Case l:17-cv-00812-RGA Document 4 Filed 06/23/17 Page 1 of 1 PagelD #: 30
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`filed in the U.S. District Court
`on the following
`• Trademarks or
`! the patent action involves 35 U.S.C'. § 292.):
`2f Patents.
`
`( i
`
`DOCKET NO.
`
`DATE FILED
`6/23/2017
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`BAYER INTELLECTUAL PROPERTY GMBH, BAYER
`AG, and JANSSEN PHARMACEUTICALS, INC.
`
`DEFENDANT
`INVAGEN PHARMACEUTICALS, INC.
`
`PATENT OR
`TRADEMARK NO.
`i 9,539,218
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1/10/2017
`
`Bayer Intellectual Property GmbH
`
`4
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`| | Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`[J Answer
`
`• Cross Bill
`
`• Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`4
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon iui'iiaiktii of action, nsai! this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—-Upon filing document adding patent(s), nsai! this copy to Director Copy 4—Case file copy
`
`0001
`
`MYLAN - EXHIBIT 1004 Part 1 of 10
`
`

`

`Case l:17-cv-00675-RGA Document 4 Filed 06/02/17 Page 1 of 1 PagelD #: 32
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`filed in the U.S. District Court
`on the following
`• Trademarks or
`! the patent action involves 35 U.S.C'. § 292.):
`2f Patents.
`
`( i
`
`DOCKET NO.
`
`DATE FILED
`6/2/2017
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`BAYER INTELLECTUAL PROPERTY GMBH, BAYER
`AG, and JANSSEN PHARMACEUTICALS, INC.
`
`DEFENDANT
`ALEMBIC PHARMACEUTICALS LIMITED, ALEMBIC
`GLOBAL HOLDING SA, AND ALEMBIC
`PHARMACEUTICALS, INC.
`
`PATENT OR
`TRADEMARK NO.
`i 9,539,218
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1/10/2017
`
`Bayer Intellectual Property GmbH
`
`4
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`| | Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`[J Answer
`
`• Cross Bill
`
`• Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`4
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon iui'iiaiktii of action, nsai! this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—-Upon filing document adding patent(s), nsai! this copy to Director Copy 4—Case file copy
`
`0002
`
`

`

`Case l:17-cv-00648-RGA Document 4 Filed 05/26/17 Page 1 of 1 PagelD #: 31
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`filed in the U.S. District Court
`on the following
`• Trademarks or
`! the patent action involves 35 U.S.C'. § 292.):
`2f Patents.
`
`( i
`
`DOCKET NO.
`
`DATE FILED
`5/26/2017
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`BAYER INTELLECTUAL PROPERTY GMBH, et a!.
`
`DEFENDANT
`SIGMAPHARM LABORATORIES, LLC
`
`PATENT OR
`TRADEMARK NO.
`i 9,539,218 B2
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1/10/2017
`
`Bayer Intellectual Property GmbH
`
`4
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`| | Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`[J Answer
`
`• Cross Bill
`
`• Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`4
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon iui'iiaiktii of action, nsai! this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—-Upon filing document adding patent(s), nsai! this copy to Director Copy 4—Case file copy
`
`0003
`
`

`

`Case l:17-cv-00584-RGA Document 4 Filed 05/19/17 Page 1 of 1 PagelD #: 31
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`filed in the U.S. District Court
`on the following
`• Trademarks or
`! the patent action involves 35 U.S.C'. § 292.):
`2f Patents.
`
`( i
`
`DOCKET NO.
`
`DATE FILED
`5/19/2017
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`BAYER INTELLECTUAL PROPERTY GMBH, et a!.
`
`DEFENDANT
`MYLAN PHARMACEUTICALS INC.
`
`PATENT OR
`TRADEMARK NO.
`i 9,539,218 B2
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1/10/2017
`
`Bayer Intellectual Property GmbH
`
`4
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`| | Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`[J Answer
`
`• Cross Bill
`
`• Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`4
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon iui'iiaiktii of action, nsai! this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—-Upon filing document adding patent(s), nsai! this copy to Director Copy 4—Case file copy
`
`0004
`
`

