Ul\TfED STATES DEPA RTME'IT OF COMMERCE
`United States Patent and Trademark Office
`Adiliess. COMMISSIO'JER FOR PATENTS
`PO Box 1450
`Alexandria, Virgmia 22313-1450
`\VVi\V.USpto.gov
`
`FIRST NAMED APPLICANT
`Mark Manning
`
`ATTY. DOCKET NO./TITLE
`40299-0021019
`CONFIRMATION NO. 8206
`POA ACCEPTANCE LETTER
`
`APPLICATION NUMBER
`15/360,678
`
`FILING OR 3 71 (C) DATE
`11/23/2016
`
`152762
`FISH & RICHARDSON P.C. (COHERUS BIOSCIENCES INC.)
`P.O. BOX 1022
`MINNEAPOLIS, MN 55440-1022
`
`111111111111111111111111]~!1]!~1!~1! ~!11~!1!11!111111111111111111111111111
`
`Date Mailed: 03/20/2019
`
`NOTICE OF ACCEPTANCE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 03/15/2019.
`
`The Power of Attorney in this application is accepted. Correspondence in this application will be mailed to the
`above address as provided by 37 CFR 1.33.
`
`Questions about the contents of this notice and the
`requirements it sets forth should be directed to the Office
`of Data Management, Application Assistance Unit, at
`(571) 272-4000 or (571) 272-4200 or 1-888-786-0101.
`
`/ytdemisse/
`
`page 1 of 1
`
`1 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`APPLICATION NUMBER
`15/360,678
`
`FILING OR 3 71 (C) DATE
`11/23/2016
`
`32116
`WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`Ul\TfED STATES DEPA RTME'IT OF COMMERCE
`United States Patent and Trademark Office
`Adiliess. COMMISSIO'JER FOR PATENTS
`PO Box 1450
`Alexandria, Virgmia 22313-1450
`\VVi\V.USpto.gov
`
`FIRST NAMED APPLICANT
`Mark Manning
`
`ATTY. DOCKET NO./TITLE
`COH10746P00049US
`CONFIRMATION NO. 8206
`POWER OF ATTORNEY NOTICE
`
`111111111111111111111111]~!1]!~1!~1! ~!ll~!l!lli1111111111111111111 11111111
`
`Date Mailed: 03/20/2019
`
`NOTICE REGARDING CHANGE OF POWER OF ATTORNEY
`
`This is in response to the Power of Attorney filed 03/15/2019.
`
`• The Power of Attorney to you in this application has been revoked by the applicant. Future correspondence
`will be mailed to the new address of record(37 CFR 1.33).
`
`Questions about the contents of this notice and the
`requirements it sets forth should be directed to the Office
`of Data Management, Application Assistance Unit, at
`(571) 272-4000 or (571) 272-4200 or 1-888-786-0101.
`
`/ytdemisse/
`
`page 1 of 1
`
`2 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`[
`
`FAppllcation Number
`
`Filing Date
`...
`
`I
`
`)
`
`::
`
`POWER OF ATTORNEY BY APPLICANT
`! hereby revoke all previous powers of attorney given in the application identified in eitr1e[ the attached transmittal letter or
`----
`the boxes below.
`~
`
`(Note: The boxes above may be left b!ank if information is provid~id on the Transmittal.)
`~ I hereby appoint the Patent Practitioner(s) associated with the following Customer Number as my/our attorney{s) or agent(s), and
`to transact all busin,~ss in the United States Patent and Trademark Office connected therewith for the application referenced in
`the attached transmittal letter. which may be an application filed after the dah~ of this power of attorney, or identified above:
`.. --- -
`
`OR
`
`□ ! hBmtly appoint Practitioner(s) named in the atlached list as my/our attorney(s) cir- agent(s), and to transact all business in the
`Unlted States Patent and Trademark Office connected therewith for the patent application referenced in the attached transmittal
`letter, which may be an app!ic:ation filed after the date of this power of attorney, or identified above.
`Please recognize or change the correspondence address for the application identified in the attached transmittal
`letter to:
`□ The address associated with the above-mentionBd Customer NL1mber
`OR
`~ The address associated with Custorner Number: 152762
`OR
`Firm or
`individual Name
`
`Address
`
`...
