`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
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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 NO.
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`12/553, 107
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`0910312009
`
`Brian Ault
`
`103526-1 US/NS
`
`5949
`
`01/05/2012
`7590
`22466
`ASTRA ZENECA PHARMACEUTICALS LP
`GLOBALINIBLLECTUALPROPERTY
`1800 CONCORD PIKE
`WILMINGTON, DE 19850-5437
`
`EXAMINER
`
`YU,GINAC
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`ART UNIT
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`PAPER NUMBER
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`1617
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`MAILDATE
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`DELIVERY MODE
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`01/05/2012
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL-90A (Rev. 04/07)
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`MYLAN PHARMS. INC. EXHIBIT 1034 PAGE 1
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`
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`Office Action Summary
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`Application No.
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`12/553, 107
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`Examiner
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`Applicant(s)
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`AULT ET AL.
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`Art Unit
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`1617
`GINA C. YU
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, 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 timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is 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 timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
`1 )0 Responsive to communication(s) filed on __ .
`2a)0 This action is FINAL.
`2b)[8] This action is non-final.
`3)0 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.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 G.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`5)[8] Claim(s) 19-31.33.34.38-40.42 and 45 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8] Claim(s) 19-31. 33. 34. 38-40. 42 and 45 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
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`Application Papers
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`10)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`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).
`12)0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
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`Priority under 35 U.S.C. § 119
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`13)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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)).
`*See the attached detailed Office action for a list of the certified copies not received.
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`Attachment{s)
`1) [8] Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
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`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
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`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 03-11)
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`Office Action Summary
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`Part of Paper No./Mail Date 20120101
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`MYLAN PHARMS. INC. EXHIBIT 1034 PAGE 2
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`
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 2
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`DETAILED ACTION
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`Claim Rejections - 35 USC § 112
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`The following is a quotation of the first paragraph of 35 U.S.C. 112:
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`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the
`art to which it pertains, or with which it is most nearly connected, to make and use the same and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
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`Claims 19-31, 33, 34, 38-40, 42 and 45 are rejected under 35 U.S.C. 112, first
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`paragraph. The specification, while being enabling for delivering naproxen and
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`esomeprazole as described in the examples to patients suffering from inflammatory
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`diseases, does not reasonably provide enablement for the presently claimed method of
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`delivering the drugs in unspecified routes to unspecified patient population. The
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`specification does not enable any person skilled in the art to which it pertains, or with
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`which it is most nearly connected, to make and use the invention commensurate in
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`scope with these claims.
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`The method of claims 19-31, 33, 34, 38 and 39 encompass all types of
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`administration routes in a single entity for drug administration, whereas the specification
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`only enables for oral administration of a multilayer tablet, specifically comprising enteric
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`coated naproxen and non-enteric coated esomeprazole. The scope of the patient
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`population of claims 19-31, 33, 34, 38-40, 42 and 45 also fail to comply with enablement
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`requirement, as at the time of the present invention naproxen was known for treating
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`inflammatory diseases. Applicant provides no other direction or working example in the
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`specification to provide enablement for the full scope of the presently claimed method.
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`Undue experimentations would be necessary to make and use the full scope of the
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`MYLAN PHARMS. INC. EXHIBIT 1034 PAGE 3
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`
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 3
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`present invention in order to determine 1) effective routes, dosage, vehicles, etc., that
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`meet the scope of the presently claimed delivery method; and 2) which user population
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`(e.g., cancer patients) are within the term "a patient in need thereof" as recited the
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`claim.
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`Double Patenting
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`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper timewise extension of the "right to exclude" granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory
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`obviousness-type double patenting rejection is appropriate where the conflicting claims
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`are not identical, but at least one examined application claim is not patentably distinct
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`from the reference claim(s) because the examined application claim is either anticipated
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`by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140
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`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29
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`USPQ2d 2010 (Fed. Cir. 1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
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`1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761(CCPA1982); In re Vogel, 422
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`F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
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`USPQ 644 (CCPA 1969).
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
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`may be used to overcome an actual or provisional rejection based on a nonstatutory
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`double patenting ground provided the conflicting application or patent either is shown to
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`MYLAN PHARMS. INC. EXHIBIT 1034 PAGE 4
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`
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 4
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`be commonly owned with this application, or claims an invention made as a result of
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`activities undertaken within the scope of a joint research agreement.
