UNITED STAT
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`EPARTMENT OF COMMERCE
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`United States I’: eat and Trademark Omce
`Address: COMMISSIONER FOR PATENTS
`PO. Box I450
`Aleundxis. vicginig 12311-I450
`wwvnusploigov
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATION NO.
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`I0/525.006
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`o3/23/zoos
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`Shirou Sawa
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`200S_O232A
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`I756
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`SI3
`7590
`09/27/2007
`WENDEROTH, LIND & PONACK, L.L.P.
`2033 K STREET N. W.
`SUITE 800
`WASHINGTON. DC 20006-1021
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`‘
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`THOMAS. TIMOTHY P
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`I6|4
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`09/27/2007
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL-90A (Rev. 04/07)
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`PAGE 1 OF 14
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`SENJU EXHIBIT 2084
`LUPIN v SENJU
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`IPR2015—01105
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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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`M Unit
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`4- 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 IVIONTH{S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
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`— Extensions cl 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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`it No period for reply is specified above, the rnaxirnum 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(1)).
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`Status
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`HE] Responsive to communication(s) filed on 20 August 2007.
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`2a)I:I This action is FINAL.
`2b) This action is non-final.
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`3)I:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Ex pan‘e Quayie, 1935 C.D. 11, 453 0G. 213.
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`Disposition of Claims
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`4)IXI C|aim(s) 191-59 lslare pending in the application.
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`4a) Of the above claim(s)I 39 and 40 is/are withdrawn from consideration.
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`5)EI‘ Claim(s) _ islare allowed.
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`6)IXI Claim(s) 12-_3§ islare rejected.
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`?)I:] Claim(s) __ isfare objected to, ‘
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`8)I:I Claim(s) j are subject to restriction and/or election requirement.
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`Application Papers
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`9)[] 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)lj 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 drawlng{s) is objected to. See 3? CFR 1.121(d).
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`1‘l)IZ 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)E Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)IZ All
`b)I:] Some * c)I:] None of:
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`LE Certified copies of the priority documents have been received.
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`2.[:I Certified copies of the priority documents have been received in Application No. _
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`3.[:I 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 172(3)).
`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachmenfls)
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`1) E Notice of References Cited (PTO—892}
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`2) CI Notice of Drafispersons Patent Drawing Review (PTO-948)
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`3;
`lnformation Disclosure Statement(s) (PTOISBIOS)
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`Paper No(s)/Mail Date See Continuation Sheet.
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`U.S. Patent and Trademark Office
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`PTOL-326 (Rev. 08-06)
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`4) 1:] interview Summary (PTO-413)
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`P399? N0(S)/Mal‘ 0316- _-
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`5} CI N°tl¢e °flnf°m"alPa1e"lAP9li¢3ii°"
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`6) 1:} Other: _.
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`Office Action Summary
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`Part of Paper No.IMail Date 20070919
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`PAGE 2 OF 14
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`Continuation Sheet (PTOL-326)
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`Application No. 10/525,006
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`Continuation of Attachment(s) 3). Information Disclosure Statement(s) (PTO/SB:'O8), Paper No(s)/MaiI Date 22/17/2005,
`411 1/2005, 7/12/2007.
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`PAGE 3 OF 14
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`DETAILED ACTION
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`Election/Restrictions
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`1.
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`Applicant's election without traverse of group I, claims 19-38 in the reply filed on
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`8/20/2007 is acknowledged.
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`2.
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`Applicants election without traverse of claim 20 as the alkyl aryl polyether
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`alcohol type polymer or polyethylene glycol fatty acid ester species (interpreted as
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`tyloxapol, contained in the claim) in the reply filed on 8/20/2007 is acknowledged.
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`3.
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`Claims 39-40 are withdrawn from further consideration pursuant to 37 CFR
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`1.142(b) as being drawn to a nonelected invention, there being no allowable generic or
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`linking claim. Election was made without traverse in the reply filed on 8/20/2007.
