throbber
DocCode — SCORE
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: 15837677
`
`Document Date: 12/11/2017
`
`The presenceof 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 imagesin the IFW
`record were created from the original documentsthat are stored in SCORE.
`
`Drawing
`
`At the time of document entry (noted above):
`e USPTO employees may access SCORE content via eDAN using the Supplemental Content
`tab, or via the SCORE web page.
`e External customers may access SCORE content via PAIR using the Supplemental Content
`tab.
`
`Form Revision Date: August 26, 2013
`
`Page 1 of 355
`
`CSL EXHIBIT 1002
`
`Page 1 of 355
`
`CSL EXHIBIT 1002
`
`

`

`DocCode — SEQ. TXT
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: 15837677
`
`Document Date: 12/11/2017
`
`The presence ofthis 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 documentsor physical media exist. The TIFF images in the IFW
`record were created from the original documents that are stored in SCORE.
`
`SequenceListing
`
`At the time of documententry (noted above):
`e USPTO employees may access SCORE content via eDAN using the Supplemental Content
`tab, or via the SCORE webpage.
`e External customers may access SCORE content via PAIR using the Supplemental Content
`tab.
`
`Form Revision Date: August 26, 2013
`
`Page 2 of 355
`
`Page 2 of 355
`
`

`

`PTO/AIA/15 (03-13)
`Approved for use through 01/31/2014. 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 displays a valid OMB control number
`
`UTILITY
`
`PATENTAPPLICATION
`
`ADDRESS TO:
`
`N/A; Electronically fi led
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`ACCOMPANYING APPLICATION PAPERS
`
`AssignmentPapers
`(cover sheet & document(s))
`Nameof Assignee
`
`
`J
`
`Under 35 U.S.C. 122(b)(2)(B)(i). Applicant must attach form PTO/SB/35
`or equivalent.
`
`Other; Certification and Requestfor Prioritized Examination
`
`Under 37 CFR 1.102(e)
`
`
`
`
`
`
`]
`[Total Pages 16
`Specification
`Both the claims and abstract must start on a new page.
`(See MPEP § 608.01(a) for information on the preferred arrangement}
`5.L%] Drawing(s) (35 U.S.C. 113)
`[Total Sheets 2
`Information Disclosure Statement
`6. Inventor’s Oath or Declaration
`[Total Pages 10
`(PTO/SB/08 or PTO-1449)
`(including substitute statements under 37 CFR 1.64 and assignments
`Copiesofcitations attached
`serving as an oath or declaration under 37 CFR 1.63(e}}
`: EC] Newly executed (original or copy)
`Preliminary Amendment
`. [-] A copy fromaprior application (37 CFR 1.63(d))
`Return Receipt Postcard
`(MPEP § 503) (Should be specifically itemized)
`Application Data Sheet
`* See note below.
`See 37 CFR 1.76 (PTO/AIA/14 or equivalent)
`Certified Copy of Priority Document(s}
`CD-ROM or CD-R
`(ifforeign priority is claimed)
`in duplicate, large table, or Computer Program (Appendix)
`EC] Landscape Table on CD
`9. Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. —c. are required)
`a.
`Computer Readable Form (CRF)
`b. C] Specification SequenceListing on:
`i. [| CD-ROM or CD-R(2 copies); or
`if | Paper
`Statementsverifying identity of above copies
`
`Powerof Attorney
`
`37 CFR 3.73(c) Statement
`(whenthere is an assignee)
`English Translation Document
`(if applicable)
`
`Hoo
`OOOf Nonpublication Request
`
`TRANSMITTAL
`(Onlyfor new nonprovisionai applications under 37 CFR 1.53{b)}
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`1.[_] Fee Transmittal Form
`(PTO/SB/17 or equivalent)
`Applicant asserts small entity status.
`See 37 CFR 1.27
`Applicant certifies micro entity status. See 37 CFR 1.29.
`Applicant must attach form PTO/SB/15AorB or equivalent.
`
`]
`
`
`
`a b
`
`c.
`
`*Note:
`
`(1) Benefit claims under 37 CFR 1.78 and foreign priority claims under 1.55 must be included in an Application Data Sheet (ADS).
`(2) For applications filed under 35 U.S.C. 111, the application must contain an ADSspecifying the applicant if the applicant is an
`assignee, person to whom the inventor is under an obligation to assign, or person who otherwise showssufficient proprietary
`interest in the matter. See 37 CFR 1.46(b).
`19. CORRESPONDENCE ADDRESS
`
`The address associated with Customer Number: 199375
`Name
`Address
`cry |starePT Zio code
`country|i telephone|Eel
`Signature
`//Julio J. Mendez/
`December 11, 2017
`Name
`73,848
`[Julio J. Mendez
`Noreoe)
`This collection of information is required by 37 CFR 1.53(b). The information is required to obtain or retain a benefit by the public whichis tofile (and by the USPTO
`to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14.This collection is estimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending uponthe individual case. Any comments on
`the amountof time you require to complete this form and/or suggestions for reducing this burden, should be sentto the Chief Information Officer, U.S. Patent and
`TrademarkOffice, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMSTO THIS ADDRESS. SEND
`TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`ifyou need assistance in completing the form, call 1-800-PTO-9199 and select option 2.
`
`OR [| Correspondenceaddress below
`
`Registration No.
`
`Page 3 of 355
`
`Page 3 of 355
`
`