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`Effective January 1, 1994, a registered attorney or agent of record may sign a
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`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
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`37 CFR 3.73(b).
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`Claims 19-31, 33, 34, 38-40, 42 and 45 are rejected on the ground of
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`nonstatutory obviousness-type double patenting as being unpatentable over
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`claims 1-55 of U.S. Patent No. 6926907 82.
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`Although the conflicting claims are not identical, they are not patentably distinct
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`from each other because both sets of claims are directed to a method of delivering to a
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`patient (a) an acid inhibitor at a dose effective to raise the gastric pH of said patient to at
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`least 3.5; and b) an NSAID that is released at a pH of 3.5 or greater, wherein
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`esomeprazole is selected as the acid inhibitor and the NSAID is naproxen. See '907,
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`Claims 24-32. The AM and PM dosage of the present claim would have been an
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`obvious method step to utilize the patented invention, as the specification teaches to
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`administer a naproxen/acid inhibitor according to the prior art invention twice daily. See
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`Examples 9 and 10. Patented claim 53 also describes the multi player tablet of instant
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`claim 40. Although the patented claims do not specifically disclose the pharmacokinetic
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`profile of the drugs released from the multilayered tablet, a person of ordinary skill in the
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`art who makes and uses the prior art method according to the teachings would have
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`obviously observed such.
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`MYLAN PHARMS. INC. EXHIBIT 1034 PAGE 5
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`
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 5
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`This application currently names joint inventors. In considering patentability of
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`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
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`the various claims was commonly owned at the time any inventions covered therein
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`were made absent any evidence to the contrary. Applicant is advised of the obligation
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`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
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`not commonly owned at the time a later invention was made in order for the examiner to
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`consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g)
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`prior art under 35 U.S.C. 103(a).
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`Claims 19-31, 33, 34, 38-40, 42 are rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Plachetka (US 6926907 82).
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`Plachetka teaches a method for a coordinated delivery of naproxen in a
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`gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain
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`and symptom relief with a reduced risk of developing gastrointestinal damage such as
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`ulcers, erosions and hemorrhages. See abstract. The reference discloses a trilayer
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`table that separates an acid inhibitor contained in a film coat from a core comprising
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`controlled-release naproxen formulated using excipients which control the drug release.
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`The film coat is an enteric coating configured to delay the release of naproxen until the
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`MYLAN PHARMS. INC. EXHIBIT 1034 PAGE 6
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 6
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`dosage form reaches an environment where the pH is above 3.5, or preferably above 4.
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`See Drawings; col. 3, line 18 - 53. Plachetka teaches the acid inhibitor present in an
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`amount effective to raise the gastric pH of a patient to at least 3.5, preferably to at least
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`4, and more preferably to at least 5, when the dosage is administered. The most
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`preferred and effective acid inhibitors include esomeprazole, among others. See col. 3,
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`lines 18 - 38. The AM and PM dosage of the present claim would have been an
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`obvious method step to utilize the patented invention, as the specification teaches to
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`administer a naproxen/acid inhibitor according to the prior art invention twice daily. See
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`Examples 9 and 10.
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`Selection of esomeprazole as the suitable acid inhibitor according to the explicit
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`teaching of the reference would have been an obvious choice to a person of ordinary
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`skill in the art who is motivated to achieve the coordinated delivery of naproxen without
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`causing gastrointestinal damage to the patient. Although Plachetka does not
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`specifically disclose the pharmacokinetic profile of the drugs released from the
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`multilayered tablet, a person of ordinary skill in the art who makes and uses the prior art
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`method according to the teachings to combine naproxen and any of the disclosed acid
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`inhibitors would have been able to obviously observe pharmacokinetic properties of
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`each drug.
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`No claims are allowed.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to GINA C. YU whose telephone number is (571 )272-8605.
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`MYLAN PHARMS. INC. EXHIBIT 1034 PAGE 7
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`
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 7
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`The examiner can normally be reached on Monday through Friday, from 9:00AM until
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`5:00 PM ..
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Fereydoun G. Sajjadi can be reached on 571-272-3311. 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.
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`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.
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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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`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.
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`/GINA C. YU/
`Primary Examiner, Art Unit 1617
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`MYLAN PHARMS. INC. EXHIBIT 1034 PAGE 8
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