`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313- 1450
`www.mspto.gov
`
`APPLICATION NO.
`
`12/553,107
`
`
`
`
`
` F ING DATE
`
`09/03/2009
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
`
`Brian Ault
`
`POZN.P0026US
`
`5949
`
`.
`EXAMINER
`parkerngmanderpLLc —
`759°
`108197
`06’1““ —
`
`
`IUSTICE, GINA CH *UN YU
`1120 South Capital of Texas Highway
`
`ART UNIT
`2'APER NUMBER
`Bldg. 1, Suite 200
`Austin, TX 78746
`
`1617
`
`
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`06/ 16/2014
`
`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 1081 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 1
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`

`

`
`Application No.
`Applicant(s)
`12/553,107
`AULT ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`GINA C. YU JUSTICE
`1617
`StatusNo
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`Office ACtion summary
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g 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() 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. § 183).
`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).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`1)IXI Responsive to comm unication(s) filed on January 30, 2013.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)IXI This action is non-final.
`2a)I:I This action is FINAL.
`3)I: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)I:I 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 Quay/e, 1935 CD. 11,453 O.G. 213.
`
`Disposition of Claims*
`
`5)IX| 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.
`
` AAA
`
`6)I:I Claim 3) _ is/are allowed.
`NZ Claim 8) 19 29 33 34 40 42 and 45 is/are rejected.
`8)|:| Claim 3)
`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
`S
`atentsh :‘it events/ , .h/index.‘ ://‘.wrw.usr)to. OV/c
`
`htt
`
`
`
`
`1 or send an inquiry to PPI-Ifeedback-{c'fiuspto.dov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:| The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I 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:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)I:I AII
`b)I:I Some“ c)I:I None of the:
`1.I:I Certified copies of the priority documents have been received.
`2.|:I Certified copies of the priority documents have been received in Application No.
`3.I:| 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)
`
`
`
`3) D Interview Summary (PTO-413)
`1) D Notice of References Cited (PTO—892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) E 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 20140610
`
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`

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`Application/Control Number: 12/553,107
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`Page 2
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`Art Unit: 1617
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`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`Continued Examination Under 37 CFR 1.114
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
`
`application is eligible for continued examination under 37 CFR 1.114, and the fee set
`
`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January
`
`30, 2013 has been entered.
`
`All claim rejections of the previous Office action dated June 30, 2012 are
`
`withdrawn in view of applicant’s disclosure submitted on January 30, 2013. More
`
`specifically, the teachings of 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) prompted new grounds of rejection.
`
`New: 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
`
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`Application/Control Number: 12/553,107
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`Page 3
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`Art Unit: 1617
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`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).
`
`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 B2).
`
`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 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 NSAID-associated ulcers and provide GI protection. The study concludes that
`
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`Application/Control Number: 12/553,107
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`Page 4
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`Art Unit: 1617
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`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.
`
`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.
`
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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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`Plachetka further teaches a trilayer tablet that separates an acid inhibitor
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`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,
`
`line 18 — 53. Plachetka teaches the acid inhibitor present in an amount effective to raise
`
`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
`
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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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`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.
`
`The pharmacokinetic profile of the dose is viewed the results of following the
`
`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).
`
`New: 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
`
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`Application/Control Number: 12/553,107
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`Page 7
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`Art Unit: 1617
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`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).
`
`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
`
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`Application/Control Number: 12/553,107
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`Page 8
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`Art Unit: 1617
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`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
`
`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 0[ the two drugs were estimated by non-compartmental
`
`analysis and were calculated using analysis of variance (ANOVA). The study teaches
`
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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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`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 NSAlD-associated ulcers and provide GI protection. The
`
`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
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`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.
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`Application/Control Number: 12/553,107
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`Page 10
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`Art Unit: 1617
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`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.
`
`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
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`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 NSAID-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
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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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`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
`
`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 with respect to the previously rejection made in view of
`
`Plachetka have been considered but are moot because the arguments do not apply to
`
`the Hassan-Alin reference which is used in the current rejection.
`
`Applicant’s arguments regarding unexpected results of esomeprazole over
`
`famotidine have been fully considered but are unpersuasive in view of the disclosure of
`
`Hasan-Alin, which discloses that esomeprazole is known to provide more time with
`
`intragastric pH>4 than other proton pump inhibitors. According to the reference,
`
`esomeprazole is expected to be more effective than other acid reducing agents for the
`
`prevention of NSAlD-associated ulcers and provide GI protection. Thus applicant’s data
`
`is not deemed to be unexpected or surprising.
`
`Conclusion
`
`No claims are allowed.
`
`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 12
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`Application/Control Number: 12/553,107
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`Page 12
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`Art Unit: 1617
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`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to GINA C. 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
`
`supervisor, Johann Richter can be reached on 571-272—0646. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`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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`/G|NA C. YU JUSTICE/
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`Primary Examiner, Art Unit 1617
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`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 13
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`MYLAN PHARMS. INC. EXHIBIT 1081 PAGE 13
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`