`
`...
`
`l State
`
`! Zip·- I
`
`!
`
`I
`Cily
`Co,intry
`I
`! Email
`Teiephone
`I am the Aoo!icant (if the Apolicant is a iuristic entity, list the Applicant name in the box):
`L_Coherus BloSciences Inc.
`□ Inventor or Joint Inventor (title not required below)
`□ Legal Representative of a Dec:easBd or Legally Incapacitated Inventor (tltie not required below)
`~ Assigne1~ or Person to Whom the Inventor is Under an Ob!ination to Assign (provide signer's title If applicant is a juristic entity)
`□ Person Who Othi~rwise Shows Sufficient Proprietary lntBrest (e.g., a petition under 37 CFR 1.46(b)(2} was granted in the
`apolication or is concurrently being filed with this dix:umBnt\ (provide signer's title if aoo!icant is a •uristic entitv)
`SIGNATURE of Applicant for Patent
`The undersigrmd (whose ti!ie)s supplied below) is authorized to aGt on behalf of the app!ic<3nt (e.g., where the applicant is a juristic entity).
`l
`I Date {O;)tionai)
`Signature
`l- ,.A\)tjJ ~J):~j $?
`Name
`t··' s<> ~
`t ~ .. rh:· t tf' ~- -:·'"JI"--f\ .£
`i~.(.
`Lft~~ ~·t?.l l)>b.-5~-~---i'::::.·-~-~i·~~--->
`Title
`{\}>f';l-t.·;-.-·-l~,-,_
`NOTE: Signature • This form must bB signed by the. applicant in adordance with 37 CFR 1.33. See 37 CFR i .4 for signature requlrnrmmts and
`certifications. !f more than one applicant, usB multiple forms.
`----~
`□ 'Totai of
`61653977.doc
`
`I
`
`t~z' :i;;·_>~\t1~t(,.-~~(::i~~;::::l $
`
`forms are submitted.
`
`3 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`35432710
`
`15360678
`
`International Application Number:
`
`Confirmation Number:
`
`8206
`
`Title of Invention:
`
`STABLE AQUEOUS FORMULATIONS OF ADALIMUMAB
`
`First Named Inventor/Applicant Name:
`
`Mark Manning
`
`Customer Number:
`
`32116
`
`Filer:
`
`Tiffany A. Reiter/Sherry Hunt
`
`Filer Authorized By:
`
`Tiffany A. Reiter
`
`Attorney Docket Number:
`
`COH 107 46P00049US
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`15-MAR-2019
`
`23-NOV-2016
`
`10:05:59
`
`Application Type:
`
`Utility under 35 USC 111 (a)
`
`Payment information:
`
`Submitted with Payment
`
`I no
`
`File Listing:
`
`Document
`Number
`
`1
`
`Document Description
`
`File Name
`
`File Size(Bytes}/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`4916883
`
`40299_0021019_ Transmittal.
`pdf
`
`1 a7cf238a 14a68Sc4ea0fef62a03e6b4beae
`Sa82
`
`yes
`
`2
`
`4 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Start
`
`End
`
`Transmittal Letter
`
`Power of Attorney
`
`1
`
`2
`
`1
`
`2
`
`Warnings:
`
`Information:
`
`Total Files Size (in bytes)
`
`4916883
`
`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 Agglications 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 Agglication 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 Agglication 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 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/1 OS) 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.
`
`5 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`TRANSMITTAL FOR POWER OF ATTORNEY TO ONE OR MORE
`REGISTERED PRACTITIONERS
`
`Application Number
`
`15/360,678
`
`Filing Date
`
`November 23, 2016
`
`First Named Inventor
`
`Mark Manning
`
`Title
`
`Art Unit
`
`Examiner Name
`
`STABLE AQUEOUS FORMULATIONS OF ADALIMUMAB
`
`Attorney Docket Number
`
`40299-0021019
`
`SIGNATURE of Applicant or Patent Practitioner
`/Tiffany Reiter/
`
`Signature
`
`Name
`
`Tiffany Reiter
`
`Title (if Applicant is a
`juristic entity)
`
`Date (Optional) March 15, 2019
`
`Registration
`Number
`
`61,359
`
`Applicant Name (if Applicant is a juristic entity)
`
`I
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications. If
`more than one applicant, use multiple forms.
