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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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`l’l'()L—90A ( Rev. 04/07)
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`PAGE 1 OF 12
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`SENJU EXHIBIT 2085
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`LUPIN V SENJU
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`IPR2015—01l05
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`Office Action Summary
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`Application No.
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`10/525,006
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`Examine,
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`App|icant(s)
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`SAWA ET AL.
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`Art Unit
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`1614
`Donna Jagoe
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
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`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
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`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
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`- 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
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`after SIX (6) MONTHS from the mailing date of this communication.
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`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.
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`- 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).
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`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
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`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
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`1)IZ Responsive to communication(s) filed on 15 January 2009.
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`2a) This action is FINAL.
`2b)|:I This action is non—fina|.
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`3)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 Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)IZ CIaim(s) 19-29 31-34 36-51 53-56 and 58-63 is/are pending in the application.
`4a) Of the above c|aim(s) 39 40 61 and 62 is/are withdrawn from consideration.
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`5)I:I CIaim(s)j is/are allowed.
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`6)IZ CIaim(s) 19-29 31-34 36-38 41-51 53-56 58-60 and 63 is/are rejected.
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`7)I:I CIaim(s)j is/are objected to.
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`8)I:I CIaim(s)j are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
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`10)I:I The drawing(s) filed on j 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).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
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`a)I:I All
`b)I:I Some * c)I:I None of:
`Certified copies of the priority documents have been received.
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`Certified copies of the priority documents have been received in Application No. j
`Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`4) D Interview Summary (PTO—413)
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`Paper N0(3)/M3” D3I9- j
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`5) I:I N0“Ce Of '"f0rma' Patent Application
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`6) D Other:
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`Attach ment(s)
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`1) D Notice of References Cited (PTO—892)
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`2) El Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
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`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
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`Paper No(s)/Mail Date 3/11/09.
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`U.S. Patent and Trademark Office
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mail Date 20090528
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`PAGE 2 OF 12
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`DETAILED ACTION
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`Claims 19-29, 31-34, 36-51, 53-56 and 58-63 are pending in this application.
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`Claims 39, 40, 61 and 62 are withdrawn from further consideration.
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`Claims 19-29, 31-34, 36-38, 41-51, 53-56, 58-60 and 63 are rejected.
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`Applicants’ arguments filed January 15, 2009 have been fully considered but they
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`are not deemed to be persuasive. Rejections and/or objections not reiterated from
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`previous office actions are hereby withdrawn. The following rejections and/or objections
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`are either reiterated or newly applied. They constitute the complete set presently being
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`applied to the instant application.
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`Change of Examiner
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`The examiner assigned to the instant application has changed. The new
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`examiner is Donna Jagoe. Contact information is provided at the end of this Office
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`Action.
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`Priority
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`As recited in the Office Action dated September 27, 2007, Applicant is reminded
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`that a certified translation has not been proved for the claim to foreign priority of
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`JP2003—012427, filed 1/21/2003. Since no translation has been provided, prior art
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`Page 3
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`dates have been determined with reference to the priority date for the PCT application
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`date, PCT/JP04/00350, filed 1/16/2004.
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`Claim Rejections - 35 USC § 112
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`The following is a quotation of the second paragraph of 35 U.S.C. 112:
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`The specification shall conclude with one or more claims particularly pointing out and distinctly
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`claiming the subject matter which the applicant regards as his invention.
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`Claims 19-29, 31-34, 36-38, 41-51, 53-56, 58-60 and 63, are rejected under 35
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`U.S.C. 112, second paragraph, as being indefinite forfailing to particularly point out and
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`distinctly claim the subject matter which applicant regards as the invention.
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`Claims 19 and 41 recite an aqueous liquid preparation comprising at least 2-
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`amino—3—(4—bromobenzoyl)phenylacetic acid (bromfenac) and an alkyl aryl polyether
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`alcohol type polymer or polyethylene glycol fatty acid ester “wherein said liquid
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`preparation is in the form of an eye drop”.
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`It is unclear what is meant by “in the form of
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`an eye drop.
