`
`L460 I 42
`
`i|L459 and estradiol
`
`L461 Ill52
`
`i L459 and transdermal
`
`L462j 186
`
`Kanios.in. and David.in.
`
`L463 140
`
`1 L462 NOT L459
`
`L464 10
`
`(11/245097). APP.
`
`| US-PGPUB; USPAT;
`| USOCR; FPRS; EPO;
`! JPO: DERWENT
`| US-PGPUB; USPAT;
`| USCXDR; FPRS; EPO;
`j JPO: DERWENT
`| US-PGPUB; USPAT;
`| USOCR; FPRS; EPO;
`j JPO: DERWENT
`I US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`j JPO: DERWBMT
`s USPAT; USOCR
`
`|OR
`
`llOFF
`
`iOR
`
`liOFF
`
`jjOR
`
`liOFF
`
`!|OR
`
`liOFF
`
`OR
`
`! USPAT; USOCR
`
`liOR
`
`! USPAT; USOCR
`
`jjOR
`
`llOR
`
`I OFF
`
`!iOFF
`
`!|OFF
`
`!!OFF
`
`112017/04/17!
`i 13:10
`
`iii:
`
`12017/04/171
`113:10
`
`j 2017/04/171
`{13:10
`
`12017/04/171
`113:10
`
`2017/04/17!
`13:10
`l|2017/04/17!
`1113:10
`l|2017/04/17|
`||l3:10
`i|2017704/17!
`|13:10
`
`1(2017/04/17!
`113:10
`
`12017/04/17j
`113:10
`
`!iOR
`
`liOFF
`
`ilOR
`
`liOFF
`
`HOR
`
`..
`
`—-
`
`:V.V.V.V.s.s.s.s.t
`L465 ||715
`
`L466>132
`
`L452 and ("dipropylene
`! glycol" oleyl)
`L454 and ("dipropylene
`! glycol" oleyl)
`nr?
`L467 !|15844 "liestradiol
`and transdermal
`!
`!
`!|
`L468 j 5484
`
`L467 and ("surface area"
`j flux)
`
`L469 I 921
`
`L470 I 35
`
`iUUUi
`
`!lUS-PGPUB; USPAT;
`| USOCR; FPRS; EPO;
`j JPO: DERWBMT
`I US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`j JPO: DERWBMT
`L468 and acrylic and
`| US-PGPUB; USPAT;
`i silicone and (FVP polyvinyl I USOCR; FPRS; EPO;
`i pyrrolidone)
`! JPO; DERWBMT
`j US-PGPUB; USPAT;
`i L469 and estradiol.ab.
`! USOCR; FPRS; EPO;
`I JPO; DERWBMT
`I US-PGPUB; USPAT;
`! USOCR; FPRS; EPO;
`IjjPO; DERWENT
`l|US-PGPUB; USPAT;
`! USOCR; FPRS; EPO;
`![jPO; DERWENT
`IjUS-PGPUB; USPAT;
`\ USOCR; FPRS; EPO;
`| JPO; DERWENT
`US-PGPUB; USPAT;
`! USOCR; FPRS; EPO;
`| JPO; DERWBMT
`j US- PGPuir USPAT; liOR
`! USOCR; FPRS; EPO;
`I JPO: DERWBMT
`I US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`I JPO: DERWBMT
`j US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`I JPO; DERWBMT
`IjUS-PGPUB; USPAT;
`| USOCR; FPRS; EPO;
`I JPO: DERWBMT
`j USPAT; USOCR
`
`liOFF
`
`liOFF
`
`HOFF
`
`llOFF
`
`liOFF
`
`HOFF
`
`HOFF
`
`12017/04/17j
`i 13:10
`
`{12017/04/171
`113:10
`
`12017/04/17!
`i 13:10
`
`2017/04/17!
`13:10
`
`||2017/04/17l
`j 13:10
`
`{12017/04/171
`I
`113:10
`
`12017/04/17!
`113:10
`
`OFF
`
`{2017/04/171
`|13:10
`
`iiOR
`
`!iOR
`
`liOR
`
`liOR
`
`liOR
`
`OR
`
`liOR
`
`liOFF
`
`IOR
`If
`
`::::::::::::::::
`
`12017/04/171
`113:10
`
`
`
`
`
`HOFF
`!j2017/04/17!
