UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`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
`
`APPLICATION NO.
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`FILING DATE
`
`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
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`12/553, 107
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`0910312009
`
`Brian Ault
`
`103526-1 US/NS
`
`5949
`
`22466
`7590
`07/30/2012
`ASTRA ZENECA PHARMACEUTICALS LP
`GLOBALINIBLLECTUALPROPERTY
`1800 CONCORD PIKE
`WILMINGTON, DE 19850-5437
`
`EXAMINER
`
`JUSTICE, GINA CHIEUN YU
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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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`07/30/2012
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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 1035 PAGE 1
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`

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`Office Action Summary
`
`Application No.
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`12/553, 107
`
`Examiner
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`Applicant(s)
`
`AULT ET AL.
`
`Art Unit
`
`1617
`GINA C. JUSTICE
`-- 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).
`
`Status
`1 )IZ! Responsive to communication(s) filed on 08 Mav 2012.
`2a)[8J This action is FINAL.
`2b)0 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 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`5)[8J Claim(s) 19.29.33.34.40.42 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)[8J Claim(s) 19. 29. 33. 34. 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).
`
`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.
`
`Attachment{s)
`1) [8J 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 __ .
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 03·11)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20120726
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`MYLAN PHARMS. INC. EXHIBIT 1035 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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`Receipt is acknowledged of amendment filed on May 8, 2012. Claims 19, 29, 33,
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`34, 40, 42 and 45 are now pending.
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`The previous claim rejection made under 35 U.S.C. § 112, first paragraph, which
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`was indicated in the Office action dated January 5, 2012, is withdrawn in view of the
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`claim amendment.
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`The obviousness double patenting rejection, indicated in the same Office action,
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`is modified to address claim amendment, particularly the weight amount limitation of
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`naproxen and esomeprazole.
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`The claim rejection made under 35 U.S.C. § 103 (a) over Plachetka (US 6926907
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`B2) is modified to address the same claim amendment. The rejection is also modified
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`to address claim 45 which was inadvertently omitted in the previous Office action.
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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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`MYLAN PHARMS. INC. EXHIBIT 1035 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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`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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`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, 29, 33, 34, 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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`MYLAN PHARMS. INC. EXHIBIT 1035 PAGE 4
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 4
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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 multiplayer 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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`Regarding the amount of naproxen in claim 19, Plachetka teaches,
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`[n]aproxen is particularly useful when contained in tablets or capsules in
`an amount from 250 to 500 mg. For naproxen sodium, tablets of about
`275 or about 550 mg are typically used. Initial doses of from 100 to 1250
`mg, and particularly 350 to 800 mg are also used, with doses of about 550
`mg being generally preferred.
`
`See col. 6, lines 6 - 11. The reference also teaches, "[t]he most preferred NSAID is
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`naproxen in an amount of between 50 mg and 1500 mg, and more preferably, in an
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`amount of between 200 mg and 600 mg. See col. 4, lines 45-47.
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`Regarding the amount of esomeprazole, the reference teaches using 5-100 mg,
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`with about 40 mg per unit dosage form being preferred. See col. 7, lines 12-13.
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`Generally, differences in concentration or temperature will not support the
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`patentability of subject matter encompassed by the prior art unless there is evidence
`
`indicating such concentration or temperature is critical. "[W]here the general conditions
`
`of a claim are disclosed in the prior art, it is not inventive to discover the optimum or
`
`workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105
`
`USPQ 233, 235 (CCPA 1955). In this case, prior art teaches the ranges of effective and
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`preferred amounts of naproxen and esomeprazole in making unit dosage preparations.
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`MYLAN PHARMS. INC. EXHIBIT 1035 PAGE 5
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 5
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`Since the reference teaches the acid inhibitor is used in an effective amount to raise the
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`pH of the gastrointestinal tract to above 4 and reduce damages to mucosal tissue by
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`naproxen, discovery of the optimum amount of the esomeprazole according to the
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`teachings of the reference and by routine experimentations would have been well within
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`the skill in the art.
