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`GFFEQE
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`Attorney Docket No. 19107 (AP)
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`Appiicant: Kevin 8. Warner etai.
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`Group Art Unit: 1629
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`Seriat Ncr: 14/082,955
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`Examiner: LesiieA Reyes
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`Draper
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`Fiied: November 18, 2013
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`Ccnfirmatieh No: 1222
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`Far: TGPESAL EAPSQNE Attti)
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`FELED ELECTRONECALLY
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`flAPfiQNEIABAPALENE CQMPQSETiflhifi AME
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`METHGES FGR U$E THEREGF
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`
`
`Cemrnissiener for Patents
`RC). Box 1450
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`Atexandria, VA 223134451)
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`1, Kevin 3. Warner, 13th hereby deeiare:
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`1.
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`i am a ce~inventer in the abcvewcaptioned patent appiicatieh.
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`2i
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`i am an empicyee ef the Appiicant, Aiiergan, inc.
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`1 have a Bacheier’s of Science
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`in chemistry tram Brigham Young University and a PhD. from the University at
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`Utah in Pharmaceutics and Pharmaceutieai Chemistry.
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`1 have 12 years of
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`experience conducting research in the areas of dermai and ophthaimic
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`fermuiation deveiopment and teading project teams respensihte for at: CMC
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`aspects of product deveiepment from phase 1 to phase 3 at Aiiergan, Eric,
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`3,
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`i have read the above—captioned patent appiicatieh and its pending eiaims as at
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`the date of this Dectaratieh.
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`i have read the pbvieusness rejecticns made in the
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`Attorney Docket No. 1910? (AP)
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`Office Action dated December 1, 2514 and the pubiications cited by the patent
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`examiner therein (internationai Patent Puhiication No. W0 2009/10814? At,
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`internationai Patent Pubtication No. WC) 2010/105052 At iUS Patent Puhiication
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`No. 205510204526, and the Luhrizoi product description of Carbopoi 980).,
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`.
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`i am part of a team at Aiiergan responsihie tor deveioping a new formutation of
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`Aiiergan’s Aczone (dapsone) Get, 5% product, wherein dapsone concentration is
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`increased to 'i’.5% w/w from the 5% w/w ievei in Aczone 5% Get. An object of
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`this deveioprnent project was to faciiitate once deity dosing by increasing the
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`concentration of dapsone, as compared to the current twice daity dosing regimen
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`forAczone 5% Get,
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`. During the course of deveioprnent of the 7.5% w/w depsone torrnuiation, we
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`tasked to increase DGME concentration above the 25% ievei in Aczone 5% Get
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`in order to increase the saturation sotubiiity of daosone. Uapscne soiubiiity
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`increases with DGME concentration“ This increase aiiows for a dissoived fraction
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`of dapsone (dissotved fraction is caicuiated as the ratio of dapsone saturated
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`soiubiiity at 25 “C I dapsone concentration) comparabie to that of Aczone 5% get.
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`. Under my supervision, a preiirninary evatuation of thickeners suitabie for use in
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`the dapsone 7.5% gei formuiation was performed, Five candidates were
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`screened for their ahiiity to thicken the proposed formuiation: Carbopoi® 985,
`Sepineom P 500, PPG—iZ/SMDE Copotymer (4342
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`Diisocyanatcdicyciohexyirnethane, poiypropyiene giycoi pciymer),
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`Povidone/Eicosene (30:70), and Potyvinyi Aicohoi. From this screening
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`evaiuation, we identified Carbopoi 980 and Sepinec P 650 as promising getting
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`agents.
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`.
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`in additionai experiments under my supervision, formuiations containing
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`Carbopoi 980 showed undesired poiyrner aggregates at 45% diethyiene giycoi
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`rnonoethyi ether ("DGME") concentration“ This aggregation was not observed
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`Attorney Docket No. 1910? (AP)
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`with formuiations containing Sepineo P 600 at 40% DGME. These resuits
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`indicated that Sepineo P 600 is a more robust thickener and therefore more
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`desirabie for use in the get formuiation.
