EAST Search History
`\
`4
`\\\\\
`\
`4
`\
`4
`\
`4
`\
`4
`\
`4
`\
`4
`\
`4
`
`32017/04/173
`=13:10
`
`3 3
`
`2017/04/173
`313:10
`3
`
`
`
`L459 and estradiol
`
`L460
`
`\
`
`
`
`\\\\\\ \\\\\\
`
`30R
`
`USPGPUB; USPAT;
`USOCR; FPRS; EPO;
`....................................................................................................................
`JPO; DERWENT
`
`
`L459 and transdermal
`
`USPGPUB; USPAT;
`iUSOCR; FPRS; EPO;
`44444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
`iJPO; DERWENT
`
`3Kanios.in. and David.in.
`
`USPGPUB; USPAT;
`iUSOCR; FPRS; EPO;
`44444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
`iJPO; DERWENT
`
`017/04/173
`313:10
`3
`
`L462 NOT L459
`
`UisPGPUB; USPAT;
`017/04/173
`313:10
`3
`iUSOCR; FPRS; EPO;
`444444444444444444. 4444444444444444444444444444444444444444444444444444444444444444
`44444444444444444444444444444444444444444444444444. 4444444444444444444444444. 44444444444444444444444444444444444444444444444
`iJPO; DERWENT
`
`(11/245097).APP.
`
`iUSPAT; USOCR
`
`017/04/173
`
`L452 and ("dipropylene
`3g|yco|" oleyl)
`
`L454 and ("dipropylene
`QJXiEQi'L'iiEL‘iii/J)
`
`L467 and ("surface area"
`flux)
`
`L468 and acrylic and
`silicone and (PVP polyvinyl
`3pyrrolidone)
`L469 and estradio|.ab.
`
`iUSPAT; USOCR
`
`iUSPAT; USOCR
`
`iUSOCR; FPRS; EPO;
`iJPO; DERWENT
`
`UisPGPUB; USPAT;
`iUSOCR; FPRS; EPO;
`iJPO; DERWENT
`
`2017/04/173
`310
`
`‘2017/04/173
`313:10
`3
`
`32017/04/173
`313:10
`3
`
`UisPGPUB; USPAT;
`iUSOCR; FPRS; EPO;
`iJPO; DERWENT
`
`2017/04/173
`
`iusPGPUB; USPAT;
`iUSOCR; FPRS; EPO;
`\ .........uu\ .........uuuuuul .......................................“nu“...uuuuu..................................................................................
`
`L469 and transderma|.ab.
`
`iusPGPUB; USPAT;
`32017/04/173
`iUSOCR; FPRS; EPO;
`313:10
`
`iJPO; DERWENT
`
`iusPGPUB; USPAT;
`32017/04/173
`3L469 and (estradiol NEAR
`iUSOCR; FPRS; EPO;
`313:10
`3f|ux)
`\ ‘.‘....‘.‘.‘.\ .....................:
`..............................................................¢ ..................................................: ............................................................
`iJPO; DERWENT
`
`L467 and (estradiol NEAR
`3f|ux)
`
`iusPGPUB; USPAT;
`iUSOCR; FPRS; EPO;
`3
`' DERWENT
`
`iU PGPUB, USPA ,
`iUSOCR; FPRS; EPO;
`\JPO; DERWENT
`
`32017/04/173
`313:10
`4444444444444444444u 444444444444444444444444444
`
`44444:
`
`2017/04/173
`
`L474 and estradiol
`
`iusPGPUB; USPAT;
`iUSOCR; FPRS; EPO;
`4444444444444444444 444444444444444444444444444444444444444444444444444444444444445 44444444444444444444444444444444444444444444444444: 444444444444444444444444:
`iJPO; DERWENT
`
`4444444444444444444. 44444444444444444444444444:
`
`L474 and transdermal
`
`iusPGPUB; USPAT;
`017/04/173
`iUSOCR; FPRS; EPO;
`313:10
`3
`\
`..................................................................................................................................................................................................................................
`iJPO; DERWENT
`
`3Kanios.in. and David.in.
`
`iusPGPUB; USPAT;
`iUSOCR; FPRS; EPO;
`iJPO; DERWENT
`
`32017/04/173
`313:10
`3
`
`3 ‘
`
`
`
`EASTSearchHistory.14024985_AccessibleVersion.htm[4/17/2017 1:22:48 PM]
`
`Part 2 of2
`
`0358
`
`L477 NOT L474
`  
`
`