`113:10
`II MYLAlsi: EffllBIT
`Part 2 of 2
`0358
`
`L471 I [263
`
`L472i 51
`
`L473 190
`
`L474 1 259
`
`L475 1 42
`
`L476 1152
`
`L477 iRse
`
`L478 !f40
`
`L479 I 0
`
`! L469 and transdermal.ab.
`
`! L469 and (estradiol NEAR
`! flux)
`
`! L467 and (estradiol NEAR
`! flux)
`
`1 MANTELLEin. and
`| JUAN.in.
`
`1 L474 and estradiol
`
`I L474 and transdermal
`
`I Kanios.in. and David.in.
`
`j L477 NOT L474
`
`1(11/245097). APP.
`
`EASTSearchHistoiy.l4024985_AccessibleVersion.htm[4/17/2017
`
`1:22:48
`
`PM]
`
`1038
`
`
`
`EAST Search History
`
`j L467 and ("dipropylene
`L480 1715
`| j glycol" oleyl)
`L481 s 132
`L469 and ("dipropylene
`Hglycol" oleyl)
`]j"6638528".pn.
`
`L482 p
`
`jfUSPAT; USOCR
`
`jfUSPAT; USOCR
`
`L483 I [4
`
`I"4624665".pn.
`
`L484 lis
`
`j "20090041831 ".pn.
`
`L485 ll 15844
`
`L486 15484
`
`L485 and ("surface area"
`j
`j flux)
`
`L487 j 921
`
`L488 135
`
`L486 and acrylic and
`! silicone and (PVP polyvinyl
`| pyrrol idone)
`I L487 and estradiol.ab.
`
`OR
`
`OR
`
`OR
`
`OR
`
`OFF
`
`OFF
`
`OFF
`
`OFF
`
`! OR
`
`j OFF
`
`liOR
`
`iiOFF
`
`! OR
`
`IIOFF
`
`j OR
`
`IIOFF
`
`12017/04/17j
`113:10
`112017/04/17j
`113:10
`12017/04/17i
`M3:10
`
`12017/04/17j
`h3:10
`
`12017/04/17!
`h3:10
`
`12017/04/17!
`{13:10
`
`12017/04/17|
`{13:10
`
`12017/04/17|
`i 13:10
`
`...
`
`IIOFF
`
`,,
`
`! 2017/04/17!
`113:10
`|
`
`L489 | 263
`
`I L487 and transdermal.ab.
`
`! OR
`
`![OFF
`
`L490 I 51
`
`I L487 and (estradiol NEAR
`i flux)
`
`j OR
`
`iiOFF
`
`12017/04/17!
`! 13:10
`|
`
`12017/04/17!
`i 13:10
`
`j US-PGPUB; USPAT;
`| USOCR; FPRS; EPO;
`IJPO: DERWBMT
`| US-PGPUB; USPAT;
`| USOCR; FPRS; EPO;
`! JPO: DERWBMT
`j US-PGPUB; USPAT;
`| USOCR; FPRS; EPO;
`j JPO; DERWBMT
`estradiol and transdermal | US-PGPUB; USPAT;
`| USOCR; FPRS; EPO;
`j JPO: DERWBMT
`! US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`j JPO: DERWBMT
`| US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`! JPO: DERWBMT
`j US-PGPUB; USPAT; HOR
`I USOCR; FPRS; EPO;
`j JPO; DERWBMT
`j US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`I JPO; DERWBMT
`I US-PGPUB; USPAT;
`! USOCR; FPRS; EPO;
`I JPO: DERWENT
`I US-PGPUB; USPAT;
`j USOCR; FPRS; EPO;
`I JPO; DERWENT
`! US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`| JPO; DERWENT
`! US-PGPUB; USPAT;
`! USOCR; FPRS; EPO;
`| JPO; DERWENT
`ljUS-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`| JPO; DERWENT
`1|US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`| JPO; DERWENT
`| US-PGPUB; USPAT;
`! USOCR; FPRS; EPO;
`I JPO: DERWENT
`IUSPAT; USOCR
`
`i L485 and (estradiol NEAR
`i flux)
`
`i MANTELLEin. and
`! JUAN.in.