`

`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 mayresult in termination
`of proceedings or abandonmentof the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of
`records may be disclosed to the Department of Justice to determine whether disclosure of these
`records is required by the Freedom ofInformation Act.
`A record from this system of records may be disclosed, as a routine use, in the course of presenting
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`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
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`A record in this system of records may bedisclosed, 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 agencyfor
`purposesof 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 managementpractices and programs,
`under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the
`GSAregulations governing inspection of records for this purpose, and any other relevant (/.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 wasfiled in an application which became abandonedor 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.
`
`Page 4 of 355
`
`Page 4 of 355
`
`

`

`
`
`Sub-Total in
`Amount
`Fee Code
`Quantity
`Description
`USD($)
`
`
`
`600
`
`720
`
`4000
`
`6
`
`00
`
`720
`
`4000
`
`1
`
`1 1
`
`1311
`
`1817
`
`280
`280
`UTILITY APPLICATION FILING
`
`
`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`Title of Invention:
`
`C1-INH COMPOSITIONS AND METHODSFOR THE PREVENTION AND
`TREATMENT OF DISORDERS ASSOCIATED WITH C1 ESTERASE INHIBITOR
`DEFICIENCY
`
`First Named Inventor/Applicant Name:
`
`Attorney Docket Number:
`
`Filing Fees for Track | Prioritized Examination - Nonprovisional Application under 35 USC 111(a)
`
`
`
`Basic Filing:
`
`UTILITY SEARCH FEE
`
`UTILITY EXAMINATION FEE
`
`REQUEST FOR PRIORITIZED EXAMINATION
`
`Miscellaneous-Filing:
`
`Page 5 of 355
`
`Page 5 of 355
`
`

`

`Description
`
`Fee Code
`
`antit
`
`Sub-Total in
`
`PROCESSING FEE, EXCEPT PROV. APPLS
`
`1830
`
`1
`
`140
`
`140
`
`Total in USD (S$)
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance
`
`Extension-of-Time:
`
`Miscellaneous:
`
`Page 6 of 355
`
`Page 6 of 355
`
`

`

`
`
`aa a
`
`Electronic AcknowledgementReceipt
`
`ae
`
`e
`
`Title of Invention:
`
`C1-INH COMPOSITIONS AND METHODSFOR THE PREVENTION AND
`TREATMENT OF DISORDERS ASSOCIATED WITH C1 ESTERASE INHIBITOR
`DEFICIENCY
`
`First Named Inventor/Applicant Name:
`
`Stephen Ruddy
`
`Customer Number:
`
`139375Pe
`
`e
`
`Utility under 35 USC 111{a)
`Application Type:
`
`
`Paymentinformation:
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`
`
`[Beposkaccune——SSSSCSiS
`
`Page 7 of 355
`
`Page 7 of 355
`
`

`

`
`
`Pages
`Multi
`File Size(Bytes)/
`Document Description
`Document
`
`
`
`Number Message Digest|Part/.zip|P (if appl.)
`1823566
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`Application Data Sheet
`
`1204US3_ADS.PDF
`
`85ecfdc01 bf30b472fc1¢34c1f75e1 36fc3f1
`cc
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`Information:
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`TrackOne Request
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`1204US3_Certification_and_Re|
`quest_for_Prioritized_Examinat
`ion.PDF
`
`2342983427f081329dd39303¢Ibecc316a
`51105,
`
`142243
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`Information:
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`439215
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`Oath or Declaration filed
`
`1204US3_DECLARATION.pdf
`
`fef635983f5765ebcb10845a9ee4056b9f8er
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`
`
`Claims
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`Warnings:
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`Power of Attorney
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`1204US3_POA.pdf
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`d6ae2299b3f57697146144408feb755796aq)
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`131530
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`135988
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`1204US3_FIRST_PRELIMINARY
`AMENDMENT.pdf
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`1982608c310da1d6873592f896b9185069F
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`Multipart Description/PDF files in .zip description
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`DocumentDescription
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`Preliminary Amendment
`
`Specification
`
`Information:
`
`Page 8 of 355
`
`Page 8 of 355
`
`

