Attorney r):- (,.k et N$
`
`PATENT
`n7)
`
`N THE. MTED STATES PATENT AND TRADEMARK OFFICE
`N THE. MTED STATES PATENT AND TRADEMARK OFFICE
`
`in re ApOication ofi
`in re Application ofi
`
`Dale P. D EVO RE et a .
`Dale P. DEVO RE et al.
`
`1617
`Groo D A tt
`GrouD:,'-%rt Unit: 1617
`ri
`
`Appiication No.:131813,557
`Application No.:131813,557
`
`Fed: Januav 31
`Filed: January 31,
`
`C,OLLAGEN-BASED ifv1PLANT3
`COLLAGEN-B.ASED i.NIPLANT3
`FOR SUSTNED E)ELNERY OF
`I_ \../ERY OF
`FOR SU ST,Al NED E)
`DRUGS
`
`'
`
`}
`\ Examiner: Aii Soroush
`) Exa
`her : Ail Soro us h
`
`) E:_x��r11�nt�1r: l\li �)t1rc�ust1
`
`Confirnlation NO. 3557
`Confirnlation No.: 3557
`
`
`) c:c)t1f)rrr1c{tk)t) NtJ.: 3557�
`
`\
`
`' •'
`
`Commssioner for patents
`Commissioner for patents
`P.O. Box 1450
`P.O. Box 1450
`Alexandria. VA 22.313-1450
`Nexandrie. V.A 22.313-1450
`
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`declare:
`Dr: Dekl Dk-N-Nort.i. declare:
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`Prialleniwn v. Allergan
`Prialleniwn v. Allergan
`IPR2019-1:11505, er al.
`IPR2019-1:11505, er al.
`DeVore Depo. Ex. 72
`DeVore Depo. Ex. 72
`
`ALL 2172
`PROLLENIUM V. ALLERGAN
`IPR2019-01505 et al.
`
`

`

`Acton No.: 13/8'13,567
`Acton No.: 13/8'13,567
`
`
`/\fJp�icatit)n N·c).: �1 :3/8 ··1 :3,t1s·7
`
`Attorney Docket No 05503.006$-00Attorney Docket No 05503.0064-00
`
`i\tt()rnF3'/ CJcJckt�t N ().: ()55l)3. 00f34·�·00
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`application and its currently pending set of claims, the Office Action of Mar» 31, 2015,
`application and its currently pending set of claims, the Office Action of Mar» 31, 2015,
`
`and the references cited therein, inciud
`and the references cited therein, includ
`
`-
`-
`U.S. Patent No. o
`U.S. Patent No. o
`
`e'v;q
`e'v;q
`
`Pi(sh
`
`t'.:1
`
`("Reich") and
`(",?eicti
`and
`
`,
`,
`
`,
`,
`
`s Patent No. 6201,547
`U.S. Patent No. 6201,547
`
`Bawa
`Bawa
`
`el. CSawa")
`
`
`
`4.,4.,
`
`
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`in my opinion, none of the references cited by the Examiner teach or suggestin my opinion, none of the references cited by the Exarnlner teach or suggest
`
`the claimed collagen-based .films, wafers, or membrane constructs or inetheds for
`the ciaimed colladen-based .films wafers, or membrane constructs or -r):,Jthods for
`
`preparing such collagen-based fifths, ,:siafers or membrane constructs
`preparing such collagen-based films, t:vafers, or membrane constructs
`
`5, The Exarniner asserts that the combination of Reich and Sawa .teach or
`5, The Exarniner asserts that the combination of Reich and Bawa.tEach or
`
`suggest dams 1-17,
`suggest claims 1-17,
`
`in rny opinon, this is incorrect
`ln rny opinon, this is incorrect,
`
`6,
`6,
`
`in general Reich -teaches a blosoluble ophthalmic shield that can be paced in
`in general Reich -teaches a blosoluble ophthalmic shield that can be paced in
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`or on the eve and can optionally- contain an ophthalmlc drug that is slowly released into
`or on the eye and can optionally- contain an ophthalmlo drug that is slowly released into
`
`the eve as the shield tssolves f3avva describes ophthalmic compositions containing
`the eve as the shield rilssolyes f3ava describes ophthalmic compositions containing
`
`xanthan gum.
`xanthan gum.
`
`7. The shields taudht by Reich all dissolve within one week. For exampie, at
`7. The shields taught by Reich all dissolve within one week. For exemoe, at
`
`coiumn 6, lines 23-31, Reich's Exambles 1-12 teach that,
`coiumn 6, lines 23-31, Reich's Elxambles 1-12 teach that,
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`c:rosslinking by exposure to UV irradiation for 4 minutes; 6 minutes, and 10 rtlinutes, the
`crosslinking by exposure to U\S irradiation for 4 minutes, 6 minutes, and 10 rilinutes. the
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`resulting shields "all showed excellent blosolubty propetes n physiolodical fluids with
`resulting shields "ail showed excellent biosolubty prepetes in physiological fluids with
`
`no reaidoe observaWe after one week," Strilarly,
`no residue observaWe after one week," Smilarly, in Example 13 (column 7, ities '2-
`Example 13 (column 7, lties '2-
`
`9'), the collagen shield crosslinked by U,) light for 4-10 rtnutes "howed excellent
`9'), the collagen shield crosslinked by U',/ light for 4-10 minutes "snowed excellent
`
`biosolubility properties and should con..01etav diss.olve
`biosolubility properties and should con..01etav oiss.olve
`
`eye. with no resklue
`eye. with no resklue
`
`observabe on a suNeots eye after one week,"
`observabe on a suNects eye after one week,"
`
`

