EAST Search History
`
` 33333333333333
`
`L114 and (estradiol NEAR
`flux)
`
`US-PGPUB; USPAT;
`USOCR; FPRS; EPO;
`
`PO; DERWENT
`
`‘2016/08/22:
`
`4L112 and (estradiol NEAR
`flux)
`
`‘MANTELLE.in. and JUAN. in.
`
`|
`
`4L119 and estradiol
`
`4L119 and transdermal
`
`‘Kanios.in. and David. in.
`
`{L122 NOT L119
`
`'|US-PGPUB; USPAT:
`USOCR; FPRS; EPO;
`4¥JPO; DERWENT
`
`|US-PGPUB; USPAT:
`USOCR; FPRS; EPO;
`
`'|US-PGPUB; USPAT:
`USOCR; FPRS; EPO;
`
`US-PGPUB; USPAT;
`USOCR; FPRS; EPO;
`¥JPO; DERWENT
`
`1(11/245097).APP.
`
`'USPAT; USOCR
`
`41112 and ("dipropylene
`USPAT; USOCR
`wavneansaveeesaaneeeeebisaeaseseaeasespenneaaeanpaeaeasaavasaaseaeasasead bessvasassaeaeassseersaaed hasan
`oeglycol”oleyl)
`4L114 and ("dipropylene
`USPAT; USOCR
`_{iglycol”oley!)aanREE
`(C/MANTELLE") near3
`‘US-PGPUB; USPAT;
`NUSOCR
`
`112/216811
`
`US-PGPUB; USPAT;
`USOCR; FPRS; EPO;
`
`i
`
`:
`
`;
`
`i
`
`{(12/216811) APP.
`
`USPAT; USOCR
`
`A61K31/565.cpc.
`
`1A61K9/70.cpe.
`
`{L133 L134
`
`L135 and estradiol
`
`'|US-PGPUB; USPAT:
`USOCR; FPRS; EPO;
`
`'|US-PGPUB; USPAT:
`USOCR; FPRS; EPO;
`
`\US-PGPUB; USPAT;
`USOCR; FPRS; EPO;
`‘JJPO; DERWENT
`\US-PGPUB; USPAT;
`%3USOCR; FPRS; EPO;
`
`8/ 22/ 2016 10:22:21 AM
`C:\ Users\ mjavier\ Documents\ EAST\ Workspaces\ 13553972.wsp
`
`EASTSearchHistory.13553972_AccessibleVersion.htm[8/22/2016 10:22:26 AM]
`
`MYLAN- EXHIBIT 1035
`
`
` 

 
`   
` 
`
`Part 2 of 2
`
`0428
`
`

`

` (use as many sheets as necessary)
`
`Substitute for form 1449/PTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Date Submitted: August 2, 2016
`
`Sheet
`
`Complete if Known
`
`| 13/553972
`Application Number
`| 7/20/2012
`Filing Date
`Juan Mantelie
`First Named Inventor
`1611
`Art Unit
`Melissa L. Javier
`Examiner Name
`Attorney Docket Number
`
`041457-0992
`
`|
`|
`
`13553972 - GAU: 16l1l
`
`PTO/SB/08 (modified
`
`Cite _nn
`Initiais*
`
`Examiner
`
`|
`
`initials*
`
`| No." |
`
`U.Ss. PATENT DOCUMENTS
`Document Number
`oo.
`| Pages, Columns, Lines,
`Publication Date
`|
`Where Relevant
`Number-KindCode” (if
`MM-DD-YYYY
`Passagesor Relevant
`___ Figures Appear
`
`
`| Name of Patentee or Applicant of
`Cited Document
`
`UNPUBLISHED U.S. PATENT APPLICATION DOCUMENTS
`U.S. Patent Application
`caeoaoe|CLttt(‘w!LRages,Columns,Lines,|
`Filing Date of
`| Name of Patentee or Applicant of |
`Where Relevant
`Documentent
`Cited Document
`|
`MM-DD-YYYY
`Cited Document
`Passages or Relevant
`innaFiguresApperr
`
`
`
`
`| Pages, Columns, Lines,
`Where Relevant
`Passagesor Relevant
`Figures Appear
`
`|
`
`Name of Patentee or
`Applicant of Cited Documents
`
`Publication Date|
`MM-DD-YYYY
`
`Country Code“Number”
`Kind Code° (if Known)
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`item (book, magazine, journal, serial, symposium, catalog, etc.) date, page(s), volume-issue
`number(s), publisher, city and/or country where published.
`
`MANTELLE, “DOT Matrix® Technology,” Modified-Release Drug Delivery Technology, Rathboneetal.,
`_ eds., Chapter 30, pp. 405-415, May 28, 2008.
`
`
`
`
`
`
`
`
`Examiner |
`Signature |
`4820-3175-0709.1
`
`/MELISSA L JAVIER/
`
`Date
`| Considered
`
`| 08/22/2016
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/M.L.J/
`
` 
`
`0429
`
`Examiner
`Initials*
`
`Examiner
`Initials*
`
`Examiner
`
`|
`
`

