PTOVAIAM 4 (02-18)
`Approved for use through 11/30/2020. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under ithe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information uniess it contains a valid OMB control number.
`
`i Application Number
`
`PEDIATRIC SUSPENSION FORMULATION
`Title of invention
`IeceeceeceeceeeeeeeeeeeeeceteeeceeceenneeneeeetentnetatneAnneeEEEEEEEREneetntonnenntnneeennenennentnntentnntantnntnntenteneenenn
`The application data sheet is part of the provisional or nonprovisicnal application for which i is being submitted. Thefollowing 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 may be printed and inchided in a paperfiled 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)
`
`
`
`rfttttttttttA
`
`inventor Information:
`
`
`i 4 inventor
`
`
`i Legal Name
`| Suffix
`Family Name
`Prefix,GivenName Middle Name
`|
`Clancy
`Maurice
`Joseph Anthony
`() Active US Military Service
`@) Non US Residency
`Residence Information (Select One) () US Residency
`
`
`(Mailing Address of Inventor:
`Address 14
`c/o Xeolas Pharmaceuticals Ltd.
`
`fF
`| Address 2
`
`
`
`DGU Gampus
`
`
`
`| Inventor
`i Legal Name
`Prefix]GivenName Middie Name
`
`Family Name
`
`| Suffix
`
`Residence Information (Select One} © US Residency
`@) Non US Residency
`©) Active US Military Service
`‘Country of Residence!
`City
`
`(Mailing Address of Inventor:
`i Address 1
`cio Keolas Pharmaceuticais Ltd.
`annnnnnn
`
`
`
`DCU Campus
`
`i Address 2
`
`3
`inventor
`i
`
`i Legal Name
`
`EFS Web 2.2.43
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`

`

`PTOVAIAM 4 (02-18)
`Approved for use through 11/30/2020. 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 ———_____{+_____eee
`i Attomey Docket Number|4384.0010002/MSB/THN
`
`| Application Number
`
`
`
`Title of Invention
`PEDIATRIC SUSPENSION FORMULATION
`
`
`iCountry of Residence|
`
`i“Address 1
`"Address 2
`
`
`
`DCU Campus
`
`Dublin 9
`
`State/Province
`
`Inventor Information blocks may be
`Inventors Must Be Listed - Additional
`All
`
`i generated within this forrn by selecting the Add button.
`
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence information section below.
`i For further information see 37 CFR 1.33{a).
`| [| An Address is being provided for the correspondence Information of this application.
`| Customer Number
`26111
`
`Email Address
`
`f-----------------------------------------------------------=
`
`Application Information:
`
`
`| Title of the Invention
`{ PEEHATRIC SUSPENSION FORMULATION
`
`_Aitomey Docket Numbe
`| 4384,0010002/MS8/THN
`Small Entity Status Claimed [|
`
`
`Provisional
`
`
`| Suggested Figure for Publication (if any}
` Filing By Reference:
`
`
`Only complete this section whenfiling an application by reference under 35 U.S.C. 11 1(c} and 37 CFR 1.57(a). Do not complete this section if
`lapplication papers including a specification and any drawings are being filed. Any dornestic benefit orforeignpriority information must be
`
`iprovidedin the appropriate section(s) below ({Le., “Domestic Benefit/National Stage information” and “Foreign Priority information”).
`
`iFor the purposes ofa filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
`;
`ireference to the previously filed application, subject to conditions and requirernents of 37 CFR 1.57(a).
`| Application numberof the previously
`Filing date (YYYY-MM-DD}
`Intellectual Property Authority or Country ,
`
`filed application
`
`