`
`□ *Total of
`
`23872963.doc
`
`forms are submitted.
`
`6 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`DocCode - PATENT.GRANT
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: 15360678
`
`Document Date: 01/09/2018
`
`The presence of this form in the IFW record indicates that the following document type was received
`in electronic format on the date identified above. This content is stored in the SCORE database.
`
`Since this was an electronic submission, there is no physical artifact folder, no artifact folder is
`recorded in PALM, and no paper documents or physical media exist. The TIFF images in the IFW
`record were created from the original documents that are stored in SCORE.
`
`• Patent Grant with Color/Grayscale Drawings
`
`At the time of document entry (noted above):
`• USPTO employees may access SCORE content via eDAN using the Supplemental Content
`tab, or via the SCORE web page.
`• External customers may access SCORE content via PAIR using the Supplemental Content
`tab.
`
`Form Revision Date: August 26, 2013
`
`7 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`UNITED STA TES p A TENT 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
`
`APPLICATION NO.
`
`15/360,678
`
`ISSUE DATE
`
`01/09/2018
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`9861695
`
`COHl 0746P00049US
`
`8206
`
`7590
`12/20/2017
`32116
`WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE1130
`CHICAGO, IL 60661
`
`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 O 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):
`
`Mark Manning, Johnstown, CO;
`Coherus Biosciences, Inc., Redwood City, CA;
`Robert W. Payne, Fort Collins, CO;
`
`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)
`
`8 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`32116
`
`e
`
`2017-11-29
`
`WOOD. PHILLIPS. KATZ. CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE 1130
`CHICAGO. IL 60661
`
`UNITED STATES DEPARTMENT OF COMMERCE
`U.S. Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria. Virginia 22313-1450
`www.uspto.gov
`
`Paper No.
`
`Application No.:
`
`15/360,678
`
`Date Mailed:
`
`2017-11-29
`
`First Named Inventor:
`
`Mark Manning
`
`Examiner:
`
`ELECTRONIC
`
`KIM, YUNSOO
`
`Attorney Docket No.:
`
`C0H10746P00049US
`
`Art Unit:
`
`1644
`
`Confirmation No.:
`
`8206
`
`Filing Date:
`
`11/23/2016
`
`Please find attached an Office communication concerning this application or proceeding.
`
`PTO-90c (Rev.08-06)
`
`Commissioner for Patents
`
`9 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA22313-1450
`www.uspto.gov
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`November 27, 2017
`
`WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`In re Application of
`MANNING ET AL.
`Application No. 15/360,678
`Filed: 23 November, 2016
`Attorney Docket No. COH10746P00049US
`
`DECISION ON PETITION
`
`ACCEPTANCE OF COLOR
`DRAWINGS
`
`This is a decision on the Petition to Accept Color Drawings under 37 C.F.R 1.84 (a) (2), received in the United States Patent
`and Trademark Office (USPTO) on November 23, 2016.
`
`The petition is GRANTED.
`
`A grantable petition under 37 C.F.R. 1.84(a) (2) must meet the following requirements:
`
`1. Payment of the fee set forth under 37 C.F.R. 1. l 7(h),
`
`2. Submission of three (3) sets of color drawings, or one (1) set of color drawings if filed by EFS-Web, and
`
`3. The first paragraph of the brief description of the drawings in the Specification contains the required language
`pertaining to colored drawings.
`
`A review of U.S. Patent and Trademark records indicates that each of the above three requirements have been satisfied.
`Accordingly, the petition under 37 C.F.R. 1.84(a)(2) is GRANTED.
`
`Telephone inquiries relating to this decision may be directed to the undersigned in the Office of Data Management at 571-
`272-4200.