 
`
`
`USPGPUB; USPAT;
`iUSOCR; FPRS; EPO;
`iJPO; DERWENT
`
`017/04/173
`313:10
`3
`
`32017/04/173
`3:10
`
`IBIT 1004
`
`

`

`EAST Search History
`
`USPAT; USOCR
`
`L469 and (" dipropylene
`
`USPAT; USOCR
`
`32017/04/173
`
`32017/04/173
`310 u
`
`
`
`"6638528".pn.
`
`"4624665".pn.
`
`"20090041831 ".pn.
`
`estradiol and transdermal
`
`L485 and ("surface area"
`flux)
`
`L486 and acrylic and
`silicone and (PVP polyvinyl
`
`L487 and estradio|.ab.
`
`L487 and transderma|.ab.
`
`L487 and (estradiol NEAR
`3f|ux)
`
`L485 and (estradiol NEAR
`3f|ux)
`
`MANTELLE.in. and
`
`3JUAN.in.
`
`L492 and estradiol
`
`L492 and transdermal
`
`3Kanios.in. and David.in.
`
`L495 NOT L492
`
`Us‘EEéEU‘é3S33U‘sBXTTW
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`USPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3usPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3usPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3usPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3USPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3UsPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`3usPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3usPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`3usPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3usPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3UsPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3usPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`3usPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`U3sPGPUB; USPAT;
`3USOCR; FPRS; EPO;
`3JPO; DERWENT
`
`2017/04/173
`313:10
`
`32017/04/173
`= 3:10
`3
`
`32017/04/173
`313:10
`3
`
`32017/04/173
`313:10
`3
`
`32017/04/173
`313:10
`3
`
`32017/04/173
`313:10
`3
`
`32017/04/173
`‘ 3:10
`3
`
`32017/04/173
`313:10
`a
`
`32017/04/173
`313:10
`
`32017/04/173
`313:10
`
`32017/04/173
`313:10
`
`2017/04/173
`
`32017/04/173
`313:10
`3
`
`017/04/173
`313:10
`3
`
`017/04/173
`
`017/04/173
`
`(11/245097).APP.
`
`3USPAT; USOCR
`
`L485 and (" dipropylene
`
`USPAT; USOCR
`
`I
`I
`
`3
`3
`33333
`3333
`3 4993
`
`USPAT; USOCR
`
`2017/04/173
`
`33L5OO 3315844
`
`339stradio|andtransdermal
`
`
`
`US PGPUB; USPAT;
`
`
`
`EASTSearchHistory.14024985_AccessibleVersion.htm[4/17/2017 1:22:48 PM]
`
`
`
`0359
`
`

