EAST Search History
`
`
`
`L459 and estradiol
`
`¢$$$$$$$$$$$$$$$$
`
`US-PGPUB; USPAT; OR
`USOCR; FPRS; EPO;
`JPO; DERWENT
`
`%333333
`
`L452 and ("dipropylene
`glycol" oleyl)
`4L454 and ("dipropylene
`glycol”oley!)
`estradiol and transdermal
`
`'1US-PGPUB; USPAT; oR OFF 2017/04/173
`
`L459 and transdermal
`
`US-PGPUB; USPAT;
`
`Kanios.in. and David.in.
`
`L462 NOT L459
`
`(11/245097).APP.
`
`L467 and ("surface area"
`flux)
`
`L468 and acrylic and
`silicone and (PVP polyvinyl!
`ypyrrolidone)
`L469 and estradiol.ab.
`
`L469 and transdermal.ab.
`
`L469 and (estradiol NEAR
`
`JUSOCR; FPRS; EPO;
`
`¥US-PGPUB; USPAT;
`
`¥US-PGPUB; USPAT;
`'|USOCR; FPRS; EPO;
`'JPO; DERWENT
`|US-PGPUB; USPAT;
`'|USOOR; FPRS; EPO;
`
`‘1US-PGPUB; USPAT;:
`USOCR; FPRS; EPO;
`¥JPO; DERWENT
`{US-PGPUB; USPAT;
`WUSOCR; FPRS; EPO;
`
`L467 and (estradiol NEAR
`
`||US-PGPUB; USPAT;
`
`L474 and estradiol
`
`L474 and transdermal
`
`Kanios.in. and David. in.
`
`L477 NOT L474
`
`|US-PGPUB; USPAT:
`}USOCR; FPRS; EPO;
`¥JPO; DERWENT
`
`|US-PGPUB; USPAT:
`{USOCR; FPRS; EPO;
`‘PO; DERWENT
`
`'|US-PGPUB; USPAT:
`}USOCR; FPRS; EPO;
`‘PO; DERWENT
`
`EASTSearchHistory.14024985_AccessibleVersion.htm[4/17/2017 1:22:48 PM]
`
`  
`
`

