Doc Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`PTO/AIA/424 (04-14)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`Hans-Juergen Krause
`
`Nonprovisional Application
`Number (if known):
`
`Not Yet Assigned
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`AND REQUESTS PRIORITIZED EXAMINATION FOR
`
`First Named
`Inventor:
`Title of
`Invention:
`APPLICANT HEREBY CERTIFIES THE FOLLOWING
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i)(1) and the prioritized examination fee set forth in
`37 CFR 1.17(c) have been filed with the request.
`The publication fee requirement is met because
`
`that fee, set forth in 37 CFR 1.18(d), is currently $0. The basic filing fee, search fee, and
`
`examination fee are filed with the request or have been already been paid. I understand that any
`
`required excess claims fees or application size fee must be paid for the application.
`
`2. I understand that the application may not contain, or be amended to contain, more than four
`
`independent claims, more than thirty total claims, or any multiple dependent claims, and that any
`
`request for an extension of time will cause an outstanding Track I request to be dismissed.
`3. The applicable box is checked below:
`
`I. (cid:9)
`
`x (cid:9) Original Application (Track One) -
`
`Prioritized Examination under § 1.102(e)(1)
`
`i. (a) The application is an original nonprovisional
`utility application filed under 35 U.S.C. 111(a).
`This certification and request is being filed
`with the utility application via EFS-Web.
`---OR---
`(b) The application is an original nonprovisional
`plant application filed under 35 U.S.C. 111(a).
`This certification and request is being filed
`with the plant application in paper.
`
`ii. An executed inventor's oath or declaration under 37 CFR 1.63 or 37 CFR 1.64 for each
`
`
`inventor, or the application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is
`filed with the application.
`
`II. (cid:9)
`
`Request for Continued Examination
`
`- Prioritized Examination under § 1.102(e)(2)
`
`i. A request for continued examination has been filed with, or prior to, this form.
`ii. If the application is a utility application, this certification and request is being filed via EFS-Web.
`iii. The application is an original nonprovisional utility application filed under 35 U.S.C. 111(a), or is
`a national stage entry under 35 U.S.C. 371.
`iv. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`v. No prior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.102(e)(2).
`
`/BRIAN M. Gummow/
`
`August 6, 2014
`
`Date
`Signature
`Practitioner
`Name
`Brian M. Gummow, Ph.D.
`63,933
`Registration Number
`(Print/Typed)
`Note: This form must be signed in accordance with 37 CFR 1.33. See 37CFR 1.4(d) for signature requirements and certifications.
`Submit multiple forms if more than one signature is required. *
`
`X (cid:9)
`
`"Total of (cid:9)
`
`1 (cid:9)
`
`forms are submitted.
`
`1
`
`Ex. 1008 - Page 1 of 221
`
`AMGEN INC.
`Exhibit 1008
`
`

`

`PTOIAIA/14 (12-13)
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`110222-0005-310
`
`Application Number
`
`Title of Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`Secrecy Order 37 CFR 5.2
`1-7 Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`I—I 37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`
`Inventor Information:
`
`1 (cid:9)
`Inventor (cid:9)
`
`Legal Name
`
`Remove
`
`Prefix Given Name
`
`Middle Name
`
`Family Name
`
`Suffix
`
`Krause
`Hans-Juergen
`Residence Information (Select One) (cid:9) 0 US Residency (cid:9)
`C) (cid:9) Non US Residency (cid:9)
`City
`Country of Residence i
`
`Gruenstadt
`
`0 Active US Military Service
`
`DE
`
`Mailing Address of Inventor:
`
`Address 1
`
`Address 2
`City (cid:9)
`Postal Code
`
`2 (cid:9)
`Inventor (cid:9)
`
`Legal Name
`
`St. Killian-Strasse 14
`
`Gruenstadt (cid:9)
`
`D-67269 (cid:9)
`
`State/Province
`Country i
`DE
`
`Remove
`
`Prefix Given Name
`
`Middle Name
`
`Family Name
`
`Suffix
`
`Baust
`Lisa
`Residence Information (Select One) (cid:9) 0 US Residency (cid:9) 0 (cid:9) Non US Residency (cid:9)
`City
`Country of Residence i
`
`Ludwigshafen
`
`0 Active US Military Service
`
`DE
`
`Mailing Address of Inventor:
`
`Address 1
`
`Address 2
`City (cid:9)
`Postal Code
`
`Gothestr. 15 a
`
`Ludwigshafen (cid:9)
`
`D-67063 (cid:9)
`
`State/Province
`Country i
`DE
`
`3 (cid:9)
`Inventor (cid:9)
`
`Legal Name
`
`EFS Web 2.2.11
`
`Remove
`
`Ex. 1008 - Page 2 of 221
`
`