`

`
`
`USOCR; FPRS; EPO;
`JPODERWENT
`...................:
`
`
`
`
`
`
`USPGPUB; USPAT;
`
`
`L501 E5484
`:2017/04/17:
`L500 and ("surface area"
`
`E13:10
`Eflux)
`EUSOCR; FPRS; EPO;
`
`
`:
`
`.................................................................................................................................................................................................................................
`EJPO; DERWENT
`
`
`
`
`
`
`
`EusPGPUB; USPAT;
`L501 and acrylic and
`E2017/04/17:
`Esilicone and (PVP polyvinyl USOCR; FPRS; EPO;
`13:10
`3
`
`
`1
`.................................................................................................................................................................................................................................
`Epyrrolidone)
`EJPO; DERWENT
`‘
`
`
`
`
`
`
`USPGPUB; USPAT;
`017/04/17E
`EUSOCR; FPRS; EPO;
`:13:10
`:
`:
`
`
`xxxxxxxxxxxxxx\\\\\\\\\\\\\\\\\\\\\\\\
`2222222222220 \«x‘x‘x‘x‘x‘x‘x‘x‘x‘x‘ xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx\\\\\\\\\\\\\\\\\\\\\\\\
`2“: xx\\\\\\\\\\\\\\\\\\\\\\\‘ \\\\\\\\\\\\\\\\\\\“““““““““““““““““
`EJPO; DERWENT
`E
`
`
`L502 and transdermalab. USPGPUB; USPAT;
`
`
`
`017/04/17:
`EUSOCR; FPRS; EPO;
`
`E13:10
`:
`
`
`EJPO; DERWENT
`
`
`
`
`
`
`017/04/17E
`EL502 and (estradiol NEAR EusPGPUB; USPAT;
`
`:13:10 :
`Eflux)
`EUSOCR; FPRS; EPO;
`
`uuuuuua: uuuuuuuuuuu uaaauaaauaaauaaauaaauaaauaaauaaauuuuuuuuuuuu aaaauaaauaaauaaauaaaua\uuuuuuuuuuu. aa\uuuuuuuuuuu. uuuuuuauuuLLLLLLLLLLLLLLLLLLLLLLLLLLLL
`=
`EJPO; DERWENT
`
`
`
`
`
`
`:L500 and (estradiol NEAR EusPGPUB; USPAT;
`:2017/04/17E
`
`Eflux)
`EUSOCR; FPRS; EPO;
`E13:10
`3
`
`
`
`\ .............\ .....................: ...............................................................é ..................................................: .........................: ...................a ..........................:
`
`
`
`
`
`
`
`MANTELLE.in. and
`us PGPUB; USPAT;
`201 7/ 04/ 1 7E
`
`E
`EJUAN.in.
`EUSOCR; FPRS; EPO;
`E13:10
`
`
`
`\ .............\ .....................: ...............................................................é ..................................................: .........................: ...................a ..........................:
`~
`EJPO; DERWENT
`E
`
`
`
`
`
`
`
`
`EusPGPUB; USPAT;
`EL507 and estradiol
`:2017/04/17E
`=
`EUSOCR; FPRS; EPO;
`:13:10
`
`
`
`: .....................:
`.n.nn.nn.nn.nn.nn.nn.nn.........................\ .nn.nn.nn.nn.nn.n......................: .n......................: ....................~ .n.......................:
`\ nun...
`EJPO; DERWENT
`‘
`
`
`
`
`
`E2017/04/17E
`L507 and transdermal
`13:10
`
`
`LLLLLLLLLL
`
`
`
`
`017/04/17E
`
`:13:10
`
`
`
`E186
` LLLLLLLLLL
`
`
`
`
`E2017/04/17:
`EusPGPUB; USPAT;
`L510 NOT L507
`
`
`
`EUSOCR; FPRS; EPO;
`:13:10
`:
`E
`
`
`auuuuuuuuuua auaaauaaauaaauaaauaaauaaauaaauaa\uuuuuuuuuauo aaauaaauaaauaaauaaauaauuuuuuuuauuua u\uuuuuuauuuua \uuuuuuuuu. auuuuuuuuuuauua
`EJPO; DERWENT
`=
`
`
`
`
`
`
`
`USPAT; USOCR
`(11/245097).APP.
`E2017/04/17E
`aa:aaaa:aaaa:aaaa:aaaa:aaaa:aaaa:aaaa:aaLLLLLLLLLLLLLLLLLLLLLLLE aaaa:aaaa:aaaa:aaaa:aaaa:aa““2“““222222222222: a:““2“““22222222222: ““2“““22222225 aa:““2“““222222222222:
`:13:10
`‘
`E
`
`
`
`
`E2017/04/17E
`USPAT; USOCR
`L500 and ("dipropylene
`E
`:13:10
`E
`:egc
`I
`I
`
`
`
`
`.......................
`Op.|ene..
`E
`
`
`2017/04/17E
`
`\1\\§\:\\1\\9\\\\\\\\\\\\\\:
`\\\\\\\\\uuuuuuuuuuuuuuuu\\\\\\\\\\\uuu\\\\\\\\\\\\\\\\\\\\\\\\\uuuuuuuuuuuuu\\\\\\\\\\uuuu\\\\\\\\\\\\\\\\\\\\\\\: \\\\\\\\\\\\\\\\\\\\\\\\\...................g
`\ nun.nnn1 \\\\\\\\\\\\\\\\\\\\\:
`
`
`
`
`
`
`
`1255486 (monolith$2 estradiol
`USPGPUB; USPAT;
`E2017/04/17E
`
`Etransdermal adhesive coat EUSOCR; FPRS; EPO;
`E13:10
`E
`
`E ““22“““« “L““LLLLLLLLLLLLLL:
`aa:aaaa:aaaa:aaaa:aaaa:aaaa:aaaa:aaaa:aaLLLLLLLLLLLLLLLLLLLLLLLE aaaa:aaaa:aaaa:aaaa:aaaa:aa““2“““222222222222: a:““2“““22222222222: ““2“““22222225 aa:““2“““222222222222:
`
`
`
`
`:A61K9/7069.cpc.
`EUSPGPUB; USPAT;
`E2017/04/17E
`USOCR; FPRS; EPO;
`13:10
`E
`
`
`E \uuuuuu. auuuuuuuuuua auaaauaaauaaauaaauaaauaaauaaauaa\uuuuuuuuuauo aaauaaauaaauaaauaaauaauuuuuuuuauuua u\uuuuuuauuuua \uuuuuuuuu. auuuuuuuuuuauua
`EJPO; DERWENT
`E
`
`
`
`
`
`E2017/04/17E
`EUSPGPUB; USPAT;
`:A61K31/565.cpc.
`13:10
`E
`USOCR; FPRS; EPO;
`
`
`E \uuuuuu. auuuuuuuuuua auaaauaaauaaauaaauaaauaaauaaauaa\uuuuuuuuuauo aaauaaauaaauaaauaaauaauuuuuuuuauuua u\uuuuuuauuuua \uuuuuuuuu. auuuuuuuuuuauua
`EJPO; DERWENT
`E
`
`
`
`
`
`
`
`E2017/04/17:
`EusPGPUB; USPAT;
`L516 and L517
`
`13:10
`E
`USOCR; FPRS; EPO;
`:
`
`
`1
`..................................................................................................................................................................................................................................
`EJPO; DERWENT
`E
`
`
`
`
`
`
`L518 and flux
`EUsPGPUB; USPAT;
`E2017/04/17:
`:
`EUSOCR; FPRS; EPO;
`:13:10
`:
`
`
`“u“...“u‘ .u...u...u...uu.~ u.uu.uu.uu.uu.uu.uu.uu.uu..u...u...u..uu.x uu.uu.uu.uu.uu.uu..u...u...u...uu.~ ...u...u...u...uu.u~ “nu“...“uuu.............................
`
`EJPO; DERWENT
`E
`
`
`
`EAST Search History
`
`
`
`L502 and estradio|.ab.
`
`
`
`EKanioan. and David.in.
`
`
`
`:
`
`
`
`
`USPGPUB; USPAT;
`USOCR; FPRS; EPO;
`JPODERWENT
`
`
`
`EusPGPUB; USPAT;
`EUSOCR; FPRS; EPO;
`JPODERWENT
`
`“L““LLLLLLLLLLLLLL:
`‘
`
`EASTSearchHistory.14024985_AccessibleVersion.htm[4/17/2017 1:22:48 PM]
`
`
`
`0360
`
`