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`i did not expect to observe Carbopoi 980
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`incompatibiiity at a concentration of 40% DGME, especiaiiy because Carbopoi
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`980 is compatibie at concentrations of 25% DGiviE.
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`8. Based on the unexpected observation of Carbopoi 980 incompatibiiity with 40%
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`DGME, the thickener was changed from Carbopoi 980 to Sepineo P 690 to
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`mitigate the risk of poiymer aggregation in DGME containing tormuiations.
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`9.
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`in additionai experiments under my supervision, a dapsone particie size
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`assessment reveaied that iormuiations thickened with Sepineo P 600 provided a
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`smaiier dapsone particie size as compared to Carbopoi 98b. The compositions
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`of the formuiations evaiuated for particie size are outiined in Tabie t of Appendix
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`A of this Deciaration. Particie size data are provided in Tabie 2 (HOREBA data) of
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`Appendix A of this Deciaration. The data show that recrystaiiized dapsone
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`particie size is smaiier in the Sepineo P 600 formuiation as compared to a
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`Carbopoi 980 iormuiation.
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`i observed this difference even after 6 months storage
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`under acceierated conditions (40 °Cfl§% RH) thereby showing no significant
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`change in the particie size over time. This stabiiity data suggests that particie
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`size does not change over time irrespective of the stabiiizer used (Carbopoi or
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`Sepineo). Thus a smaiier initiai particie size appears to be more reievant
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`parameter that defines improved iormuiation characterization.
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`it). Based on the above resuits, my co~inventors and i seiected Sepineo P 666 as
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`the getting agent for our dapsone 7.5% gei formuiation. We made this seiection
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`due to Sepineo P 500’s competibiiity with concentrations of [.36in greater than
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`25% and its improvement in dapsone particie size reiative to Carbopoi 989.
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`iti hereby deciare that aii statements made herein of my own knowiedge are true
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`and that aii statements made on information and beiiei are beiieved to be true;
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`Attorney Docket Ne. 1910? (AP)
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`and further that these statements were made with the knowtedge that wittfut feiee
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`statements and the like so made are punishable by fine er imprieenment, or both,
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`under Sectten 1001 of "We 18 0f the United States Code. and that such wittfut
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`fatee statements may jeopardize the validity at the epptteetion or any patent
`issued thereen.
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`Date: February2,2015
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`% a: __u g MW
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`Kevin S, Werner, PM).
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`Niamey Docket No. 19107 (AP)
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`APPENQEX A
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`Tame 1
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`715% 035330316,
`30% QGMES
`1% Carbopas
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`Compesitinn of Farmuflaticns Anafiyzed for flapsane Particle Size
`Comparison in 00:30:90 P 600 vs. Carbopci 080
`
`
`
`ACZQNE (dapsane)
`
`
`
`7.5% Dapsone,
`$91, 7.5%:
`Camponent
`15% flapsane,
`25% QGME,
`
`5
`30% DGME,
`1% Carbopai
`
`4% Sepinem P 000
`
`
`
`.....
`
`.....Wm...
`
`
`{DGME
`Carbmpci 080
`
`
`
`:
`
`____-----
`
`_
`
`I
`:
`
`
`
`
`Purified Water
`
`Sepineu P 600
`__________
`Methyflparaben
`...WWWM ...
`
`Trie‘thanoiamine
`QSpHa510é
`
`Q8100
`
`
`
`N/A m NotAppiicabie
`
`Tame 2
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`Particie 31m (HGREBA) E3313 Comparing Dapsane Particie Size in Sepineo P
`000 vs. Carbepoi 900 at Time a 0 and 6 Months at 40 ”$175179 RH
`
`....WW—m
`
`.106 Months
`
`72
`
`
`
`
`w 40 ”017511; RH
`
`
`
`7.5% Dapsone, 30% DGME,
`4% Sepineo P 600
`(Lot ELE)
`
`
`
`1% Carbnpoi
`....me......
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`7.5% Dapsone
`30% DGME
`
`
`
`1% Carbopoi
`
`(Lot ELG)
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`7.5% Dapsone
`i 25% DGME
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` vs! “111%
`\.\_:
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMNHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`www.msptogov
`
`
`
`
`
`14/885,805
`
`10/16/2015
`
`Kevin S. Warner
`
`19107 DIV (AP)
`
`9004
`
`ALLERGAN, INC.