`
`i L492 and estradiol
`
`
`
`| L492 and transdermal
`
`
`
`| Kanios.in. and David.in.
`
`]
`L495 NOT L492
`
`(11/245097). APP.
`
`i L485 and ("dipropylene
`i glycol" oleyl)
`i L487 and ("dipropylene
`i glycol" oleyl)
`j estradiol and transdermal
`
`IUSPAT; USOCR
`
`OR
`
`IUSPAT; USOCR
`
`! OR
`
`I US-PGPUB; USPAT;
`
`OR
`
`EASTSearchHistory.l4024985_AccessibleVersion.htm[4/17/2017 1:22:48 PM]
`
`L491 i 90
`
`L492 l 259
`
`L493 |42
`
`L494 I1152
`
`L495 I1186
`
`L496 II40
`
`L497 ! 0
`
`L498 1715
`
`L499 1132
`
`L500 1115844
`
`i OR
`
`! OR
`
`i OR
`
`OR
`
`OR
`
`OR
`
`I OR
`
`i OFF
`
`I [OFF
`
`I [OFF
`
`OFF
`
`OFF
`
`OFF
`
`! OFF
`
`OFF
`
`OFF
`
`OFF
`
`12017/04/17!
`113:10
`
`I2017/04/17]
`(13:10
`
`| [2017/ 04/171
`113:10
`i
`j
`112017/04/17!
`113:10
`
`112017/04/17!
`113:10
`j
`|
`l|2017/04/17!
`113:10
`
`(2017/04/171
`113:10
`]|2017/04/17!
`j
`||2017/04/171
`j 13:10
`112017/04/171
`
`0359
`
`
`
`EAST Search History
`
`! L501 ! 5484
`
`I L502 I 921
`
`IL503 135
`
`I L504 1263
`
`IL505 I 51
`
`i|L506 |[90
`
`I L507 |[259
`
`IL508 | 42
`
`| L509 1152
`
`| L510 1186
`
`........V
`
`| L511 | 40
`
`| L512 : 0
`
`I L502 and estradiol.ab.
`
`ifL502 and (estradiol NEAR
`j flux)
`
`! MANTELLEin. and
`! JUAN.in.
`
`! L507 and estradiol
`
`| US-PGPUB; USPAT;
`\ USOCR; FPRS; EPO;
`I JPO; DERWENT
`L502 and transdermal.ab. | US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`j|jFO; DERWENT
`IIUS-PGRUBTUSPAT;
`I USOCR; FPRS; EPO;
`||jPO; DERWENT
`I L500 and (estradiol NEAR 1|US-PGPIIB; USPAT;
`I USOCR; FPRS; EPO;
`! flux)
`JJPO; .DERyyENJ
`"11 US-PGPUB;' USPAT;
`I USOCR; FPRS; EPO;
`| JPO; DERWENT
`~1 [US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`1 JPO: DERWENT
`I US-PGPUB; USPAT;
`! USOCR; FPRS; EPO;
`I JPO: DERWENT
`j US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`I JPO: DERWENT
`j US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`I JPO: DERWENT
`^ Lv.v.v.v.'-.v.'-.
`j USPAT; USOCR
`
`L507 and transdermal
`
`::::::::::::::::::::::::::::::::::::
`
`i Kanios.in. and David.in.
`
`i L510 NOT L507
`
`!(11/245097). APP.
`
`L500 and ("surface area"
`jflux)
`
`I USOCR; FPRS; EPO;
`| JPO; DERWENT
`| US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`I JPO; DERWENT
`j L501 and acrylic and
`IfUS-PGPUB; USPAT; IfOR
`I silicone and (PVP polyvinyl j USOCR; FPRS; EPO;
`
`!