`

`EAST Search History
`
`4/ 17/ 2017 1:22:43 PM
`
`C:\ Users\mjavier\ Documents\ EAST\Workspaces\14024985.wsp
`
`EASTSearchHistory.14024985_AccessibleVersion.htm[4/17/2017 1:22:48 PM]
`
`
`
`0361
`
`

`

`Issue Classification 14024985
`
`MANTELLE, JUAN
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`1611
`
`MELISSA JAVIER
`
`
`
`
`
`
`
`
`Version
`
`
`O.G. Print Figure
`
`(Assistant Examiner)
`/MELISSA FISHER/
`Primary Examiner.Art Unit 1611
`
`Total Claims Allowed:
`
`14
`
`04/17/2017
`
`O.G. Print Claim(s)
`
`(Primary Examiner)
`US Patent and Trademark Office
`
`(Date)
`
`1
`
`None
`Part of Paper No. 20170417
`
`
`
`0362
`
`

`

`Issue Classification 14024985
`
`MANTELLE, JUAN
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`MELISSA JAVIER
`
`1611
`
`US ORIGINAL CLASSIFICATION
`
`INTERNATIONAL CLASSIFICATION
`
`CLASS
`
`CROSS REFERENCE(S)
`
`_IIII—
`_IIII—
`I—IIII—
`—IIII—
`—IIII—
`IIII—
`
`SUBCLASS (ONE SUBCLASS PER BLOCK)
`
`(Assistant Examiner)
`/MELISSA FISHER/
`Primary Examiner.Art Unit 1611
`
`US Patent and Trademark Office
`
`O.G. Print Figure (Primary Examiner)
`
`
`Total Claims Allowed:
`
`14
`
`04/17/2017
`
`O.G. Print Claim(s)
`
`(Date)
`
`1
`
`None
`Part of Paper No. 20170417
`
`0363
`
`

`

`Issue Classification 14024985
`
`MANTELLE, JUAN
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`MELISSA JAVIER
`
`1611
`
`El
`
`Claims renumbered in the same order as presented by applicant
`
`El
`
`IX
`
`T.D
`
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`
`
`
`
`
`
`
`
`
`
` LOOO\IO§U'IJ>LOl\)—‘ LOOO\IO§U'IJ>LOl\)—‘
`
`07
`
`
`
`
`
`
`
`
`O
`
`l\)
`(a)
`J;
`U'l
`
`(Assistant Examiner)
`/MELISSA FISHER/
`Primary Examiner.Art Unit 1611
`
`US Patent and Trademark Office
`
`O.G. Print Figure (Primary Examiner)
`
`
`Total Claims Allowed:
`
`14
`
`04/17/2017
`
`O.G. Print Claim(s)
`
`(Date)
`
`1
`
`None
`Part of Paper No. 20170417
`
`0364
`
`

