Ex. 2009
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`EX. 2009
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`Notice of Allowance dated Nov. 20, 2007
`Notice of Allowance dated Nov. 20, 2007
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`Notice of Allowability
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`Application No.
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`Applicant(s)
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`10/741,592
`Examiner
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`PLACHETKA ET AL.
`Art Unit
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`Sharon E. Kennedy
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`1615
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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 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. X} This communication is responsive to 10/10/2007.
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`2. E The allowed claim(s) is/are 1-20.
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`3. D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a) [I All
`b) [:1 Some‘
`c) E] None
`of the:
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`1. E] Certified copies of the priority documents have been received.
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`2. I] Certified copies of the priority documents have been received in Application No. __
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`3. E] Copies of the certified copies of the priority documents have been received in this national stage application from the
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`International Bureau (PCT Rule 17.2(a)).
`" 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.
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` 4. E] A SUBSTITUTE OATH OR DECLARATION must be submitted. Note the attached EXAMlNER'S AMENDMENT or NOTICE OF
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`INFORMAL PATENT APPLICATION (PTO-152) which gives reason(s) why the oath or declaration is deficient.
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`5. [:1 CORRECTED DRAWINGS (as “replacement sheets") must be submitted.
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`(a) Cl including changes required by the Notice of Draftsperson's Patent Drawing Review ( PTO-948) attached
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`1) El hereto or 2) D to Paper No./Mail Date
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`(b) D including changes required by the attached Examiner's Amendment / Comment or in the Office action of
`Paper No./Mail Date
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`Identifying lndlcia 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. E] 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; E Notice of References Cited (PTO-892)
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`5. E] Notice of Informal Patent Application
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`2. E] Notice of Draftperson's Patent Drawing Review (PTO-948)
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`3. E] Information Disclosure Statements (PTO/SB/O8),
`Paper No./Mail Date 10/10/2007
`4. El Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
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`6. E] Interview Summary (PTO-413),
`Paper No./Mail Date
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`7. El Examiner's Amendment/Comment
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`8. IE Examiner's Statement of Reasons for Allowance
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`Art Unit: 1615
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`9. E] Other
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`Sharon E. Kennedy
`Primary Examiner
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` U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-06)
`Notice of Allowability
`Part of Paper No./Mail Date 20071105
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`

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`Application/Control “Number: 10/741,592
`Art Unit: 1615
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`Page 2
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`d
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`DETAILED ACTION
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`Allowable Subject Matter
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`Claims 1-20 are allowed.
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`The following is an examiner's statement of reasons for allowance:
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`Applicant has filed a supplement information Disclosure Statement (IDS) on
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`October 10, 2007, including the European Search Report for the corresponding
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`European Patent Application. The European Search Report has been carefully
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`considered. The search report cites 4 references which are indicated as “X”—type
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`references, or are particularly relevant to the European claimed invention. All of these
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`references have been previously cited and considered, with the exception of US
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`2002/0016348, which is listed for the examiner's consideration on the October 10, 2007
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`IDS. This reference does not appear to have been previously cited to the examiner,
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`however, it is noted that the corresponding patented version of the ‘348 application, US
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`6,384,034, has already been cited and considered. There are no substantive
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`differences between the two versions.
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`The claims of the present application are directed to a multi-layer pharmaceutical
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`tablet comprising naproxen and a triptan, wherein substantially all of the triptan is in a
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`first layer and substantially all of the naproxen is located within a second layer, arranged
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`in a side by side relationship such that the dissolution of the naproxen occurs
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`independently of the triptan. Claim 19 is directed to a multi-layer pharmaceutical tablet
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`comprising an NSAID and a triptan having the same characteristics (relationship) as the
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`naproxen and triptan combination.
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`Application/Control Number: 10/741,592
`Art Unit: 1615
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`Page 3
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`The examiner has already established that it is well-known to form multi-layered
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`pharmaceutical tablets, and that it is also well-known to form a pharmaceutical tablet
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`comprising naproxen and a triptan in combination for preventing migraines. See the
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`non-final rejection dated December 20, 2006. Applicant filed an amendment with a
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`rebuttal on April 5, 2007. See especially pages 6-7 of that response. As stated therein,
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`the claims are limited to one very specific tablet architecture. Applicant argues that an
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`advantage of forming such a tablet is demonstrated in the Examples section of the
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`application. The examiner has very carefully considered these comments.
`With specific regard to the additionally filed IDS of October 10, 2007, including
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`the European Search Report, the examiner provides the following comments:
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`All the references cited therein are merely cumulative to the prior an already
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`considered. Regarding the newly cited patent application by Simitchieva et al., US
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`2002/0016348, this reference, in the form of the final patent, has already been
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`considered. Simitchieva discloses a combination of a 5HT13,1D agonist (for example
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`rizatriptan, etc.) as disclosed in paragraph [0013], and a COX-2 selective inhibitor such
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`as Ce|ebrexR, VioxxR, etc, which are NSAlDs, for the treatment of migraines. The drugs
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`may be delivered combined in a single dosage form or delivered via separate dosage
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`forms. A specific example of tablet formulation is provided at [0042]- [0044]. All
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`ingredients are mixed together and subsequently pressed into a tablet. As is evident,
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`this does not disclose or suggest the claimed invention, and is merely cumulative to the
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`references already uncovered.
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`Application/Control Number: 10/741,592
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`Page 4
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`Art Unit: 1615
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`The international patent to Plachetka, WO 98/06392, is directed to a method and
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`dosage for treating migraines in humans by administering a combination of a long-
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`acting NSAID with a 5-HT agonist. As stated on page 8 of the reference, the 5-HT
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`agonist and NSAID can be administered simultaneously, either in separate formulations
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`or combined in a unit dosage form. Additional information is provided on page 19, lines
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`14+. Examples are provided on pages 24+. There is no disclosure or suggestion of
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`forming a multi-layer tablet containing the therapeutic agents in separate areas.
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`The international patent to Jackson, WO 00/06161, is also directed to the
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`prevention of migraine headache reoccurrences (page 3, lines 11-12) comprising
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`administering the combination of a 5-HT13/10 agonist in various types of dosage forms,
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`including dual-release formulations such as a bi-layer tablet. See also page 8. The
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`reference further states that dual-dash release formulations can also combine the active
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`compound in an immediate—re|ease form with an additional active compound in a
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`pulsed-dash release form. However, there is no indication that the additional agent
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`should be an NSAID or naproxen.
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`The European patent to Sands, EP 1 051 993, has also been carefully re-
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`considered. Again, while this disclosure is directed to 5-HT receptor agonists in
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`combination with, e.g., an NSAID, essentially this reference is cumulative to the
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`references already considered. Sands, EP—‘993 does not disclose or suggest the multi-
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`layer tablet as claimed. See, for example, paragraph [0018], disclosing Table 1 and the
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`various desired triptan medications in combination with the additional agents set forth in
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`Table 3. As stated in EP—‘993, the two active agents may be administered together or
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`Application/Control Number: 10/741,592
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`Page 5
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`Art Unit: 1615
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`separately as per the conventional methods. See paragraph [0020]. There is no
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`disclosure or suggestion that the tablets may be delivered as claimed by applicant.
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`For all the above reasons, the claims are again allowed.
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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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`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 Sharon E. Kennedy whose telephone number is
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`571/272-4948. The examiner can normally be reached on Monday-Thursday.
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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.
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`/S/iaron E. Kennez{y/
`Sharon E. Kennedy
`Primary Examiner
`Art Unit 1615