`2525 DUPONT DRIVE, T2-7H
`IRVINE, CA 92612-1599
`
`DRAPER’ LESLIE AROYDS
`
`ART UNIT
`
`1629
`
`PAPER NUlVIBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`03/07/2016
`
`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):
`
`patents_ip @ allergan.c0m
`pair_allergan @ firsttofile.c0m
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`PTOL—90A (Rev. 04/07)
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`
`
`Applicant(s)
`Application No.
` 14/885,805 WARNER ET AL.
`
`
`AIA (First Inventorto File)
`Art Unit
`Examiner
`Office Action Summary
`
`
`Leslie A. Royds Draper $2215 1629
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 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. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
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`1)IXI Responsive to communication(s) filed on 18 February 2016.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)I:I This action is non-final.
`a)IXI 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 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| CIaim(s)1-_12is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6)I:I Claim(s)_ is/are allowed.
`7)IXI Claim(s) 1-Sand 7-9 is/are rejected.
`8)IZ| Claim(s) 63nd 10- 12is/are objected to.
`
`9)I:I Claim((3)
`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
`htt
`://\wvw.usoto. ov/ atents/init events/
`h/index.‘
`
`
`
`
`, or send an inquiry to PPeredback-{cfiusptoeov.
`
`
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I 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:
`
`b)I:I Some” c)I:I None of the:
`a)I:I AII
`1.I:I Certified copies of the priority documents have been received.
`2.|:| Certified copies of the priority documents have been received in Application No.
`3.|:| 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 (PT0_413)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) IZI InformatIon DIscIosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date 18Feb16.
`US. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Sumery
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`Part of Paper No./MAMⅈ12Q380301
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`Application/Control Number: 14/885,805
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`Art Unit: 1629
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`Page 2
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`The present application, filed on or after March 16, 2013, is being examined under the first
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`inventor to file provisions of the AIA.
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`DETAILED ACTION
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`Claims 1-12 are presented for examination.
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`Applicant’s Amendment and Information Disclosure Statement (IDS) filed February 18, 2016 have
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`each been entered into the present application. As reflected by the attached, completed copy of form
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`PTO/SB/O8A (three pages total), the Examiner has considered the cited references.
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`Claims 1-12 are pending and under examination. Claims 11-12 are newly added. Claims 1, 5-7, 9
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`and 10 are amended.
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`Applicant’s arguments, filed February 18, 2016, have been fully considered. Rejections and/or
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`objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections
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`and/or objections are either reiterated or newly applied. They constitute the complete set of rejections
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`and/or objections presently being applied to the instant application.
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`Applicant’s Arguments and Declaration Filed February 18, 2016
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`In the submission filed February 18, 2016, Applicant provides various remarks directed to the
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`obviousness rejections of record under 35 U.S.C. §103 (Reply, p.5-8), as well as a declaration of inventor
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`Kevin 8. Warner (hereinafter “the Warner Declaration”) executed under 37 C.F.R. §1.132 in support of
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`nonobviousness.
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`Applicant’s most pertinent argument set forth in the record with regard to the nonobviousness of
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`the claimed invention appears to be the data provided in the Warner Declaration (p.2, para.[4]—p.3,
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`para.[10]). In the Warner Declaration, the Declarant states that he was involved with the development of a
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`topical dapsone formulation with greater dapsone concentration (7.5% w/w) than the conventional 5.0%
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`w/w ACZONE gel formulation (p.2, para.[4]). In order to increase the dapsone concentration from 5.0%
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`w/w to 7.5% w/w as desired, the Warner Declaration states that a corresponding increase in diethylene
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`glycol monoethyl ether (DGME) from its 25% w/w amount typically found in the 5.0% w/w ACZONE gel
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`was necessary to solubilize dapsone in the formulation (p.2, para.[5]). A screening of various thickening
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`Application/Control Number: 14/885,805
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`Page 3
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`agents for use in the dapsone formulation identified two specific agents selected for their ability to thicken
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`the proposed dapsone formulation: (i) CARBOPOL 980 (the same thickener agent employed in the
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`closest prior art to Garrett) and (ii) SEPINEO P 600 (which is an acrylamide/sodium acryloyldimethyl
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`taurate copolymer as recited for use in the instantly claimed formulation).