`

`
`Application No.: 13/81'3,557Application No.: 13/81'3,557
`
`
`i\r}f)�icr.lttr)n Nf).: ·13/S·l:3)55·7
`
`Attorney DooketAttorney Dooket
`
`05503.0064-()005503.0064-()0
`
`
`/\ttc�rn��y [)c)t'Jt�1t Nr),: 0550:3 J)Ot1-4--�0t1
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`8,
`8,
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`in nlv m'Anion, the composons and
`in nlv m'Anion, the composons and
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`
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`tea.,ght by Reich woulol not betea.,ght by Reich woulol not be
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`
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`sutbe to produce a coaqen bed mpant,sutbe to produce a coaqen bed mpant,
`
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`S
`
`certainly not for three or more months.
`certainly not for three or more months.
`
`not
`not
`
`o uooet that k4.; r;
`o uooet that k4.; r;
`
`r exoosue to UV
`r exoosue to UV
`
`ight oeuld lead to collagen-based films, waters, or rnembrane constructs sanabe of
`ight oeuld lead to collagen-based films, waters, or rnembrane constructs sanabe of
`
`asting .at ieast three months. That s, Reich teaches that 4 minute exposure times and
`asting .at ieast three months. That s, Reich teaches that 4 minute exposure times and
`
`10 minute exposure times both resuh 'ft shed s that dissolve in litiss than one weel. Put
`10 minute exposure times both resuh 'ft shed s that dissolve in litiss than one weel. Put
`
`another way, more than doubling the IN exposure time from 4 minutes to 10 minutes
`another way, more than doubling the IN exposure time from 4 minutes to 10 minutes
`
`does not aboreciablv change the bioso4ibzation times One of ordinary skili in the art
`does not aboreciablv change the bioso4ibzation times One of ordinary skili in the art
`
`wouid not have a reasonable expectatlon that inoreasing the UV exposure times to 17 to
`wouid not have a reasonable expectatlon that inoreasing the UV exposure times to 17 to
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`-IO minutes i\eould dreativ affect the biosolubilization time. And it is unexpected that
`-IO minutes i\eould dreativ affect the biosolubilization time. And it is unexpected that
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`collagen-ba,sEA films, waters or mei-nbrane construct.3 couw
`collagen-ba,sEA films, waters or mei-nbrane construct.3 couw
`
`made to iast 3
`made to iast 3
`
`months
`months
`
`12 times longer that Reich's shieids---with less than a two-fold exposure
`12 times longer that Reich's shieids---with less than a two-fold exposure
`
`- rKso"'
`- rKso"'
`
`4 ,-,
`4 ,-,
`
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`44:A
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`4t.
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`4.
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`membrane construct, and does not address the deficits of ,Reich noted above,
`membrane construct, and does not address the deficits of ,Reich noted above,
`
`11.
`11.
`
`ln sum, neither Reich nor :9awa teach or suggest a film, wafer, or Membrane
`ln sum, neither Reich nor :9awa teach or suggest a film, wafer, or Membrane
`
`construct that can delker drugs for at ieast ihree months. The abiiite of the cialmed film,
`construct that can delker drugs for at ieast ihree months. The abiiite of the cialmed film,
`
`,
`,
`watei, or membrane construct to prolong drug delive.ry 12 limes longer than any snieio
`watei, or membrane construct to prolong drug delive.ry 12 limes longer than any snieio
`
`,
`,
`
`taught by RekM
`taught by RekM
`
`a' expected And one of ordinary skill in the art woud not have a
`a' expected And one of ordinary skill in the art woud not have a
`
`reasonable expeotation of success of obtaining the claimed
`reasonable expeotation of success of obtaining the claimed
`
`wafers, and membranes in gi+it of the teachings of Reich and i7.3awa.
`wafers, and membranes in gi+it of the teachings of Reich and i7.3awa.
`
`

`

`Attorney
`
`Appctk No 13/$13557
`Appcehor No<
`. A r
`No.. 00500.0U04-LSU
`
`I3/$I3557
`
`,.
`-
`Thus,
`1E), Thus, it is my ohinion that the references discussed aboyu
`f*encs cikbssed above and cited by the
`that the
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`Examiner in the Office Action do not teach or suggest e
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`f the features recited in the
`do not t,,,,N,a,csh or su.,,,gest ail of the
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`ciaims of this application,
`cams of this application,
`
`17.
`
`declare that all statements made here n of my knowledge are true, and that
`declare that a st,a,temerrts made herein of my knowiedge are true and that
`
`ail statements made on information and beief are believed to be. true, end that these
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`statements were made with the knowledge that wil* su $,C
`statements were nled wìh he know
`that wig fu fk
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`made are punishable by fine or imprisonment, or both, under Section 1001 ()f Tifie 18 of
`made are punishable by fine or Imprisonment, or both, under Section 1001 of Titie 18 of
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`L.R......,,,,k...:
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`1:;
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`the United States Code,
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`Dated: Augtst 2,3, 201
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