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EAST Search History
`\\\\\\\\\
`$$$$$$$
` L117$
`
`
`
`US—PGPUB; USPAT;
`
`$2016/08/22$
`$OFF
`$OR
`US-PGPUB; USPAT;
`L$114 and (estradiol NEAR
`309:57
`USOCR; FPRS; EPO;
`flux)
`$
`............J ............................................................................................................
`
`$2016/08/22$
`$09:57
`
`016/08/22$
`$09:57
`
`016/08/22$
`$09:57
`
`016/08/22$
`$09:57
`
`$2016/08/22$
`$09:57
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`$2016/08/22$
`$09:57
`
`$2016/08/22$
`
`‘ 016/08/22$
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`
`$2016/08/22$
`$10:09
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`$2016/08/22$
`
`$2016/08/22$
`$10:15
`
`$10:15
`
`$2016/08/22$
`$10:16
`‘
`3
`
`L112 and (estradiol NEAR
`$flux)
`
`MANTELLE.in. and JUAN.in.
`
`L119 and estradiol
`
`L119 and transdermal
`
`$Kanios.in. and David.in.
`
`$L122 NOT L119
`
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`$JPO; DERWENT
`U$9PGPUB; USPAT;
`$USOCR; FPRS; EPO;
`$JPO; DERWENT
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`$USOCR; FPRS; EPO;
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`$U9PGPUB; USPAT;
`$USOCR; FPRS; EPO;
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`$U9PGPUB; USPAT;
`$USOCR; FPRS; EPO;
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`US-PGPUB; USPAT;
`$USOCR; FPRS; EPO;
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`
`$2016/08/22$
`
`(11/245097).APP.
`
`$USPAT; USOCR
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`L112 and ("dipropylene
`........................uuuuuuu\ .........................................u............: ...........u............: ...........
`_____________ 90.99.111.991.”
`USPAT; USOCR
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`KKKKKKKKKKKKK\KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK
`91993159!ng
`$(("MANTELLE") nears
`
`US-PGPUB; USPAT;
`USOCR
`
`$12/216811
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`$USOCR; FPRS; EPO;
`JPODERWENT
`
`$(12/216811).APP.
`
`USPAT; USOCR
`
`A61 K31/565.cpc.
`
`A61 K9/70.cpc.
`
`L133 L134
`
`L135 and estradiol
`
`$U9PGPUB; USPAT;
`$USOCR; FPRS; EPO;
`
`$U9PGPUB; USPAT;
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`$USOCR; FPRS; EPO;
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`
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`JPODERWENT
`
`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 1004
`
`  
`
`
 
`
`
`Part 2 of 2
`
`0428
`
`

`

`Substitute for form 1449/PTO
`
`
`Complete if Known
`
`
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Date Submitted: August 2, 2016
`
`(use as many sheets as necessary)
`
`Sheet
`
`Application Number
`Filing Date
`First Named Inventor
`An Unit
`Examiner Name
`Attorney Docket Number
`
`I 13/553972
`I 7/20/2012
`I Juan Mantelle
`l 1611
`I Melissa L. Javier
`041457—0992
`
`13553§72 -- GAE}: 1611
`
`PTO/SB/08 modified
`
`
`U.S. PATENT DOCUMENTS
`
`Examiner
`lnitials‘
`
`i
`DocumentNumber
`2
`‘:
`I Cite P7»»»»»»»»»»»»»»»»»em»»»»»»»»»»»»»»»»»»*3
`I No.1 I
`Number«Kind C01182 (if
`
`. Pages Coiumns Lines >
`‘
`Where Relevant
`. Name of Patentee orAppIicant of
`Publication Date
`Cited Document
`Passages or Relevant
`MM—DD-YYYY
`
`w Figures Appear
`
`
`US Patent Application
`Document
`SeriaI Number—Kind Code? i
`ark/town)
`
`I Pages Columns Lines
`I
`’ Name of Patentee or Applicant of I
`Where Relevant
`Cited Document
`Passages or Relevant
`MMDDYYYY
`,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,W__,L_,,.,_‘_,c_wWWI.MMMMMflquesbp ea W,,,,,,
`
`
`
`i
`
`’
`
`'2
`‘
`
`.
`
`.
`
`Publication Date”I
`
`MM-DD-YYYY
`
`‘
`
`
`
`;
`
`Examiner
`lnitials‘
`
`Examiner
`
`initials‘
`
`,
`E
`Inflgger
`
`I
`I
`
`S
`
`‘
`
`’
`
`‘
`
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`
`_
`
`.
`
`'
`
`:
`
`I
`
`
`
`
`Name of Patentee or
`
`I
`
`Where Relevant
`
`Passages or Relevant
`Applicant of Cited Documents
`Fi-ures A ear
`
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title ofthe
`item (book, magazine, journal, serial, symposium, cataiog, etc.) date, page(s), volume-issue
`number(s), publisher, city and/0r country where published.
`
`MANTELLE, “DOT Matrix® Technology,” Modified-Release Drug Delivery Technology, Rathbone et al.,
`I eds, Chapter 30, pp. 405415, May 28, 2008.
`
`IOffice Action issued on 05/05/2016in application number 14/024, 985 (US 2014——0200530)
`
`Notice ofAllowance issued on 10/02/2015 in application number 14/024,985 (08 2014—0200530)
`
`
`
`Office Action issue on 04/29/2016in application number 14/738, 255 (US 2015--0272905)
`
`
`
`
`Examiner I
`
`Date
`
`4820—3175—0709,1
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH”
`
`lM.,L.J/
`
`
`
`0429
`
`