 
`
`
`Part 2 of 2
`
`0358
`
`

`

`EAST Search History
`
`
`L467 and ("dipropylene
`{USPAT; USOCR
`(2017/04/17:
`
`
`
`etapaataad
`acca
`
`
`
`
`
`:
`1US-PGPUB; USPAT;
`"6638528" pn.
`
`:
`{USOCR; FPRS; EPO;
`;
`
`
`
`basessneaeeseaeaeaeeseaeapseaeaspseaeaspseaeasaseaeasaseaeasasniasssuacaeasyaeasasyaeasasuaeasasvaessaseaeasaseaeasRaasasssyaeassseaeasasaaen Qasavasassaeaeasssead desseasassaeasasaseaesaaeas
`aavnsenenened havaeassneneasesenenesd
`¥JPO; DERWENT
`
`
`
`
`US-PGPUB; USPAT;
`'("4624665"pn.
`USOCR; FPRS; EPO;
`
`Setenee bannnnnnnenBeneneeeeee Generbeeen:
`}JPO; DERWENT
`
`
`
`{US-PGPUB; USPAT;
`
`"20090041831".pn.
`
` 3
`
`weeseeeeeened
`
`estradiol and transdermal
`
`heeneeeeeeeeeGeneeneneeeneeeeeeeeeeeeeet Beeneeeeeeeeeeeeeeeeee beeeeeeeeet beehet
`
`reneeeee RewBeEEEEEEEE BREEEEEEEEEEEEEECebed fet
`
`
`
`
`
`
`L485 and ("surface area"
`flux)
`
`L486 and acrylic and
`
`aaveeeeeeens haveBateeeenettenened RacePenn beeeeceeeeeennd hie
`
`
`
`
`US-PGPUB; USPAT;
`{L487 and estradiol.ab.
`
`
`'USOCR; FPRS; EPO;
`
`
`WJPO; DERWENT
`
`
`
`
`
`
`‘1US-PGPUB; USPAT:
`L487 and transdermal.ab.
`USOCR; FPRS; EPO;
`:
`
`
`
`3
`3
`MNLTRRMAREEEERESEREREEEEERED RADEEEREEEEEEEEEEEEEEEED ARERRREREREEREREIMEEEEEEEEEEEEEEEEEEEEEERERET
`iJPO; DERWENT
`
`
`
`
`
`L487 and (estradiol NEAR+4§{US-PGPUB; USPAT;
`USOCR; FPRS; EPO;
`flux)
`
`
`eet beeened Aineneeeeneeeeennnneeeeneened Reneeennatennantenerete! haseeee! haseeen beeen!
`Sanneeee
`4JPO; DERWENT
`
`
`
`
`
`L485 and (estradiol NEAR +§US-PGPUB; USPAT;
`
`}USOCR; FPRS; EPO;
`‘fflux)
`
`
`Swed bt MEEEEEEEEEEEEEEEEEEEEEEE POEEEEEEEEEEEEEEE fd Biet beEEE
`
`
`
`|MANTELLE.in. and
`‘JUAN. in.
`SBaweeeeeeed eeeed heEEEEEEEEEEEREEEEEEEEaedent bE
`
`
`
`L492 and estradiol
`
`ened Recenteeeeeeeee! teeneeeeeeeneeeeeeeens
`aaeneneneet
`
`
`
`
`
`{US-PGPUB; USPAT;
`L492 and transdermal
`
`
`}USOCR; FPRS; EPO;
`
`
`aavnaneneaed havaeaeeaeaeaseennaCaseeaeaeeneaeaeaneaeaeaspseaeaeaseaeasaseaeasaseaeasaseaeasase assessesasuaeasaseasesgseaeasaseaeasaseaeasaseaeasRvasassseaeasaseaeasasaaee bavavasaseaeaeaseaead fesavasasaaeasasaaeasasaseas
`'UPO; DERWENT
`
`
`
`
`
`
`Kanios.in. and David. in.
`1US-PGPUB; USPAT;
`
`}USOCR; FPRS; EPO;
`:
`
`
`basessneaeeseaeaeaeeseaeapseaeaspseaeaspseaeasaseaeasaseaeasasniasssuacaeasyaeasasyaeasasuaeasasvaessaseaeasaseaeasRaasasssyaeassseaeasasaaen Qasavasassaeaeasssead desseasassaeasasaseaesaaeas
`aavnsenenened havaeassneneasesenenesd
`‘PO; DERWENT
`
`
`
`
`
`US-PGPUB; USPAT;
`L495 NOT L492
`
`:
`}USOCR; FPRS; EPO;
`
`3
`haveeeeGeneeeeeeeent Beeeeeeeebeet beet het
`weeseeeeeeeed
`‘PO; DERWENT
`
`
`
`‘|(11/245097) APP.
` | SS aee
`
`
`
`[L500 [e844
`[estradiol and transdermal
`§US-PGPUB; USPAT;
`
`navehavebd RaPebeeen hate
`
`
`
`
`
`aavnenenened haeneaseneneensennaUiSavacaeaeaeaseseasesaneaeaepseaeasaseaeasasyaeasasessaaan iassayaeaeaseaeaaseaeasaseaeasaseaeaaseaeasasaaeas Rassasssyaeasaseaeasasaaenbasavasassaeaeasaaead besavaeasaaeasasaseeasaaaas
`
`aveened bed KEeeeaten haventfusereeeennabaste
`
`
`
`EASTSearchHistory.14024985_AccessibleVersion.htm[4/17/2017 1:22:48 PM]
`
`
`
`0359
`
`