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`Experimental studies described in the Warner Declaration demonstrated that the use of 7.5% w/w
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`dapsone with 40% w/w DGME and CARBOPOL 980 “showed undesired polymer aggregates” at this high
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`concentration of DGME, but that "[t]his aggregation was not observed with [7.5% w/w dapsone]
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`formulations containing SEPINEO P 600 at 40% DGME” (p.2-3, para.[7]). The Warner Declaration further
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`notes that this incompatibility of CARBOPOL 980 with 40% DGME was unexpected as “CARBOPOL 980
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`is compatible at concentrations of 25% DGME” (p.3, para.[7]). Further comparisons of dapsone particle
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`size of a gel formulation comprising 7.5% w/w dapsone, 30% w/w DGME and 4% w/w SEPINEO P 600
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`with a 7.5% w/w dapsone gel containing either 25% or 30% w/w DGME and 1% w/w CARBOPOL 980
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`were made, noting that the 7.5% w/w dapsone gel formulation using SEPINEO P 600 effectively reduced
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`recrystallized dapsone particle size as compared to either CARBOPOL 980 formulation (Warner
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`Declaration, p.5, Tables 1-2). Note that the quantity of CARBOPOL 980 used in the comparative
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`formulations is lower than that of SEPINEO P 600, but it is understand from the Warner Declaration that
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`the use of a greater quantity of CARBOPOL 980 would have further contributed to the polymer
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`aggregation known to occur between higher concentrations of DGME (as used in the comparative
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`formulations) and CARBOPOL 980.
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`The Warner Declaration, therefore, provides clear evidence that the improved properties of
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`Applicant’s claimed 7.5% w/w dapsone formulation (specifically, the reduction in undesirable polymer
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`aggregates, as well as the reduction in dapsone particle size, thereby providing a smoother, less gritty gel
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`formulation with reduced recrystallization of dapsone) yields directly from the selection of the
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`acrylamide/sodium acryloyldimethyl taurate copolymer as the polymeric thickener of the formulation. As
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`the proffered data appears to be reasonably representative of, and commensurate in scope with, the
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`instantly claimed 7.5% w/w dapsone formulation as stipulated by MPEP §716.02(d), and further in view of
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`the fact that the comparative dapsone formulations employed the same thickening agent used by the
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`closest prior art to Garrett in the same quantity suggested by this prior art reference (thereby constituting
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`a reasonable comparison of the instantly claimed formulation with that of the closest prior art; MPEP
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`§716.02(e)), the Warner Declaration appears to be probative of unexpected properties of the claimed
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`formulation.
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`Accordingly, the obviousness rejections under 35 U.S.C. §103 (as well as the nonstatutory
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`obviousness-type double patenting rejections over U.S. Patent No. 8,586,010 and U.S. Patent Application
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`No. 14/063,841) are withdrawn in light of the evidence.
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`Objection to the Claims (New Grounds of Objection)
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`In view of the evidence and the withdrawal of the above-noted rejections, it is noted that instant
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`claims 6 and 10-12 are objected to as being dependent upon a rejected base claim, but would be
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`allowable if rewritten in independent form including all of the limitations of the base claim and any
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`intervening claims.
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`Claim Rejections - 35 USC § 112(a) (Pre-AIA First Paragraph), Scope of Enablement
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`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`
`IN GENERAL—The specification shall contain a written description of the invention, and of the
`(a)
`manner and process of making and using it, in such full, clear, concise, and exact terms as to enable
`any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and
`use the same, and shall set forth the best mode contemplated by the inventor orjoint inventor of
`carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the
`art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
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`Claims 1-5 and 7-9 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first
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`paragraph, because the specification, while being enabling for administering the claimed topical dapsone
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`preparation for the treatment of acne vulgaris or rosacea, does not reasonably provide enablement for
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`administering the claimed topical dapsone preparation for the treatment of any dermatological condition,
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`because the specification does not enable any person skilled in the art to which it pertains, or with which it
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`Application/Control Number: 14/885,805
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`Art Unit: 1629
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`Page 5
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`is most nearly connected, to use the invention commensurate in scope with these claims, for the reasons
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`of record set forth at p.2-5 of the previous Office Action dated November 18, 2015, of which said reasons
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`are herein incorporated by reference.