`

`O.G. Print Figure (Primary Examiner)
`
`af
`
`CPC Combination Sets
`
`(Assistant Examiner)
`/MELISSA JAVIER/
`Examiner.Art Unit 1611
`
`U.S. Patent and Trademark Office
`
`Total Claims Allowed:
`
`at
`
`08/22/2016
`
`O.G. Print Claim(s)
`
`(Date)
`
`1
`
`None
`Part of Paper No. 20160822
`
` 
`
`0430
`
`Application/Control No.
`Issue Classification| 43554975
`
`Applicant(s)/Patent Under Reexamination
`MANTELLE, JUAN
`
`MELISSA JAVIER
`
`1614
`
`cPc
`
`=oir
`
`essor
`heii
`feier.
`foreSOOOier
`
`

`

`Application/Control No.
`Issue Classification| 43554975
`
`Applicant(s)/Patent Under Reexamination
`MANTELLE, JUAN
`
`MELISSA JAVIER
`
`1614
`
`US ORIGINAL CLASSIFICATION
`
`INTERNATIONAL CLASSIFICATION
`
`susciassrenaiocy|||||—*+Y||
`
`aTo
`“rman |
`CROSS REFERENCE(S) iocosio||[||pate||«|
`
`
`PPPyeyPp
`
`Torass|SuBclass(one
`
`(Assistant Examiner)
`/MELISSA JAVIER/
`Examiner.Art Unit 1611
`
`(Primary Examiner)
`U.S. Patent and Trademark Office
`
`08/22/2016
`
`(Date)
`
`None
` 
`
`Total Claims Allowed:
`
`at
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`1
`
`Part of Paper No. 20160822
`
`0431
`
`

`

`Application/Control No.
`Issue Classification| 43554975
`
`Applicant(s)/Patent Under Reexamination
`MANTELLE, JUAN
`
`MELISSA JAVIER
`
`1614
`
`Oo
`
`Claims renumbered in the sameorder as presented by applicant
`
`Final
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`Final
`
`Original
`
`
`
`
`
`
`
`
`
`
`Original
`Final
`Original
`17
`16
`1
`
`
`
`
`
`
`
`
`
`
` Ola;nN!)oa;a!;r]wo]nm
`
`
`
`
`
`
`
`(Assistant Examiner)
`/MELISSA JAVIER/
`Examiner.Art Unit 1611
`
`(Primary Examiner)
`U.S. Patent and Trademark Office
`
`None
` 
`
`Total Claims Allowed:
`
`at
`
`08/22/2016
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`(Date)
`
`1
`
`Part of Paper No. 20160822
`
`0432
`
`