`
`/JAMES LEIJA/
`Office of Data Management
`Publications Branch
`
`10 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`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 223)3.(450
`www.ui;pto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`15/360,678
`
`11/23/2016
`
`Mark Manning
`
`COH I 0746P00049US
`
`8206
`
`10/18/2017
`7590
`32116
`WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`EXAMINER
`
`KIM, YUNSOO
`
`ART UNIT
`
`PAPER NUMBER
`
`1644
`
`NOTIFICATION DA TE
`
`DELIVERY MODE
`
`I 0/18/2017
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address( cs):
`docketing@woodphillips.com
`
`PTOL-90A (Rev. 04/07)
`
`11 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`Response to Rule 312 Communication
`
`Application No.
`
`Applicant(s)
`
`15/360,678
`
`Examiner
`
`Art Unit
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -
`
`1. [8J The amendment filed on 09 October 2017 under 37 CFR 1.312 has been considered, and has been:
`a) C8J entered.
`
`b) D entered as directed to matters of form not affecting the scope of the invention.
`
`c) D disapproved because the amendment was filed after the payment of the issue fee.
`Any amendment filed after the date the issue fee is paid must be accompanied by a petition under 37 CFR 1.313(c)(1)
`and the required fee to withdraw the application from issue.
`
`d) D disapproved. See explanation below.
`
`e) D entered in part. See explanation below.
`
`Trevon Couch
`
`/Publishing Division/
`
`U.S. Patent and Trademark Office
`PTOL-271 (Rev. 04-01)
`
`Reponse to Rule 312 Communication
`
`Part of Paper No.
`
`12 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Serial No.
`pt Inventor
`Filed
`
`TC/AU.
`Examiner
`
`15/360,678
`Mark Manning
`11/23/2016
`
`1644
`Kim, Yunsoo
`
`Confirmation No.: 8206
`
`TITLE
`
`Stable Aqueous Formulations of Adalimumab
`
`Docket No.
`Customer No.
`
`COH10746P00049US
`32116
`
`AMENDMENT AND RESPONSE TO NOTICE TO FILE CORRECTED APPLICATION
`PAPERS
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`This Amendment is being submitted in connection with the Notice to File
`
`Corrected Application Papers mailed 10/05/2017, in the above-identified Application.
`
`Amendment to the Specification begins on page two (2) of this paper.
`
`Remarks begin on page three (3) of this paper.
`
`13 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`Serial No. 15/360,678
`
`AMENDMENT TO THE SPECIFICATION
`
`Please replace Specification with a Substitute Specification submitted herewith.
`
`Page 2 of 3
`
`14 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`Serial No. 15/360,678
`
`REMARKS
`
`This Amendment is being submitted in response to the Notice to File Corrected
`
`Application Papers mailed 10/05/2017. A copy of the Notice to File Corrected
`
`Application Papers is attached.
`
`The Amendment corrects deficiencies in the specification identified in the Notice.
`
`Specifically, the Amendment replaces the specification with a substitute specification
`
`wherein the shading has been removed from all tables. Further,
`
`the substitute
`
`specification corrects minor typographical errors wherein Table G-8 was mistakenly
`
`identified as Table G-7 on pages 121 and 123 of the marked-up copy (corresponding to
`
`pages 86 and 88 of the clean copy); and wherein the sentence on page 76, lines 23-24
`
`of the marked-up copy (corresponding to page 58, lines 25-26 of the clean copy) was
`
`corrected. Applicant has submitted marked-up and clean copies of the specification, as
`
`well as a statement that the substitute specification contains no new matter.
`
`If any fees are incurred as a result of the filing of this paper, authorization is given
`
`to charge Deposit Account No. 23-0785.