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`Response to Applicant’s Arguments
`
`In reply, Applicant opines "that all of the pending claims comply with the enablement requirement”
`
`in view of the fact that “[t]he disclosure of the present application clearly states that compositions
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`described in the application are effective in treating dermatological conditions, including, but not limited to
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`those recited in [c]|aims 5 and 9” (Reply, p.4). Applicant further alleges that “[s]ince the disorders being
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`treated by the claimed methods are disclosed in the application as specifically tied to the compositions
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`and formulations therein, sufficient information regarding the subject matter of the claims exists so as to
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`enable one skilled in the art to make and use the claimed methods" (Reply, p.5).
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`The arguments have been fully and carefully considered, but are not found persuasive.
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`Applicant’s remarks fail to address the evidence cited in support of the rejection's position that the
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`instant claims, directed to methods for treating any dermatological condition (including, but clearly not
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`limited to, those recited in instant claims 5 and 9), are not adequately enabled for the treatment of any
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`such dermatological condition aside from acne vulgaris or rosacea. Garrett (WO 2009/108147; 2009) and
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`Ahluwahlia et al. (WO 2011/014627; 2011) were cited as evidence of the state of the art with regard to
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`topical dapsone therapy, each documenting the efficacy of topical dapsone preparations in the treatment
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`of acne vulgaris and rosacea only. Neither Garrett nor Ahluwahlia et al., however, provide any evidentiary
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`support to corroborate Applicant’s assertions that topical dapsone therapy was known to be useful or
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`effective for the treatment of the various specific dermatological conditions claimed (e.g., atopic
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`dermatitis, bed sores, keratosis pilaris, nodular prurigo, sebaceous cysts, etc.), let alone any or all
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`numerous and varied dermatological conditions known (or unknown) in the art as of the effective filing
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`date of the claimed invention (e.g., melanoma, squamous cell carcinoma, psoriasis, ichthyosis, Stevens-
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`Johnson syndrome, tinea pedis, keloid formation, etc.). Applicant’s remarks provide nothing more than
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`speculative and conclusory statements that the instant claims are enabled for the entire breadth of
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`Application/Control Number: 14/885,805
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`Art Unit: 1629
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`Page 6
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`dermatological conditions known in the art, but points to nothing in Garrett or Ahluwahlia et al. (or even
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`any extraneous evidence in support of his position) that would bolster his allegation that topical dapsone
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`therapy would have been effective for more than just the treatment of acne vulgaris or rosacea.
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`It was additionally noted that a diligent search of the prior and contemporaneous art at the time of
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`the effective filing date of the claimed invention did not reveal any clear teachings supporting the use of
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`topical dapsone therapy for the treatment of any possible type of dermatological condition known in the
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`art as instantly claimed (aside from acne vulgaris or rosacea). McGeer et al. (U.S. Patent No. 5,532,219;
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`1996) was previously cited in further support of this position, in which other therapeutic uses of dapsone
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`therapy were suggested, but of which none specifically related to other dermatologic uses of topical
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`dapsone therapy (aside from acne vulgaris or rosacea). The state of the art, therefore, as of the effective
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`filing date of the claimed invention did not clearly and unequivocally recognize the usefulness of topical
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`dapsone therapy for dermatological applications outside of the treatment of acne vulgaris or rosacea as
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`established by Garrett and Ahluwahlia et al. Applicant, therefore, cannot rely upon the state of the art as
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`of the effective filing date of the claimed invention to enable his claimed topical dapsone formulation for
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`the treatment of any or all dermatological conditions known (or unknown) in the art as of the effective
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`filing date of the claimed invention.