`

`Atty. Dkt. No. 041457-0992
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`First Inventor Name:
`
`Juan Mantelle
`
`Title:
`
`Transdermal Estrogen Device and Delivery
`
`Appl. No.:
`
`13/553972
`
`Appl. Filing Date:
`
`7/20/2012
`
`Examiner:
`
`Melissa L. Javier
`
`Art Unit:
`
`1611
`
`Confirmation Number:
`
`3635
`
`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 encloseditemslisted below are being filed prior
`
`to the earliest of: (1) paymentof the issue fee (unless a petition under 37 C.F.R. § 1.313 is
`
`granted); (2) abandonmentofthe application; or (3) the filing of a notice of appealto 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).
`
`4845-4883-6925. 1
`
`-l-
`
` 
`
`0433
`
`

`

`Atty. Dkt. No. 041457-0992
`
`Submission required under 37 C.F.R. §1.114:
`
`[X]
`
`Information Disclosure Statement.
`
`[X]
`
`Form PTO/SB/08 with copies of 9 listed reference(s).
`
`Thefiling fee is calculated belowat the large entity rate:
`
`
`Claims as
`Amended
`
`Previously
`Paid For
`
`Extra Claims
`Present
`
`Rate
`
`Fee Totals
`
`RCEFee 1.17(e):
`
`Total Claims:
`
`Independents
`
`13
`
`3
`
`-
`
`-
`
`26
`
`5
`
`= 0
`
`= 0
`
`First presentation of any Multiple Dependent Claims:
`
`$1,700.0 = $1,700.00
`
`0
`
`x
`
`x
`
`+
`
`$80.00 =
`
`$0.00
`
`$420.00 =
`
`$0.00
`
`$780.00 =
`
`$0.00
`
`RCE and CLAIMS FEE TOTAL: =_$1,700.00
`
`
`The above-identified fees of $1700.00 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-Web being 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.
`
`4845-4883-6925.1
`
`-2-
`
` 
`
`0434
`
`

`

`Please directall correspondence to the undersigned attorney or agent at the address
`
`indicated below.
`
`Atty. Dkt. No. 041457-0992
`
`Date Oe 25 d &}lo
`
`FOLEY & LARDNER LLP
`Customer Number: 22428
`Telephone:
`(202) 295-4094
`Facsimile:
`(202) 672-5399
`
`Respectfully submitted,
`
`tor pow
`
`by (ota © May]
`
`Courtenay C. Brinckerhoff
`Attorney for Applicant
`Registration No. 37,288
`
`4845-4883-6925.1
`
` 
`
`0435
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Atty. Dkt. No. 041457-0992
`
`First Inventor Name:
`
`Juan Mantelle
`
`Title:
`
`Transdermal Estrogen Device
`and Delivery
`
`Application No.:
`
`13/553,972
`
`Filing Date:
`
`7/20/2012
`
`Examiner:
`
`Melissa L. Javier
`
`Art Unit:
`
`1611
`
`Confirmation No.:
`
`3635
`
`INFORMATION DISCLOSURE STATEMENT
`UNDER37 CFR 81.56
`
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`Applicant submits herewith documents for the Examiner’s consideration in accordance
`
`with 37 CFR §§1.56, 1.97 and 1.98.
`
`Applicant respectfully requests that each listed documentbe considered by the Examiner
`and be madeofrecord in the present application andthat an initialed copy of Form PTO/SB/08
`
`be returned in accordance with MPEP §609.
`
`The submission of any document herewith is not an admission that such document
`
`constitutes prior art against the claims of the present application or that such documentis
`
`considered material to patentability as defined in 37 CFR §1.56(b). Applicant does not waive
`
`any rights to take any action which would be appropriate to antedate or otherwise removeas a
`
`competent reference any document submitted herewith.
`
`4823-6143-6221.1
`
`-|-
`
` 
`
`0436
`
`

