`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COlVllVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 223 13- 1450
`www.uspto.gov
`
`
`
`
`
`12/553,107
`
`09/03/2009
`
`Brian Ault
`
`POZN.P0026US
`
`5949
`
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. 1, Suite 200
`Austin, TX 78746
`
`JUSTICE. GINA CHIEUN YU
`
`1617
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`03/26/2015
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e—mail address(es):
`
`docket @ phiplaw.com
`
`PTOL—90A (Rev. 04/07)
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 1
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`

`

`
`Application No.
`Applicant(s)
`12/553,107
`AU LT ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`GINA YU JUSTICE
`1617
`StatusNo
`
`Office Action Summary
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date ofthis 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 iftimely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`
`1)IXI Responsive to communication(s) filed on December 16 2014.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`.
`
`2b)|:l This action is non-final.
`2a)IZI This action is FINAL.
`3)|: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.
`
`4)|:| 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 Exparte Quay/e, 1935 CD. 11,453 QC. 213.
`
`Disposition of Claims*
`
`5)IXI 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 El Claim 3)
`
`is/are allowed.
`
`19 29 33 34 40 42 and 45 is/are rejected.
`
`is/are objected to.
`
`
`
`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`zilxwiiwusnto. ov/ atents/init events/
`h/index.‘s
`
`
`
`
`htt
`
`or send an inquiry to PPI-ifeedbackfieusgto.gov.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)|:l The drawing(s) filed on
`is/are: a)I:I accepted or b)|:l 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).
`
`Priority under 35 U.S.C. § 119
`
`12)I:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)I:l AII
`b)|:l Some” c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.I:l Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Flute 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`
`
`Attachment(s)
`
`
`
`3) D Interview Summary (PTo_4-13)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) I] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`Paper No(s)/Mai| Date .
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20150320
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 2
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`

`

`Application/Control Number: 12/553,107
`
`Page 2
`
`Art Unit: 1617
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`Applicant’s response filed on December 16, 2014 has been received. No claim
`
`amendment has been made; Claims 19, 29, 33, 34, 40, 42 and 45 remain pending.
`
`In this Office action, all claim rejections as indicated in the previous Office action
`
`dated June 16, 2014 are maintained for reasons of record.
`
`Maintained: Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(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.
`
`This application currently names joint inventors.
`
`In considering patentability of
`
`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
`
`the various claims was commonly owned at the time any inventions covered therein
`
`were made absent any evidence to the contrary. Applicant is advised of the obligation
`
`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
`
`consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g)
`
`prior art under 35 U.S.C. 103(a).
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 3
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`

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`Application/Control Number: 12/553,107
`
`Page 3
`
`Art Unit: 1617
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`Claims 19, 29, 33, 34, 40, 42 and 45 are rejected under 35 U.S.C. 103(a) as
`
`being unpatentable over Hassan-Alin et al. (“Lack of drug-drug interaction
`
`between esomeprazole and naproxen in healthy subjects”, Gastroenterology,
`
`124(4), Supp. 1, p. A541, April 2003) ("Hassan-Alin" hereunder) in view of
`
`Plachetka (US 6926907 BZ).
`
`Hassan-Alin that no drug-drug interactions between esomeprazole and naproxen
`
`was observed in a study conducted with 32 healthy subjects and mean weight of 69 Kg
`
`who received once/day dose of 40 mg of esomeprazole and twice/day 250 mg of
`
`naproxen or the two drugs in combination for 7 days. Blood samples for determination
`
`of the drugs were collected 24 hours post-dose on day 7 and were analyzed using
`
`normal-phase liquid chromatography with UV-detection. Pharmacokinetic parameters 0[
`
`the two drugs were estimated by non-compartmental analysis and were calculated
`
`using analysis of variance (ANOVA). The study teaches that naproxen was chosen as
`
`a widely used representative of non-selective NSAIDs. The reference also teaches that
`
`esomeprazole provides more time with intragastric pH>4 than other proton pump
`
`inhibitors and is expected to be even more effective than these for the prevention
`
`of NSAID-associated ulcers and provide GI protection. The study concludes that
`
`there was no evidence of any increase of adverse events as esomeprazole was well
`
`tolerated both alone and in combination in naproxen. The study further suggests that
`
`naproxen can be administered without dosage alteration, which is interpreted to mean
`
`that the amount of the NSAID which potentially damages GI track does not need to be
`
`reduced.
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 4
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`