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`4.
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`Claims 19-40 are pending. Claims 39-40 are withdrawn. Claims 19-38 are
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`Status of Claims
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`examined on the basis of the merits.
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`Priority
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`5.
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`Applicant is advised of possible benefits Applicant is advised of possible benefits
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`under 35 U.S.C. 119(a)-(cl). wherein an appiication for patent filed in the United States
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`may be entitled to the benefit of the filing date of a prior application filed in a foreign
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`6.
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`Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which
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`papers have been placed of record in the file.
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`Acknowledgement is made of applicant’s claim to foreign priority and the receipt
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`of a copy of the application, JP2003-012427, filed 1/21/2003. However, since no
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`PAGE 4 OF 14
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`Application/Control Number: 10/525,006
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`Art’Unit: 1614
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`Page 3
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`translation has been provided, prior art dates have been determined with reference to
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`the priority date for the PCT application date, PCT/JP04/00350, filed 1/16/2004.
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`Oath/Declaration
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`7.
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`with 37 CFR 1.67(a) identifying this application by application number and filing date is
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`required. See MPEP §§ 602.01 and 602.02.
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`The oath or declaration is defective because:
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`It was not executed in accordance with either 37 CFR 1.66 or 1.68.
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`The oath or declaration contains no signatures of the inventors with date signed
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`Claim Rejections - 35 USC § 102
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`8.
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(a) the invention was known or used by others in this country, or patented or described in a printed
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`publication in this or a foreign country. before the invention thereof by the applicant for a patent.
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`(b) the invention was patented or described in a printed publication in this or a foreign country or in public
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`use or on sale in this country, more than one year prior to the date of application for patent in the United
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`States.
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`(e) the invention was described in (1) an application for patent, published under section 122(b), by
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`another filed in the United States before the invention by the applicant for patent or (2) a patent
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`granted on an application for patent by another filed in the United States before the invention by the
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`applicant for patent, except that an international application filed under the treaty defined in section
`351 (a} shall have the effects for purposes of this subsection of an application filed in the United States
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`only if the international application designated the United States and was published under Article 21(2)
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`of such treaty in the English language.
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`Claims 19-24 and 31 are rejected under 35 U.S.C. 102(b) as being anticipated by
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`9.
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`Gamache, et al. (VVO 01115677 A2; 03/2001).
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`Gamache teaches all of the components of the claims: compositions for otic and
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`intranasal use (p.6, lines 5-6) that contain a combination of a 5-HT agonist and an anti-
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`PAGE 5 OF 14
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`Applicationlcontrol Number: 10/525,006
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`Art Unit: 1614
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`Page 4
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`inflammatory agent (p. 6, lines 1-4; p. 12 lines 9-10) or alternatively sequentiai or
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`concurrent dosing of separate compositions that contain the 5-HT antagonist in one
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`composition and the anti-inflammatory agent in a second composition (p. 12, lines 9-
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`11); specifically claimed is the anti-inflammatory specie bromfenac (the first compound
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`of instant claim 19; claim 11; ); typical concentrations ofranti-inflammatory agents, such
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`as bromfenac, are taught in the range 0.01—1.0 % (w/v) (overlapping with 0.01-0.5; p.
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`13, lines 6-8); aqueous formulations are preferred (p. 10, lines 11-14);
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`tyloxapol is
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`taught at the concentration of 0.05 % (wlv) (p. 16, line‘30).
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`it is noted that 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 the claims 21 and dependent claims (which depend on and include the
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`options of claim 20). Gamache anticipates 1) the claim to bromfenac in the
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`concentration range of claim 20 (which is also an option of claims 21-24 and 31). 2)
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`The form of bromfenac in solution will be the same when the acid is dissolved in a
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`33) as when the sodium salt is dissolved in solution adjusted to the same pH; for this
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`sodium salt concentration limitation of claim 22 and further dependent claims, since the
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`claim is drawn to an aqueous liquid, preparation, irrespective of how it is prepared.