`

`Atty. Dkt. No. 041457-0992
`
`TIMING OF THE DISCLOSURE
`
`The listed documents are being submitted in compliance with 37 CFR §1.97(b), before
`
`the mailing of a first Office action after the filing of a RCE.
`
`Although Applicant believes that no fee is required, the Commissioneris hereby
`
`authorized to charge any additional fees which may be duefor this application to Deposit
`
`Account Number 19-0741.
`
`Respectfully submitted,
`
`Date November 28, 2016
`
`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
`
`4823-61 43-6221.1
`
` 
`
`0437
`
`

`

`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Date Submitted: November 28, 2016
`
`use as many Sheets as necessary)
`
`Application Number
`Filing Date
`First Named Inventor
`Art Unit
`Examiner Name
`Attorney Docket Number
`
`Complete if Known
`| 13/553972
`| 7/20/2012
`Juan Mantelle
`|
`1611
`|
`Melissa L. Javier
`|
`
`041457-0992
`
`U.S. PATENT DOCUMENTS
`
`Examiner
`Initials*
`
`Document Number
`
`Number-Kind Code?(if
`known)
`
`
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or Applicant of
`Cited Document
`
`Pages, Columns, Lines,
`Where Relevant
`Passages or Relevant
`Figures Appear
`
`UNPUBLISHED U.S. PATENT APPLICATION DOCUMENTS
`earn
`
`Examiner
`initials”
`
`Cite
`No."
`
`i|i
`
`U.S. Patent Application
`Document
`Serial Number-Kind Code
`(if known)
`
`Filing Date of
`Cited Document
`MM-DD-YYYY
`
`Name of Patentee or Applicantof
`Cited Document
`
`Pages, Columns, Lines,
`Where Relevant
`Passages or Relevant
`Figures Appear
`
`FOREIGN PATENT DOCUMENTS
`
`Examiner
`Initials*
`
`Foreign Patent Document
`Country Code™Number™
`Kind Code?(if known)
`
`Publication Date
`MNM-DD-YYYY
`
`Nameof Patentee or
`Applicant of Cited Documents
`
`|
`
`Pages, Columns,Lines,
`Where Relevant
`Passages or Relevant
`Figures Appear
`
`
`
`
`
`
`
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`Examiner
`
`
`item (book, magazine, journal, serial, symposium, catalog, etc.) date, page(s), volume-issue
`Initiais*
`
`
`
`number(s), publisher, city and/or country where published.
`
`
`Al
`TOOLEET AL., “Evaluationofirritation and sensitisation of two 50 g/day oestrogen patches,”
`
`A2
`
`| Maturitas, Vol. 43, pp. 257-263, December 2002.
`
`| MARTY,“New trendsin transdermal technologies: Developmentof the skin patch, Menorest®,”
`| International Journal of Gynecology & Obstetrics, Vol. 52, Suppl. 1, pp. $17-S20, March 1996.
`
`| A3|NOVARTIS, “Estraderm®,” Prescribing information, June 2004.
`
`
`
`
`
`
`|
`
`A4
`
`NOVARTIS, “Vivelle®,” Prescribing information, June 2004.
`
`
`
`A5
`
`A6
`
`
`NOVARTIS, “Vivelle-Dot®,” Prescribing information, June 2004.
`
`
`BAYER HEALTHCARE, “Climara®,” Prescribing information, 2007
`
`|
`
`
`3M PHARMACEUTICALS, “Menostar™,” Prescribing information, June 2004.
`
`
`A8 WATSON PHARMA, INC., “Alora®,” Prescribing information, May 2005.
`
`
`
`Examiner
`Signature
`4832-4407-5069. 1
`
`Date
`Considered
`
`
` 
`
`0438
`
`