`

`Applicant Arguments/Remarks Made in an Amendment
`
`Warnings:
`Information:
`
`3304781
`
`
`
`1204US3_SPECIFICATION.pdf
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`4478258b59d268a38e47bS0f769b70024f3}
`dfdbc
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`Multipart Description/PDF files in .zip description
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`
`
`
`Information:
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`DocumentDescription
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`Specification
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`Claims
`
`Warnings:
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`Drawings-other than black and white
`.
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`1204US3_DRAWINGS.pdf
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`88392a5c9070U441063659.8a6338ddd}
`84567
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`SequenceListing (Text File)
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`SHR-1204US_ST25.TXT
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`Information:
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`Transmittal Letter
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`SHR_1204US3_Letter.pdf
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`b4bd0760bt83ed70d1 7a79at0281 Sbac767|
`64a31
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`Information Disclosure Statement (IDS)
`Form (SB08)
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`SHR_1204US3_SB08.pdf
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`3aeeal2f4c2dba7a8641 82aa0eeeeh9ch20
`daa70
`
`
`
`Warnings:
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`This is not an USPTO supplied IDSfillable form
`
`Page 9 of 355
`
`Page 9 of 355
`
`

`

`Non Patent Literature
`
`1204US_C12_R7_Press.pdf
`
`c02ea41b777e31740191 24aec407b2e7170}
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`Information:
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`3006303
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`Non Patent Literature
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`1204US_C50_IPR_Petition_US9
`616111.pdf
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`d262d7e41272a6962c58a2c9375d89te62a|
`20349
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`Information:
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`Non Patent Literature
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`1204US_C51_R4_CSL.pdf
`
`7A43cf57d 12ef500 1e078a635 N081 2h6cA
`Sb7a
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`Warnings:
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`Non Patent Literature
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`1204US_C59_R1_Excerpt.pdf
`
`2ba9e8171f31024c0a261515ada448a1850)
`7026
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`170576
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`Non Patent Literature
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`1204US_C70_CAA30314.pdf
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`e72b8b7bcd567cSfatd21fd78d6f655 1678
`1e49
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`790497
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`
`
`
`
`
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`Non Patent Literature
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`1204US_C85_R2_Informed.pdf fec2b27ee1 8c93881501 e6547dea07ae7abel
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`Warnings:
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`Information:
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`1667120
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`ac68e05987¢3bfe8252fdasnfd9fadés3h2e}
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`1204US_C100_R3_Declaration.
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`Non Patent Literature
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`Warnings:
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`
`Page 10 of 355
`
`Page 10 of 355
`
`

`

`Non Patent Literature
`
`1204US_C114_R12_Material.
`pdf
`
`8794fdf618d553 1bd33dd83fa7d3584fea:
`4
`
`119033
`
`Information:
`
`1017902
`
`Non Patent Literature
`
`1204US_C131_R6_ViroPharma
`_Poster.pdf
`
`ac23ebb91cf7e09341 6c6c94e0668026259)
`7dd67
`
`
`
`Information:
`
`
`Warnings:
`
`Information:
`
`Non Patent Literature
`
`1204US_C141_Protest.pdf
`
`9ab6l Of78ddb077dch7c70.683cd 3a8c2F5 9
`Aca43
`
`577982
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`Warnings:
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`Non Patent Literature
`
`1204US_C38_Progress_in_Phar]
`maceutical_Sciences.pdf
`
`ad622e89ea93d467acc5d01f24b94c46e08)
`cadol
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`264289
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`Transmittal of New Application
`
`SHR-1204US3_UTILITY_TRANS
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`
`17547¢5860164b1fe2b9970f32ca05a8411
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`278822
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`fee-info.pdf
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`fec8eb334427cf048979773b8060a0cet1595
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`Page 11 of 355
`
`Page 11 of 355
`
`

`

`This Acknowledgement Receipt evidences receipt on the noted date by the USPTOofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable.It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`the application.
`
`New Applications Under 35 U.S.C. 111
`If a new applicationis being filed and the application includes the necessary componentsfora 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 shownonthis
`Acknowledgement Receiptwill establish thefiling date of the application.
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903indicating acceptance of the application as a
`national stage submission under35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`andof the International Filing Date (Form PCT/RO/105)will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receiptwill establish the international filing date of
`
`Page 12 of 355
`
`Page 12 of 355
`
`