`

`Atty. Dkt. No. 041457-1016
`
`IN THE UNITED STATES PATENTAND TRADEMARK OFFICE
`
`First Inventor Name:
`
`Juan Mantelle
`
`Title:
`
`Transdermal Estrogen Device and Delivery
`
`Appl. No.:
`
`14/024,985
`
`Appl. Filing Date:
`
`9/12/2013
`
`Examiner:
`
`Melissa L. Fisher
`
`Art Unit:
`
`161 1
`
`Confirmation Number:
`
`7031
`
`RE! QUEST FOR CONTINUED EXAMINATION (RCE!
`TRANSMITTAL
`
`Mail Stop RCE
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`This is a Request for Continued Examination (RCE) under 37 C.F.R. § 1.114 of the
`
`above-identified application. This RCE and the enclosed items listed below are being filed prior
`
`to the earliest of: (1) payment of the issue fee (unless a petition under 37 C.F.R. § 1.313 is
`
`granted); (2) abandonment of the application; or (3) the filing of a notice of appeal to the US.
`
`Court of Appeals for the Federal Circuit under 35 U.S.C. §141, or the commencement of a civil
`
`action under 35 U.S.C. §145 or §146 (unless the appeal or civil action is terminated).
`
`4845-1381-2810.1
`
`
`
`0365
`
`

`

`Atty. Dkt. No. 041457-1016
`
`Submission required under 37 C.F.R. §l.ll4:
`
`[ X ] Amendment/Reply.
`
`The filing fee is calculated below at the large entity rate:
`
`Claims as
`Amended
`
`Previously
`Paid For
`
`Extra Claims
`Present
`
`Rate
`
`Fee Totals
`
`RCE Fee l.l7(e):
`
`$1,700.0 = $1,700.00
`
`0
`
`Total Claims:
`
`15
`
`Independents
`
`l
`
`-
`
`-
`
`20
`
`= 0
`
`3
`
`= 0
`
`X
`
`X
`
`$80.00 =
`
`$0.00
`
`$420.00 =
`
`$0.00
`
`First presentation of any Multiple Dependent Claims: +
`
`$780.00 =
`
`$0.00
`
`CLAHVIS FEE TOTAL: = $1,700.00
`
`The above-identified fees of $1,700.00 are being paid by credit card Via EFS—Web.
`
`The Commissioner is hereby authorized to charge any additional fees which may be
`
`required regarding this application under 37 C.F.R. §§ 1.16-1.17, or credit any overpayment, to
`
`Deposit Account No. 19-0741. Should no proper payment be enclosed herewith, as by the credit
`
`card payment instructions in EFS—Web being incorrect or absent, resulting in a rejected or
`
`incorrect credit card transaction, the Commissioner is authorized to charge the unpaid amount to
`
`Deposit Account No. 19-0741.
`
`4845-1381-2810.1
`
`
`
`0366
`
`

`

`Please direct all correspondence to the undersigned attorney or agent at the address
`
`indicated below.
`
`Atty. Dkt. No. 041457-1016
`
`Date June 6 2017
`
`FOLEY & LARDNER LLP
`Customer Number: 22428
`Telephone:
`(202) 295-4094
`Facsimile:
`(202) 672-5399
`
`Respectfully submitted,
`
`By /Courtenay C. Brinckerhoff/
`
`Courtenay C. Brinckerhoff
`Attorney for Applicant
`Registration No. 37,288
`
`4845-1381-2810.1
`
`
`
`0367
`
`

`

`Atty. Dkt. No. 041457-1016
`
`IN THE UNITED STATES PATENTAND TRADEMARK OFFICE
`
`Applicant:
`
`Juan Mantelle
`
`Title:
`
`Transdermal Estrogen Device and Delivery
`
`Appl. No.:
`
`14/024,985
`
`Filing Date:
`
`September 12, 2013
`
`Examiner:
`
`Javier
`
`Art Unit:
`
`161 1
`
`Confirmation
`
`7031
`
`Number:
`
`MAIL STOP: Amendment
`
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`AMENDMENT
`
`This paper is filed with a Request for Continued Examination. If any extensions of time
`
`are required for timely acceptance, Applicant hereby petitions for such extension of time. The
`
`Commissioner is hereby authorized to charge any fees which may be due for this application,
`
`including any extension of time fees or excess claim fees not submitted herewith, to Deposit
`
`Account No. 19-0741.
`
`Amendments to the Claims are reflected in the listing of claims which begins on page 2.
`
`Remarks/Arguments begin on page 5 of this document.
`
`Please amend the application as follows:
`
`4829-6342-2025.1
`
`
`
`0368
`
`