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`10.
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`Claim 19 is rejected under 35 U.S.C. 102(b) as being anticipated by Dobrozsi
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`(US 6,319,513 B1;11/2001).
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`PAGE 6 OF 14
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`Appiicationlcontrol Number: 10/525,006
`Art Unit: 1614
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`Page 5
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`Dobrozsi teaches aqueous liquid compositions comprising _a pharmaceutically
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`active agent selected from a group that includes analgesics (abstract); a specie taught
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`is bromfenac (column 10, line 11); tyioxapol is taught at 0.15 and 0.035 % (Example
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`11.
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`Claims 19-38 are rejected under 35 U.S.C. 102(e) as being anticipated by Sawa
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`(US 2007/0082857 A1; priority date 1112003).
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`The applied reference has a common inventor with the instant application.
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`Based upon the earlier effective U.S. filing date of the reference, it constitutes prior art
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`under 35 U.S.C. 102(e).
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`.This rejection under 35 U.S.C. 102(e) might be overcome
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`either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in
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`invention “by another,” or by an appropriate showing under 37 (‘FR 1.131.
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`Sawa teaches the elements of the claims: aqueous solution preparations
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`comprising an aminoglycoside antibiotic and bromfenac or a salt of bromfenac
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`(abstract); bromfenac sodium and bromfenac sodium hydrate is taught (at 0.1 and 0.2 %
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`(Tables 1, 3, 6, 9-15); tyioxapol at 0.3 % resulted in solutions that were clear, when the
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`control (no additive) was turbid (Table 5, 8), tyloxapol is also taught at 0,02 % (Table
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`15); additives taught include benzalkonium chloride (Table 8), boric acid (Tables 9, 12),
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`sodium edentate (Table 15), and sodium hydroxide (Table 15); pH values include 7.5,
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`7.8 and 8.0 (Tables 9-15); eye drop formulations are also taught (Examples 1-7).
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`it is
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`noted that the aqueous preparations contain an active ingredient not in the instant
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`PAGE 7 OF 14
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`Application/Control Number: 101525006
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`Art Unit: 1614
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`Page 6
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`claims. However, Sawa still anticipates the instant claims, due to the open language
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`construction of the claims (use of “comprising”).
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`12.
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`Applicant cannot rely upon the foreign ‘priority papers to overcome this rejection
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`because a translation of said papers has not been made‘ of record in accordance with
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`37 CFR 1.55. See MPEP § 201.15.
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`Claim Rejections - 35 USC § 103
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`13.
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
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`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
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`the prior art are such that the subject matter as a whole would have been obvious at the time the
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`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
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`Patentability shall not be negatived by the manner in which the invention was made.
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`14.
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`The factualrinquiries set forth in Graham v. John Deere C0,, 383 U.S. 1. 148
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`USPQ 459 (1966), that are applied for establishing a background for determining
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`obviousness under 35 U.S.C. 103(3) are summarized as follows:
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`Determining the scope and contents of the prior art.
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`Ascertaining the differences between the prior art and the claims at issue.
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`Resolving the level of ordinary skill in the pertinent art.
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`Consideringobjeotive evidence present in the application indicating
`obviousness or nonobviousness.
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`15.
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`This application currently names joint inventors.
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`ln considering patentability of
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`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
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`the various claims was commonly owned at the time any inventions covered therein
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`were made absent any evidence to the contrary. Applicant is advised of the obligation
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`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
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`not commonly owned at the time a later invention was made in order for the examiner to
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`PAGE 8 OF 14
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`Applicationlcontrol Number: 10/525,006
`Art Unit: 1614
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`Page 7
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`consider the applicability of 35 U.S.C. 103(0) and potential 35 U.S.C. 102(e), (f)or (9)
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`prior art under 35 U.S.C. 103(a).