`
`Respectfully submitted,
`
`By: /Mark Polyakov/
`Mark Polyakov, Reg. No. 54,377
`
`WOOD, PHILLIPS, KATZ,
`CLARK & MORTIMER
`500 West Madison Street
`Suite 1130
`Chicago, IL 60661-2562
`(312) 876-2110
`
`Page 3 of 3
`
`15 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`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.usplo.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`15/360,678
`
`11/23/2016
`
`Mark Manning
`
`COH10746P00049US
`
`8206
`
`10/05/2017
`7590
`32116
`WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
`500 W. MADISON STREET
`SUITE 1130
`CHICAGO, IL 60661
`
`EXAMINER
`
`KIM, YUNSOO
`
`ART UNIT
`
`PAPER NUMBER
`
`1644
`
`NOTIFICATION DA TE
`
`DELIVERY MODE
`
`10/05/2017
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`docketing@woodphillips.com
`
`PTOL-90A (Rev. 04/07)
`
`16 of 701
`
`Fresenius Kabi
`Exhibit 1011
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`\I\N\/W.uspto.gov
`
`Application No. : 15360678
`Applicant : Manning
`Filing Date
`11/23/2016
`Date Mailed : 10/05/2017
`
`NOTICE TO FILE CORRECTED APPLICATION PAPERS
`
`Notice of Allowance Mailed
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`This application has been accorded an Allowance Date and is being prepared for issuance. The
`application, however, is incomplete for the reasons below.
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`Applicant is given two (2) months from the mail date of this Notice within which to respond. This
`time period for reply is extendable under 37 CFR 1.136(a) for only TWO additional MONTHS.
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`The informalities requiring correction are indicated in the attachment(s). If the informality pertains to the
`abstract, specification (including claims) or drawings, the informality must be corrected with an
`amendment in compliance with 37 CFR 1.121 (or, if the application is a reissue application, 37 CFR
`1.173). Such an amendment may be filed after payment of the issue fee if limited to correction of
`informalities noted herein. See Waiver of 3 7 CFR 1. 312 for Documents Required by the Office of Patent
`Publication, 1280 Off. Gaz. Patent Office 918 (March 23, 2004). In addition, if the informality is not
`corrected until after payment of the issue fee, for purposes of 35 U.S.C. 154(b)(l)(iv), "all outstanding
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`/Quang Nguyen/
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`17 of 701
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`Exhibit 1011
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`

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`Application No. 15360678
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`NON-COMPLIANT ILLUSTRATIONS IN SPECIFICATION OR CLAIMS
`D The illustration(s) in the location(s) referenced below do not come within the exceptions of 37 CFR
`1.58(a). Please delete the illustration(s) from the specification or claims, provided the illustration(s) as
`part of the formal drawing(s) in accordance with 37 CFR 1.84, and amend the specification to provide
`a brief description of the drawings in accordance with 37 CFR 1.74. Please see the following item(s):
`D Specification document coded dated, page(s) .
`D Claims document coded dated, claim(s).
`D Amendment document coded dated .
`D Other:.
`00 The chemical formula(s), mathematical formula(s), or table(s) in the location(s) referenced below
`contain shading (color/grayscale) and therefore do not comply with 37 CFR 1.52 and do not come
`within the exceptions of 37 CFR 1.58(a). Please delete chemical formula(s), mathematical formula(s),
`or table(s) with shading from the specification or claims, provide them as formal color drawing(s) in
`accordance with 37 CFR 1.84, including petition, fee, and amendment in accordance with 37 CFR
`1.84(a)(2), and amend the specification to provide a brief description of the drawings in accordance
`with 37 CFR 1.74. Please see the following item(s):
`00 Specification document coded SPEC dated 11/23/2016, page(s) 26-27 32 34 36-40 44-51 53-59
`61-67 69-78 81-87 93 95 98 102.
`D Claims document coded dated, claim(s).
`D Amendment document coded dated .
`D Other:.
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`First Named Inventor:
`Mark Manning
`
`Atty. Dkt. No.
`COH107 46P00049US
`
`Serial No.:
`
`15/360,678
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`Art Unit: 1644
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`Filing Date: 11/23/2016
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`Confirmation No. 8206
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`For: Stable Aqueous Formulations
`Of Adalimumab
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`Examiner: Kim, Yunsoo
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`STATEMENT ACCORDING TO 37 C.F.R. 1.125
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`A substitute specification (both clean and marked up copies) has been submitted
`
`herewith. The substitute specification includes no new matter.
`
`If any fees are required
`
`with the filing of this paper, authorization is given to charge such fees to Deposit
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`Account No. 23-0785.