`

`Issue Classification 13553972
`
`MANTELLE, JUAN
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`MELISSA JAVIER
`
`1611
`
`"
`
`;
`
`—I_—
`—I_—
`—I_—
`—I_—
`—I_—
`
`
`
`CPC Combination Sets
`
`Total Claims Allowed:
`
`21
`
`(Assistant Examiner)
`/MELISSA JAVIER/
`Examiner.Art Unit 1611
`
`08/22/2016
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`(Primary Examiner)
`U.S. Patent and Trademark Office
`
`(Date)
`
`1
`
`None
`Part of Paper No. 20160822
`
`
`
`0430
`
`

`

`Issue Classification 13553972
`
`MANTELLE, JUAN
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`MELISSA JAVIER
`
`1611
`
`II—I-II—
`
`US ORIGINAL CLASSIFICATION
`
`INTERNATIONAL CLASSIFICATION
`
`——III—fl---I—
`CROSS REFERENCHS, "E_III-—
`
`——llll—l-ll—
`——————----—--—-—
`_-IIII—---I—
`-IIII—---I—
`I---—----—
`I---—----—
`III—I...—
`III—I...—
`
`(Assistant Examiner)
`/MELISSA JAVIER/
`Examiner.Art Unit 1611
`
`(Primary Examiner)
`US Patent and Trademark Office
`
`None
`
`
`Total Claims Allowed:
`
`21
`
`08/22/2016
`
`(Date)
`
`O.G. Print Claim(s)
`
`O.G. Print Figure
`
`1
`
`Part of Paper No. 20160822
`
`0431
`
`

`

`Issue Classification 13553972
`
`MANTELLE, JUAN
`
`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`MELISSA JAVIER
`
`1611
`
`07
`
`
`
`
`
`
`
`
`I]
`
`Claims renumbered in the same order as presented by applicant
`
`I]
`
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`Original
`Final
`
`
`
`1 16 17
`
`
`
`
`
`
`
` LOOO\IO§U'IJ>LOI\)
`
`O
`
`l\)
`(a)
`J;
`U'l
`
`(Assistant Examiner)
`/MELISSA JAVIER/
`Examiner.Art Unit 1611
`
`(Primary Examiner)
`U.S. Patent and Trademark Office
`
`None
`
`
`Total Claims Allowed:
`
`21
`
`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 PATENTAND TRADEAMRK 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
`
`RE! QUEST FOR CONTINUED EXAMINATION (RCE!
`TRANSMITTAL
`
`Mail Stop RCE
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`This is a Request for Continued Examination (RCE) under 37 C.F.R. § 1.114 of the
`
`above-identified application. This RCE and the enclosed items listed below are being filed prior
`
`to the earliest of: (1) payment of the issue fee (unless a petition under 37 C.F.R. § 1.313 is
`
`granted); (2) abandonment of the application; or (3) the filing of a notice of appeal to the US.
`
`Court of Appeals for the Federal Circuit under 35 U.S.C. §l4l, or the commencement of a civil
`
`action under 35 U.S.C. §145 or §l46 (unless the appeal or civil action is terminated).
`
`4845-4883-69251
`
`
`
`0433
`
`