`
`"lOR
`
`OFF
`
`OFF
`
`IIOFF
`
`IIOFF
`
`lOR
`
`ijOR
`
`^IOR"
`
`ijOFF
`
`! OR
`
`I [OFF
`
`!OR
`
`"IfOFF
`
`!!13:10
`
`1(2017/04/17j
`j 13:10
`51
`:
`12017/04/17!
`113:10
`!
`
`1(2017/04/171
`! 13:10
`
`! 2017/04/171
`113:10
`
`12017/04/17!
`113:10
`
`12017/04/17!
`1113:10
`!
`
`12017/04/17!
`j l S M O
`
`iOR
`I
`
`—
`
`OR
`
`OR
`
`OR
`
`OR
`
`! OR
`
`! OR
`
`j OR
`
`j OR
`
`j OR
`
`j OR
`
`:::::
`
`j OR
`
`!!OFF
`
`||2017/04/17!
`113:10
`
`IpFF
`I
`
`liOFF
`
`IIOFF
`
`liOFF
`
`!!OFF
`
`!!OFF
`
`liOFF
`
`1(2017/04/17!
`113:10
`
`1(2017/04/171
`{13:10
`
`{[2017/04/171
`113:10
`
`|2017/04/17!
`1(13:10
`1(2017/04/17!
`113:10
`i!2017/ 04/17!
`13:10
`{[2017/04/17!
`i 13:10
`
`HOFF
`
`{[2017/04/17l
`{13:10
`
`![OFF
`I
`
`liOFF
`
`12017/04/17!
`{13:10
`
`{2017/04/17!
`{13:10
`
`OFF
`
`1(2017/04/17!
`{13:10
`
`uun
`
`0360
`
`i L513 !!715
`
`| L514j132
`
`| L500 and ("dipropylene
`! glycol" oleyl)
`! L502 and ("dipropylene
`! glycol" oleyl)
`|[L515 jjl255486 ! (monolith$2 estradiol
`! transdermal adhesive coat
`! weight flux).elm.
`j A61 K9/7069.cpc.
`
`I L516 ! 3958
`
`I L517 116828
`
`j A61 K31/565.cpc.
`
`! L518 1422
`
`! L516 and L517
`
`! L519 147
`
`""""
`
`! L518 and flux
`
`ifUSPAT; USOCR
`
`USPAT; USOCR
`
`I US-PGPUB; USPAT;
`j USOCR; FPRS; EPO;
`i JPO: DERWENT
`I US-PGPUB; USPAT;
`! USOCR; FPRS; EPO;
`I JPO: DERWENT
`I US-PGPUB; USPAT;
`! USOCR; FPRS; EPO;
`I JPO; DERWENT
`I US-PGPUB; USPAT;
`I USOCR; FPRS; EPO;
`I JPO: DERWENT
`I US-PGPUB; USPAT;
`| USOCR; FPRS; EPO;
`! JPO: DERWENT
`
`EASTSearchHistory.l4024985_AccessibleVersion.htm[4/17/2017 1:22:48 PM]
`
`
`
`EAST Search History
`
`4/17/2017 1:22:43 PM
`C:\ Users\ mjavier\ Documents\ EAST\ Workspaces\ 14024985.wsp
`
`EASTSearchHistory.l4024985_AccessibleVersion.htm[4/17/2017 1:22:48 PM]
`
`0361
`
`
`
`Issue Classification
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`14024985
`
`Examiner
`
`MELISSA JAVIER
`
`MANTELLE, JUAN
`
`Art Unit
`
`1611
`
`CPC
`Symbol
`
`A61K
`
`A61K
`
`A61K
`
`A61K
`
`A61K
`
`A61K
`
`9
`
`9
`
`31
`
`47
`
`47
`
`9
`
`CPC Combination Sets
`Symbol
`
`i 7069
`i
`7061
`i 565
`i
`10
`i
`32
`i 0014
`1
`1
`1
`1
`1
`1
`i
`i
`i
`
`1
`i
`
`(Assistant Examiner)
`/MELISSA FISHER/
`Primary Examiner.Art Unit 1611
`
`(Primary Examiner)
`
`U.S. Patent and Trademark Office
`
`F
`
`Type
`
`Version
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`2013-01-01
`
`Type
`
`Set
`
`Ranking
`
`Version
`
`Total Claims Allowed:
`
`14
`
`(Date)
`
`04/17/2017
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`(Date)
`
`1
`
`None
`
`Part of Paper No. 20170417
`
`0362
`
`
`
`Issue Classification
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`14024985