`

`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.
`
`Title of Invention|AsgoclATED WITH C1 ESTERASE INHIBITOR DEFICIENCY
`
`ati
`Application Data Sheet 37 CFR 1.76
`Application Number
`C1-INH COMPOSITIONS AND METHODS FOR THE PREVENTION AND TREATMENT OF DISORDERS
`
`The application data sheetis part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arrangedin 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 maybe printed and included in a paperfiled application.
`
`Secrecy Order 37 CFR 5.2:
`
`Oo Portionsorall of the application associated with this Application Data Sheet mayfall under a Secrecy Order pursuantto
`
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may notbefiled electronically.)
`
`Inventor Information:
`
`
`Middle Name
`
`
`
`ResidenceInformation (Select One)
`
`@ US Residency
`
`Non US Residency
`
`Active US Military Service
`
`
`Mailing Addressof Inventor:
`pAddresst—[eoseuimbme
`Address?|
`
`
`|city| xton State/Province PA
`
`[PostalCode«pee——SSCSC~idoutsWS
`mentebo
`Legal Name
`
`[Pret]GivenName_—«d;MiddleName————*idFamilyNameSi
`a
`
`Non US Residency
`Active US Military Service
`
`Residence Information (Select One)
`
`(@) US Residency
`
`
`
`
`Mailing Addressof Inventor:
`
`I630Sorrel Lane
`Address 1
`Address 2
`
`
`reity|fomnsiomn—__] StateProvinee | F
`
`
`Postal Code
`g
`-
`i
`| US
`
`Inventor
`Ri
`PetSreneneieee[enoneot
`
`HiBe|F a
`Residence Information (Select One)
`(@) US Residency
`Non US Residency
`Active US Military Service
`
`
`Legal Name
`
`EFS Web 2.2.12
`
`Page 13 of 355
`
`Page 13 of 355
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`

`

`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 unlessit contains a valid OMB control number.
`
`Attorney Docket Number|SHR-1204US3
`Application Data Sheet 37 CFR 1.76
`—
`Application Number
`
`Title of Invention
`
`C1-INH COMPOSITIONS AND METHODS FOR THE PREVENTION AND TREATMENT OF DISORDERS
`ASSOCIATED WITH C1 ESTERASE INHIBITOR DEFICIENCY
`
`
`
`
`
`
`
`=~stal Code
`
`
`
`State/Province
`| US
`
`| ko
`
`Information blocks may be
`Inventor
`Inventors Must Be Listed - Additional
`All
`generated within this form by selecting the Add button.
`
`
`Correspondence Information:
`
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`
`|]An Addressis being provided for the correspondence Information of this application.
`Customer Number
`i 39375
`Email Address
`| DocketingBioPatentBoston@proskauer.com
`
`
`
`
`
`Application Information:
`
`Small Entity Status Claimed
`
`_[]
`
`
`
`
`Total Numberof Drawing Sheets {if any) Bo Suggested Figure for Publication (if any) ||
`Filing By Reference:
`
`Only complete this section whenfiling an application by reference under 35 U.S.C. 111(c) and 37 CFR 1.57(a). Do not complete this sectionif
`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 purposesofa 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). i
`Application numberof the previously
`Filing date (YYYY-MM-DD)
`Intellectual Property Authority or Country
`filed application
`
`Po
`
`
`publication at eighteen months afterfiling. EFS Web 2.2.12
`
`Publication Information:
`
`
`
`
`
`Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`Request Not to Publish. | hereby requestthat 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
`
`Page 14 of 355
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`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 unlessit contains a valid OMB control number.
`
`Attorney Docket Number|SHR-1204US3
`Application Data Sheet 37 CFR 1.76
`Application Number
`C1-INH COMPOSITIONS AND METHODS FOR THE PREVENTION AND TREATMENT OF DISORDERS
`
`Title of Invention|agsociATED WITH C1 ESTERASE INHIBITOR DEFICIENCY
`
`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 powerof 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.
`
`
`i 39375
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`Please Select One:
`Customer Number
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`e@ Customer Number
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`US Patent Practitioner © Limited Recognition (37 CFR 11.9)
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`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.
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`Application Number
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`Continuity Type
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`Filing or 371(c) Date
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`Prior Application Status [Patented[Remove|
`Application
`Prior—— Filing Date
`Fowe| Date
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`Number
`Continuity Type
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`Patent Number
`YYYY-MM-DD)
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`fseataras |entiationot Epfaesstes 4"09-15
`por04-11
`
`
`
`|per6111
`
`Filing or 371(c) Date
`Continuity Type
`(YYYY-MM-DD)
`Prior Application Number
`Application Number
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`
`| ontinuatonof=f PCTUS1430309
`| 41855168
`2014-03-17
`Prior Application Status [Exired
`Remove
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`2013-03-15
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`Prior Application Number
`Continuity Type
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`-| 61791399
`| laims benefit of provisional
`| PCTUS1430309
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`by selecting the Add button.
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`Foreign Priority Information:
`EFS Web 2.2.12
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`Page 15 of 355
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`Page 15 of 355
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`