`

`Atty. Dkt. No. 041457-1016
`
`Amendments to the Claims:
`
`This listing of claims will replace all prior versions, and listings, of claims in the application:
`
`Listing of Claims:
`
`1. (Previously Presented) A monolithic transdermal drug delivery system for estradiol,
`
`consisting of (i) a backing layer, (ii) a single adhesive polymer matrix layer defining an active
`
`surface area and, optionally, (iii) a release liner, wherein the single adhesive polymer matrix
`
`layer comprises an adhesive polymer matrix comprising estradiol as the only drug, wherein the
`
`adhesive polymer matrix layer has a coat weight of greater than about 10 mg/cm2 and includes
`
`greater than 0.156 mg/cm2 estradiol, and the system achieves an estradiol flux of from about
`
`0.0125 to about 0.05 mg/cmZ/day, based on the active surface area.
`
`2. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`
`adhesive polymer matrix comprises a polymer blend comprising an acrylic adhesive, a silicone
`
`adhesive, and soluble PVP.
`
`3. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`
`adhesive polymer matrix comprises about 2-25% by weight acrylic adhesive, about 45-70% by
`
`weight silicone adhesive, about 2-25% by weight soluble PVP, about 5-15% penetration
`
`enhancer, and about 01-10% by weight estradiol, all based on the total dry weight of the
`
`adhesive polymer matrix.
`
`4. (Original) The transdermal drug delivery system of claim 3, wherein the penetration
`
`enhancer comprises oleyl alchol.
`
`5. (Original) The transdermal drug delivery system of claim 3, wherein the penetration
`
`enhancer comprises dipropylene glycol.
`
`6. (Original) The transdermal drug delivery system of claim 3, wherein the penetration
`
`enhancer comprises oleyl alcohol and dipropylene glycol.
`
`4829-6342-2025.1
`
`
`
`0369
`
`

`

`Atty. Dkt. No. 041457-1016
`
`7. (Original) The transdermal drug delivery system of claim 3, wherein the acrylic
`
`adhesive and silicone adhesive are present in a ratio of from about 1:2 to about 1:6, based on the
`
`total weight of the acrylic and silicone adhesives.
`
`8. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`
`adhesive polymer matriX comprises an amount of estradiol effective to deliver a therapeutically
`
`effective amount of estradiol over a period of time selected from the group consisting of at least
`
`1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days and at least 7
`
`days.
`
`9. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`
`adhesive polymer matriX comprises an amount of estradiol effective to deliver an amount of
`
`estradiol selected from the group consisting of about 0.025, 0.0375, 0.05, 0.075 and 01 mg/day.
`
`Claims 10-20 (Canceled)
`
`21. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`
`system achieves an estradiol flux of about 0.0125 mg/cmZ/day, based on the active surface area.
`
`22. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`
`system achieves an estradiol flux of about 0.0133 mg/cmZ/day, based on the active surface area.
`
`23. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`
`system achieves an estradiol flux of about 0.015 mg/cmZ/day, based on the active surface area.
`
`24. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`
`system achieves an estradiol flux of about 0.0167 mg/cmZ/day, based on the active surface area.
`
`25. (Previously Presented) The transdermal drug delivery system of claim 1, wherein
`
`the system achieves an estradiol flux of about 0.0175 mg/cmZ/day, based on the active surface
`
`area.
`
`4829-6342-2025.1
`
` 
`
`0370
`
`

`

`Atty. Dkt. No. 041457-1016
`
`26. (New) The transdermal drug delivery system of claim 1, wherein the adhesive
`
`polymer matrix comprises about 1.6 % by weight estradiol, based on the total dry weight of the
`
`adhesive polymer matrix.
`
`4829-6342-2025.1
`
` 
`
`0371
`
`

`

`Atty. Dkt. No. 041457-1016
`
`REMARKS
`
`A Notice of Allowance allowing claims 1-9 and 21-25 was mailed April 26, 2017.
`
`Claim 26 is added to recite specific embodiment described in the specification as filed,
`
`including in paragraphs [0011], [0069] and [0082]. No new matter is added.
`
`Upon entry of these amendments claims 1-9 and 21-26 will be pending. Applicant
`
`believes that these claims are in condition for allowance.
`
`Should there be any questions regarding this submission, or should any issue remain, the
`
`Examiner is urged to contact the undersigned by telephone to advance prosecution.
`
`Respectfully submitted,
`
`Date: June 6, 2017
`
`By /Courtenay C. Brinckerhoff/
`
`FOLEY & LARDNER LLP
`Customer Number: 22428
`Telephone:
`(202) 295-4094
`Facsimile:
`(202) 672-5399
`
`Courtenay C. Brinckerhoff
`Attorney for Applicant
`Registration No. 37,288
`
`4829-6342-2025.1
`
` 
`
`0372
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Title of Invention:
`
`TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`Quantity
`
`_
`
`First Named Inventor/Applicant Name:
`
`Juan Mantelle
`
`Filed as Large Entity
`
`Filing Fees for Utility under 35 USC111(a)
`
`Description
`
`Fee Code
`
`Sub-Total in
`
`U5Dl$l
`
` 
`
`0373
`
`