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`16.
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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) and lSTA
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`Pharmaceuticals (“New Drug Applications: Xibrom”,
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`httgzi/www.drugscom/nda/xibrom 040525.html, accessed online 9/19/2007) or Nolan,
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`et al. (“The topical anti-inflammatory and analgesic properties of bromfenic in rodents:;
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`Agents and Actions; 1988 Aug; 25(1-2):77-85, abstract).
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`Claims 19-24 and 31 are rejected as outlined above. With respect to claims 21-
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`38 (claims 21-24 and 31, with respect to the sodium salt of bromfenic and associated
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`concentrations), in addition to the points made above, Gamache also teaches the
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`additives and pH of the instant claims, edetate disodium, benzylalkonium chloride,
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`sodium hydroxide, and a p,Hyof 7.3-7.4 (Example 2); polyvinyl pyrrolidone (p. 14,.line 5);
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`and sodium borate buffer (p. 13, line 11). Gamache does not specifically teach the
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`sodium salt of bromfenic, nor a hydrate, nor the concentration range or specific
`bromfenic sodium concentrations of 0.05-0.2, or at 0.1 or 0.2 %, nor the tyloxapol
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`concentrations of 0.02 or 0.3 %. The ISTA Pharmaceuticals news release
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`demonstrates that products containing 0.1 % bromfenac sodium acquired US marketing
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`rights for Xibrom in May 2002 (were known by others in this country before applicant's
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`priority date, a 35 USC 102(a) date). Nolan teaches bromfenac (the sodium salt,
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`sesquihydrate form) was effective as a topical analgesic at concentrations of 0.1-0.32 %
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`it would have been
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`PAGE 9 OF 14
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`obvious for one of ordinary skill in the art at the time of the invention to select
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`concentrations of bromfenac sodium, sesquihydrate of 0.1, about 0.2 and about 0.32 %,
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`in the invention of Gamache, since these values have demonstrated efficacy for topical
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`use.
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`it would have been obvious to adjust the concentration of tyloxapol, to see what
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`the effect would be on the solubility and stability of the aqueous preparations, which
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`would have resulted in the effective concentrations of the instant claims.
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`it would also
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`have been obvious to adjust the pH to values in the 7.5 to 8.5 range, with the potential
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`of dissolving and/or stabilizing more of the acidic drug, bromfenic, in a more aqueous
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`soluble ionic form. The motivation would have been to prepare pharmaceutical
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`products with optimal drug dosage and stability.
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`17.
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`Claims 19-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Yakuji Nippo Ltd. (“New Drugs in Japan"; 2001; English translation provided; lDS
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`Reference AP) and Xia (US 6,369,112 B1).
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`Yakuji Nippo teaches a bromfenac sodium sesquihydrate ophthalmic formulation
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`that contains: 0.1% (w/v) bromfenac (items 1-3); boric acid buffer, sodium sulfate,
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`disodium eentate, polyvinylpyrrolidone, and benzalkonium chloride (item 2, additives); a
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`pH of 8.0-8.8 (item 2, pH). Yakuji Nippo does not teach tyloxapol. Xia teaches a
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`solution useful for contact lenses that provides enhanced cleaning and disinfecting
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`efficacy of the contact lens (abstract), which contains tyloxapol as one of three
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`ingredients (abstract; column 3, lines 7-21); tyloxapol is taught at concentrations of 0.25
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`and 0.025 (about 0.02 and 0.3; Table 1). Xia teaches the addition of tyloxapol to the
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`solution improves the stability and therefore the disinfecting efficacy over time of the
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`PAGE 10 OF 14
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`Application/Control‘Number: 1015251306
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`Art Unit: 1614
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`Page 9
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`active component (column 7, lines 8-18).