`

`Case l:17-cv-00560-RGA Document 4 Filed 05/12/17 Page 1 of 1 PagelD #: 32
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`filed in the U.S. District Court
`on the following
`• Trademarks or
`! the patent action involves 35 U.S.C'. § 292.):
`2f Patents.
`
`( i
`
`DOCKET NO.
`
`DATE FILED
`5/12/2017
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`BAYER INTELLECTUAL PROPERTY GMBH, et a!.
`
`DEFENDANT
`MICRO LABS LTD., MICRO LABS USA INC.
`
`PATENT OR
`TRADEMARK NO.
`i 9,539,218 B2
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1/10/2017
`
`Bayer Intellectual Property GmbH
`
`4
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`| | Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`[J Answer
`
`• Cross Bill
`
`• Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`4
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon iui'iiaiktii of action, nsai! this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—-Upon filing document adding patent(s), nsai! this copy to Director Copy 4—Case file copy
`
`0005
`
`

`

`Case l:17-cv-00483-RGA Document 4 Filed 04/28/17 Page 1 of 1 PagelD #: 32
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`filed in the U.S. District Court
`on the following
`• Trademarks or
`! the patent action involves 35 U.S.C'. § 292.):
`2f Patents.
`
`( i
`
`DOCKET NO.
`
`DATE FILED
`4/28/2017
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`BAYER INTELLECTUAL PROPERTY GMBH, et a!.
`
`DEFENDANT
`AUROBINDO PHARMA LIMITED, et al.
`
`PATENT OR
`TRADEMARK NO.
`i 9,539,218 B2
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1/10/2017
`
`Bayer Intellectual Property GmbH
`
`4
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`| | Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`[J Answer
`
`• Cross Bill
`
`• Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`4
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon iui'iiaiktii of action, nsai! this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—-Upon filing document adding patent(s), nsai! this copy to Director Copy 4—Case file copy
`
`0006
`
`

`

`Case l:17-cv-00462-RGA Document 4 Filed 04/21/17 Page 1 of 1 PagelD #: 32
`AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`for the District of Delaware
`filed in the U.S. District Court
`on the following
`• Trademarks or
`! the patent action involves 35 U.S.C'. § 292.):
`2f Patents.
`
`( i
`
`DOCKET NO.
`
`DATE FILED
`4/21/2017
`
`U.S. DISTRICT COURT
`for the District of Delaware
`
`PLAINTIFF
`BAYER INTELLECTUAL PROPERTY GMBH, et a!.
`
`DEFENDANT
`TARO PHARMACEUTICAL INDUSTRIES LTD., et al.
`
`PATENT OR
`TRADEMARK NO.
`i 9,539,218 B2
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
`1/10/2017
`
`Bayer Intellectual Property GmbH
`
`4
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`
`DATE INCLUDED
`
`INCLUDED BY
`
`PATENT OR
`TRADEMARK NO.
`
`| | Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`[J Answer
`
`• Cross Bill
`
`• Other Pleading
`
`HOLDER OF PATENT OR TRADEMARK
`
`4
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon iui'iiaiktii of action, nsai! this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—-Upon filing document adding patent(s), nsai! this copy to Director Copy 4—Case file copy
`
`0007
`
`

`

`^ UNITED STATES PATENT AND TRADEMARK OFFICE
`1
`
`it
`1
`
`•AT OF CO
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Bo DX 1450
`dria, Virginia 22313-1450
`Alexan
`to.gov www.usp
`
`
`APPLICATION NO.
`
`11/883,218
`
`ISSUE DATE
`
`01/10/2017
`
`PATENT NO.
`
`9539218
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`11987-00042
`
`9960
`
`21839
`7590
`12/21/2016
`BUCHANAN, INGERSOLL & ROONEY PC
`POST OFFICE BOX 1404
`ALEXANDRIA, VA 22313-1404
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 2951 day(s). Any patent to issue from the above-identified application will
`include an indication of the adjustment on the front page.
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information
`Retrieval (PAIR) WEB site (http://pair.uspto.gov).
`
`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 Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)-272-4200.
`
`APPLICANT(s) (Please see PAIR WEB site http://pair.uspto.gov for additional applicants):
`
`Frank Misselwitz, Heidelberg, GERMANY;
`Dagmar Kubitza, Ratingen, GERMANY;
`Son-Mi Park, Wuppertal, GERMANY;
`Klaus Wehling, Wuppertal, GERMANY;
`
`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation, and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`works to encourage and facilitate business investment. To learn more about why the USA is the best country in
`the world to develop technology, manufacture products, and grow your business, visit SelectUSA.gov.
`
`IR103 (Rev. 10/09)
`
`0008
`
`