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`The skilled artisan, therefore, has nothing else to rely upon but Applicant’s own specification to
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`bridge this clear gap between the knowledge accepted in the art as of the effective filing date of the
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`claimed invention and the asserted applications of Applicant’s claimed topical dapsone therapy. This lack
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`of knowledge in the art regarding the effective use of topical dapsone therapy for the treatment of any or
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`all dermatological conditions (including, but not limited to, those recited in instant claims 5 and 9) is not
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`remedied by Applicant's own specification. Applicant’s working examples fail to demonstrate the ability of
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`the claimed topical dapsone preparations to treat any type of dermatological condition (including those
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`specific conditions claimed) in a patient in need thereof and, therefore, fail to provide the necessary
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`enabling guidance that is absent from the state of the art. Applicant’s proffered working examples are
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`limited to specific topical preparations of dapsone and do not demonstrate the efficacy of such
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`formulations in the treatment of any type of dermatological condition (including any or all of those specific
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`Application/Control Number: 14/885,805
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`Art Unit: 1629
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`Page 7
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`conditions instantly claimed). The working examples, therefore, fail to provide any evidentiary basis to
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`conclude that Applicant’s claimed method of administering the recited topical dapsone therapy was
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`effective to treat any or all types of dermatological conditions. Accordingly, it remains that the disclosure
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`and supporting examples provided in the present specification, coupled with the nascent state of the art at
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`the time of the invention with regard to topical dapsone therapy for the treatment of any or all
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`dermatological conditions, fails to adequately enable the full scope of embodiments presently claimed.
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`The rejection stands.
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`For these reasons supra, rejection of claims 1-5 and 7-9 is proper.
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`Rejection of claims 1-5 and 7-9 is proper.
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`Conclusion
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`Claims 6 and 10-12 are objected to for depending from a rejected base claim.
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`No claims of the present application are allowed.
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`Applicant is requested to specifically point out the support for any amendments made to the
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`disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In
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`doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-
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`filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for
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`interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the
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`aforementioned issue(s) is/are addressed.
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth
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`in 37 CFR1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE MONTHS from
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`the mailing date of this action.
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`In the event a first reply is filed within TWO MONTHS of the mailing date
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`of this final action and the advisory action is not mailed until after the end of the THREE-MONTH
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`shortened statutory period, then the shortened statutory period will expire on the date the advisory action
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`is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`Application/Control Number: 14/885,805
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`Art Unit: 1629
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`Page 8
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later than SIX
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`MONTHS from the mailing date of this final action.
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`Any inquiry concerning this communication or earlier communications from the examiner should
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`be directed to Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can
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`normally be reached on Monday-Friday (8:30 AM-5:00 PM).
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Jeffrey S. Lundgren can be reached on (571)-272-5541. The fax phone number for the organization
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`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 published applications may be obtained from
`
`either Private PAIR or Public PAIR. Status information for unpublished applications is available through
`
`Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC)
`
`at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative
`
`or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-
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`1000.
`
`/Leslie A. Royds Draper/
`Primary Examiner, Art Unit 1629
`
`March 2, 2016
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Applicant:
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`Kevin S. Warner, et al.
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`Serial No.:
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`14/885,805
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`Filed:
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`October 16, 2015
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`For:
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`TOPICAL DAPSONE AND
`DAPSONE/ADAPLENE
`COMPOSITIONS AND
`METHODS FOR USE
`
`THEREOF
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`)
`)
`)
`)
`)
`)
`)
`)
`)
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`Group Art Unit: 1629
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`Examiner: Draper, Leslie A. Royds
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`Conf. No.: 9004
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`RESPONSE TO FINAL OFFICE ACTION
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`Commissioner for Patents
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`PO. Box 1450
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`Alexandria, VA 22313-1450
`
`Dear Sir,
`
`This is filed in response to a Final Office Action mailed on March 7, 2015. Please
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`amend the above referenced patent application as follows. Authorization is hereby given
`
`to charge any fee required for the filing of this paper, to Deposit Account No. 01-0885.
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`Amendments to the Specification begin on page 2 of this paper.