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`Application/Control Number: 12/553,107
`
`Page 4
`
`Art Unit: 1617
`
`The user group of the Hassan-Alin study were healthy individuals and not in need
`
`of NSAID therapy as presently claimed. The regime in the study is also different from
`
`the claimed method in that the presently claimed method requires AM and PM dosage
`
`of 500 mg naproxen, which is greater than the amount used in prior art (250 mg twice a
`
`day). However, administering to patients having inflammatory diseases an amount of a
`
`NSAID greater than what was given to healthy subjects would have been obvious to
`
`those skilled in pharmaceutical art.
`
`For example, Plachetka teaches a method for a coordinated delivery of naproxen
`
`in a gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve
`
`pain and symptom relief with a reduced risk of developing gastrointestinal damage such
`
`as ulcers, erosions and hemorrhages. See abstract. Regarding the amount of
`
`naproxen in claim 19, Plachetka defines the effective amount of the NSAID in the
`
`specification, col. 6, lines 6 — 11:
`
`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.
`The reference also teaches, “[t]he most preferred NSAID is naproxen in an
`amount of between 50 mg and 1500 mg, and more preferably, in an
`amount of between 200 mg and 600 mg. See col. 4, lines 45-47.
`Plachetka further teaches a trilayer tablet that separates an acid inhibitor
`
`contained in a film coat from a core comprising controlled-release naproxen formulated
`
`using excipients which control the drug release. The film coat is an enteric coating
`
`configured to delay the release of naproxen until the dosage form reaches an
`
`environment where the pH is above 3.5, or preferably above 4. See Drawings; col. 3,
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 5
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`

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`Application/Control Number: 12/553,107
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`Page 5
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`Art Unit: 1617
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`line 18 — 53. Plachetka teaches the acid inhibitor present in an amount effective to raise
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`the gastric pH of a patient to at least 3.5, preferably to at least 4, and more preferably to
`
`at least 5, when the dosage is administered. The most preferred and effective acid
`
`inhibitors include esomeprazole, among others. See col. 3, lines 18 — 38.
`
`As discussed above, Hassan-Alin teaches 1) that esomeprazole provides more
`
`time with intragastric pH>4 than other proton pump inhibitors and is expected to be even
`
`more effective than these for the prevention of NSAlD-associated ulcers and 2) that
`
`there is no interaction between esomeprazole and naproxen. Given such teachings,
`
`one of ordinary skill in the art would have been obviously motivated to look to prior arts
`
`such as Plachetka which teaches co-administration of naproxen and proton pump
`
`inhibitors, the effective amount of naproxen to treat inflammatory diseases and suitable
`
`pharmaceutical carriers for the drugs and adequate amount of esomeprazole to
`
`encounter the increased dosage of naproxen (Le, 40 mg of esomeprazole for every 500
`
`mg of naproxen as taught by Hassan-Alin).
`
`In view of the combined teachings of the
`
`references, the skilled artisan would have been motivated to treat patients with
`
`inflammatory diseases such as arthritis with an effective amount of naproxen with
`
`esomeprazole with a reasonable expectation of successfully treating the inflammation
`
`without developing gastrointestinal damage.
`
`Regarding the AM and PM dosage of the present claims, such dosage would
`
`have been obvious in view of Hassan-Alin and Plachetka, as administration twice daily
`
`would be about 12 hours apart.
`
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`

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`Application/Control Number: 12/553,107
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`Page 6
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`Art Unit: 1617
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`The pharmacokinetic profile of the dose is viewed the results of following the
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`suggestion of Hassan-Alin and Plachetka to use esomeprazole and naproxen to treat
`
`inflammatory diseases without gastrointestinal damages.
`
`It is well settled in patent law
`
`that the fact that applicant has recognized another advantage which would flow naturally
`
`from following the suggestion of the prior art cannot be the basis for patentability when
`
`the differences would otherwise be obvious. See Exparte Obiaya, 227 USPQ 58, 60
`
`(Bd. Pat. App. & lnter. 1985).
`
`Maintained: Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the “right to exclude” granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory
`
`obviousness-type double patenting rejection is appropriate where the conflicting claims
`
`are not identical, but at least one examined application claim is not patentably distinct
`
`from the reference claim(s) because the examined application claim is either anticipated
`
`by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140
`
`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29
`
`USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
`
`1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422
`
`F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
`
`USPQ 644 (CCPA 1969).
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 7
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`