`

`PTOIAIA/14 (12-13)
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`110222-0005-310
`
`Application Number
`
`Title of Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`Prefix Given Name
`
`Middle Name
`
`Family Name
`
`Suffix
`
`Michael
`Dickes
`Residence Information (Select One) (cid:9) C) US Residency (cid:9) 0 (cid:9) Non US Residency (cid:9)
`City
`State/Province
`
`Rodersheim-Gronau
`
`0 Active US Military Service
`
`Country of Residence i DE
`
`Mailing Address of Inventor:
`
`Address 1
`
`Address 2
`City (cid:9)
`Postal Code
`
`Schafergasse 58
`
`Rodersheim-Gronau (cid:9)
`
`D-67127
`
`State/Province
`Country i
`
`DE
`
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`Add
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`An Address is being provided for the correspondence Information of this application.
`
`Customer Number
`
`118276
`
`Email Address
`
`USPatentMail@ropesgray.com
`
`Add Email
`
`Remove Email
`
`Application Information:
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED
`DISORDERS
`Attorney Docket Number 110222-0005-310
`
`Small Entity Status Claimed
`
`Title of the Invention
`
`Application Type
`
`Nonprovisional
`
`Subject Matter
`
`Utility
`
`Total Number of Drawing Sheets (if any)
`
`0
`
`Suggested Figure for Publication (if any)
`
`Filing By Reference :
`
`Only complete this section when filing an application by reference under 35 U.S.C. 111(c) and 37 CFR 1.57(a). Do not complete this section if
`application papers including a specification and any drawings are being filed. Any domestic benefit or foreign priority information must be
`provided in the appropriate section(s) below (i.e., "Domestic Benefit/National Stage Information" and "Foreign Priority Information").
`
`For the purposes of a filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
`reference to the previously filed application, subject to conditions and requirements of 37 CFR 1.57(a).
`
`Application number of the previously
`filed application
`
`Filing date (YYYY-MM-DD)
`
`Intellectual Property Authority or Country i
`
`EFS Web 2.2.11
`
`Ex. 1008 - Page 3 of 221
`
`

`

`PTOIAIA/14 (12-13)
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`110222-0005-310
`
`Application Number
`
`Title of Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`Publication Information:
`q Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`Request Not to Publish. I hereby request that the attached application not be published under
`q 35 U.S.C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months after filing.
`
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
`Either enter Customer Number or complete the Representative Name section below. If both sections are completed the customer
`Number will be used for the Representative Information during processing.
`
`Please Select One:
`
`C) (cid:9) Customer Number
`
`0 US Patent Practitioner 0 (cid:9) Limited Recognition (37 CFR 11.9)
`
`Customer Number
`
`118276
`
`Domestic Benefit/National Stage Information:
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(c) or indicate National Stage
`entry from a PCT application. Providing this information in the application data sheet constitutes the specific reference required
`by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
`When referring to the current application, please leave the application number blank.
`
`Prior Application Status Pending
`
`Remove
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`Continuation of
`
`14322581
`
`2014-07-02
`
`Prior Application Status Patented
`Application
`Number
`
`Continuity Type
`
`Prior Application
`Number
`
`Filing Date
`(YYYY-MM-DD)
`
`Patent Number
`
`Issue Date
`(YYYY-MM-DD)
`
`Remove
`
`14322581
`
`Continuation of
`
`14091938
`
`2013-11-27
`
`8795670
`
`2014-08-05
`
`Prior Application Status Pending
`
`Remove
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`14091938
`
`Continuation of
`
`13471820
`
`2012-05-15
`
`Prior Application Status Patented
`
`Remove
`
`Application
`Number
`
`Continuity Type
`
`Prior Application
`Number
`
`Filing Date
`(YYYY-MM-DD)
`
`Patent Number
`
`Issue Date
`(YYYY-MM-DD)
`
`13471820
`
`Continuation of
`
`10525292
`
`2005-10-27
`
`8216583
`
`2012-07-10
`
`Prior Application Status Expired
`
`Remove
`
`EFS Web 2.2.11
`
`Ex. 1008 - Page 4 of 221
`
`