`

`EAST Search History
`
`USOCR; FPRS; EPO;
`WJPO; DERWENT
`
`'1US-PGPUB; USPAT;
`}USOCR; FPRS; EPO;
`
`'|US-PGPUB; USPAT;
`
`L502 and estradiol.ab.
`
`L502 and transdermal.ab.
`
`4L502 and (estradiol NEAR
`flux)
`
`4L500 and (estradiol NEAR
`flux)
`
`|US-PGPUB; USPAT;
`'JUSOCR; FPRS; EPO;
`
`|US-PGPUB; USPAT;
`'JUSOOR; FPRS; EPO;
`
`YMANTELLE.in. and
`JUAN. in.
`
`4L507 and estradiol
`
`L507 and transdermal
`
`‘JPO; DERWENT
`
`‘1US-PGPUB; USPAT;
`USOCR; FPRS; EPO:
`{JPO; DERWENT
`{US-PGPUB; USPAT;
`USOCR; FPRS; EPO;
`
`(monolith$2 estradiol
`transdermal adhesive coat
`
`\
`
`4A61K9/7069.cpc.
`
`4A61K31/565.cpc.
`
`L516 and L517
`
`L518 and flux
`
`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
`
`

`

`Application/Control No.
`Issue Classification| , ,04985
`
`Applicant(s)/Patent Under Reexamination
`MANTELLE,JUAN
`
`
`
`MELISSA JAVIER
`
`4614
`
`cPc
`
`Version
`
`
`
`
`O.G. Print Figure (Primary Examiner)
`
`(Assistant Examiner)
`/MELISSA FISHER/
`Primary Examiner.Art Unit 1611
`
`U.S. Patent and TrademarkOffice
`
`Total Claims Allowed:
`
`14
`
`04/17/2017
`
`O.G. Print Claim(s)
`
`(Date)
`
`1
`
`None
`Part of Paper No. 20170417
`
`
`
`0362
`
`

`

`Application/Control No.
`Issue Classification| , ,04985
`
`Applicant(s)/Patent Under Reexamination
`MANTELLE,JUAN
`
`MELISSA JAVIER
`
`4614
`
`
`
`
`
`|USORIGINALCLASSIFICATION=|ORIGINAL CLASSIFICATION INTERNATIONAL CLASSIFICATION
`
`
`
`CROSSREFERENCE(S) PeTPP
`
`ts—“Csé‘CSCSCSCSdyS
`
`Px[svsesceoosoron [TT[TT
`|
`
`(Assistant Examiner)
`/MELISSA FISHER/
`Primary Examiner.Art Unit 1611
`
`U.S. Patent and TrademarkOffice
`
`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
`
`

`

`Application/Control No.
`Issue Classification| , ,04985
`
`Applicant(s)/Patent Under Reexamination
`MANTELLE,JUAN
`
`MELISSA JAVIER
`
`4614
`
`
`
`
`
`
`
`
`
`
` Olo;l;Nn!ayyal;FI]oO!)nm]—=
`
`O
`
`Claims renumbered in the sameorderas presented by applicant
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(Assistant Examiner)
`/MELISSA FISHER/
`Primary Examiner.Art Unit 1611
`
`U.S. Patent and TrademarkOffice
`
`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 PATENT AND 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:
`
`1611
`
`Confirmation Number:
`
`7031
`
`REQUEST FOR CONTINUED EXAMINATION (RCE)
`TRANSMITTAL
`
`Mail Stop RCE
`Commissionerfor 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 itemslisted below are beingfiled prior
`
`to the earliest of: (1) paymentof the issue fee (unless a petition under 37 C.F.R. § 1.313 1s
`
`granted); (2) abandonmentof 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 commencementofa 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. §1.114:
`
`[X] Amendment/Reply.
`
`Thefiling fee is calculated below at the large entity rate:
`
`Claims as
`Amended
`
`Previously
`Paid For
`
`Extra Claims
`Present
`
`Rate
`
`Fee Totals
`
`RCEFee 1.17(e):
`
`$1,700.0 = $1,700.00
`
`0
`
`Total Claims:
`
`Independents
`
`15
`
`1
`
`-
`
`-
`
`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
`
`CLAIMS FEE TOTAL: =_$1,700.00
`
`The above-identified fees of $1,700.00 are being paid by credit card via EFS-Web.
`
`The Commissioneris 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 paymentinstructions in EFS-Webbeing incorrect or absent, resulting in a rejected or
`
`incorrect credit card transaction, the Commissioneris authorized to charge the unpaid amountto
`
`Deposit Account No. 19-0741.
`
`4845-1381-2810.1
`
`
`
`0366
`
`