`

`a\ UNITED STATES PATENT AND TRADEMARK OFFICE
`ai —.
`i.
`...
`i
`,Q
`
`&
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`ndria, Virgini
`Alcxa
`3 22313-1450
`
`io.gov www.usp
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`MTORNEY DOCKET NO. CONFIRMATION NO.
`
`11/883,218
`
`07/16/2008
`
`Frank Misselwitz
`
`11987-00042
`
`9960
`
`12/01/2016
`7590
`BUCHANAN, INGERSOLL & ROONEY PC
`POST OFFICE BOX 1404
`ALEXANDRIA, VA 22313-1404
`
`EXAMINER
`
`KAROL, JODY LYNN
`
`ART UNIT
`
`1627
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`12/01/2016
`
`ELECTRONIC
`
`NOTICE OF NON-COMPLIANT INFORMATION DISCLOSURE STATEMENT
`C b o M )
`An Information Disclosure Statement (IDS) filed /1 3-I 'U=>
`in the above-identified application fails to
`meet the requirements of 37 CFR 1.97(d) for the reason(s) specified below. Accordingly, the IDS will be
`placed in the file, but the information referred to therein has not been considered.
`
`The IDS is not compliant with 37 CFR 1.97(d) because:
`
`•^fhe IDS lacks a statement as specified in 37 CFR 1.97(e).
`
`• The IDS lacks the fee set forth in 37 CFR 1.17(p).
`
`• The IDS was filed after the issue fee was paid. Applicant may wish to consider filing a petition to
`withdraw the application from issue under 37 CFR 1.313(c) to have the IDS considered. See
`MPEP 1308.
`
`tfHS
`p 571-272-4200 or 1-888-786-0101
`-fyy' Application Assistance Unit
`Office of Data Management
`
`FORM PTOM327-B (Rev. 02/08)
`
`Page 1 of 1
`
`0009
`
`

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`0010
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`

`

`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`11883218
`
`16-Ju 1-2008
`
`Title of Invention:
`
`Prevention and Treatment of Thromboembolic Disorders
`
`First Named Inventor/Applicant Name:
`
`Frank Misselwitz
`
`Filer:
`
`Christine Hansen/Darcy White
`
`Attorney Docket Number:
`
`11987-00042
`
`Filed as Large Entity
`
`Filing Fees for U.S. National Stage under 35 USC 371
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USD($)
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`Basic Filing:
`
`Pages:
`
`Claims:
`
`Miscellaneous-Filing:
`
`Petition:
`
`Patent-Appeals-and-lnterference:
`
`Post-Allowance-and-Post-lssuance:
`
`UTILITY APPL ISSUE FEE
`
`1501
`
`1
`
`960
`
`960
`
`0011
`
`

`

`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USD($)
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`Extension-of-Time:
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`Miscellaneous:
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`960
`
`0012
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`27632672
`
`11883218
`
`International Application Number:
`
`Confirmation Number:
`
`9960
`
`Title of Invention:
`
`Prevention and Treatment of Thromboembolic Disorders
`
`First Named Inventor/Applicant Name:
`
`Frank Misselwitz
`
`Customer Number:
`
`21839
`
`Filer:
`
`Christine Hansen/Darcy White
`
`Filer Authorized By:
`
`Christine Hansen
`
`Attorney Docket Number:
`
`Receipt Date:
`
`Filing Date:
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`11987-00042
`
`29-NOV-2016
`
`16-JUL-2008
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`11:30:53
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`U.S. National Stage under 35 USC 371
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`112916INTEFSW11322400
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`024800
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`Christine Hansen
`
`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)
`
`37 CFR 1.19 (Document supply fees)
`
`0013
`
`

`

`37 CFR 1.20 (Post Issuance fees)
`
`37 CFR 1.21 (Miscellaneous fees and charges)
`
`37 CFR 1.492 (National application filing, search, and examination fees)
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`37 CFR 1.492(a) (Basic national fee only)
`File Listing:
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`436677
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`1
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`Issue Fee Payment (PTO-85B)
`
`I F_T ra n s_exec u ted. pdf
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`no
`
`1
`
`Warnings:
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`40ea842957f76095885bf0a263a9029fcc73
`a9d4
`
`30794
`
`2
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`no
`
`2
`
`9002cc844bS41 cedfdb04ec882f094b1a185
`8346
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`Total Files Size (in bytes):
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`467471
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. Ill
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
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`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`0014
`
`