`

`Substitute for form 1449/PTO
`
`NON PATENT LITERATURE DOCUMENTS
`
`exami
`Initials”
`
`Include nameof the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`item (book, magazine, journal, serial, symposium,catalog, etc.) date, page(s), volume-issue
`number(s), publisher, city and/or country where published.
`
`SERONO LABORATORIES, INC., “Esclim®,” Prescribing information, August 1998.
`
`Complete if Known
`13/553972
`Application Number
`INFORMATION DISCLOSURE
`7/20/2012
`Filing Date
`STATEMENTBY APPLICANT
`Juan Mantelle
`First Named Inventor
`Date Submitted: November28, 2016
`
`Examiner Name
`Melissa L. Javier
`use as many sheets as necessary)
`Attorney Docket Number_|041457-0992
`
`
`
`Examiner
`Signature
`4832-4407-5069.1
`
`|
`
`Date
`Considered
`
`
` 
`
`0439
`
`

`

`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:
`
`
`
`0440
`
`

`

`Miscellaneous:
`
`Total in USD ($)
`
`
`
`RCE- 2NDAND SUBSEQUENTREQUEST 1700|700|1820
`
`
`
` 
`
`0441
`
`

`

`Title of Invention:
`
`TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`Electronic AcknowledgementReceipt
`
`Application Number:
`
`13553972
`
`International Application Number:
`
`Confirmation Number:
`
`3635
`
`
`
`aera
`
`Paymentinformation:
`
`37 CFR 1.21 (Miscellaneous fees and charges)
`
`Deposit Account
`
`Authorized User
`
`190741
`
`Christine Arthur
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
`
`37 CFR 1.17 (Patent application and reexamination processing fees)
`
` 
`
`0442
`
`

`

`File Listing:
`
`Pages
`Multi
`File Size(Bytes)/
`DocumentDescription
`Document
`
`
`
`Number Message Digest|Part/.zip|P (if appl.)
`245161
`
`1
`
`rceids.pdf
`
`a6b73ea014c2005861632761 2b3fe1cd19
`2e9eb
`
`Request for Continued Examination (RCE)
`
`Transmittal Letter
`
`Information Disclosure Statement (IDS) Form (SB08)
`
`Information:
`
`2
`
`Non Patent Literature
`
`toole2002. pdf
`
`¢70337f8aec67eb6cdf1f41477645405053
`0c21
`
`Multipart Description/PDF files in .zip description
`
`1a437
`
`Information:
`
`3
`
`Non Patent Literature
`
`Marty1996.pdf
`
`Information:
`
`4
`
`Non Patent Literature
`
`estradermjune2004.pdf
`
`Information:
`
`7295311
`
`050613821 102d409c0ad0da289a4Sd6fe93
`1183e
`
`327689
`
`1d97460ef7b258eaf4b26e41 6aef8d93dd14q
`dcac
`
`522915
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`5
`
`Non Patent Literature
`
`vivelle2004.pdf
`
`bed5c72638aff66d5b0122934eb1 7e6a87d
`
` 
`
`

`

`Information:
`
`pe
`
`Information:
`
`Information:
`
`pe
`
`Information:
`
`Non Patent Literature
`
`vivelledot2004.pdf
`
`Non Patent Literature
`
`climara2007.pdf
`
`Non Patent Literature
`
`menostar2004.pdf
`
`391153
`
`e91f07c4d292c5 18223c7e77c6e7f5a77b8t|
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`934392
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`
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`
`Non Patent Literature
`
`alora2005.pdf
`
`Non Patent Literature
`
`esclim98.pdf
`
`= =
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`62c13ec7b0cc5c97fa0bf42d451 c06e96e8d
`5e71
`
`Information:
`
`Total Files Size (in bytes)
`
`
`
`0444
`
`