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`It would have been obvious to one of ordinary »
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`skill in the art at the time of the invention to add tyloxapol to the ophthalmic formulation
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`of Yakuji Nippo. The motivation to do so is that taught by Xia, the stability enhancing
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`effect of this component on the active ingredient. There would have been an
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`expectation of success, since tyloxapol has demonstrated efficacy with the contact lens
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`cleaning solutions.
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`18.
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`Claim19—38 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Yakuji Nippo Ltd. (“New Drugs in Japan"; 2001; English translation provided; lDS
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`Reference AP) and Xia (US 6,369,112 B1) as applied to claims 19-30 above, and
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`further in view of Nolan, et al. (“The topical anti-inflammatory and analgesic properties
`of bromfenic in rodents:; Agents and Actions; 1988 Aug; 25(1-2):77-85, abstract).
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`Neither Yakuji Nippo or Xia teach the bromfenac sodium hydrate solutions at a
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`bromfenac concentration of 0.2 %. Nolan teaches topical solutions are efficacious in
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`the concentration range of 0.1—0.32 %.
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`It would have been obvious to one of ordinary
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`skill in the art at the time of the invention to use a concentration of about 0.2%
`bromfenic sodium hydrate (right in the middle of the range Nolan teaches is effective), in
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`the modified Yakuji Nippo ophthalmic solution with tyloxapol added. The motivation to
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`use a higher bromfenac concentration would be to provide an option of almore
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`concentrated solution for patients in cases where a physician determines that higher
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`anti-inflammatory concentration is desirable, such as when the lower dosage does not
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`completely relieve the inflammation or pain.
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`PAGE 11 OF 14
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`Applicationlcontrol Number: 10./525,006
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`Art Unit: 1614
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`Double Patenting
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`19.
`- The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in_ the statute) so as to prevent the
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`unjustified or improper timewise extension of the "right to exclude” granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory
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`obviousness-type double patenting rejection is appropriate where the conflicting claims
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`are not identical, but at least one examined application claim is not patentably distinct
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`from the reference claim(s) because the examined application claim is either anticipated
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`by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140
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`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29
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`USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
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`1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422
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`F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thonlngton, 418 F.2d 528, 163
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`USPQ 644 (CCPA 1969).
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d)
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`may be used to overcome an actual or provisional rejection based on a nonstatutory
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`double patenting ground provided the conflictlng application or patent either is shown to
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`be commonly owned with this application, or claims an invention made as a result of
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`activities undertaken within the scope of a joint research agreement.
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`Effective January 1, 1994, a registered attorney or agent of record may sign a
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`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
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`37 CFR 3.73(b).
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`20.
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`Claims 19-38 are provisionally rejected on the ground of nonstatutory
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`obviousness-type double patenting as being unpatentable over claims 1-43 of
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`copending Application No. 11/755662. Although the conflicting claims are not identical,
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`«
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`they are not patentably distinct from each other because the copending application
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`contains claims drawn to method of treating pain and/or inflammation associated with
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`an ocular condition, by administering the aqueous solutions of the instant claims.
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`It
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`would have been obviousto one of ordinary skili in the art at the time of the invention to
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`use the formulations of the instant claims in the methods of the copending application,
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`since the claims recite that the formulations are eye drops, and the instant abstract also
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`teaches some of the conditions treated of the copending application.
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`'
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`PAGE 12 OF 14
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`Application/Control Number: 10/525,006
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`Art Unit: 1614
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`y
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`Page 11
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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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`Conclusion
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`21.
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`No claim is allowed.
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`22.
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`Any inquiryconcerning this communication or earlier communications from the
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`examiner should be directed to Timothy P. Thomas whose telephone number is (571)
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`272-8994. The examiner can normally be reached on Monday-Thursday 6:30 a.m. -
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`5:00 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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`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).o|f 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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`PAGE 13 OF 14
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`Application/Control Number: 10/525,006
`Art Unit: 1614
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`Timothy P. Thomas
`Patent Examiner
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`PAGE 14 OF 14