`

`0081565-000006
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`Frank Misselwitz et al.
`
`Application No.: 11/883,218
`
`Filed: July 16, 2008
`
`For:
`
`PREVENTION AND TREATMENT OF
`THROMBOEMBOLIC DISORDERS
`
`Confirmation No.: 9960
`
`Art Unit: 1627
`
`Examiner: Karol, Jody Lynn
`
`INFORMATION DISCLOSURE STATEMENT QDS^ AND CERTIFICATION
`STATEMENT PURSUANT TO 37 C.F.R. S1.97(E>m
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
`
`Pursuant to 37 C.F.R. §§1.56, 1.97 and 1.98, the attention of the Patent and Trademark
`Office is hereby directed to the references submitted herewith. It is respectfully requested that
`the information be expressly considered during the prosecution of this application, and that the
`references be made of record therein and appear among the "References Cited" on any patent to
`issue therefrom.
`
`Consideration of this Information Disclosure Statement is believed appropriate pursuant
`37 C.F.R. §1.97 (d). The Information Disclosure Statement is filed on or before payment of the
`issue fee and is accompanied by the fee set forth in 37 C.F.R. §1.17 (p). Furthermore,
`consideration of the references is believed proper under 37 C.F.R. §1.97 (e) because the
`references are the Patentee's Response to the Notices of Oppositions concerning European Patent
`1 845 961 with supporting documentation filed by Bayer Intellectual Property GmbH on
`November 16, 2016 in the European Patent Office. This Response was not filed until November
`16, 2016 and therefore was not cited in a foreign patent office proceeding in a counterpart
`
`0015
`
`

`

`U.S. Application Ser. No.: 11/883,218
`
`Docket No.: 0081565-000006
`
`foreign application more than three months prior to the filing of the Information Disclosure
`Statement.
`
`Certain documents are in the German language: (1) Krauspe, R. "Der erste orale Faktor-
`Xa-Inhibitor Rivaroxaban (Xarelto®) zur Thromboseprophylaxe - eine neue Dimension." PZ
`Innovationspreis 2009, September 26, 2009, Dusseldorf, Germany; (2) "Thrombosen verhindem
`- eine Tablette kann Leben retten: Kurzbeschreibung der Institute und Untemehmen zu ihren
`nominierten Projekten Nominierte 2009," Deutscher Zukunftspreis, 2009; (3) "Xarelto®: Eine
`neue Dimension der Thromboseprophylaxe," version DE/2, Bayer Sobering Pharma AG, May
`2009; and (4) "Deutscher Zukunftspreis 2009 fur Frank Misselwitz, Dagmar Kubitza und
`Elisabeth Perzbom," Pressemitteilung des Bundesprasidialamtes, December 2, 2009. A brief
`statement of their relevancy can be found in the discussion on pages 14-15 of the Patentee's
`Response to the Notices of Oppositions.
`
`The reference Fulgraff, G and Palm D, Pharmakotherapie: Klinische Pharmakologie,! 1th
`ed., Urban & Fischer Verlag Munchen, 2001, pp. 114-123, is in the German Language. A brief
`statement of its relevancy can be found on pages 52 and 71-72 of the Patentee's Response to the
`Notices of Oppositions. The reference Schmutzler, R and Novotny, U., Antikoagulation in Klinik
`und Praxis, ComMed Basel, Verlagsagentur, 1999, Chapter 4, pp. 76-93, is in the German
`language. A brief statement of its relevancy may be found on pages 59 and 95 of the Patentee's
`Response to the Notices of Oppositions. The reference Jaehde et al., Lehrbuch der Klinischen
`Pharmazie, 2nd ed., Wissenschaftliche Verlagsgesellschaft mbH Stuttgart, 2003, Chapter 9, pp.
`129-139 is in the German language. A brief statement of its relevancy may be found on pages 68,
`69, 102, 129, 135 and 136 of the Patentee's Response to the Notices of Oppositions. The
`reference Pschyrembel Klinisches Worterbuch, 258th ed., Walter de Grunyter & Co., 1997, p.
`714 is in the German language. A brief statement of its relevancy may be found on page 71 of
`the Patentee's Response to the Notices of Oppositions. The reference Aktories et al., Allgemeine
`und spezielle Pharmakologie und Toxikologie, 9th ed., Elsevier GmbH, Munchen, 2005, pp. 72­
`74, is in the German language. A brief statement of its relevancy may be found on page 100 of
`the Patentee's Response to the Notices of Oppositions. The reference Aktories et al., Allgemeine
`
`2
`
`0016
`
`