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`Amendments to the Claims are reflected in the listing of claims which begin on
`
`page 12 of this paper.
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`Remarks begin on page 14 of this paper.
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`AMENDMENTS TO THE SPECIFICATION
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`Please amend paragraph [009] as shown below:
`
`19107 DIV (AP)
`
`[009] Use of topicet compositions of depsone can he prooiematie. Topicai compositions
`
`may act as drying agents for the skin. They remove essentiat oiis and naturai stdn
`
`softeners from the skin thus causing it to he dry, itch and crack. inoiosion of eaeeeeeees
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`exogenous skin emotiients, oiis and the tike, however, causes phase separation and
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`precipitation of dapsone. Use of
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`typicai emotsitiers does not soive the dapsone
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`precipitation owing
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`to the
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`towered dapsone
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`soiuhiiity
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`and conflicting
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`physicai
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`characteristics of
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`the phases of
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`the resuiting composition.
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`in partictiiar,
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`topioai
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`con‘tpositions inciuding depsone and methods are needed that wouid, tor exampie, exhibit
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`improved effectiveness, reduced side effects, or both, when used in a particuiar patient
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`with a skin condition. Such improved topicai compositions inciuding dapsone and
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`methods of their uses are atso needed to improve treatment of patients with acne or
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`suspected acne. The present dapsone and dapsoneladapaiene compositions can he
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`usetui for treating a variety of dermatoiogicai conditions. Some csetoi compositions
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`incitide dapsone anoior adapaiene in a potymeric viscosity htiitder Some compositions
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`can be adjusted to optimize the dermei deiivery profiie of depsone to attactivety treat
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`dermatoiogicat conditions and improve the efficiency of pharmaceutics! products appiied
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`to the skin Diethyiene giyeoi monoethyt ether is a soiuhiiizer for dapsone;
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`thereoy
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`aiiowing compositions to he prepared with increased soiuhiiized concentrations of
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`dapsone. As a resuit]
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`the compositions described herein are effective in treating
`
`dermatoiogicat conditions in a subject in need thereof.
`
`Please amend paragraph [018] as shown below:
`
`[018] Some embodiments inciode compositions and products for treatment of skin
`
`conditions and methods of treating skin conditions. The term “skin condition” as used
`
`herein encompasses human and animai conditions] disorders, or diseases effecting skin.
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`2
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`19107 DIV (AP)
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`Such skin oonditinns incincie, but are net iimited to, conditions invoiving skin inflammation,
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`conditions inveiving sebaoeens giands and hair toiiieies, conditions Characterized by
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`aeneitorm symptoms, and conditions inveiving skin dryness, skin thickening, skin scaiing
`
`er skin tiaiting. Skin conditions that can be treated using some compositions, products
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`and methods described herein incinde, but are net iimited in, acne, rosaeee, feiiioniitis,
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`periorai dermatitis, nhotodamage,
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`skin aging, nsnriasis,
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`iehtiesis— ichthyosis. atenio
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`dermatitis,
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`treatment of chronic weunois, bee sores,
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`iteratesis eisaiis; giiaris, sears,
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`inoioding snrgioai and acne scars, sebaceous cysts,
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`intiammatory dermatoses, post
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`intiammatery hyperpigmentatien, eczema, xeresis,
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`reiterate Qtiiritus,
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`iicheh pianos,
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`nodniar prnrigo, eezeme, and n‘iiiiaria
`
`Please amend paragraph [040] as shown below:
`
`[040] The teiiewing embodiments are sneeitioaiiy eehtempiated herein,
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`Embediment ‘i
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`A oompositien comprising daosnne, a first soitibiiizing agent wnion is dietnyiene giycei
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`meneethyi ether, optionaiiy at ieast one seoend seieoiiizing agent, a ooiymerio viscosity
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`buiider, and water, wherein the dapsone is present in the eon‘inosition at a concentratien
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`of sheet 3% wiw to abeut 10% wlw
`
`Embodimentz
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`The eemposition of embodiment 1, wherein the diethyiene giycei menoethyi ether is
`
`present at a censentration of abnut 10% wlw tn about 40% wlw.
`
`E