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`Application/Control Number: 12/553,107
`
`Page 7
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`Art Unit: 1617
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the conflicting application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
`
`activities undertaken within the scope of a joint research agreement.
`
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`
`37 CFR 3.73(b).
`
`Claims 19, 29, 33, 34, 40, 42 and 45 are rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over
`
`claims 1-55 of U.S. Patent No. 6926907 B2 in view of Hassan-Alin.
`
`Although the conflicting claims are not identical, they are not patentably distinct
`
`from each other because both sets of claims are directed to a method of delivering to a
`
`patient (a) an acid inhibitor at a dose effective to raise the gastric pH of said patient to at
`
`least 3.5; and b) an NSAID that is released at a pH of 3.5 or greater, wherein
`
`esomeprazole is selected as the acid inhibitor and the NSAID is naproxen. See ‘907,
`
`Claims 24-32. The AM and PM dosage of the present claim would have been an
`
`obvious method step to utilize the patented invention, as the specification teaches to
`
`administer a naproxen/acid inhibitor according to the prior art invention twice daily. See
`
`Examples 9 and 10. Patented claim 53 also describes the multiplayer tablet of instant
`
`claim 40. Although the patented claims do not specifically disclose the pharmacokinetic
`
`profile of the drugs released from the multilayered tablet, a person of ordinary skill in the
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 8
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`