`

`PTOVAIAM 4 (02-18)
`Approved for use through 11/30/2020. 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.
`
`
`
`
`
`. Attorney Docket Number|4384.0010002/MSB/THN.
`| Application Data Sheet 37 CFR 1.76 -————renaen
`
`| Application Number
`
`
`Title of Invention
`PEDIATRIC SUSPENSION FORMULATION
`
`
`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(0) and certify that the invention disclosed in the attached application has not and will not be ihe
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen monthsafter filing.
`
`Representative information:
`
`i 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.
`
`
`
`
`Domestic Benefit/National Stage information:
`iThis 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
`iNational Stage entry from a PCT application. Providing benefit claim information in the Application Data Sheet constitutes
`ithe specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
`iWhen referring to the current application, please leave the “Application Number”field blank.
`
`Filing of 371(¢) Date
`(YYY-MM-DD)
`Prior Application Number
`Continully Type
`Application Number
`nnnnnnnnnnnnnnn
`
`t
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`Additional Domestic Benefit/National Stage Data may be generated within this form
`| by selecting the Add button.
`
`Foreign Priority information:
`
`iThis section allows for the applicant fo claim oriority to a foreign application. Providing this information in the application data sheet
`constitutes the claimfor priory as required by 35 U.S.C. 119(b) and 37 CFR 1.55. When priority is claimed to a foreign application
`ithat is eligible for retrieval under the priority document exchange program (PDX)! the information wil be used by the Office to
`lautornatically attempt retrieval pursuant to 37 CFR 1.55()(1} and @). Under ihe PDX program, applicant bears ine ultimate
`responsibility for ensuring that a copy of ihe foreign application is received by the Office from the participating foreign intellectual
`iproperty office, or a certified copy of the foreign priority application is fled, within the time period specified in 37 CFR 1.55(g\(1).
`
`EFS Web 2.2.13
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`

`

`PTOVAIAM 4 (02-18)
`Approved for use through 11/30/2020. 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 ———_____{+_____eee
`i Attomey Docket Number|4384.0010002/MSB/THN
`
`| Application Number
`
`| Title of Invention
`PEDIATRIC SUSPENSION FORMULATION
`
`
`
` Application Number
`
`
`
`Country!
`Filing Date (YYY-MM-BD)
`Access Code! (f applicable)
`
`
`
`i Additional Foreign Priority Daia may be generated within this form by selecting the
`| Add button.
`
`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 io a claimed invention that has an effective filing date on or after March
`|
`i [| 16, 2043.
`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
`16, 2073, will be examined under the first inventor to file provisions ofthe AIA.
`
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`

`

`PTOVAIAM 4 (02-18)
`Approved for use through 11/30/2020. 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.
`
`
`
`. Attorney Docket Number|4384.0010002/MSB/THN.
`
`| Application Data Sheet 37 CHR V0nnn
`| Application Number
`
`
`
`
`Title of Invention
`PEDIATRIC SUSPENSION FORMULATION
`
`
`Authorization or Opt-Out of Authorization to Permit Access:
`
`iWhen this Application Data Sheet is properly signed andfiled with the application, applicant has provided written
`iauthority to permit a participating foreign intellectual property (iP) office access to the instant application-as-fited (see
`iparagraph Ain subsection 1 below) and the European Patent Office (EPO) access to any search results from the insiant
`iapplication (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
`iauthorization by checking the corresponding box A or B or both in subsection 2 below.
`NOTE: This section of the Application Data Sheet isONLY 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
`iauthorization for access by a foreign IP office(s).
`Instead, Form PTO/SB/38 or PTO/SB/6$ must be used as appropriate.
`
`4. Authorization to Permit Access by a Foreign intellectual Property Office(s}
`
`jundersigned hereby grants the USPTO authority to provide the European Patent Office (EPO), the Japan Patent Office
`i(JPO), the Korean Intellectual Properly Office (KIPO)}, the State Intellectual Property Office of the People’s Republic of
`iChina (SIPQ), the Worldintellectual 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
`lapplication claiming priority to the instant patent applicationis fled, accessto: (1) the instant patent application-as-filed
`iand 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 G) the date of filing of this Authorization. See 37 CFR 1.744)
`(4).
`B. SearchResultsfromU.S.ApplicationtoEPO - Unless box B in subsection 2 (opt-out of authorization) is checked,
`ithe undersigned hereby grants the USPTO authority to provide ihe EPO accessto the bibliographic data and search
`iresults from the instant patent application when a European patent application claiming priority to the instant patent
`iapplication is filed. See 37 CFR 1.14(n}(2).
`The applicant is reminded that the EPO’s Rule 141(4) EPC (European Patent Convention) requires applicants fo submit a
`icopy of search results from the instant application without delay in a European patent application ihat claimspriority to
`ithe instant application.
`doneecneetanenenentntnatetanetenetnatetanttanteetetanttanttintetatttinttanttetetanttinttiatetatttinttentttatttatttintttetttanttinttsatttetttanttintttatttatetintttetttanttinttintetatttanttintttatetanetententetatetaneed
`| 2. Opt-Out of Authorizations to PermAccess 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
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`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
`in application. lf this box is checked, the USPTO will not be providing the EPO with search results fram the instant
`application.
`NOTE: Once the application has published oris otherwise publicly available, the USPTO mayprovide access to the
`lapplication in accordance with 37 CFR 1.14.
`
`EFS Web 2.2.13
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`