`
`Examiner
`
`MELISSA JAVIER
`
`MANTELLE, JUAN
`
`Art Unit
`
`1611
`
`US ORIGINAL CLASSIFICATION
`
`INTERNATIONAL CLASSIFICATION
`
`CLASS
`
`SUBCLASS
`
`CLAIMED
`
`NON-CLAIMED
`
`CROSS REFERENCE(S)
`
`CLASS
`
`SUBCLASS (ONE SUBCLASS PER BLOCK)
`
`A
`
`A
`
`6
`
`6
`
`1
`
`1
`
`K
`
`K
`
`31 / 565 (2006.01.01)
`
`9/70 (2006.01.01)
`
`(Assistant Examiner)
`/MELISSA FISHER/
`Primary Examiner.Art Unit 1611
`
`(Primary Examiner)
`
`U.S. Patent and Trademark Office
`
`Total Claims Allowed:
`
`14
`
`(Date)
`
`04/17/2017
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`(Date)
`
`1
`
`None
`
`Part of Paper No. 20170417
`
`0363
`
`
`
`Issue Classification
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`14024985
`
`Examiner
`
`MELISSA JAVIER
`
`MANTELLE, JUAN
`
`Art Unit
`
`1611
`
`G
`
`Claims renumbered in the same order as presented by applicant
`
`•
`
`CPA
`
`M
`
`T.D.
`
`• R.I.47
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`10
`
`1 1
`
`12
`
`13
`
`14
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`1 1
`
`12
`
`13
`
`14
`
`15
`
`16
`
`(Assistant Examiner)
`/MELISSA FISHER/
`Primary Examiner.Art Unit 1611
`
`(Primary Examiner)
`
`U.S. Patent and Trademark Office
`
`Total Claims Allowed:
`
`14
`
`(Date)
`
`04/17/2017
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`(Date)
`
`1
`
`None
`
`Part of Paper No. 20170417
`
`0364
`
`
`
`Atty. Dkt. No. 041457-1016
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`First Inventor Name:
`
`Juan Mantelle
`
`Title:
`
`Appl. No.:
`
`Transdermal Estrogen Device and Delivery
`
`14/024,985
`
`Appl. Filing Date:
`
`9/12/2013
`
`Examiner:
`
`Art Unit:
`
`Melissa L. Fisher
`
`1611
`
`Confirmation Number:
`
`7031
`
`REQUEST FOR CONTINUED EXAMINATION (RCE)
`TRANSMITTAL
`
`Mail Stop RCE
`Commissioner for Patents
`P.O. 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 U.S.
`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
`
`
`
`Submission required under 37 C.F.R. §1.114:
`
`[ X ] Amendment/Reply.
`
`The filing fee is calculated below at the large entity rate:
`
`Claims as
`Amended
`
`Previously
`Paid For
`
`Extra Claims
`Present
`
`RCE Fee 1.17(e):
`
`Atty. Dkt. No. 041457-1016
`
`Rate
`
`Fee Totals
`$1,700.0 = $1,700.00
`0
`
`Total Claims:
`
`Independents
`
`15
`
`1
`
`20
`
`3
`
`= 0
`
`= 0
`
`x
`
`X
`
`$80.00 =
`
`$0.00
`
`$420.00 =
`
`$0.00
`
`First presentation of any Multiple Dependent Claims: +
`
`$780.00 =
`
`$0.00
`
`CLAIMS 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
`
`
`
`Atty. Dkt. No. 041457-1016
`
`Please direct all correspondence to the undersigned attorney or agent at the address
`indicated below.