`

`Atty. Dkt. No. 041457-1016
`
`Please direct all correspondenceto the undersigned attorney or agent at the address
`
`indicated below.
`
`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
`
`4845-1381-2810.1
`
`
`
`0367
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Atty. Dkt. No. 041457-1016
`
`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
`Number:
`
`7031
`
`MAIL STOP: Amendment
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`AMENDMENT
`
`This paperis 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
`
`Commissioneris hereby authorized to charge any fees which maybe dueforthis 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, andlistings, 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,(11) a single adhesive polymer matrix layer defining an active
`
`surface area and, optionally, (111) 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/cm’ and includes
`greater than 0.156 mg/cm’estradiol, and the system achievesan estradiol flux of from about
`0.0125 to about 0.05 mg/cm7/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
`
`weightsilicone adhesive, about 2-25% by weight soluble PVP, about 5-15% penetration
`
`enhancer, and about 0.1-10% by weightestradiol, 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
`
`-2-
`
`
`
`0369
`
`

`

`Atty. Dkt. No. 041457-1016
`
`7. (Original) The transdermal drug delivery system of claim 3, wherein the acrylic
`
`adhesive andsilicone adhesive are presentin 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 amountofestradiol effective to deliver a therapeutically
`
`effective amountof estradiol over a period of time selected from the group consisting ofat least
`
`1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days andat least 7
`
`days.
`
`9. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`
`adhesive polymer matrix comprises an amountofestradiol 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 achievesan estradiol flux of about 0.0125 mg/cm’/day, based on the active surface area.
`
`22. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`system achievesan estradiol flux of about 0.0133 mg/cm’/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/cm7/day, based on the active surface area.
`
`24. (Previously Presented) The transdermal drug delivery system of claim 1, wherein the
`system achievesan estradiol flux of about 0.0167 mg/cm’/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/cm’/day, based ontheactive surface
`area.
`
`4829-6342-2025.1
`
`-3-
`
` 
`
`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
`
`A Notice of Allowance allowing claims 1-9 and 21-25 was mailed April 26, 2017.
`
`REMARKS
`
`Claim 26 is addedto recite specific embodiment described in the specification asfiled,
`
`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
`
`Examineris 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
`
`-5-
`
` 
`
`0372
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Title of Invention:
`
`TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`a
`
`Extension-of-Time:
`
`Filing Fees for Utility under 35 USC 111(a)
`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`
`USD(S)
`
`Basic Filing:
`
`Miscellaneous-Filing:
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
` 
`
`0373
`
`

`

`Miscellaneous:
`
`Total in USD ($)
`
`
`
`RCE- 2NDAND SUBSEQUENTREQUEST 1700|700|1820
`
`
`
` 
`
`0374
`
`

`

`Electronic AcknowledgementReceipt
`
`Application Number:
`
`14024985
`
`International Application Number:
`
`Confirmation Number:
`
`7031
`
`Title of Invention:
`
`TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`
`
`aera
`
`Paymentinformation:
`
`[Peoitacone——SSCSCSC~*idSCSS
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
`
` 
`
`0375
`
`