`
`Respectfully submitted,
`
`By:/Mark Polyakov/
`Mark Polyakov, Reg. No. 54,377
`
`WOOD, PHILLIPS, KATZ,
`CLARK & MORTIMER
`500 W. Madison St., Suite 1130
`Chicago, IL 60661
`Tel.: (312) 876-2110
`Fax.: (312) 876-2020
`
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`Stable Aqueous Formulations of Adalimumab
`
`COH 107 46P00049US
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`Field of the Invention
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`The present invention relates to aqueous pharmaceutical compositions
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`suitable for long-term storage of adalimumab (including antibody proteins considered
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`5
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`or intended as "biosimilar'' or "bio-better'' variants of commercially available
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`adalimumab), methods of manufacture of the compositions, methods of their
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`administration, and kits containing the same.
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`Background of the Invention
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`Tumor necrosis factor alpha (TNFa) is a naturally occurring mammalian
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`10
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`cytokine produced by various cell types, including monocytes and macrophages in
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`response to endotoxin or other stimuli. TNFa is a major mediator of inflammatory,
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`immunological, and pathophysiological reactions (Grell, M., et al. (1995) Cell, 83:
`793-802).
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`Soluble TNFa is formed by the cleavage of a precursor transmembrane
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`15
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`protein (Kriegler, et al. (1988) Cell 53: 45-53), and the secreted 17 kDa polypeptides
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`assemble to soluble homotrimer complexes (Smith, et al. (1987), J. Biol. Chem. 262:
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`6951-6954; for reviews of TNF, see Butler, et al. (1986), Nature 320:584; Old (1986),
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`Science 230: 630). These complexes then bind to receptors found on a variety of
`cells. Binding produces an array of pro-inflammatory effects, including (i) release of
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`20
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`other pro-inflammatory cytokines such as interleukin (IL)-6, IL-8, and IL-1, (ii) release
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`of matrix metalloproteinases and (iii) up-regulation of the expression of endothelial
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`adhesion molecules, further amplifying the inflammatory and immune cascade by
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`attracting leukocytes into extravascular tissues.
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`There are many disorders associated with elevated levels of TNFa. For
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`25
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`example, TN Fa has been shown to be up-regulated in a number of human diseases,
`including chronic diseases such as rheumatoid arthritis (RA), inflammatory bowel
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`disorders, including Crohn's disease and ulcerative colitis, sepsis, congestive heart
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`failure, asthma bronchiale and multiple sclerosis. TNFa is also referred to as a pro(cid:173)
`inflammatory cytokine.
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`COH 107 46P00049US
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`Physiologically, TNFa is also associated with protection from particular
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`infections (Cerami. et al. (1988), lmmunol. Today 9:28). TNFa is released by
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`macrophages that have been activated by lipopolysaccharides of Gram-negative
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`bacteria. As such, TNFa appears to be an endogenous mediator of central
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`5
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`importance involved in the development and pathogenesis of endotoxic shock
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`associated with bacterial sepsis.
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`Adalimumab
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`(Humira®, AbbVie,
`
`Inc.)
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`is a
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`recombinant human
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`lgG1
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`monoclonal antibody specific for human TNF. This antibody is also known as D2E7.
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`Adalimumab consists of 1330 amino acids and has a molecular weight of
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`10
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`approximately 148 kilodaltons. Adalimumab has been described and claimed in U.S.
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`Pat. No. 6,090,382, the disclosure of which is hereby incorporated by reference in its
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`entirety. Adalimumab is usually produced by recombinant DNA technology in a
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`mammalian cell expression system, such as, for example, Chinese Hamster Ovary
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`cells. Adalimumab binds specifically to TNFa and neutralizes the biological function
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`15
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`of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
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`Various formulations of adalimumab are known in the art. See, for example,
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`U.S. Patents 8,216,583 and 8,420,081. There
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`is still need
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`for stable
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`liquid
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`formulations of adalimumab that allow its long term storage without substantial loss
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`in efficacy.
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`20
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`Summary of the Invention
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`The invention provides stable aqueous formulations comprising adalimumab
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`that allow its long term storage.