`
`Respectfully submitted,
`
`Date June 6. 2017
`
`By /Courtenav C. Brinckerhoff/
`
`FOLEY & LARDNER LLP
`Customer Number: 22428
`(202) 295-4094
`Telephone:
`Facsimile:
`(202) 672-5399
`
`Courtenay C. Brinckerhoff
`Attorney for Applicant
`Registration No. 37,288
`
`4845-1381-2810.1
`
`0367
`
`
`
`Atty. Dkt. No. 041457-1016
`
`IN THE UNITED STATES PATENT AND 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:
`
`1611
`
`Confirmation 7031
`Number:
`
`MATT, STOP: Amendment
`Commissioner for Patents
`P.O. 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/cm2/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 0.1-10% 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 0.1 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/cm2/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/cm2/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/cm2/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/cm2/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/cm2/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
`
`-4-
`
`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 /Courtenav C. Brinckerhoff/
`
`FOLEY & LARDNER LLP
`Customer Number: 22428
`(202) 295-4094
`Telephone:
`Facsimile:
`(202) 672-5399
`
`Courtenay C. Brinckerhoff
`Attorney for Applicant
`Registration No. 37,288
`
`4829-6342-2025.1
`
`0372
`
`
`
`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`14024985
`
`12-Sep-2013
`
`Title of Invention:
`
`TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`First Named Inventor/Applicant Name:
`
`Juan Mantelle
`
`Filer:
`
`Courtenay C. Brinckerhoff
`
`Attorney Docket Number:
`
`041457-1016
`
`Filed as Large Entity
`
`Filing Fees for Utility under 35 USC 111 (a)
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USD($)
`
`Basic Filing:
`
`Pages:
`
`Claims:
`
`Miscellaneous-Filing:
`
`Petition:
`
`Patent-Appeals-and-lnterference:
`
`Post-Allowance-and-Post-lssuance:
`
`Extension-of-Time:
`
`0373
`
`
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USD($)
`
`Miscellaneous:
`
`RCE- 2ND AND SUBSEQUENT REQUEST
`
`1820
`
`1
`
`1700
`
`1700
`
`Total in USD ($)
`
`1700
`
`0374
`
`
`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`29406834
`
`14024985
`
`International Application Number:
`
`Confirmation Number:
`
`7031
`
`Title of Invention:
`
`TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`First Named Inventor/Applicant Name:
`
`Juan Mantelle
`
`Customer Number:
`
`22428
`
`Filer:
`
`Courtenay C. Brinckerhoff/Christine Arthur
`
`Filer Authorized By:
`
`Courtenay C. Brinckerhoff
`
`Attorney Docket Number:
`
`Receipt Date:
`
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`Time Stamp:
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`041457-1016
`
`06-JUN-2017
`
`12-SEP-2013
`
`12:46:24
`
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`
`Utility under 35 USC111(a)
`
`Payment information:
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`$1700
`
`060617INTEFSW12465100
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`0375
`
`
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`File Listing:
`Document
`Number
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`Document Description
`
`File Name
`
`1
`
`Request for Continued Examination
`(RCE)
`
`RCE.pdf
`
`File Size(Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(ifappl.)
`
`102172
`
`3da374833353b7928de%21aa0b2e774dc
`62738b
`
`no
`
`3
`
`Warnings:
`
`This is not a USPTO supplied RCE SB30 form.
`
`Information:
`
`2
`
`Amendment Submitted/Entered with
`Filing of CPA/RCE
`
`amendment.pdf
`
`105720
`
`152db8670311 aeSe7d06fbd6a1 ael 9feSf6f
`22a6
`
`no
`
`5
`
`Warnings:
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`
`3
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`no
`
`2
`
`7ab9b89a3f8c5c5fe052bc328c0d2eae1e88
`7611
`
`30589
`
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`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.
`
`New Applications Under 35 U.S.C. Ill
`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
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`
`0376
`
`
`
`PTO/SB/06 (09-11)
`Approved for use through 1/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. 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
`Filing Date
`09/12/2013
`Substitute for Form PTO-875
`
`Application or Docket Number
`14/024,985
`
`To be Mailed
`
`APPLICATION AS FILED - PART I
`
`(Column 1)
`
`(Column 2)
`
`ENTITY:
`
`^ LARGE • SMALL • MICRO
`
`FOR
`
`NUMBER FILED
`
`NUMBER EXTRA
`
`RATE ($)
`
`FEE ($)
`
`• BASIC FEE
`(37 CFR 1.16(a), (b), or (c))
`
`• SEARCH FEE
`(37 CFR 1.16(10, (i), or (m))
`
`• EXAMINATION FEE
`(37 CFR 1.16(0), (p), or (q))
`TOTAL CLAIMS
`(37 CFR 1.16(1))
`INDEPENDENT CLAIMS
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`
`N/A
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`
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`
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`(37 CFR 1.16(s))
`
`minus 3
`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).