`

`File Listing:
`
`Pages
`Multi
`File Size(Bytes)/
`DocumentDescription
`Document
`
`
`
`Number Message Digest|Part/.zip|P (if appl.)
`102172
`
`Request for Continued Examination
`(RCE)
`
`3da374833353b7928de9621aa0b2e774dc
`62738b
`
`This is not a USPTO supplied RCE SB30 form.
`
`Information:
`
`Amendment Submitted/Entered with
`Filing of CPA/RCE
`
`amendment.pdf
`
`152db8670311ae5e7d06fbd6a1ael SfeSféf|
`22a6
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`105720
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`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary componentsfora filing date (see 37 CFR
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`Fee Worksheet (SB06)
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`fee-info.pdf
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`7ab9b89a3f8c5c5fe052bc328c0d2eae! e88}
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`This AcknowledgementReceipt evidences receipt on the noted date by the USPTO ofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable.It serves as evidence of receipt similar to a
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` 
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`0376
`
`

`

`PTO/SB/06 (09-11)
`Approvedfor use through 1/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF GOMMERCE
`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[|4ppiication or Docket Number Filing Date
`
`Substitute for Form PTO-875 09/12/2013|KX Tobe Mailed14/024,985
`
`
`
`ENTITY:
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`[X)carRGce [] smatt [] micro
`
`APPLICATION AS FILED — PART|
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`(Column 1)
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`NUMBER FILED
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`(Column 2)
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`NUMBER EXTRA
`
`37 CFR 1.16(a),
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`(b), or
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`(¢
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`37 CFR 1.16(k),
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`(i), or
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`(m
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`CL EXAMINATION FEE
`
`.
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`.
`
`TOTAL CLAIMS
`37 CFR 1.16(i
`INDEPENDENT CLAIMS
`37 CFR 1.16(h
`
`LAPPLICATION SIZE FEE
`(37 CFR 1.16(s))
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`j
`minus 20 =
`J
`minus 3 =
`If the specification and drawings exceed 100 sheets
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`for small entity) for each additional 50 sheets or
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`CFR 1.16(s).
`[_] MULTIPLE DEPENDENTCLAIM PRESENT(37 CFR 1,16(j)
`* If the difference in column 1 is less than zero, enter “O” in column 2.
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`APPLICATION AS AMENDED - PARTII
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`(Column 1)
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`(Column 2)
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`(Column 3)
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`HIGHEST
`CLAIMS
`NUMBER
`REMAINING
`
`06/06/2017|,--,p PREVIOUSLY PRESENT EXTRA ADDITIONALFEE ($)
`AMENDMENT
`PAID FOR
`
`
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`
`
`AMENDMENT
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`The “Highest Number Previously Paid For’ (Total or Independent) is the highest numberfound in the appropriate box in column 1.
`
`1.16(i
`Ind
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`dent
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`.
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`[_] Application Size Fee (37 CFR 1.16(s))
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`Cc FIRST PRESENTATION OF MULTIPLE DEPENDENTCLAIM (37 CFR 1.16(j))
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`(Column 1)
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`(Column 2)
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`(Column 3)
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`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`+
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`Total (37 CFR
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`PRESENT EXTRA
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`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`aosCiae;
`i
`tik
`Ind
`dent
`*
`esCdee
`[_] Application Size Fee (37 CFR 1.16(s))
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`Cc FIRST PRESENTATION OF MULTIPLE DEPENDENTCLAIM (37 CFR 1.16(j))
`
`AMENDMENT
`
`* If the entry in column 1 is less than the entry in column 2, write “O” in column 3.
`** If the “Highest NumberPreviously Paid For” IN THIS SPACEis less than 20, enter “20”.
`*** If the “Highest Number Previously Paid For’ IN THIS SPACEis less than 3, enter “3”.
`
`LIE
`LISA THOMAS
`
`This collection of information is required by 37 CFR 1.16. The information is required to obtain or retain a benefit by the public whichis tofile (and by the USPTOto
`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 uponthe individual case. Any comments on the amountof time you
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`
`
`0377
`
`

