`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO, Box 1450
`Alexandria, Virginia 22313—1450
`www,usptovg0v
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION N01
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`10/1582 I 6
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`05/31/2002
`
`John R. Plachetka
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`7569/7328]
`
`5014
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`7590
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`10/20/2004
`
`Michael A Sanzo
`Fitch Even Tabin & Flannery
`1301 K Street NW Suite 4011
`Washinton, DC 20006-1201
`
`'
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`EXAMINER
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`SPEAR, JAMES M
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`PAPER NUMBER
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`‘
`1615
`DATE MAILED: 10/20/2004
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`PTO—90C (Rev. 10/03)
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`CFAD EXHIBIT 1025
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`

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` Application No.
`Applicant(s)
`
`
`PLACHETKA, JOHN R.
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` Office Action Summary
`
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`Art Unit
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`1615
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`10l158,216
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`Examiner
`
`James M Spear
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTH(S) FROM
`THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1 136(a). in no event. however may a reply be timelyIfiled
`after SIX (6) MONTHS from the mailing date of this communication
`If the penod for reply specified aboveIs less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.
`-
`If NO period for replyIs specified above the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U. S C § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timelyIfled may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
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`MEI Responsive to communication(s) filed on
`2a)® This action is FINAL.
`2b)l:] This action is non-final.
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`3)E] Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Ex parte Quayle, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
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`ME] Claim(s)1—_5_4 is/are pending in the application.
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`43) Of the above Claim(s) __ is/are withdrawn from consideration.
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`5)IXI Claim(s) g4-_49 is/are allowed.
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`(5)12! Claim(s) 1-6 9-12 21—23 and 50 is/are rejected.
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`DIX! Claim(s) 7 8 13-20 and 51-54 is/are objected to.
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`8)|:| Claim(s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:] The specification is objected to by the Examiner.
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`10)I:] The drawing(s) filed on _ is/are: a)|:] accepted or b)|:l objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:] The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)|:] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(dj or (f).
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`a)I:l All
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`b)I:l Some * c)EI None of:
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`1.I:I Certified copies of the priority ddcuments have been received.
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`2:] Certified copies of the priority documents have been received in Application No. _
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`3E] Copies ,of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`.Attachment(s)
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`1) [:| Notice of References Cited (PTO-892)
`2) I] Notice of Draftsperson'5 Patent Drawing Review (PTO--948)
`3) El Information Disclosure Statement(s) (PTO-1449 or PTO/SB/OB)
`Paper No(s)/Mail Date __.
`U.S. Patent and Trademark Office
`
`4) E] Interview Summary (PTO-413)
`Paper NotS)/Mai| Date. __
`5) CI Notice of Informal Patent Application (PTO-152)
`6) [:1 Other: __
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`PTOL-326 (Rev. 1-04)
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`Office Action Summary
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`Part of Paper No./Mai| Date 10162004
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`
`
`

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`Application/Control Number: 10/158,216
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`Page 2
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`Art Unit: 1615
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`The response and Information Disclosure Statement filed July 22, 2004 have
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`been entered. Claims 1-54 are pending in the application as set forth in the Preliminary
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`Amendment filed October 17, 2003. A complete copy of the IDS filed April 24, 2003 is
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`enclosed and has been considered.
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`a.
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`The following is a quotation of the appropriate paragraphs of 35
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`U.S.C. 102 that form the basis for the rejections under this section made in this
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`Office action:
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`A person shall be entitled to a patent unless -
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`‘ (b) the invention was patented or described in a printed publication in this or a foreign country or in public
`use or on sale in this country, more than one year prior to the date of application for patent in the United
`States.
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`2.
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`Claims 1-5, 9, 10, 11,21, 22 and 50 are rejected under 35 U.S.C. 102(b)’as
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`being anticipated by Goldman et al US 5,204,118. The claims remain rejected for the
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`reasons set forth in the Office Action mailed April 22, 2004.
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`3.
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`Applicant's arguments filed July 22, 2004 have been fully considered but they are
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`not persuasive. Applicants state that “all of applicant’s claims have requirements not
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`only with respect to the type of active ingredients present in compositions or methods,
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`but also with respect to the way in which active ingredients are delivered in relation to
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`one another”. “Specifically claim 1 requires that there be a single unit dosage form
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`containing both an acid inhibitor and an NSAID and that, upon administration to a
`patient, the dosage form deliver these drugs in a coordinated fashion such that the acid
`inhibitor is released first and the NSAID is not released until after the gastric ph of the
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`patient is 3.5 or higher. Applicant submits that these characteristics are not disclosed in
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`Goldman." Applicants further state that, “by preventing NSAID from being released until
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`

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`Application/Control Number: 10/158,216
`Art Unit: 1615
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`g
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`‘
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`Page 3
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`the surrounding environment becomes more basic, the pharmaceutical composition
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`defined in claim 1 provides for safer delivery." However claim 1 is a product claim.
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`Applicant’s arguments directed to release are more suited for process limitations while
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`claim 1 is a composition. There is nothing in claim 1 that enables the release applicant
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`is referring to. The Goldman reference shows the same components as applicants and
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`the composition would therefore inherently function the same as applicant’s. Amending
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`claim 1 to incorporate a polymer coating as set forth in claims 24 and 51-54 would be
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`given favorable consideration in overcoming the prior art rejection.
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`4.
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`Claims 1, 2, 5, 6, 9-12, 21 and 23 are rejected under 35 U.S.C. 102(e) as being
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`anticipated by Depui et al US 6,613,354 B2. The claims remain rejected for the reasons
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`set forth in the Paper mailed April 22, 2004. Applicants argue that the Depui et al
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`reference, while containing both an NSAID and a proton pump inhibitor, teaches the use
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`of tablet coatings for the purpose of preventing the degradation of gastric inhibitor. not
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`for the purpose of retarding the release of NSAID or protecting the gastrointestinal tract
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`of a patient from damage caused by NSAID released at low ph. Applicant’s arguments
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`are not persuasive because applicant’s claim 1 does not disclose a coating. The prior
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`art teaches the same elements as applicant’s claims.
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`It is the position of this office that
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`since the composition components are the same the dosage form would inherently
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`provide the same release rates and effects on the gastric ph irrespective of the
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`additional coating components.
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`

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`Application/Control Number: 10/158,216
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`‘
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`Page 4
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`Art Unit: 1615
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`5.
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`Claims 7, 8, 13-20 and 51-54 are objected to as being dependent upon a
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`rejected base claim, but would be allowable if rewritten in independent form including all
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`of the limitations of the base claim and any intervening claims.
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`Claims 1-6, 9—12, 21-23 and 50 are rejected.
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`Claims 24-49 are allowed.
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`6.
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(3).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this actiOn.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until afterthe end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period forvreply expire later
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`than SIX MONTHS from the mailing date of this final action.
`<
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to James M Spear whose telephone number is 571 272
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`0605. The examiner can normally be reached on Monday thru Friday from 6:30 AM to 3
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`PM.
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`

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`Application/Control Number: 10/158,216
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`Page 5
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`Art Unit: 1615
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Thurman K Page, can be reached on 571 272 0602. The fax phone number
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`for the organization where this application or proceeding is assigned is 703-872-9306.
`Information regarding the status of an application may be obtained from the
`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.
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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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`BusinessCenter(EBC)at866-217-9197(toll-free). WJames M Spear
`
`Primary Examiner
`Art Unit 1615
`
`October 16; 2004
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`