`

`-
`
`-
`
`.
`
`Sub-Total in
`
`Total in USD (5)
`
`RCE— 2ND AND SUBSEQUENT REQUEST
`
`1820
`
`1700
`
`1700
`
` 
`
`0374
`
`

`

`——
`
`Title of Invention:
`
`TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`Electronic Acknowledgement Receipt
`
`“—
`
`
`
`——
`
`Payment information:
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`——
`
` 
`
`0375
`
`

`

`File Listing:
`
`Document
`Number
`
`Document Descri
`
`tion
`
`p
`
`File Size(Bytes)/
`Message Digest
`102172
`
`Pages
`Multi
`Part /.zip (if appl.)
`
`Request for Continued Examination
`(RCE)
`
`3da374833353b7928de9621aaOb2e774dc
`62738b
`
`This is not a USPTO supplied RCE 5830 form.
`
`Information:
`
`Amendment Submitted/Entered with
`Filing ofCPA/RCE
`
`amendment'pdf
`
`152db8670311ae5e7d06fbd631ae19fe5f6f
`2236
`
`105720
`
`Information:
`
`Information:
`
`Fee Worksheet (SBO6)
`
`fee—info.pdf
`
`731391389an86c5fe052bc328c0d2eae1 e88
`761 1
`
`
`
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)—(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Total Files Size (in bytes)
`
`238481
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
` 
`
`0376
`
`

`

`PTO/SB/06 (09-11)
`Approved for use through 1/31/2014. OMB 0651-0032
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`
`PATENT APPLICATION FEE DETERMINATION RECORD
`Substitute for Form PTO—875
`
`Appiicaiion or Dockei Number
`14/024,985
`
`Fiiing Daie
`09/12/2013
`
`IZI To be Mailed
`
`APPLICATION AS FILED — PART I
`
`(Column 1)
`
`(Column 2)
`
`ENTHY:
`
`EQLARGE [JSMALL [JAMCRO
`
`37CFR1.16a, b,or c
`
`37CFR1.16k,
`
`i,or m
`
`I] EXAMINATION FEE
`
`TOTAL CLAIMS
`37 CFR1.16i
`INDEPENDENT CLAIMS
`37 CFR1.16h
`
`DAPPLICATION SIZE FEE
`(37 CFR1.16(s))
`
`*
`
`*
`
`,
`”Imus 20:
`,
`”WU“:
`If the specification and drawings exceed 100 sheets
`of paper, the application size fee due is $310 ($155
`for small entity) for each additional 50 sheets or
`fraction thereof. See 35 U.S.C. 41(a)(1)(G) and 37
`CFR 1.16(s).
`
`
`
`El MULTIPLE DEPENDENT CLAIM PRESENT (37 CFR1.16(j))
`* If the difference in column 1 is less than zero, enter “0" in column 2.
`
`APPLICATION AS AMENDED — PART II
`
`CLAIMS
`
`QEIAEAFIKNING
`AMENDMENT
`
`(Column 2)
`
`HIGHEST
`
`ERIE/EEESLY
`PAID FOR
`
`(Column 3)
`
`PRESENT EXTRA
`
`ADDITIONAL FEE ($)
`
`I: Application Size Fee (37 CFR1.16(s))
`
`D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR1.16(j))
`
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`
`-
`
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`PRESENT EXTRA
`
`1.16(i))
`
`(37 CFR1.16(h))
`
`Minus
`
`***
`
`El Application Size Fee (37 CFR1.16(s)
`
`D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR1.16(j))
`
`AMENDMENT
`
`AMENDMENT
`
`* If the entry in column 1 is less than the entry in column 2, write “0" in column 3.
`** If the “Highest Number Previously Paid For" IN THIS SPACE is less than 20, enter “20".
`*** If the “Highest Number Previously Paid For" IN THIS SPACE is less than 3, enter “3
`The “Highest Number Previously Paid For" (Total or Independent) is the highest number found in the appropriate box in column 1.
`This collection of information is required by 37 CFR 1.16. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to
`process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete, including gathering,
`preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you
`require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, US. Patent and Trademark Office, US.
`Department of Commerce, PO. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS
`ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800—PTO-9199 and select option 2.
`
`LI E
`LISA THOMAS
`
`
`
`0377
`
`