`

`PTOVAIAM 4 (02-18)
`Approved for use through 11/30/2020. 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 ———_____{+_____eee
`i Attomey Docket Number|4384.0010002/MSB/THN
`
`| Application Number
`
`
`
`Title of Invention
`PEDIATRIC SUSPENSION FORMULATION
`
`
`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.
`|
`nnnnnnnnnnnn
`
`4
`i Applicant
`if the applicant is the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`iThe information to be provided in this section is the name and address of the legal representative who is the applicant under 37 CFR
`i 43: or the name and address of the assignee, person to whomthe inventor is under an obligation to assign the invention, or person
`iwho otherwise shows sufficient proprietary interest in the matter who is the applicant under 37 GFR 1.46. If the applicantis an
`lapplicant under 37 CFR 1.46 (assignee, person to whornthe inventor is obligated to assign, or person who otherwise shows sufficient
`iproprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`lidentified in this section.
`
`Joint Inventor
`
`\@) Assignee
`
`C) Legal Representative under 35 U.S.C. 117
`
`©)
`
`Person who shows sufficient proprietary interest
`iC)
`iC) Person to whom theinventor is obligated to assign.
`iif applicant is the legal representative, indicate the authority to file the patent application, the inventoris:
`
` |Name of the Deceased or Legally incapacitated Inventor:
`
` | ifthe Applicant is an Organization check here.
`| Organization Name
`Xeolas Pharmaceuticals Lid.
`i Mailing Address Information For Applicant:
`
`nnnnnnnnnnnnnnnnnnnnn
`Address 1
`DCU Campus
`
`Address 2
`
`f |
`
`Additional Applicant Data may be generated within this form by selecting the Add bution.
`
`
`Assignee Information including Non-Applicant Assignee Information:
`
`iProviding assignment information in this section do
`§ 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 2.2.13
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`

`

`PTOVAIAM 4 (02-18)
`Approved for use through 11/30/2020. 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 ———_____{+_____eee
`i Attomey Docket Number|4384.0010002/MSB/THN
`
`| Application Number
`
`| Title of Invention
`PEDIATRIC SUSPENSION FORMULATION
`
`
`
`If
`
`Assignee
`1
`iComplete ihis section if assignee information, incliding non-applicant assignee information, is desired to be included on the patent
`lapplication publication. An assignee-applicantidentified in the “Applicant Information” section will appear on the patent application
`ipubi ication aS an applicant. For an assignee-apolicant, complete this section only if identification as an assigneeis also desired on the
`ip ient application publication.
`
`Family Name
`innnnn
`
`
`
`r [
`
`
`Mailing Address information For Assignee including Non-Applicant Assignee:
`| Address 7
`
`| City
`
`| Countryi
`
`|
`
`Email Address
`
`State/Province
`
`Postal Code
`
`
`Additional Assignee or Non-Applicant Assignee Data may be generated within this form by
`| selecting the Add button.
`
`Signature:
`NOTE: This Application Data Sheet must be signed in accordance with 37 CFR 1.33(b). However,if this Application
`
`isubsection 2 of the “Authorization or Opt-Out of Authorization to Permit Access” section, then this form must
`iaiso 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). ifthe applicant is two or more joint inventors, this form must be signed by a
`ipatent practitioner, ail joint inventors who are the appiicant, or one or more joint inventor-applicants who have been given
`
`see 37 CFR 1.4(d) for ihe manner of making signatures and certifications.
`
` | Signature
`
`(/Matthew S. Bodenstein/
`
`Bate (YYY-MM-DD)|
`
`2020-03-07
`
`I
`
`| First Name|Matthew 8. Last Name j Bodenstein Registration Number | 58,885
`
`
`
`innannnnnnnnnnnnnanannanannnnnnnnnnnnn
`r
`
`Additional Signature may be generaied within this form by selecting the Add button.
`
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`

`PTOVAIAM 4 (02-18)
`Approved for use through 11/30/2020. 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.
`
`
`
`. Attorney Docket Number|4384.0010002/MSB/THN.
`
`
`| Application Data Sheet 37 CFR 1.76 -————renaen
`
`i
`| Application Number
`
`
`Title of Invention
`PEDIATRIC SUSPENSION FORMULATION
`
`
`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 io complete, including gathering, preparing, and submitiing ihe 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 io
`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. Depariment 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.
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`6. Arecordin this system of records may be disclosed, as a routine use, to another federal agencyfor purposes of National Security review (35 U.S.C. 181}
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