`

`PTO/AIA/14 (12-13)
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`110222-0005-310
`
`Application Number
`
`Title of Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`10525292
`
`a 371 of international
`
`PCTIB2003004502
`
`2003-08-15
`
`Prior Application Status Abandoned
`
`Remove
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`PCTIB2003004502
`
`Continuation of
`
`10222140
`
`2002-08-16
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`
`Add
`
`Foreign Priority Information:
`
`This section allows for the applicant to claim priority to a foreign application. Providing this information in the application data sheet
`constitutes the claim for priority as required by 35 U.S.C. 119(b) and 37 CFR 1.55(d). When priority is claimed to a foreign application
`that is eligible for retrieval under the priority document exchange program (PDX) 'the information will be used by the Office to
`automatically attempt retrieval pursuant to 37 CFR 1.55(h)(1) and (2). Under the PDX program, applicant bears the ultimate
`responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual
`property office, or a certified copy of the foreign priority application is filed, within the time period specified in 37 CFR 1.55(g)(1).
`
`Application Number
`
`Country i
`
`Filing Date (YYYY-MM-DD)
`
`Access Code' (if applicable)
`
`Remove
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
`
`
`Add
`
`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
`Applications
`
`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
`contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March
`pi 16, 2013.
`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
`16, 2013, will be examined under the first inventor to file provisions of the AIA.
`
`Authorization to Permit Access:
`pi Authorization to Permit Access to the Instant Application by the Participating Offices
`
`EFS Web 2.2.11
`
`Ex. 1008 - Page 5 of 221
`
`

`

`PTOIAIA/14 (12-13)
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`110222-0005-310
`
`Application Number
`
`Title of Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`If checked, the undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO),
`the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the World Intellectual Property Office (WIPO),
`and any other intellectual property offices in which a foreign application claiming priority to the instant patent application
`is filed access to the instant patent application. See 37 CFR 1.14(c) and (h). This box should not be checked if the applicant
`does not wish the EPO, JPO, KIPO, WIPO, or other intellectual property office in which a foreign application claiming priority
`to the instant patent application is filed to have access to the instant patent application.
`
`In accordance with 37 CFR 1.14(h)(3), access will be provided to a copy of the instant patent application with respect
`to: 1) the instant patent application-as-filed; 2) any foreign application to which the instant patent application
`claims priority under 35 U.S.C. 119(a)-(d) if a copy of the foreign application that satisfies the certified copy requirement of
`37 CFR 1.55 has been filed in the instant patent application; and 3) any U.S. application-as-filed from which benefit is
`sought in the instant patent application.
`
`In accordance with 37 CFR 1.14(c), access may be provided to information concerning the date of filing this Authorization.
`
`Applicant Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title 37 of CFR
`to have an assignment recorded by the Office.
`
`Applicant (cid:9) 1
`If the applicant is the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be provided in this section is the name and address of the legal representative who is the applicant under 37 CFR
`1.43; or the name and address of the assignee, person to whom the inventor is under an obligation to assign the invention, or person
`who otherwise shows sufficient proprietary interest in the matter who is the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom the inventor is obligated to assign, or person who otherwise shows sufficient
`proprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
`
`Remove
`
`Clear
`
`0 Assignee
`
`0 (cid:9) Legal Representative under 35 U.S.C. 117
`
`0 (cid:9)
`
`Joint Inventor
`
`0 (cid:9) Person to whom the inventor is obligated to assign.
`
`0 (cid:9)
`
`Person who shows sufficient proprietary interest
`
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`Name of the Deceased or Legally Incapacitated Inventor :
`
`If the Applicant is an Organization check here.
`
`X
`
`Organization Name
`
`AbbVie Biotechnology Ltd
`
`Mailing Address Information:
`
`2 Church Street
`
`Clarendon House
`
`Hamilton
`
`Address 1
`
`Address 2
`
`City
`
`Country i BM
`
`Phone Number
`
`EFS Web 2.2.11
`
`State/Province
`
`Postal Code
`
`HM11
`
`Fax Number
`
`Ex. 1008 - Page 6 of 221
`
`

`

`PTOIAIA/14 (12-13)
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`110222-0005-310
`
`Application Number
`
`Title of Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`Email Address
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
`
`Add
`
`Assignee Information including Non-Applicant Assignee Information:
`
`Providing assignment information in this section does not subsitute for compliance with any requirement of part 3 of Title 37 of CFR to
`have an assignment recorded by the Office.
`
`Assignee (cid:9)
`
`1
`
`Complete this section if assignee information, including non-applicant assignee information, is desired to be included on the patent
`application publication . An assignee-applicant identified in the "Applicant Information" section will appear on the patent application
`publication as an applicant. For an assignee-applicant, complete this section only if identification as an assignee is also desired on the
`patent application publication.
`
`If the Assignee or Non-Applicant Assignee is an Organization check here. (cid:9) q
`
`Prefix
`
`Given Name
`
`Middle Name
`
`Family Name
`
`Suffix
`
`Remove
`
`Mailing Address Information For Assignee including Non-Applicant Assignee:
`
`Address 1
`
`Address 2
`
`City
`
`Country i
`
`Phone Number
`
`Email Address
`
`State/Province
`
`Postal Code
`
`Fax Number
`
`
`Additional Assignee or Non-Applicant (cid:9) Assignee Data may be (cid:9) generated
`selecting the Add button.
`
`
`
`
`within this form by
`
`
`
`Add
`
`Signature:
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4 for signature requirements and
`certifications
`
`Remove
`
`Signature
`
`/Brian M. Gummow/
`
`Date (YYYY-MM-DD) 2014-08-06
`
`First Name
`
`Brian
`
`Last Name Gummow
`
`Registration Number
`
`63933
`
`Additional Signature may be generated within this form by selecting the Add button. (cid:9)
`
`Add
`
`EFS Web 2.2.11
`
`Ex. 1008 - Page 7 of 221
`
`

`

`PTOIAIA/14 (12-13)
`Approved for use through 0113112014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`110222-0005-310
`
`Application Number
`
`Title of Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALPHA ASSOCIATED DISORDERS
`
`This collection of information is required by 37 CFR 1.76. 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 23 minutes to complete, including gathering, preparing, and submitting the completed application data
`sheet form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to
`complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR
`COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`EFS Web 2.2.11
`
`Ex. 1008 - Page 8 of 221
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the attached form related to
`a patent application or patent Accordingly, pursuant to the requirements of the Act, please be advised that: (1) the general authority for the collection
`of this 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 the Freedom of Information Act requires disclosure of these records.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`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.
`
`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.
`
`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).
`
`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.
`
`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)).
`
`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.
`
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of the application pursuant
`to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37
`CFR 1.14, as a routine use, to the public if the record was filed in an application which became abandoned or in which the proceedings were
`terminated and which application is referenced by either a published application, an application open to public inspections or an issued
`patent.
`
`9.
`
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law enforcement agency, if the
`USPTO becomes aware of a violation or potential violation of law or regulation.
`
`EFS Web 2.2.11
`
`Ex. 1008 - Page 9 of 221
`
`