`

`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`14/024,985
`
`
`
`
` FILING DATE
`
`09/12/2013
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATIONNO.
`
`Juan Mantelle
`
`041457-1016
`
`7031
`
`Foley & Lardner LLP
`Dae
`Fole pensePEXAMINERit
`
`
`3000 K STREET N.W.
`FISHER, MELISSA L
`SUITE 600
`WASHINGTON,DC 20007-5109
`
`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 @foley.com
`
`PTOL-90A (Rev. 04/07)
`
` 
`
`0378
`
`

`

`
`
`Application No.
`
`Applicant(s)
`
` . wg: . 14/024,985 MANTELLE, JUAN
`
`
`
`
`Applicant-initiated Interview Summary
`_
`_
`Examiner
`Art Unit
`
`Melissa Fisher
`
`1611
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) Melissa Fisher.
`
`(2) Courtenay Brinckerhoff.
`
`Date of Interview: 08 June 2017.
`
`(3) Richard Guy.
`
`(4)
`
`.
`
`Type:
`
`[] Video Conference
`[J Telephonic
`1 Personal [copy given to: [] applicant
`
`(CJ applicant’s representative]
`
`Exhibit shown or demonstration conducted:
`If Yes, brief description:
`
`[[] Yes
`
`] No.
`
`[J101 [1112 [102 (103 Klothers
`Issues Discussed
`(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 referencesetc...)
`
`Discussed the attached agenda.
`
`Specifically, Applicant's representative and Dr. Guy explained howthe included data supported the unexpectedresults
`that increasing the coat weight of the drug-containing adhesive layer resulted in an increased flux per unit area, and
`permitted the developmentof smaller transdermal drug delivery systems that achieve comparable daily dosages..
`
`Primary Examiner, Art Unit 1611 U.S. Patent and Trademark Office
`
`Applicant recordation instructions: The formal written reply to the last Office action must include the substanceofthe interview. (See MPEP
`section 713.04). If a reply to the last Office action has already beenfiled, 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, whicheveris later, to file a statement of the substance of the
`interview
`
`Examiner recordation instructions: Examiners must summarize the substanceof anyinterview of record. A complete and proper recordation of the
`substance of an interview should include the itemslisted in MPEP 713.04 for complete and proper recordation including the identification of the
`general thrust of each argumentor issue discussed, a generalindication of any other pertinent matters discussed regarding patentability and the
`general results or outcome ofthe interview, to include an indication as to whether or not agreement was reached onthe issuesraised.
`
`1] Attachment
`/Melissa Fisher/
`
`PTOL-413 (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20170609
`
`0379
`
` 
`
`