`

`U.S. Application Ser. No.: 11/883,218
`
`Docket No.: 0081565-000006
`
`und spezielle Pharmakologie und Toxikologie, 9th ed., Elsevier GmbH, Miinchen, 2005, pp. 82­
`84 is in the German language. A brief statement of its relevancy may be found on pages 100 and
`125 of the Patentee's Response to the Notices of Oppositions. The reference Mutschler, E et al.,
`Mutschler Arzneimittelwirkungen, 8th ed., Wissenschaftliche Verlagsgesellschaft mbH Stuttgart,
`2001, pp. 48-51 is in the German language. A brief statement of its relevancy may be found on
`pages 101, 102 and 134 of the Patentee's Response to the Notices of Oppositions. The reference
`Mutschler, E et al., Mutschler Arzneimittelwirkungen, 8th ed., Wissenschaftliche
`Verlagsgesellschaft mbH Stuttgart, 2001, p. 497 is in the German language. A brief statement of
`its relevancy may be found on page 147 of the Patentee's Response to the Notices of
`Oppositions. The reference Schwarz, JA, Leitfaden Klinische Priifungen von Arzneimitteln und
`Medizinprodukten, 3rd ed., Editio Cantor Yerlag fur Medizin und Naturwissenschaften GmbH,
`Aulendorf, 2005, pp. 63-65 is in the German language. A brief statement of its relevancy may be
`found on page 107 of the Patentee's Response to the Notices of Oppositions. The reference
`Meier, J et al., Biopharmazie: Theorie und Praxis der Pharmakokinetik, Georg Thieme Yerlag
`Stuttgart, 1981, Chapter 11.2.2, pp. 322-325 is in the German language. A brief statement of its
`relevancy may be found on page 126 of the Patentee's Response to the Notices of Oppositions.
`The reference Stapff, M. Arzneimittelstudien, 2nd ed., W. Zuckschwerdt Yerlag GmbH, 2001,
`Chapter C5, pp. 48-49 is in the German language. A brief statement of its relevancy may be
`found on page 136 of the Patentee's Response to the Notices of Oppositions.
`
`Previously, Applicants submitted copies of the grounds for Opposition and the references
`cited (that had not previously been cited) in these thirteen Oppositions. The Office considered
`these references. The application is now allowed.
`
`In accordance with 37 CFR 1.98(a)(2)(ii), Applicant has not submitted copies of U.S.
`patents and U.S. patent applications. Applicant submits herewith copies of foreign patents and
`non-patent literature in accordance with 37 CFR 1.98(a)(2).
`
`The Director is hereby authorized to charge any deficiency in the fees filed, asserted to be
`
`3
`
`0017
`
`

`

`U.S. Application Ser. No.: 11/883,218
`
`Docket No.: 0081565-000006
`
`filed or which should have been filed for consideration of this paper herewith to our Deposit
`Account No. 02-4800, under Order No. 0081565-000006.
`
`Dated: November 21, 2016
`
`Respectfully submitted,
`
`Electronic signature: /Christine M. Hansen/
`Christine M. Hansen
`Registration No.: 40,634
`BUCHANAN INGERSOLL AND ROONEY PC
`919 Market Street, Suite 1500
`Wilmington, Delaware 19801-3046
`(302) 552-4240
`(302) 552-4295 (Fax)
`Attorney for Applicant
`
`4
`
`0018
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`27582355
`
`11883218
`
`International Application Number:
`
`Confirmation Number:
`
`9960
`
`Title of Invention:
`
`Prevention and Treatment of Thromboembolic Disorders
`
`First Named Inventor/Applicant Name:
`
`Frank Misselwitz
`
`Customer Number:
`
`21839
`
`Filer:
`
`Christine Hansen/Mich Sok
`
`Filer Authorized By:
`
`Christine Hansen
`
`Attorney Docket Number:
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`11987-00042
`
`22-NOV-2016
`
`16-JUL-2008
`
`10:05:51
`
`Application Type:
`
`U.S. National Stage under 35 USC 371
`
`Payment information:
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`Submitted with Payment
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`Document Description
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`236142
`
`Multi
`Part /.zip
`
`Pages
`(ifappl.)
`
`1
`
`Transmittal Letter
`
`IDS_TL.pdf
`
`no
`
`4
`
`4473fb8753ddc00319845388f3f291f203d8
`86f7
`
`Warnings:
`
`0019
`
`

`

`Information:
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`Total Files Size (in bytes):
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`236142
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. Ill
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105) will be issued in due course, subject to prescriptions concerning
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`0020
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`

`

`Doc code: IDS
`PTO/SB/O8a (01-10)
`Approved for use through 07/31/2012. OMB 0651-0031
`Doc description: Information Disclosure Statement (IDS) Filed
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwo