`Document Description: TrackOne Request
`
`PTO/AIA/424 (04-14)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(e) (Page 1 of1)
`"
`Robert Frederick Veasey ST10'"" Applio'"ion
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`First Named
`Inventor:
`Title of
`Invention:
`
`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.
`
`i.
`
`3. The applicable box is checked below:
`I. Rl Original Application (Track One) - Prioritized Examination under § 1.102(e)(1)
`(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. n 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).
`
`/David M. Frischkorn/
`Signature
`David M. Frischkorn
`
`Name
`(Print/Typed)
`
`May 17, 2016
`Date
`32,833
`
`Practitioner
`Registration Number
`
`Note: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`Submit multiple forms if more than one signature is required. *
`
`|
`
`| Total of,
`
`forms are submitted.
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0001
`
`
`
`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:
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records may
`be disclosed to the Department of Justice to determine whether disclosure of these records is required by the
`Freedom of Information Act.
`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 inspection or an issued
`patent.
`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.
`
`9.
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0002
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/30/2017. 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
`Application Number
`
`10-1188-US-CON8
`
`Title of Invention
`
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`
`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:
`•
`Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`Inventor Information:
`
`Inventor
`1
`Legal Name
`
`Remove
`
`Tr
`
`Prefix Given Name
`obert
`Residence Information (Select One)
`City
`
`^/arwicksMre
`
`Middle Name
`Frederick
`US Residency
`
`Family Name
`easey
`• Non US Residency
`
`E
`
`Active US Military Service
`
`] Country of Residence
`
`E
`
`Mailing Address of Inventor:
`35 Hitchman Road, Leamington Spa
`Address 1
`
`Address 2 E
`
`City
`Postal Code
`
`arwickshire
`
`CV31 3QH
`
`State/Province
`Country!
`GB
`
`Inventor
`2
`Legal Name
`
`E
`
`Prefix Given Name
`obert
`Residence Information (Select One)
`City
`^/arwicksMre
`
`Mailing Address of Inventor:
`
`Remove
`
`Middle Name
`
`US Residency
`
`Family Name
`erkins
`<•) Non US Residency
`
`E
`
`Active US Military Service
`
`] Country of Residence
`
`E
`
`Suffix
`
`]
`
`Suffix
`
`]
`
`37 Erica Drive, Leamington Spa
`
`CV31 2RW
`
`| State/Province
`Country!
`GB
`
`Remove
`
`Address 1
`Address 2
`City
`^arwickshire
`Postal Code
`
`3
`Inventor
`Legal Name
`
`EFS Web 2.2.12
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0003
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/30/2017. 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.
`10-1188-US-CON8
`Attorney Docket Number
`Application Number
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`
`Prefix Given Name
`
`ai avid
`Residence Information (Select One)
`J/Vorcestershire
`City
`
`Middle Name
`Aubrey
`US Residency
`
`Family Name
`^lumptre
`<•) Ncn US Residency
`
`Active US Military Service
`
`] Country of Residence '
`
`E
`
`Suffix
`
`]
`
`Mailing Address of Inventor:
`
`36 Shire Way, Droitwich Spa
`
`Address 1
`Address 2
`City
`State/Province
`WR9 7RQ
`Postal Code
`Country!
`GB
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`orcestershire
`
`Add
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`Q An Address is being provided for the correspondence Information of this application.
`Customer Number
`38548
`Email Address
`PSGDOCKET@MBHB.COM
`
`Add Email
`
`Remove Email
`
`Application Information:
`Title of the Invention
`MPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`Attorney Docket Number 10-1188-US-CON8
`Small Entity Status Claimed Q
`Application Type
`^onprovisional
`Subject Matter
`Jtility
`Total Number of Drawing Sheets (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").
`
`Suggested Figure for Publication (if any)
`
`7
`
`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
`
`EFS Web 2.2.12
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0004
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/30/2017. 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.
`10-1188-US-CON8
`Attorney Docket Number
`Application Number
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`
`Publication Information:
`• Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`ReCjliest Not to Publish. I hereby request that the attached application not be published under
`|—| 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:
`Customer Number
`
`• Customer Number
`8548
`
`US Patent Practitioner
`
`O Limited Recognition (37 CFR 11.9)
`
`Domestic Benefit/National Stage Information:
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) or indicate
`National Stage entry from a PCT application. Providing benefit claim 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" field blank.