`

`Manual of Patent Examining Procedure (MPEP), Section 713.04, Substanceof 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 madeof 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 befiled by the applicant. An interview does not removethe necessity for reply to Office action as specified in §§ 1.111, 1.135. (35 U.S.C. 132)
`
`37 CFR §1.2 Businessto 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 substanceof interviews.
`It is the responsibility of the applicant or the attorney or agent to make the substanceof an interview of record in the applicationfile, unless
`the examinerindicates 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
`whichbeardirectly 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 boxesandfilling 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 Summary Form shall be given an appropriate Paper No., placed in the right hand portion ofthefile, and listed on the
`“Contents” section of the file wrapper.
`In a personal interview, a duplicate of the Form is given to the applicant (or attorney or agent) at the
`conclusion of the interview.
`In the case of a telephone or video-conferenceinterview, the copy is mailed to the applicant's correspondence address
`either with or prior to the next official communication. If additional correspondence from the examiner is not likely before an allowanceor if other
`circumstances dictate, the Form should be mailed promptly after the interview rather than with the next official communication.
`
`The Form provides for recordation of the following information:
`— Application Number (Series Code and Serial Number)
`—Name ofapplicant
`—Name of examiner
`— Date of interview
`—Type ofinterview (telephonic, video-conference, or personal)
`—Name ofparticipant(s) (applicant, attorney or agent, examiner, other PTO personnel, etc.)
`—Anindication whether or not an exhibit was shown or a demonstration conducted
`—Anidentification of the specific prior art discussed
`—
`Anindication whether an agreement was reached andif so, a description of the general nature of the agreement (may be by
`attachment of a copy of amendments or claims agreed as being allowable). Note: Agreementasto allowability is tentative and does
`not restrict further action by the examiner to the contrary.
`—The signature of the examiner who conductedthe interview (if Form is not an attachmentto a signed Office action)
`
`It is desirable that the examiner orally remind the applicant of his or her obligation to record the substanceofthe interview of each case. It
`should be noted, however, that the Interview Summary Form will not normally be considered a complete and proper recordation of the interview
`unlessit includes, or is supplemented by the applicant or the examinerto include, all of the applicable items required below concerning the
`substanceofthe interview.
`A complete and proper recordation of the substance of any interview should include at least the following applicable items:
`1) A brief description of the nature of any exhibit shown or any demonstration conducted,
`2) an identification of the claims discussed,
`8) an identification of the specific prior art discussed,
`4) an identification of the principal proposed amendments of a substantive nature discussed, unless these are already described on the
`Interview Summary Form completed by the Examiner,
`5) a briefidentification of the general thrust of the principal arguments presented to the examiner,
`(The identification of arguments need not be lengthy or elaborate. A verbatim or highly detailed description of the argumentsis not
`required. The identification of the argumentsis sufficient if the general nature or thrust of the principal arguments made to the
`examiner can be understoodin the context of the applicationfile. Of course, the applicant may desire to emphasize and fully
`describe those arguments which heor she feels were or might be persuasive to the examiner.)
`6) a generalindication of any other pertinent matters discussed, and
`7) if appropriate, the general results or outcome ofthe interview unless already described in the Interview Summary Form completed by
`the examiner.
`Examiners are expected to carefully review the applicant’s record of the substanceofan interview.
`accurate, the examiner will give the applicant an extendable one month time period to correct the record.
`
`If the record is not complete and
`
`Examiner to Check for Accuracy
`
`If the claims are allowable for other reasons of record, the examiner should senda letter setting forth the examiner’s version of the
`statement attributed to him or her.
`If the record is complete and accurate, the examiner should placetheindication, “Interview Record OK” on the
`paper recording the substanceof the interview along with the date and the examiner'sinitials.
`
`
`
`0380
`
`

`

`U.S. Patent Application Nos. 13/553,972; 14/024,985; 14/738,255; 14/870,574
`Atty. Docket Nos. 041457-0992, -1016, -1133, -1160
`
`Outline for June 8, 2017 Examiner Interview
`
`Summary Of Claimed Subject Matter
`
`The claimed subject matter includes transdermal drug delivery systemsestradiol that
`
`have a smaller active surface area than the prior art Vivelle-Dot® patches, but achieve daily
`
`dosages that are about equalto or greater than the Vivelle-Dot® patches. That is, the subject
`
`matter includes transdermal drug delivery systems that achieve daily dosages that are about equal
`
`to a Vivelle-Dot® patch, in a smaller size. See, e.g., Specification, at paragraph [0014].
`
`Asstated in the specification, “the Applicant surprisingly discovered that increasing the
`
`coat weight of the drug-containing adhesive layer resulted in an increased flux per unit area, and
`
`thus permitted the development of smaller transdermal drug delivery systems that achieve
`
`comparable daily dosages.” Specification, at paragraph [0014].
`
`All claims recite a monolithic transdermal drug delivery system consisting of(i) a
`
`backing layer and(ii) a single adhesive polymer matrix layer defining an active surface area and
`comprising an adhesive polymer matrix comprising estradiol as the only drug.'
`
`The claimsof the ’972, 985, and ’255 applications recite that the polymer matrix has a
`coat weight of greater than about 10 mg/cm’ andincludesgreater than 0.156 mg/cm’estradiol,
`
`and that the transdermal drug delivery system achieves an estradiol flux of