`

`Atty. Dkt. No. 041457-0992
`
`Submission required under 37 C.F.R. §1.1 14:
`
`[ X ]
`
`Information Disclosure Statement.
`
`[ X ]
`
`Form PTO/SB/08 with copies of 9 listed reference(s).
`
`The filing fee is calculated below at the large entity rate:
`
`
`Claims as
`Amended
`
`Previously
`Paid For
`
`Extra Claims
`Present
`
`Rate
`
`Fee Totals
`
`RCE Fee 1.17(e):
`
`$1,700.0 = $1,700.00
`
`0
`
`Total Claims:
`
`Independents
`
`13
`
`3
`
`-
`
`-
`
`26
`
`= 0
`
`5
`
`= O
`
`x
`
`x
`
`$80.00 =
`
`$0.00
`
`$420.00 =
`
`$0.00
`
`First presentation of any Multiple Dependent Claims: +
`
`$780.00 =
`
`$0.00
`
`
`
`RCE and CLAIMS FEE TOTAL: 2 $1,700.00
`
`The above-identified fees of $1700.00 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.
`
`4845-4883-6925.1
`
`
`
`0434
`
`

`

`Atty. Dkt. No. 041457-0992
`
`Please direct all correspondence to the undersigned attorney or agent at the address
`
`indicated below.
`
`Respectfully submitted,
`
`Date iQL’Y“ 218
`
`35%“?
`
`FOLEY & LARDNER LLP
`Customer Number: 22428
`Telephone:
`(202) 295-4094
`Facsimile:
`(202) 672—5399
`
`Courtenay C. Brinckerhoff
`Attorney for Applicant
`Registration No. 37,288
`
`4845-4883-6925.1
`
`
`
`0435
`
`

`

`IN THE UNITED STATES PATENTAND TRADEMARK OFFICE
`
`Atty. Dkt. N0. 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
`
`UNDER 37 CFR 1.56
`
`Commissioner for Patents
`
`PO. 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 document be considered by the Examiner
`
`and be made of record in the present application and that 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 document is
`
`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 remove as a
`
`competent reference any document submitted herewith.
`
`4823'6143-6221 .1
`
`_1_
`
`
`
`0436
`
`

`

`Atty. Dkt. No. 04145 7-0992
`
`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 Commissioner is hereby
`
`authorized to charge any additional fees which may be due for 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
`
`4823~6143-6221.1
`
`-2-
`
`
`
`0437
`
`