`

`
`“x
`‘\\f
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`14/024,985
`
`09/12/2013
`
`Juan Mantelle
`
`041457-1016
`
`7031
`
`22428
`7590
`06’1“)”
`Foley “Manama —
`3000 K STREET N.W.
`FISHER, MELISSA L
`SUITE 600
`WASHINGTON, DC 20007-5 109
`
`PAPER NUMBER
`
`1611
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/ 14/2017
`
`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):
`
`ipdocketing @ f01ey.c0m
`
`PTOL—90A (Rev. 04/07)
`
` 
`
`0378
`
`

`

`
`
` . .. _ 14m24985 MANTELLE,JUAN
`
`
`
`
`Applicant-Initiated Interwew Summary
`_
`_
`Examiner
`Art UnIt
`
`Application No.
`
`Applicant(s)
`
`Melissa Fisher
`
`1611
`
`All participants (applicant, applicant’s representative, PTO personnel):
`
`(1) Melissa Fisher.
`
`(3)Richard Guy.
`
`(2) Courtenay Brinckerhoff.
`
`(4)
`
`.
`
`Date of Interview: 08 June 2017.
`
`Type:
`
`D Telephonic D Video Conference
`IZI Personal [copy given to: D applicant D applicant’s representative]
`
`Exhibit shown or demonstration conducted: D Yes
`If Yes, brief description:
`
`D No.
`
`Issues Discussed D101 D112 D102 D103 IXlOthers
`(For each of the checked box(es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed:
`
`Identification of prior art discussed: None.
`
`Substance of Interview
`(For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a
`reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc...)
`
`Discussed the attached agenda.
`
`Specifically, Applicant’s representative and Dr. Guy explained how the included data supported the unexpected results
`that increasing the coat weight of the drug-containing adhesive layer resulted in an increased flux per unit area, and
`permitted the development of smaller transdermal drug delivery systems that achieve comparable daily dosages. .
`
`Primary Examiner, Art Unit 1611
`
`Applicant recordation instructions: The formal written reply to the last Office action must include the substance of the interview. (See MPEP
`section 713.04). If a reply to the last Office action has already been filed, applicant is given a non-extendable period of the longer of one month or
`thirty days from this interview date, or the mailing date of this interview summary form, whichever is later, to file a statement of the substance of the
`interview
`
`Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of the
`substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the
`general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the
`general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.
`
`IXI Attachment
`lMelissa Fisher/
`
`US. Patent and Trademark Office
`
`PTOL-413 (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20170609
`
` 
`
`0379
`
`

`

`Manual of Patent Examining Procedure (MPEP), Section 713.04, Substance of Interview Must be Made of Record
`A complete written statement as to the substance of any face-to-face, video conference, or telephone interview with regard to an application must be made of record in the
`application whether or not an agreement with the examiner was reached at the interview.
`
`Summary of Record of Interview Requirements
`
`Title 37 Code of Federal Regulations (CFR) § 1.133 Interviews
`Paragraph (b)
`
`In every instance where reconsideration is requested in view of an interview with an examiner, a complete written statement of the reasons presented at the interview as
`warranting favorable action must be filed bythe applicant. An interview does not remove the necessity for replyto Office action as specified in §§ 1.111, 1.135. (35 U.S.C. 132)
`
`37 CFR §1.2 Business to be transacted in writing.
`A“ business with the Patent or Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and
`Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to
`any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.
`
`The action of the Patent and Trademark Office cannot be based exclusively on the written record in the Office if that record is itself
`incomplete through the failure to record the substance of interviews.
`It is the responsibility of the applicant or the attorney or agent to make the substance of an interview of record in the application file, unless
`the examiner indicates he or she will do so.
`It is the examiner‘s responsibility to see that such a record is made and to correct material inaccuracies
`which bear directly on the question of patentability.
`
`Examiners must complete an Interview Summary Form for each interview held where a matter of substance has been discussed during the
`interview by checking the appropriate boxes and filling in the blanks. Discussions regarding only procedural matters, directed solely to restriction
`requirements for which interview recordation is otherwise provided for in Section 812.01 of the Manual of Patent Examining Procedure, or pointing
`out typographical errors or unreadable script in Office actions or the like, are excluded from the interview recordation procedures below. Where the
`substance of an interview is completely recorded in an Examiners Amendment, no separate Interview Summary Record is required.
`
`The Interview