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`is this aqueous liquid preparation in a container shaped like an eye drop?
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`It is suggested that the claim be amended to recite "wherein said liquid preparation is
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`formulated for ophthalmic administration".
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`Claim Rejections - 35 USC § 103
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`The text of those sections of Title 35, U.S. Code not included in this action can
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`be found in a prior Office action.
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`Claims 19-29, 31-34, 36-38, 41-51, 53-56, 58-60 and 63 are rejected under 35
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`U.S.C. 103(a) as being unpatentable over Hellberg et al. (US 5,998,465; 1999) and
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`Page 4
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`Nolan, et al. (“The topical anti—inflammatory and analgesic properties of bromfenac in
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`rodents; Agents and Actions; 1988 Aug; 25(1-2):77-85; cited with previous Interview
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`Summary).
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`Hellberg teaches pharmaceutical compositions of anti-inflammatory compounds
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`(abstract); the compounds include a non—steroidal anti-inflammatory moiety (NSAIA)
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`and an antioxidant moiety linked through an ester bond formed by the carboxylic acid
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`moiety of the NSAIA (col. 2, lines 20-24); NSAIA moieties include bromfenac (col. 3, line
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`57; claim 5); examples 2 and 3 (col. 11) teach topical ophthalmic formulations useful for
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`treating inflammation, both of these formulations include tyloxapol at 0.01-0.05 w/v %,
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`HPMC (thickener), benzalkonium chloride (preservative), edetate disodium (chelating
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`agent) (col. 11, Examples 2-3); the pH is adjusted to 7.4 (about 7.5; col. 11, line 64);
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`topical formulations administered by drops (eye drops; col. 10, lines 15-18). Hellberg
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`does not teach bromfenac (only the ester of bromfenac). Nolan teaches bromfenac (the
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`sodium salt, sesquihydrate form) was effective as a topical analgesic at concentrations
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`of 0.1-0.32 % in mice and more potent than the other drugs tested (abstract).
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`It would
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`have been obvious for one of ordinary skill in the art at the time of the invention to
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`substitute bromfenac, taught by Nolan for the compounds of Hellberg in the example
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`formulation giving formulations of the instant claims and to select concentrations of
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`bromfenac sodium, sesquihydrate of 0.1, about 0.2 and about 0.32 %, in the invention
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`of Gamache, since these values have demonstrated efficacy for topical use.
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`It would
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`also have been obvious to adjust the concentration of tyloxapol, to optimize the
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`formulations for the effect would on the solubility and stability of the aqueous
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`Page 5
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`preparations, which would have resulted in the effective tyloxapol concentrations of
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`about 0.02 and 0.3 w/v%, recited in claims 25 and 32. The motivation to substitute
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`bromfenac in the Hellberg formulations would have bee the art-recognized equivalent
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`activity of bromfenac as an anti-inflammatory agent in topical usage. The motivation to
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`adjust concentrations would have been the routine optimization of these topical
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`ophthalmic formulations for anti-inflammatory use in the eye.
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`Claims 19-29, 31-34 and 36-38 are rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Gamache, et al. (WO 01/15677 A2; 03/2001; previously cited) and
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`ISTA Pharmaceuticals (“New Drug Applications: Xibrom”,
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`http://wwwxirugscom/nda/xibrom 040525.htmi, accessed online 9/19/2007; previously
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`cited) or Nolan, et al. (“The topical anti-inflammatory and analgesic properties of
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`bromfenac in rodents; Agents and Actions; 1988 Aug; 25(1-2):77-85; provided with
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`Interview Summary).