`
`Prior Application Status pending
`
`3
`
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Continuation of
`
`- 14946203
`
`2015-11-19
`
`^tented
`
`Continuity Type
`
`Prior Application Status
`Application
`Number
`14946203
`Continuation of
`Prior Application Status J
`atented
`Application
`Continuity Type
`Number
`14635573
`Continuation of
`Prior Application Status J
`atented
`Application
`Continuity Type
`Number
`13919251
`
`Division of
`
`EFS Web 2.2.12
`
`Prior Application
`Number
`- 14635573
`
`3
`
`Prior Application
`Number
`- 13919251
`
`3
`
`Prior Application
`Number
`13040198
`
`1
`
`Remove
`
`Filing Date
`(YYYY-MM-DD)
`2015-03-02
`
`Patent Number
`
`Issue Date
`(YYYY-MM-DD)
`
`3233211
`
`2016-01-12
`
`Remove
`
`Filing Date
`(YYYY-MM-DD)
`2013-06-17
`
`Patent Number
`
`3011391
`
`Issue Date
`(YYYY-MM-DD)
`2015-04-21
`
`Remove
`
`Filing Date
`(YYYY-MM-DD)
`2011-03-03
`
`Patent Number
`
`3512297
`
`Issue Date
`(YYYY-MM-DD)
`2013-08-20
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0005
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/30/2017. 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.
`10-1188-US-CON8
`Attorney Docket Number
`Application Number
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`
`Prior Application Status J
`atented
`Application
`Prior Application
`Continuity Type
`Number
`Number
`13040198
`• 11483546
`Continuation of
`Prior Application Status J
`bandoned
`
`3
`
`Remove
`
`Filing Date
`(YYYY-MM-DD)
`2006-07-11
`
`Patent Number
`
`7918833
`
`Issue Date
`(YYYY-MM-DD)
`2011-04-05
`
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`2004-03-02
`
`Add
`
`Application Number
`
`i
`
`1483546
`
`E
`
`Continuity Type
`
`Prior Application Number
`
`ontinuation of
`
`10790225
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`
`3
`3
`
`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. 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(i)(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).
`
`Filing Date (YYYY-MM-DD)
`Application Number
`[)304822.0
`^003-03-03
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
`
`W
`
`Country
`
`Remove
`
`Access Code (if applicable)
`
`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
`• 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.
`
`EFS Web 2.2.12
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0006
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/30/2017. 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.
`10-1188-US-CON8
`Attorney Docket Number
`Application Number
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`
`Authorization or Opt-Out of Authorization to Permit Access:
`
`When this Application Data Sheet is properly signed and filed with the application, applicant has provided written
`authority to permit a participating foreign intellectual property (IP) office access to the instant application-as-filed (see
`paragraph A in subsection 1 below) and the European Patent Office (EPO) access to any search results from the instant
`application (see paragraph B in subsection 1 below).
`
`Should applicant choose not to provide an authorization identified in subsection 1 below, applicant must opt-out of the
`authorization by checking the corresponding box A or B or both in subsection 2 below.
`
`NOTE: This section of the Application Data Sheet is ONLY reviewed and processed with the INITIAL filing of an
`application. After the initial filing of an application, an Application Data Sheet cannot be used to provide or rescind
`authorization for access by a foreign IP office(s). Instead, Form PTO/SB/39 or PTO/SB/69 must be used as appropriate.
`
`1. Authorization to Permit Access by a Foreign Intellectual Property Office(s)
`
`A. Priority Document Exchange (PDX) - Unless box A in subsection 2 (opt-out of authorization) is 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 State Intellectual Property Office of the People's Republic of
`China (SIPO), the World Intellectual Property Organization (WIPO), and any other foreign intellectual property office
`participating with the USPTO in a bilateral or multilateral priority document exchange agreement in which a foreign
`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
`and its related bibliographic data, (2) any foreign or domestic application to which priority or benefit is claimed by the
`instant application and its related bibliographic data, and (3) the date of filing of this Authorization. See 37 CFR 1.14(h)
`(1).
`
`B. Search Results from U.S. Application to EPO - Unless box B in subsection 2 (opt-out of authorization) is checked,
`the undersigned hereby grants the USPTO authority to provide the EPO access to the bibliographic data and search
`results from the instant patent application when a European patent application claiming priority to the instant patent
`application is filed. See 37 CFR 1.14(h)(2).
`
`The applicant is reminded that the EPO's Rule 141(1) EPC (European Patent Convention) requires applicants to submit a
`copy of search results from the instant application without delay in a European patent application that claims priority to
`the instant application.