`

`Substitute for form 1449/PTO
`
`
`Complete if Known
`
`PTO/SB/OB modified
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`] 13/553972
`Application Number
`1 7/20/2012
`Filing Date
`First Named Inventor
`1 Juan Mantelle
`Date Submitted: November 28, 2016
`Art Unit
`1 1611
`
`Examiner Name Melissa L. Javier
`use as many sheets as necessary)
`041457-0992
`
`Attorney Docket Number
`
`Examiner
`lnitials'
`
`Document Number
`
`Number-Kind Code2 (if
`known)
`
`Publication Date
`MM-DD—YYYY
`
`Name of Patentee or Applicant of
`Cited Document
`
`Pages, Columns, Lines,
`Where Relevant
`Passages or Relevant
`Fi-ures A- near
`
`
`
`
`UNPUBLISHED U.S. PATENT APPLICATION DOCUMENTS
`WWW
`
`US. Patent Application
`DocumentMW
`Serial Number-Kind Code
`(if known)
`
`Filing Date of
`Cited Document
`MM-DD-YYYY
`
`Name of Patentee or Applicant of
`Cited Document
`
`Pages, Columns, Lines,
`Where Relevant
`Passages or Relevant
`Figures Appear
`
`Examiner
`initiais'
`
`Cite
`2N0~1
`
`Examiner
`Initials"
`
`
`
`
`
`Foreign Patent Document
`Country Code ‘Number '
`Kind Code5 (/fknown)
`
`FOREIGN PATENT DOCUMENTS
`Name of Patentee or
`Applicant of Cited Documents
`
`Publication Date
`MM-DD—YYYY
`
`Pages, Columns, Lines,
`Where Relevant
`Passages or Relevant
`Fi-ures A oear
`
`i
`;
`
`
`
`
` NON PATENT LITERATURE DOCUMENTS
`
`item (book, magazine, journal, serial, symposium, catalog, etc.) date, page(s), volume-issue
`include name of the author (in CAPlTAL LETTERS), title of the article (when appropriate), title of the
`Examiner
`
`initials’
`
`
`number(s), publisher, city and/or country where published.
`A1
`TOOLE ET AL., “Evaluation of irritation and sensitisation of two 50 ug/day oestrogen patches,"
`
`
`
`1 Maturitas, Vol. 43, pp. 257-263, December 2002.
`i MARTY, “New trends in transdermal technologies: Development of the skin patch, Menorest®,”
`International Journal of Gynecology & Obstetrics, Vol. 52, Suppl. 1, pp. 817-820, March 1996.
`
`A2
`
`EAB
`i
`
`A4
`
`NOVARTlS, “Estraderm®,” Prescribing information, June 2004.
`
`
`
`NOVARTlS, “Vivelle®,” Prescribing information, June 2004.
`
`
`
`A5
`
`NOVARTlS, “Vivelle—Dot®,” Prescribing information, June 2004.
`
`
`A6
`
`5 BAYER HEALTHCARE, “Climara®," Prescribing information, 2007
`
`
`A7
`
`3M PHARMACEUTICALS, “MenostarTM," Prescribing information, June 2004.
`
`i
`
`
`
`
`
`‘
`
`
`
`A8 WATSON PHARMA, lNC., “Alora®,” Prescribing information, May 2005.
`
`
`
`Examiner
`Signature
`4832-4407-5069.1
`
`Date
`Considered
`
`
`
`
`043 8
`
`

`

`
`PTO/SB/08 modified
`
`
`Substitute for form 1449/PTO
`
`
` Complete if Known
`
`13/553972
`INFORMATION DISCLOSURE
`
`Application Number
`
`
`
`STATEMENT BY APPLICANT
`
`
`
`
`7/20/2012
`Fm Date
`
`Juan Mantelle
`First Named inventor
`
`
`
`Date Submitted: November 28, 2016
`
`1611
`Art Unit
`
`Melissa L. Javier
`
`
`use as may): sheets as necessary)
`
`
`Attorney Docket Number
`
`041457-0992
`
`
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title ofthe
`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.
`
`
`Examiner I
`Signature I
`4832-4407—5069.1
`
`Date
`Considered
`
`
`
`
`0439
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Title of Invention:
`
`TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`First Named Inventor/Applicant Name:
`
`Juan Mantelle
`
`Quantity
`
`_
`
`Attorney Docket Number:
`
`041457—0992
`
`Filed as Large Entity
`
`Filing Fees for Utility under 35 USC111(a)
`
`Description
`
`Fee Code
`
`Sub-Total in
`
`U5Dl$l
`
`
`
`0440
`
`

`

`-
`
`-
`
`.
`
`Sub-Total in
`
`Total in USD (5)
`
`RCE— 2ND AND SUBSEQUENT REQUEST
`
`1820
`
`1700
`
`1700
`
`
`
`044 1
`
`

`

`Title of Invention:
`
`TRANSDERMAL ESTROGEN DEVICE AND DELIVERY
`
`Electronic Acknowledgement Receipt
`
`“—
`
`——
`
`
`
`——
`
`Payment information:
`
`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 overpayment as follows:
`
`37 CFR 1.17 (Patent application and reexamination processing fees)
`
`
`
`0442
`
`

`

`File Listing:
`
`Document
`Number
`
`Document Descri
`
`tion
`
`p
`
`Pages
`Multi
`Part /.zip (if appl.)
`
`1
`
`rceids. pdf
`
`36b73e3014c20b5b86f6327612b3fe1cd19
`2e9eb
`
`Multipart Description/PDF files in .zip description
`
`Request for Continued Examination (RCE)
`
`Transmittal Letter
`
`Information Disclosure Statement (IDS) Form (5808)
`
`Non Patent Literature
`
`toole2002.pdf
`
`c70337f83ec67eb6cdf1f41477645405053c
`0c21
`
`File Size(Bytes)/
`Message Digest
`245161
`
`
`
`Non Patent Literature
`
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`
`fee—info.pdf
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`0444
`
`