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`Gamache teaches compositions for otic and intranasal use (p.6, lines 5-6) that
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`contain a combination of a 5-HT agonist and an anti-inflammatory agent (p. 6, lines 1-4;
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`p. 12 lines 9-10) or alternatively sequential or concurrent dosing of separate
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`compositions that contain the 5-HT antagonist in one composition and the anti-
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`inflammatory agent in a second composition (p. 12, lines 9-11); specifically claimed is
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`the anti-inflammatory specie bromfenac (2-amino-3-(4-bromobenzoyl)phenylacetic
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`acid). Typical concentrations of anti-inflammatory agents, such as bromfenac, are
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`taught in the range 0.01-1.0 % (w/v) (overlapping with 0.01-0.5; p. 13, lines 6-8);
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`PAGE 6 OF 12
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`aqueous formulations are preferred (p. 10, lines 11-14);
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`tyloxapol is taught in a
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`concentration of 0.05 % (w/v) (p. 16, line 30).
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`It is noted that instant claim 21 and
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`further dependent claims limit the options for the salt of bromfenac to the sodium salt,
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`and that the specific concentrations recited in dependent claims apply to the sodium
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`salt; the other options (bromfenac or a hydrate of bromfenac) are still viable choices that
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`are part of instant claim 21 claims depending therefrom (which depend on and include
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`the options of claim 20). Gamache teaches bromfenac in the concentration range of
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`claim 20 (which is also an option of claims 21-24 and 31). The salt form of bromfenac in
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`solution will be the same when the acid is dissolved in a solution followed by adjustment
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`to the desired pH with NaOH/HCl (Gamache, p. 15, line 33) as when the sodium salt is
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`dissolved in solution adjusted to the same pH; in this case Gamache also teaches the
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`sodium salt limitation of instant claim 21, albeit not the sodium salt concentration
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`limitation of instant claim 22 and further dependent claims, since the claim is drawn to
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`an aqueous liquid preparation, irrespective of how it is prepared. However, the
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`concentration range of 0.01-1 .0% overlaps and encompasses the claimed concentration
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`range of the sodium salt of bromfenac instantly claimed.
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`The ISTA Pharmaceuticals news release demonstrates that products containing
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`0.1 % bromfenac sodium acquired US marketing rights for Xibrom in May 2002 (were
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`known by others in this country before app|icant’s priority date, a 35 USC 102(a) date).
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`Nolan teaches bromfenac (the sodium salt, sesquihydrate form) was effective as a
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`topical analgesic at concentrations of 0.1—0.32 % in mice and more potent than the other
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`drugs tested (abstract).
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`It would have been obvious for one of ordinary skill in the art at
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`PAGE 7 OF 12
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`Page 7
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`the time of the invention to select concentrations of bromfenac sodium, sesquihydrate of
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`0.1, about 0.2 and about 0.32 %, in the invention of Gamache, since these values have
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`demonstrated efficacy for topical use.
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`It would have been obvious to adjust the
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`concentration of tyloxapol, to see what the effect would be on the solubility and stability
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`of the aqueous preparations, which would have resulted in the effective concentrations
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`of the instant claims.
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`It would also have been obvious to adjust the pH to values in the
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`7.5 to 8.5 range, with the potential of dissolving and/or stabilizing more of the acidic
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`drug, bromfenac, in a more aqueous soluble ionic form. The motivation would have
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`been to prepare pharmaceutical products with optimal drug dosage and stability.
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`Double Patenting
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`Claims 19-29, 31-34, 36-38, 41-51, 53-56, 58-60 and 63 are provisionally
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`rejected on the ground of nonstatutory obviousness-type double patenting as being
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`unpatentable over claims 1-43 of copending Application No. 11/755662.
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`Although the conflicting claims are not identical, they are not patentably distinct
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`from each other because the copending application contains claims drawn to method of
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`treating pain and/or inflammation associated with an ocular condition, by administering
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`the aqueous solutions of the instant claims.
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`It would have been obvious to one of
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`ordinary skill in the art at the time of the invention to use the formulations of the instant
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`claims in the methods of the copending application, since the claims recite that the
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`PAGE 8 OF 12
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`Page 8
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`formulations are eye drops, and the instant abstract also teaches some of the conditions
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`treated of the copending application.
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`This is a provisional obviousness-type double patenting rejection because the
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`conflicting claims have not in fact been patented.