`
`2. Opt-Out of Authorizations to Permit Access by a Foreign Intellectual Property Office(s)
`
`A. Applicant DOES NOT authorize the USPTO to permit a participating foreign IP office access to the instant
`• application-as-filed. If this box is checked, the USPTO will not be providing a participating foreign IP office with
`any documents and information identified in subsection 1A above.
`
`B. Applicant DOES NOT authorize the USPTO to transmit to the EPO any search results from the instant patent
`• application. If this box is checked, the USPTO will not be providing the EPO with search results from the instant
`application.
`NOTE: Once the application has published or is otherwise publicly available, the USPTO may provide access to the
`application in accordance with 37 CFR 1.14.
`
`EFS Web 2.2.12
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0007
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/30/2017. 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.
`10-1188-US-CON8
`Attorney Docket Number
`Application Number
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`
`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 1
`Remove
`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.
`,
`,
`
`Clear
`
`• Assignee
`
`Legal Representative under 35 U.S.C. 117
`
`Joint Inventor
`
`Person to whom the inventor is obligated to assign.
`
`Person who shows sufficient proprietary interest
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`a
`
`Name of the Deceased or Legally Incapacitated Inventor:
`
`If the Applicant is an Organization check here. ^
`Organization Name
`
`3ANOFI-AVENTIS DEUTSCHLAND GMBH
`Mailing Address Information For Applicant:
`Briiningstrasse 50, 65929
`Address 1
`Address 2
`City
`[l>E
`Country1
`Phone Number
`
`-rankfurt am Main
`
`State/Province
`Postal Code
`Fax Number
`
`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 substitute for compliance with any requirement of part 3 of Title
`37 of CFR to have an assignment recorded by the Office.
`
`EFS Web 2.2.12
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0008
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/30/2017. 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.
`10-1188-US-CON8
`Attorney Docket Number
`Application Number
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`
`Assignee 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.
`
`Remove •
`
`Suffix
`
`a
`
`Prefix
`
`Given Name
`
`HI
`
`Middle Name
`
`Family Name
`
`I
`
`Mailing Address Information For Assignee including Non-Applicant Assignee:
`
`Address 1
`Address 2
`City
`Country!
`
`Phone Number
`
`Email Address
`
`State/Province
`Postal Code
`
`Fax Number
`
`Additional Assignee or Non-Applicant Assignee Data may be generated within this form by
`selecting the Add button.
`
`Add
`
`Signature:
`Remove
`NOTE: This Application Data Sheet must be signed in accordance with 37 CFR 1.33(b). However, if this Application
`Data Sheet is submitted with the INITIAL filing of the application and either box A or B is not checked in
`subsection 2 of the "Authorization or Opt-Out of Authorization to Permit Access" section, then this form must
`also be signed in accordance with 37 CFR 1.14(c).
`This Application Data Sheet must be signed by a patent practitioner if one or more of the applicants is a juristic
`entity (e.g., corporation or association). If the applicant is two or more joint inventors, this form must be signed by a
`patent practitioner, aM joint inventors who are the applicant, or one or more joint inventor-applicants who have been given
`power of attorney (e.g., see USPTO Form PTO/AIA/81) on behalf of aM joint inventor-applicants.
`See 37 CFR 1.4(d) for the manner of making signatures and certifications.
`
`Signature
`
`'David M. Frischkom/
`
`Date (YYYY-MM-DD)
`
`2016-05-17
`
`First Name
`
`David M.
`
`Last Name
`
`Frischkorn
`
`Registration Number
`
`32833
`
`Additional Signature may be generated within this form by selecting the Add button.
`
`Add
`
`EFS Web 2.2.12
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0009
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/30/2017. 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.
`10-1188-US-CON8
`Attorney Docket Number
`Application Number
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJECTOR
`
`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 2.2.12
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0010
`
`
`
`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
`
`2.
`
`3
`
`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.
`
`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.
`
`4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for the information in order to perform
`a contract. Recipients of information shall be required to comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C.
`552a(m).
`
`5.
`
`6.
`
`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 CooperationTreaty.
`
`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 byGSA 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.
`
`£
`
`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 2.2.12
`
`Mylan Exhibit - 1009
`Mylan v. Sanofi
`
`0011
`
`
`
`SPECIFICATION
`
`TITLE
`IMPROVEMENTS IN AND RELATING TO A PEN-TYPE INJE