`

`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)—(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`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.
`
`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 shown on this Acknowledgement Receipt will 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
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`22428
`
`7590
`
`12/09/2016
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`5111113600
`WASHINGTON, DC 20007-5109
`
`JAVIER, MELISSAL
`
`1611
`
`DATE MAILED: 12/09/2016
`
`Juan Mantelle
`07/20/2012
`13/553,972
`TITLE OF INVENTION: TRANS DERMAL ESTROGEN DEVICE AND DELIVERY
`
`041457—0992
`
`3635
`
`
`
`
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`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 ALLOWANCE IS 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 REPLY TO THIS NOTICE:
`
`I. Review the ENTITY STATUS shown above. If the ENTITY STATUS is shown as SMALL or MICRO, verify whether entitlement to that
`entity status still applies.
`
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above.
`
`If the ENTITY STATUS is changed from that shown above, on PART B - FEE(S) TRANSMITTAL, complete section number 5 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 amount of small entity
`fees.
`
`II. PART B - FEE(S) TRANSMITTAL, or its 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 is filed, 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 equivalent of Part B.
`
`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL—85 (Rev. 02/11)
`
`Page 1 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
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`or m (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
`péJropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`n icated 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.
`
`a i
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change ofaddFESS)
`
`7590
`22428
`Foley & Lardner LLP
`3000 K STREET N W
`'
`'
`
`12/09/2016
`
`SUITE 600
`WASHINGTON, DC 20007-5109
`
`Note: A certificate of mailin can only be used for domestic mailings of the
`Fee(s) Transmittal. This certi icate cannot be used for any other accompanying
`apers. Each additional paper, such as an assignment or formal drawing, must
`gave 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.
`,
`.
`(”WW“)
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
` F {ST NAMED INVENTOR
`
`Juan Mantelle
`07/20/2012
`13/553,972
`TITLE OF INVENTION: TRANS DERMAL ESTROGEN DEVICE AND DELIVERY
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`041457—0992
`
`3635
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`03/09/2017
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUB CLASS
`
`JAVIER, MELISSA L
`
`1611
`
`424—487000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`3 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/ 122) attached.
`
`
`
`
`
`2
`
`3
`
`3 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03—02 or more recent) attached. Use of a Customer
`Vumber is required.
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or 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) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`2. For printing on the patent front page, list
`(1) The names of up to 3 registered patent attorneys
`1
`or agents OR, alternatively,
`(2) The name of a single firm (having as a member a
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) :
`
`'3 Individual
`
`'3 Corporation or other private group entity '3 Government
`
`4a. The following fee(s) are submitted:
`3 Issue Fee
`
`
`
`3 Publication Fee (No small entity discount permitted)
`3 Advance Order — # of Copies
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`
`3 Payment by credit card. Form PTO—2038 is attached.
`3 The director is hereby authorized to charge the required fee(s), any deficiency, or credits any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`
`
`5. Change in Entity Status (from status indicated above)
`
` 3 Applicant certifying micro entity status. See 37 CFR 1.29
`
`3 Applicant asserting small entity status. See 37 CFR 1.27
`
`3 Applicant changing to regular undiscounted fee status.
`
`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/ 15A and 15B), issue
`fee payment in the micro entity amount will 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 of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 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.
`
`OMB 0651—0033
`
`Page 2 of 3
`
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMEESE
`
`
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
`F {ST NAMED INVENTOR
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/553,972
`
`07/20/2012
`
`Juan Mantelle
`
`041457—0992
`
`3635
`
`22428
`
`7590
`
`12/09/2016
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`51mm
`WASHINGTON, DC 20007-5109
`
`JAVIER, MELISSAL
`
`1611
`
`DATE MAILED: 12/09/2016
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`
`(Applications filed 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 0f 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 which is to file (and by the USPTO to process) an application. Confidentiality is
`governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary
`depending upon the individual case. Any comments on the amount of time you require to complete this form
`and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, PO. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, PO. Box
`1450, Alexandria, Virginia 22313-1450. 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.
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (PL. 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 information is
`35 U.S.C. 2(b)(2); (2) furnishing of the information solicited 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 may result in termination of
`proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in 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 Member with 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 management practices 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 m

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