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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, 29, 33, 34, 40, 42 and 45 are rejected under 35 U.S.C. 103(a) as
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`being unpatentable over Plachetka (US 6926907 82).
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`MYLAN PHARMS. INC. EXHIBIT 1035 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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`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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`tablet 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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`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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`multi layered tablet, a person of ordinary skill in the art who makes and uses the prior art
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`MYLAN PHARMS. INC. EXHIBIT 1035 PAGE 7
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 7
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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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`Regarding the amount of naproxen in claim 19, Plachetka defines the effective
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`amount of the NSAI D in the specification, col. 6, lines 6 - 11 :
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`Naproxen is particularly useful when contained in tablets or capsules in an
`amount from 250 to 500 mg. For naproxen sodium, tablets of about 275
`or about 550 mg are typically used. Initial doses of from 100 to 1250 mg,
`and particularly 350 to 800 mg are also used, with doses of about 550 mg
`being generally preferred.
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`The specification also teaches, "[t]he most preferred NSAID is naproxen in an amount
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`of between 50 mg and 1500 mg, and more preferably, in an amount of between 200 mg
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`and 600 mg. See col. 4, lines 45-47.
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`Regarding the effective amount of esomeprazole, the specification defines such
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`amount as 5-100 mg, with about 40 mg per unit dosage form being preferred. See col.
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`7, lines 12-13.
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`Generally, differences in concentration or temperature will not support the
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`patentability of subject matter encompassed by the prior art unless there is evidence
`
`indicating such concentration or temperature is critical. "[W]here the general conditions
`
`of a claim are disclosed in the prior art, it is not inventive to discover the optimum or
`
`workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105
`
`USPQ 233, 235 (CCPA 1955). In this case, prior art teaches the ranges of effective and
`
`preferred amounts of naproxen and esomeprazole in making unit dosage preparations.
`
`Since the reference teaches the acid inhibitor is used in an effective amount to raise the
`
`MYLAN PHARMS. INC. EXHIBIT 1035 PAGE 8
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 8
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`pH of the gastrointestinal tract to above 4 and reduce damages to mucosal tissue by
`
`naproxen, discovery of the optimum amount of the esomeprazole according to the
`
`teachings of the reference and by routine experimentations would have been well within
`
`the skill in the art.
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`Response to Arguments
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`Applicant's arguments filed on May 8, 2012 have been fully considered but they
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`are not persuasive.
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`Applicant asserts prior art fails to teach the specific pharmacokinetic profile of the
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`unit dosage of the invention. However, the Plachetka patent explicitly teaches to make
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`an NSAID/acid inhibitor formulation to control the patient's intragastric pH at about 4 or
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`greater, suggests using naproxen in combination with esomeprazole (S-omeprazole),
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`and even teaches the effective and preferred amounts of the drugs for formulation. A
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`person of ordinary skill in the art only needs to follow the suggestion and guidelines of
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`the disclosure to practice the present method of treating patients with the inflammatory
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`conditions of the claims. The pharmacokinetic profiles of such formulation are not
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`viewed as a novel subject matter which applicant made or invented; they are viewed the
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`result of administering the formulation twice a day according to the teachings and
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`suggestions of the prior art.
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`Conclusion
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`No claims are allowed.
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`MYLAN PHARMS. INC. EXHIBIT 1035 PAGE 9
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`Application/Control Number: 12/553, 107
`Art Unit: 1617
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`Page 9
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`The prior art made of record and not relied upon is considered pertinent to
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`applicant's disclosure. US 6365184, teaching a single unit dosage comprising naproxen
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`and esomeprazole (S-omeprazole).
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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. JUSTICE/
`Primary Examiner, Art Unit 1617
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`MYLAN PHARMS. INC. EXHIBIT 1035 PAGE 10
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