`

`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
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shownonthis
`AcknowledgementReceiptwill 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/903indicating acceptanceof the application as a
`national stage submission under35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`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
`Post Card, as described in MPEP 503.
`
`the application.
`
`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 shownon this AcknowledgementReceiptwill establish the international filing date of
`
` 
`
`0445
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`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
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`12/09/2016
`
`22428
`7590
`Foley & Lardner LLP
`3000 K STREET N.W.
`stir cg
`WASHINGTON, DC 20007-5109
`
`JAVIER, MELISSA L
`
`1611
`
`DATE MAILED: 12/09/2016
`
`Juan Mantelle
`07/20/2012
`13/553,972
`TITLE OF INVENTION: TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`041457-0992
`
`3635
`
`
`
`
`
`
`
`
`
`
`
`APPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
`
`
`
`
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`03/09/2017
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCEIS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATUTORY PERIOD CANNOT BE EXTENDED.
`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLYTO THIS NOTICE:
`
`I. Review the ENTITY STATUSshownabove.If the ENTITY STATUSis shown as SMALL or MICRO,verify whether entitlement to that
`entity status still applies.
`If the ENTITY STATUSis the same as shown above, pay the TOTAL FEE(S) DUE shown above.
`If the ENTITY STATUSis changed from that shown above, on PART B - FEE(S) TRANSMITTAL,complete section number5 titled
`"Change in Entity Status (from status indicated above)".
`For purposes of this notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amountof small entity
`fees.
`
`II. PART B - FEE(S) TRANSMITTAL,orits equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE(if required). If you are charging the fee(s) to your deposit account, section "4b"
`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B isfiled, a
`request to reapply a previously paid issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalentof Part B.
`
`IH. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE unless advisedto the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenancefees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL-85 (Rev. 02/11)
`
`Page | of 3
`
` 
`
`0446
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or Fax (571)-273-2885
`
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE(if required). Blocks 1
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS"for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS(Note: Use Block 1 for any changeof address)
`
`7590
`22428
`Foley & Lardner LLP
`3000 K STREET N.W
`ye
`SUITE 600
`WASHINGTON,DC 20007-5109
`
`12/09/2016
`
`can only be used for domestic mailings of the
`Note: A certificate of mailing
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`apers. Each additional paper, such as an assignment or formal drawing, must
`have its own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`—
`Deposition maine)
`(Signature)
`
`(ate)
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
`
` FIRST NAMED INVENTOR
`
`Juan Mantelle
`07/20/2012
`13/553,972
`TITLE OF INVENTION: TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATION NO.
`
`041457-0992
`
`3635
`
`
`
`
`
`
`
`
`
`APPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
`
`
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`03/09/2017
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`JAVIER, MELISSA L
`
`1611
`
`424-487000
`
`
`
`
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`LI Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`LI "Fee Address" indication (or "Fee Address” Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Numberis required.
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT(printor type)
`If an assignee is identified below, the document has been filed for
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAMEOF ASSIGNEE
`(B) RESIDENCE:(CITY and STATE OR COUNTRY)
`
`2. For printing on the patent front page,list
`:
`1
`(1) The namesofup to 3 registered patent attorneys
`or agents OR,alternatively,
`(2) The nameofa single firm (having as a member a
`registered attorney or agent) and the namesof up to
`2 registered patent attorneys or agents. If nonameis
`listed, no namewill be printed.
`
`
`
`
`
`2
`
`43
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) :
`
`LV individual LJ Corporation or other private group entity (J Government
`
`4a. The following fee(s) are submitted:
`L] Issue Fee
`_] Publication Fee (No small entity discount permitted)
`LT Advance Order - # of Copies
`
`
`
`4b. Paymentof Fee(s): (Please first reapply any previously paid issue fee shown above)
`LIA checkis enclosed.
`Lj Paymentby credit card. Form PTO-2038 is attached.
`[I The directoris hereby authorized to charge the required fee(s), any deficiency, or credits any
`overpayment, to Deposit Account Number
`(enclose an extra copy ofthis form).
`
`
`
`5. Change in Entity Status (from status indicated above)
`| Applicantcertifying micro entity status. See 37 CFR 1.29
`
` Lj Applicant changing to regular undiscounted fee status.
`
`Lj Applicant asserting small entity status. See 37 CFR 1.27
`
`
`NOTE:Absenta valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
`fee paymentin the micro entity amountwill not be accepted at the risk of application abandonment.
`
`NOTE:If the application was previously under micro entity status, checking this box will be taken
`to be a notification ofloss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification ofloss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: This form mustbe signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 14 for signature requirements and certifications.
`
`Authorized Signature
`
`Typed or printed name
`
`
`Date
`
`Registration No.
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
`
`Page 2 of 3
`
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMA
`
` 
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
`FIRST NAMED INVENTOR
`
`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
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATION NO.
`
`13/553,972
`
`07/20/2012
`
`Juan Mantelle
`
`041457-0992
`
`3635
`
`12/09/2016
`
`22428
`7590
`Foley & Lardner LLP
`3000 K STREET N.W.
`stir cg
`WASHINGTON, DC 20007-5109
`
`JAVIER, MELISSA L
`
`1611
`
`DATE MAILED: 12/09/2016
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(Applicationsfiled on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`to eliminate the
`Section 1(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i)
`requirement that the Office provide a patent term adjustment determination with the notice of allowance. See
`Revisions to Patent Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer
`providing an initial patent term adjustment determination with the notice of allowance. The Office will continue to
`provide a patent term adjustment determination with the Issue Notification Letter that is mailed to applicant
`approximately three weeks prior to the issue date of the patent, and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CFR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0101 or (571)-272-4200.
`
`PTOL-85 (Rev. 02/11)
`
`Page 3 of 3
`
`
`
`0448
`
`