`

`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 unlessit contains a valid OMB control number.
`
`Attorney Docket Number|SHR-1204US3
`Application Data Sheet 37 CFR 1.76
`—
`Application Number
`C1-INH COMPOSITIONS AND METHODS FOR THE PREVENTION AND TREATMENT OF DISORDERS
`Title of Invention|associATED WITH C1 ESTERASE INHIBITOR DEFICIENCY
`
`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).
`
`Remove
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`Application Number
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`Filing Date (YYYY-MM-DD)
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`Access Codel (if applicable)
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`Add button.
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`Additional Foreign Priority Data may be generated within this form by selecting the
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`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 effectivefiling 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 underthefirst inventorto file provisions of the AIA.
`
`EFS Web 2.2.12
`
`Page 16 of 355
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`

`

`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 unlessit contains a valid OMB control number.
`
`Attorney Docket Number|SHR-1204US3
`Application Data Sheet 37 CFR 1.76
`Application Number
`C1-INH COMPOSITIONS AND METHODS FOR THE PREVENTION AND TREATMENT OF DISORDERS
`
`Title of Invention|associATED WITH C1 ESTERASE INHIBITOR DEFICIENCY
`
`application in accordance with 37 CFR 1.14.
`
`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 Ain subsection 1 below) and the European Patent Office (EPO) access to any search results from the instant
`application (see paragraphB 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 processedwith 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 USPTOin a bilateral or multilateral priority document exchange agreementin which a foreign
`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
`andits 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 offiling 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 accessto 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 ForeignIntellectual 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 USPTOwill not be providing a participating foreign IP office with
`any documents and information identified in subsection 1A above.
`
`[_]
`
`B. Applicant DOES NOT authorize the USPTOto transmit to the EPO any search results from the instant patent
`application. If this box is checked, the USPTOwill not be providing the EPO with search results from the instant
`application.
`NOTE: Oncethe application has published or is otherwise publicly available, the USPTO may provide accessto the
`
`EFS Web 2.2.12
`
`Page 17 of 355
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`Page 17 of 355
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`

`

`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 unlessit contains a valid OMB control number.
`
`
`Attorney Docket Number|SHR-1204US3
`Application Data Sheet 37 CFR 1.76
`Application Number
`C1-INH COMPOSITIONS AND METHODS FOR THE PREVENTION AND TREATMENT OF DISORDERS
`
`Title of Invention|associATED WITH C1 ESTERASE INHIBITOR DEFICIENCY
`
`Applicant Information:
`
`
`Providing assignmentinformation 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.
`
`
`4
`Applicant
`If the applicantis the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be providedin this section is the name and addressof the legal representative whois the applicant under 37 CFR
`1.43; or the name and addressof the assignee, person to whom the inventor is under an obligation to assign the invention, or person
`who otherwise showssufficient proprietary interest in the matter whois the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom the inventoris obligated to assign, or person who otherwise showssufficient
`proprietary interest) together with one or morejoint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
`
`Legal Representative under 35 U.S.C. 117
`
`Joint Inventor
`
`Person to whom theinventoris 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:
`
`
`
`
`
`
`Name of the Deceased or Legally Incapacitated Inventor:
`
`If the Applicant is an Organization check here.
`
`x
`
`Organization Name
`
`: Shire ViroPharmaIncorporated
`
`Mailing Address Information For Applicant:
`
`Address 1
`
`Address 2
`
`300 Shire Way
`
`
`
`Email Address
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
`
`Assignee Information including Non-Applicant Assignee Information:
`
`
`Providing assignmentinformation in this section does not substitute for compliance with any requirementof part 3 ofTitle
`37 of CFR to have an assignment recordedby the Office.
`
`
`EFS Web 2.2.12
`
`Page 18 of 355
`
`Page 18 of 355
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`

`

`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 unlessit contains a valid OMB control number.
`Attorney Docket Number|SHR-1204US3
`Application Data Sheet 37 CFR 1.76
`Application Number
`C1-INH COMPOSITIONS AND METHODS FOR THE PREVENTION AND TREATMENT OF DISORDERS
`Title of Inventi

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