5. [I A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMINER’S AMENDMENT or NOTICE OF
`INFORMAL PATENT APPLICATION (PTO-152) which gives reason(s) why the oath or declaration is deficient.
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`6. I] CORRECTED DRAWINGS ( as “replacement sheets") must be submitted.
`(a) El including changes required by the Notice of Draftsperson’s Patent Drawing Review ( PTO-948) attached
`
`.
`1) El hereto or 2) [I to Paper No./Mai| Date
`(b) [I including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`
`Paper No./Mai| 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. I] 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)
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`13/536,525
`WENT ET AL.
`
`Application No.
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`Applicant(s)
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`
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`1. El Notice of References Cited (PTO—892)
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`2. El Notice of Draftperson’s Patent Drawing Review (PTO-948)
`
`3.
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`Information Disclosure Statements (PTO/SB/OS),
`Paper No./Mai| Date 9/6/12;9/7/12
`4. I] Examiner‘s Comment Regarding Requirement for Deposit
`of Biological Material
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`5. [I Notice of Informal Patent Application
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`6. [I Interview Summary (PTO-413),
`Paper No./Mai| Date
`.
`7. El Examiner‘s Amendment/Comment
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`8. IX Examiner‘s Statement of Reasons for Allowance
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`9. El Other
`
`.
`
`/KENDRA D CARTER/
`Examiner, Art Unit 1627
`
`U 8 Patent and Trademark Office
`PTOL-37 (Rev. 03-11)
`
`Notice of Allowability
`
`Part of Paper No./Mai| Date 20120910
`
`IPR201 5—0041 0
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`Petitioners' EX. 1 004
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`Page 1
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`IPR2015-00410
`Petitioners' Ex. 1004
`Page 1
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`

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`Application/Control Number: 13/536,525
`Art Unit: 1627
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`Page 2
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`DETAILED ACTION
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`Drawings
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`The drawings were received on September 6, 2012. These drawings are
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`accepted.
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`EXAMINER’S STATEMENT OF REASONS FOR ALLOWANCE
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`The declaration demonstrates the unexpected results of the clamed
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`method of treating a patient with Alzheimer’s disease, dementia, Parkinson's
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`disease and neuropathic pain to reduce side effects that could not have been
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`predicted by specifically reducing the plasma concentration as a function of time
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`(dC/dT) of memantine to be less than 50% of than of an immediate release
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`dosage form. Therefore, claims 1, 2, 5, 6, 9, 10, 13, 14, 17, 18, 21 and 22 are
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`allowed and renumbered claims 1—12.
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`Any comments considered necessary by applicant must be submitted no
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`later than the payment of the issue fee and, to avoid processing delays, should
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`preferably accompany the issue fee. Such submissions should be clearly labeled
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`“Comments on Statement of Reasons for Allowance.”
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`IPR201 5—0041 0
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`Petitioners' EX. 1 004
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`Page 2
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`IPR2015-00410
`Petitioners' Ex. 1004
`Page 2
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`

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`Application/Control Number: 13/536,525
`Art Unit: 1627
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`Page 3
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`Any inquiry concerning this communication or earlier communications from
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`the examiner should be directed to Kendra D. Carter whose telephone number is
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`(571) 272—9034. The examiner can normally be reached on 9:30 am - 6:00 pm.
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`If attempts to reach the examiner by telephone are unsuccessful,
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`the
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`examiner’s supervisor, Sreeni Padmanabhan can be reached on (571) 272-0629.
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`The fax phone number for the organization where this application or proceeding
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`is assigned is 571 -273-8300.
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`Information regarding the status of an application may be obtained from
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`the Patent Application Information Retrieval (PAIR) system. Status information
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`for published applications may be obtained from either Private PAIR or Public
`
`PAIR.
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`Status information for unpublished applications is available through
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`Private PAIR only. For more information about the PAIR system, see http://pair-
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`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-
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`free).
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`KENDRA D CARTER
`
`Examiner, Art Unit 1627
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`/SREEN| PADMANABHAN/
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`Supervisory Patent Examiner, Art Unit 1627
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`IPR201 5—0041 0
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`Petitioners' EX. 1 004
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`Page 3
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`IPR2015-00410
`Petitioners' Ex. 1004
`Page 3
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