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`Application/Control Number: 12/553,107
`
`Page 8
`
`Art Unit: 1617
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`art who makes and uses the prior art method according to the teachings would have
`
`obviously observed such.
`
`Regarding the amount of naproxen in claim 19, Plachetka teaches,
`
`[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.
`
`Regarding the amount of esomeprazole, the reference teaches using 5-100 mg,
`
`with about 40 mg per unit dosage form being preferred. See col. 7, lines 12—13.
`
`Hassan-Alin teaches that no drug-drug interactions between esomeprazole and
`
`naproxen was observed in a study conducted with 32 healthy subjects and mean weight
`
`of 69 Kg who received once/day dose of 40 mg of esomeprazole and twice/day 250 mg
`
`of naproxen, or the two drugs in combination for 7 days. Blood samples for
`
`determination of the drugs were collected 24 hours post-dose on day 7 and were
`
`analyzed using normal-phase liquid chromatography with UV-detection.
`
`Pharmacokinetic parameters of the two drugs were estimated by non-compartmental
`
`analysis and were calculated using analysis of variance (ANOVA). The study teaches
`
`that naproxen was chosen as a widely used representative of non-selective NSAle.
`
`The reference also teaches that esomeprazole provides more time with intragastric
`
`pH>4 than other proton pump inhibitors and is expected to be even more effective than
`
`these for the prevention of NSAlD-associated ulcers and provide GI protection. The
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 9
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`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 9
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`Application/Control Number: 12/553,107
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`Page 9
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`Art Unit: 1617
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`study concludes that there was no evidence of any increase of adverse events;
`
`esomeprazole was well tolerated both alone and in combination in naproxen.
`
`Generally, differences in concentration or temperature will not support the
`
`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, the patented claims teach 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 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. Particularly in view of the teachings of Hassan-Alin that esomeprazole provides
`
`more time with intragastric >7 than other agents, selection of esomeprazole over others
`
`and administration of 40 mg of esomeprazole for every 500 mg naproxen would have
`
`been an obvious choice.
`
`Claims 19, 29, 33, 34, 40, 42 and 45 are provisionally rejected on the ground
`
`of nonstatutory double patenting as being unpatentable over 57-75 of copending
`
`Application No. 14045156.
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 10
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`Application/Control Number: 12/553,107
`
`Page 10
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`Art Unit: 1617
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`Although the claims at issue are not identical, they are not patentably distinct
`
`from each other because both sets of claims are directed to a method of treating a
`
`patient for pain or inflammation, comprising administering to said patient a
`
`pharmaceutical composition in unit dose form comprising: (a) 5-100 mg of
`
`esomeprazole per unit dosage form and (b) 200-600 mg of naproxen per unit dosage
`
`form wherein the release of naproxen is controlled unless the pH of the medium is 3.5
`
`or higher. See '156 claims 72-75.
`
`This is a provisional nonstatutory double patenting rejection because the
`
`patentably indistinct claims have not in fact been patented.
`
`Claims 19, 29, 33, 34, 40, 42 and 45 are provisionally rejected on the ground
`
`of nonstatutory double patenting as being unpatentable over claims 1-4, 18-20,
`
`25, 26, 31, 38, 46-48, 64 and 65 of copending Application No. 12/822612.
`
`Although the claims at issue are not identical, they are not patentably distinct
`
`from each other because both sets of claims are directed to a method of reducing the
`
`incidence of NSAlD-associated gastric ulcers in patients taking low dose aspirin who
`
`are at risk of developing such ulcers, wherein the method comprises administering to
`
`said patient in need thereof a pharmaceutical composition in unit dose form comprising:
`
`(a) 20 mg of esomeprazole, or pharmaceutically acceptable salt thereof, in a form and
`
`route sufficient to raise the gastric pH of said patient to at least 3.5 upon administration
`
`of one or more of said unit dose forms, and (b) 500 mg of naproxen, or pharmaceutically
`
`acceptable salt thereof; wherein said unit dose form provides for coordinated release of
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 11
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`Application/Control Number: 12/553,107
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`Page 11
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`Art Unit: 1617
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`the esomeprazole and the naproxen. The patient populations of the two inventions
`
`include rheumatoid arthritis, ankylosing spondylitis. See '612 claim 4.
`
`This is a provisional nonstatutory double patenting rejection because the
`
`patentably indistinct claims have not in fact been patented.
`
`Response to Arguments
`
`Applicant's arguments filed on December 16, 2014 have been fully considered
`
`but they are not persuasive.
`
`Examiner respectfully disagrees with applicants’ simplified characterization of the
`
`cited references. Both of the cited references teach that administration of
`
`esomeprazole to reduce gastric damage caused by non-steroidal anti-inflammatories is
`
`a well-known practice. Hassan-Alin teaches that esomeprazole/naproxen pair is safe
`
`and effective to administer and strongly motivates one of ordinary skill in the art to look
`
`for prior arts such as Plachetka for effective dosage for patients in need thereof. The
`
`design of a single dose unit comprising naproxen and an acid inhibitor such as
`
`esomeprazole is disclosed in Plachetka; the effective doses of the drugs are suggested
`
`in the reference, including a method of administering such unit twice/day. Given these
`
`specific teachings and motivations, optimization of the prior art dosage of naproxen and
`
`esomeprazole is not seen unobvious or surprising. The resulting pharmacokinetics
`
`necessarily flow from such obvious administration method.
`
`Applicant’s assertion that it is “almost certain” that the esomeprazole used in the
`
`Hassan—Alin study was enterically—coated is not supported by facts. Furthermore,
`
`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 12
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`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 12
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`Application/Control Number: 12/553,107
`
`Page 12
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`Art Unit: 1617
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`designing an acid-reducing agent for faster release is well known, according to
`
`Plachetka.
`
`Conclusion
`
`No claims are allowed.
`
`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
`
`policy as set forth in 37 CFR1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action.
`
`In the event a first reply is filed within
`
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`
`mailed until after the end of the THREE-MONTH shortened statutory period, then the
`
`shortened statutory period will expire on the date the advisory action is mailed, and any
`
`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
`
`the advisory action.
`
`In no event, however, will the statutory period for reply expire later
`
`than SIX MONTHS from the mailing date of this final action.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to GINA YU JUSTICE whose telephone number is
`
`(571 )272—8605. The examiner can normally be reached on Monday through Friday,
`
`from 9:00AM until 5:00 PM..
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Johann Richter can be reached on 571-272—0646. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273—8300.
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`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 13
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`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 13
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`Application/Control Number: 12/553,107
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`Page 13
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`Art Unit: 1617
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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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`system, call 800-786-9199 (IN USA OR CANADA) or 571—272—1000.
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`/G|NA YU JUSTICE/
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`Primary Examiner, Art Unit 1617
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`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 14
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`MYLAN PHARMS. INC. EXHIBIT 1082 PAGE 14
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