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`Response to Arguments
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`Applicant asserts that Gamache et al. in view of ISTA or Nolan et al. does not
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`teach the claimed invention because the amended claims require that the aqueous
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`liquid preparation is in the form of an eye drop.
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`In response, please see the rejection
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`supra regarding claims drawn to the composition "in the form of an eye drop". Further,
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`Gamache teaches the composition to be employed intranasally and intraotically. There
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`is nothing differentiating the composition of the instant claims from the composition of
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`Gamache other than the claim that it is "in the form of an eye drop". Drops that are
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`formulated for intranasal use and otic use are sterile and isotonic. The intended use
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`must result in a structural difference between the claimed invention and the prior art in
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`order to patentably distinguish the claimed invention from the prior art. Since the drops
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`of Gamache are capable of performing the intended use, then it meets the claim.
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`Regarding the inclusion of other agents in the drops of Gamache, The claim language
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`comprising leaves the claim open for the inclusion of unspecified ingredients, even in
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`major amounts. Applicant asserts that the tyloxapol is only mentioned as being added
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`to an 1B/1 D agonist and moxifloxacin in example 4 with no explanation of why it is
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`PAGE 9 OF 12
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`Page 9
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`included.
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`In response, a reference is not limited to working examples.
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`In re Fraca/ossi
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`215 USPQ 569 (CCPA 1982). Applicant asserts that Gamache et la. is silent regarding
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`the alkyl aryl polyether alcohol type polymer or a polyethylene glycol fatty acid ester
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`component according to the claimed eye drop.
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`In response, Gamache et al. teach
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`polysorbate 20, 60, and 80 as a surfactant or co-solvent (see page 12).
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`Applicant asserts that the intended purpose of the invention disclosed in Hellberg
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`et al. is to provide compounds having anti-inflammatory activity and antioxidant activity
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`and further asserts it would not be obvious to substitute bromfenac.
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`In response,
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`bromfenac is clearly disclosed as a compound that is contemplated for use in the
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`invention of Hellberg et al. (see claims 5 and 19 of the patent). “Products of identical
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`chemical composition (i.e. bromfenac) can not have mutually exclusive properties.” A
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`chemical composition and its properties are inseparable. Therefore, if the prior art
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`teaches the identical chemical structure, the properties applicant discloses and/or
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`claims (i.e. anti inflammatory and antioxidant activity) are necessarily present. In re
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`Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (Applicant argued
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`that the claimed composition was a pressure sensitive adhesive containing a tacky
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`polymer while the product of the reference was hard and abrasion resistant. “The Board
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`correctly found that the virtual identity of monomers and procedures sufficed to support
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`a prima facie case of unpatentability of Spada’s polymer Iatexes for lack of novelty.’’).
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`In response to applicant's argument that Hellberg et al. is nonanalogous art, it
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`has been held that a prior art reference must either be in the field of applicant’s
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`endeavor or, if not, then be reasonably pertinent to the particular problem with which the
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`PAGE 10 OF 12
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`Page 10
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`applicant was concerned, in order to be relied upon as a basis for rejection of the
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`claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir.
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`1992).
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`In this case, Hellberg et al. teach a composition for intraocular administration
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`comprising inter alia, a compound (bromfenac) and tyloxapol (see examples).
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`Conclusion
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`Applicant's amendment necessitated the new ground(s) of rejection presented in
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`this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP
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`§ 706.07(a). Applicant is reminded of the extension oftime policy as set forth in 37
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`CFR1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the date of this final action.
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`Correspondence
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Donna Jagoe whose telephone number is (571) 272-
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`PAGE 11 OF 12
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`Page 11
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`0576. The examiner can normally be reached on Monday through Friday from 8:00
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`A.M. - 4:30 P.M..
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Ardin Marschel can be reached on (571) 272-0718. 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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`Information regarding the status of an application may be obtained from the
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`PatentApp|ication 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 (toII—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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`Donna Jagoe /D. J./
`Examiner
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`Art Unit 1614
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`May 30, 2009
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`/Ardin Marschell
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`Supervisory Patent Examiner, Art Unit 1614
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`PAGE 12 OF 12