`

`PTOIAIN01 (00-12)
`Approved for use through 0113112014. OMS 0051-0032
`U.S. Patent and Trademark Office; U.S DEPARTMENT OF COMMERCE
`Older the Paperwor% Reduction A6. of 1595, nc persons are reculred to respond ton ecilectkin cf inforinatlen unless is dOays a valid OMB control number.
`
`1'10222-0005-304
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`Title of
`Invention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING INF-ALPHA ASSOCIATED
`DISORDERS
`
`As the below named inventor, I hereby declare that:
`
`This declaration Xj The attached application, or
`is directed to:
`
`Li United States application or PCT international application number
`tiled on
`
`The above-identified application was made or authorized to be made by roe.
`
`I believe that I am the original inventor or an original joint inventor of a claimed invention in the application.
`
`I hereby acknowledge that any willful false statement made in this declaration is punishable under 18 U.S.C. 1C01
`by fine or imprisonment of not more than five (5) years, or both.
`
`WARNING:
`
`Petitioner/applicant Is cautioned to avoid submitting personal information in documents filed in a patent application that may
`contribute to identity theft. Personal information such as social security numbers, bank account numbers, or credit carts numbers
`(other than a check or credit card authorization form PTO-2038 submitted for payment purposes) is never required by the USPTO
`to support a petition or an application. If this type of personal information is included in documents submitted to the USPTO,
`patitionersiapplicants should consider redacting such personal information from the documents before submitting them to the
`USPTO. Petitioner/applicant is advised that the record of a patent application is available to the public after publication of the
`application (unless a non-publication request in compliance with 37 CFR 1.213(a) is made in the application) or issuance of a
`patent. Furthermore, the record from en abandoned application may also be available to the public if the application is
`referenced in a published application or an issued patent (see 37 CFR 1.14). Checks and credit card authorization forms
`P10-2038 submitted for payment purposes are not retained in the application file arid therefore are not publicly available.
`
`LEGAL NAME OF INVENTOR
`
`Inventor:
`
`Hans-Juergen Krause
`
`Date (Optional): (cid:9)
`
`4),
`
`Signature:
`
`Note: An application data sheet (PTO/S13/14 or equivalent); including naming the entire inventive entity. must accompany this form.
`Use an additional PTO/Ai/V(11 form for each additional inventor.
`
`Febtarl Unbekannter Name tar Dokurnentagensahart.
`
`Page 1 of 3
`
`Ex. 1008 - Page 10 of 221
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`IYFOIAl4/01 (06- ;2)
`Approved for igso through 011:3112014. OMB (`f i• (31332
`LiS, Patent arid Trademark OHice; 13.S. Oli)PARTMENT OF COMME1-iCE
`r:ootroi mater.
`tinder the: Paporwork Fiera/dim .4.1 of 1995, fic) persona are rvpited its ro&poral tip i ocIllo&tion of U11prc l lic r tiniest; if display: a valid (cid:9)
`
`1102n-0005-304
`DECLARATION (31 CFR '1,63) FOR UTILITY OR DESIGN APPLICATION MIK AN
`APPLICATION DATA SHEET (37 CFR 11$)
`
`Title of
`lInvention
`
`FORMULATION OF HUMAN ANTIBODIES FOR TREATING INF-ALPHA ASSOCIATED.
`DISORDERS
`
`As the below named inventor, I nerebv detlare that:
`
`Thia deolaration {X] The attached application, or
`is directed to:
`
`I United States application or PCT international application number
`filed on
`
`he above-identified 4iplication was made or authorized to be made by me.
`
`believe that I em the on
`
`(cid:9) inventor or an original .ioint inventor of a. claimed invention in the application.
`
`hereby acknowledge. that.any wilifui false statement made in this. declaration is punishable under 18: U.S,C, 1001
`by fine or imprisonment of not more than five (5) years, or both,
`
`WARNiNG
`Petitionoppiicant isoautionad taavoid 3ubrdiding personal information in documents filed in a patent application thai may
`contribute to identity theft. Personal information such as social rteatinty numbeis, bank account numbers, or credit card numbers
`(other than a check Or credit card authorization form PTO-2023 submitted for pays ni purposes) is never required bythe USPTO
`to support a petition or an application. If this type of personal information is included in documents submitted to the USPTO,
`petitioners/applicants should consider redacting such personal information from the documents before submitting them to the
`USPTO. Petitionedapplicant is advised that the fiX:Ord of a patent appiication Es available to the public after publication of the
`application (unless a non-publication request in compliance with 37 OFT-3'1.213(a) is made in the application) or issuance of a
`patent. Furthermore, the record from an abandoned application may also be available to the public it the application is
`referenced in a published application or an issued patent (see 37 C ER 1.1 4). Checks and credit card autharintion forms
`-, PTO-203B submitted forpayment purposes are not retained in the application file. and therefore are not publicly available.
`
`LEGAL NAME OF INVENTOR
`
`Inventor
`
`Signature:
`
`Lisa Baust
`
`Date (Optional): (cid:9)
`
`6 kkni
`
`Note: An application data sheet (PTO/S0/1 it or equivalent), including naming the entire inventive entity, must accompany this 1(}£[31.
`Use an additional NO/AW01 fontflor each additional inventor.
`
`actor; Hamm <34(1,:mRin poverty niztut,.
`
`Page 2 of
`
`Ex. 1008 - Page 11 of 221
`
`

`

`PTO/AAA/01 (06-12)
`Approved for use through 0113112014. OMB 0861-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a r..olectiort of inforrnagen uMess it displays a valid OMB control number.
`
`110222-0005-304
`
`DECLARATION (37 CFR 1,631 FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`Title of
`Invention
`
`FORMULATION OF HUMAN ANTI i3ODIES FOR TREATING TNF -ALPHA ASSOCIATED
`DISORDERS
`
`named inventor, I hereby declare that:
`As the below
`
`This declaration
`is directed to:
`
`X (cid:9)
`
`The attached application, or
`
`United States application or PCT international application number
`filed on
`
`application was made or authorized to be made by me.
`The above-identified
`
`am the original inventor or an original joint inventor of a claimed invention in the application.
`I believe that I
`
`that any wilful false statement made in this declaration is punishable under 18 U.S.0 1001
`t hereby acknowledge
`of not more than five (5) years, or both.
`by fine or imprisonment
`
`WARNING:
`
`is cautioned to avoid submitting personal information in documents tiled in a patent application that may
`Petitioner/applicant
`theft. Personal information such as social security numbers, bank account numbers, or credit card numbers
`contribute to identity
`or credit card authorization form PTO-2038 submitted for payment purposes) Is never required by the USPTO
`(other than a check
`or an application. If this type of personal information is included in documents submitted to the USPTO,
`to support a petition
`should consider redacting such personal info