`D MULTIPLE DEPENDENT CLAIM PRESENT (37 CFR 1.160))
`* If the difference in column 1 is less than zero, enter "0" in column 2.
`
`N/A
`
`N/A
`
`N/A
`
`X $
`
`X $
`
`TOTAL
`
`APPLICATION AS AMENDED - PART II
`
`(Column 1)
`
`(Column 2)
`
`(Column 3)
`
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`* 15
`
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`- 20
`
`Minus
`
`Minus
`
`***4
`
`= 0
`
`= 0
`
`x $80 =
`x $420 =
`
`PRESENT EXTRA
`
`RATE ($)
`
`ADDITIONAL FEE ($)
`
`06/06/2017
`
`TOtal (37 CFR
`1.16(1))
`Independent
`(37 CFR 1.16(h))
`
`I I Application Size Fee (37 CFR 1.16(s))
`I I FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR 1.16(j))
`
`(Column 1)
`
`(Column 2)
`
`(Column 3)
`
`TOTAL ADD'L FEE
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`0
`0
`
`0
`
`Z
`LU
`
`O
`z
`LU
`<
`
`Z
`LU
`
`TOtal (37 CFR
`1.16(1))
`Independent
`(37 CFR 1.16(h))
`
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`Minus
`
`PRESENT EXTRA
`
`RATE ($)
`
`ADDITIONAL FEE ($)
`
`X $
`
`X $
`
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`Q
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`I I FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR 1.16(j))
`
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`
`* 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
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`If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`LIE
`LISA THOMAS
`
`0377
`
`
`
`^ UNITED STATES PATENT AND TRADEMARK OFFICE
`1
`
`it
`1
`
`AT OF
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`DX 1450
`P.O. Bo
`dria, Virginia 22313-1450
`Alexan
`to.gov www.usp
`
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/024,985
`
`09/12/2013
`
`Juan Mantelle
`
`041457-1016
`
`7031
`
`06/14/2017
`
`22428
`7590
`Foley & Lardner LLP
`3000 K STREET N.W.
`SUITE 600
`WASHINGTON, DC 20007-5109
`
`EXAMINER
`
`FISHER, MELISSA L
`
`ART UNIT
`
`1611
`
`PAPER NUMBER
`
`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 @foley.com
`
`PTOL-90A (Rev. 04/07)
`
`0378
`
`
`
`Applicant-Initiated Interview Summary
`
`Application No.
`
`Applicant(s)
`
`14/024,985
`Examiner
`
`MANTELLE, JUAN
`Art Unit
`
`Melissa Fisher
`
`1 6 1 1
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) Melissa Fisher.
`
`(2) Courtenav Brinckerhoff.
`
`Date of Interview: 08 June 2017.
`
`(3) Richard Guv.
`
`(4).
`
`Type: • Telephonic • Video Conference
`^ Personal [copy given to: • applicant
`
`• applicant's representative]
`
`Exhibit shown or demonstration conducted: Q Yes
`If Yes, brief description:
`.
`
`• No.
`
`Issues Discussed QlOl 0112 0102 dlOS ^Others
`(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. Guv 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..
`
`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.
`
`^ Attachment
`
`/Melissa Fisher/
`Primary Examiner, Art Unit 1611
`
`U.S. Patent and Trademark Office
`PTOL-413 (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20170609
`
`0379
`
`
`
`Summary of Record of Interview Requirements
`
`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.
`
`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 by the applicant. An interview does not remove the necessity for reply to Office action as specified in §§ 1.111, 1.135. (35 U.S.C. 132)
`
`37 CFR §1.2 Business to be transacted in writing.
`All 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 mater