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`In a first embodiment, the invention provides a stable aqueous pharmaceutical
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`composition comprising adalimumab; a stabilizer comprising at least one member
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`25
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`selected from the group consisting of a polyol and a surfactant; and a buffer selected
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`from the group consisting of citrate, phosphate, succinate, histidine, tartrate and
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`maleate, wherein said composition has a pH of about 4 to about 8 and preferably
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`about 5 to about 6, and wherein said buffer does not comprise a combination of
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`citrate and phosphate, and preferably does not comprise any citrate buffer.
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`In this
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`30
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`embodiment, the stabilizer preferably comprises both polyol and surfactant.
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`COH 107 46P00049US
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`In a second embodiment, utilizing a single buffer system, the invention
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`provides a stable aqueous pharmaceutical composition comprising adalimumab, a
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`polyol, a surfactant, and a buffer system comprising a single buffering agent, said
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`single buffering agent being selected from citrate, phosphate, succinate, histidine,
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`5
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`tartrate or maleate, but not including combinations of the foregoing; wherein the
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`formulation has a pH of about 4 to 8, and preferably about 5 to about 6. Histidine
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`and succinate are particularly preferred for use as single buffering agents. As used
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`herein the term buffer, buffer system, or buffering agent, and like terminology, is
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`intended to denoted buffer components that introduce buffer capacity in
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`the
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`10
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`formulation in addition to any buffering capacity offered by the protein itself, hence
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`the term "buffer'', etc, is not intended to include the protein itself as a self buffering
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`entity.
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`In a
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`third embodiment,
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`the
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`invention provides a stable aqueous
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`pharmaceutical composition comprising adalimumab, a stabilizer comprising at least
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`15
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`one member selected from a polyol and a surfactant, wherein said composition has a
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`pH of about 4 to about 8, and preferably about 5 to about 6, and wherein said
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`composition is substantially free of a buffer.
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`In a
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`fourth embodiment,
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`the
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`invention provides a stable aqueous
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`pharmaceutical composition comprising adalimumab, a polyol, and a buffer selected
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`20
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`from the group consisting of citrate, phosphate, succinate, histidine, tartrate and
`
`maleate, wherein said composition has a pH of about 4 to about 8 and preferably
`
`about 5 to about 6, and wherein said composition is free or substantially free of a
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`surfactant. Preferably, the composition (i) does not contain the buffer combination of
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`citrate and phosphate; and (ii) the buffer is at least one member selected from the
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`25
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`group consisting of histidine and succinate; and (iii) the polyol is selected from the
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`group consisting of mannitol, sorbitol and trehalose.
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`In a fifth embodiment, the invention provides a stable aqueous pharmaceutical
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`composition comprising adalimumab, a surfactant, and a buffer selected from the
`
`group consisting of citrate, phosphate, succinate, histidine, tartrate and maleate,
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`30 wherein said composition has a pH of about 4 to 8 and preferably about 5 to about 6,
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`and wherein said composition is substantially free of polyol. Preferably, the
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`composition (i) does not contain the buffer combination of citrate and phosphate; and
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`COH 107 46P00049US
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`(ii) the buffer is at least one member selected from the group consisting of histidine
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`and succinate, including combinations thereof.
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`In each of the five embodiments discussed above, the composition may
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`optionally further comprise a stabilizer selected from the group consisting of an
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`5
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`amino acid, a salt, ethylenediaminetetraacetic acid (EDT A) and a metal ion. The
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`amino acid stabilizer may be selected from the group consisting of glycine, alanine,
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`glutamate, arginine and methionine. The salt stabilizer may be selected from the
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`group consisting of sodium chloride and sodium sulfate. The metal ion stabilizer
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`may be selected from the group consisting of zinc, magnesium and calcium.
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`10
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`Preferably, adalimumab formulations containing the stabilizers mentioned above also
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`do not contain buffer systems in which phosphate buffer and citrate buffer are
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`present in combination, and, most preferably contains buffer systems free or
`In particularly preferred embodiments, (i) the
`substantially free of citrate buffer.
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`optional additional stabilizer present in this embodiment is not sodium chloride, or
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`15
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`comprises sodium chloride present in amounts not to exceed about 100 mM, and
`comprises at least one of arginine an