`

`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
`
`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
`Budget approval before requesting most types of information from the public. When OMB approves an agency
`request to collect information from the public, OMB (i) provides a valid OMB Control Number and expiration
`date for the agency to display on the instrument that will be used to collect the information and (ii) requires the
`agency to inform the public about the OMB Control Number’s legal significance in accordance with 5 CFR
`1320.5(b).
`
`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required to obtain
`or retain a benefit by the public whichis 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, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box
`1450, Alexandria, Virginia 22313-1450. Under the Paperwork Reduction Act of 1995, no persons are required to
`respondto a collection of information unlessit displays a valid OMB control number.
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
`submission of the attached form related to a patent application or patent. Accordingly, pursuant
`to the
`requirements of the Act, please be advised that: (1) the general authority for the collection of this informationis
`35 U.S.C. 2(b)(2); (2) furnishing of the informationsolicited is voluntary; and (3) the principal purpose for which
`the information is used by the U.S. Patent and Trademark Office is to process and/or examine your submission
`related to a patent application or patent. If you do not furnish the requested information, the U.S. Patent and
`Trademark Office may not be able to process and/or examine your submission, which mayresult in termination of
`proceedings or abandonmentof the application or expiration of the patent.
`
`The information provided by youin this form will be subject to the following routine uses:
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records
`may be disclosed to the Department of Justice to determine whether disclosure of these records is required
`by the Freedom of Information Act.
`2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
`settlement negotiations.
`3. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance
`from the Memberwith respect to the subject matter of the record.
`4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having
`need for the information in order to perform a contract. Recipients of information shall be required to
`comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C.
`218(c)).
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or his/her designee, during an inspection of records conducted by GSA as part of that agency's
`responsibility to recommend improvements in records managementpractices and programs, under authority
`of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations
`governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive.
`Such disclosure shall not be used to make determinations about individuals.
`8. A record from this system of records may be disclosed, as a routine use, to the public after either publication
`of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a
`record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the
`record was filed in an application which became abandoned or in which the proceedings were terminated
`and which application is referenced by either a published application, an application open to public
`inspection or an issued patent.
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency,if the USPTO becomesawareof a violation or potential violation of law or regulation.
`
` 
`
`0449
`
`

`

`
`Application No.
`Applicant(s)
`13/553,972
`MANTELLE, JUAN
`
` Notice of Allowability
`Examinervier
`a vait
`Stacean nventor to File)
`
`No
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS