PTO/AIA/14 (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 contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1. 76
`Title of Invention I LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`Attorney Docket Number
`
`23278.2.US.8
`
`Application Number
`
`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
`D 37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`Inventor Information:
`Inventor
`1
`Legal Name
`
`-
`
`Family Name
`Prefix Given Name
`Calderari
`Giorgio
`Residence Information (Select One) 0 US Residency ® Non US Residency 0 Active US Military Service
`I country of Residence i
`City
`Rancate
`lcH
`
`Middle Name
`
`Mailing Address of Inventor:
`
`Address 1
`Address 2
`City
`I Rancate
`Postal Code
`
`2
`Inventor
`Legal Name
`
`Via Seer 35
`
`1 6862
`
`[ State/Province
`I CH
`I Countryi
`
`I TC
`
`-
`
`Family Name
`Prefix Given Name
`Daniele
`Bonadeo
`Residence Information (Select One) 0 US Residency ® Non US Residency 0 Active US Military Service
`I country of Residence i
`City
`Casalzuigno
`liT
`
`Middle Name
`
`Suffix
`
`Suffix
`
`Mailing Address of Inventor:
`
`Via Ronco Capo Caccia, 32-1
`
`1 21o3o
`
`[ State/Province
`[ Countryi
`[IT
`
`Address 1
`Address 2
`City
`I Casalzuigno
`Postal Code
`
`3
`Inventor
`Legal Name
`
`EFS Web 2.2.6
`
`I VA
`
`-
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1015
`
`Exh. 1015, Page 1 of 10
`
`

`
`PTO/AIA/14 (03-13)
`Approved for use through 01/31/2014. OMS 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 OMS control number.
`
`Application Data Sheet 37 CFR 1. 76
`
`Application Number
`Title of Invention I LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`Attorney Docket Number
`
`23278.2.US.8
`
`Family Name
`Prefix Given Name
`Cannella
`Roberta
`Residence Information (Select One) 0 US Residency ® Non US Residency 0 Active US Military Service
`City
`Varese
`!country of Residence i
`ItT
`
`Middle Name
`
`Suffix
`
`Mailing Address of Inventor:
`
`Address 1
`Address 2
`I Varese
`City
`Postal Code
`
`4
`Inventor
`Legal Name
`
`Via AI Colle 42
`
`21030
`
`I State/Province
`-~ Countryi
`TIT
`
`I VA
`
`I Remove .. I
`
`Family Name
`Prefix Given Name
`Macciocchi (Deceased)
`Alberto
`Residence Information (Select One) 0 US Residency ® Non US Residency 0 Active US Military Service
`City
`!country of Residence i
`Mel ide
`lcH
`
`Middle Name
`
`Suffix
`
`Mailing Address of Inventor:
`
`Address 1
`Address 2
`I Me !ide
`City
`Postal Code
`
`5
`Inventor
`Legal Name
`
`Via Alia Bola, 2
`
`6815
`
`I State/Province
`I Countryi 1 CH
`
`I TC
`
`I .• Remtiv~~;:j
`
`Family Name
`Prefix Given Name
`Miksztal
`Andrew
`0 Non US Residency 0 Active US Military Service
`Residence Information (Select One) (!) US Residency
`I State/Province I CA
`I Country of ResidencJ T US
`City
`Palo Alto
`
`Middle Name
`
`Suffix
`
`Mailing Address of Inventor:
`
`Address 1
`Address 2
`City
`I Palo Alto
`Postal Code
`
`7 43 Cereza Drive
`
`94306
`
`EFS Web 2.2.6
`
`I State/Province 1 CA
`1 us
`I Country i
`
`Exh. 1015, Page 2 of 10
`
`

`
`PTO/AIA/14 (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 contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1. 76
`
`Attorney Docket Number
`
`23278.2.US.8
`
`Application Number
`
`Title of Invention
`
`/ LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`6
`Inventor
`Legal Name
`
`I Renjove :<J
`
`Family Name
`Prefix Given Name
`Malefyt
`Thomas
`0 Non US Residency 0 Active US Military Service
`Residence Information (Select One) (!) US Residency
`I State/Province I CA
`I Country of Residencd
`1 us
`City
`Carmel Valley
`
`Middle Name
`
`Suffix
`
`Mailing Address of Inventor:
`
`Address 1
`Address 2
`I Carmel Valley
`City
`Postal Code
`
`7
`Inventor
`Legal Name
`
`20 Sleepy Hollow Drive
`
`93924
`
`I State/Province
`I Countryi
`1 us
`
`I CA
`
`~
`
`Prefix Given Name
`Family Name
`Middle Name
`Lee
`M
`Kathleen
`0 Non US Residency 0 Active US Military Service
`Residence Information (Select One) (!) US Residency
`I State/Province I CA
`I Country of Residencd I US
`City
`Palo Alto
`
`Suffix
`
`Mailing Address of Inventor:
`
`Address 1
`Address 2
`I Palo Alto
`City
`Postal Code
`
`Inventor
`8
`Legal Name
`
`4173 El Camino Real, Apt. 20
`
`94306
`
`I State/Province
`I Countryi
`1 us
`
`I CA
`
`I a.~.q~:~i
`
`Prefix Given Name
`Family Name
`Panuccio
`Carmine
`Residence Information (Select One) 0 US Residency ® Non US Residency 0 Active US Military Service
`City
`Casnate con Bernat
`!country of Residence i
`liT
`
`Middle Name
`
`Suffix
`
`Mailing Address of Inventor:
`
`Via XXV Aprile, No. 10
`
`Address 1
`Address 2
`I Casnate con Bernat
`City
`Postal Code
`1-22070
`
`EFS Web 2.2.6
`
`I State/Province
`I Countryi
`jiT
`
`1 co
`
`Exh. 1015, Page 3 of 10
`
`

`
`PTO/AIA/14 (03-13)
`Approved for use through 01/31/2014. OMB 0651-0032
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`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
`23278.2.US.8
`Application Number
`
`Application Data Sheet 37 CFR 1. 76
`
`Title of Invention
`
`LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`I. Add: cl
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`0 An Address is being provided for the correspondence Information of this application.
`53449
`Customer Number
`Email Address
`
`I IE~~~5ill1i!Bl
`
`~~~~~flfitill.l
`
`Application Information:
`LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`Title of the Invention
`I Small Entity Status Claimed 0
`Attorney Docket Number 23278.2.US.8
`Nonprovisional
`Application Type
`Utility
`Subject Matter
`Total Number of Drawing Sheets (if any)
`Publication Information:
`0 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
`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.
`
`I
`
`I Suggested Figure for Publication (if any) I
`
`0
`
`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
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`(!) Customer Number
`53449
`
`I 0 US Patent Practitioner lo 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, 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.
`I Re\"flove I
`Prior Application Status I Pending
`I
`
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`
`PTO/AIA/14 (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 Pape!Work 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
`
`23278.2.US.8
`
`Application Number
`
`Title of Invention
`
`LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`Continuation in part of
`
`13/087012
`
`Prior Application
`Number
`11/186311
`
`Filing Date
`(YYYY-MM-DD)
`2005-07-21
`
`Patent Number
`
`7947724
`
`2011-04-14
`I:Remavel
`Issue Date
`(YYYY-MM-DD)
`2011-05-24
`1~-~m99~\j
`Filing Date (YYYY -MM-D D)
`2004-01-30
`l~if!1i!h<,~
`Filing Date (YYYY-MM-DD)
`2003-01-30
`
`Prior Application Status Patented
`Application
`Number
`13/087012
`Prior Application Status Expired
`Application Number
`
`Continuity Type
`
`Continuation of
`
`11/186311
`Prior Application Status Expired
`Application Number
`
`Continuity Type
`Continuation of
`
`Prior Application Number
`PCT /EP2004/000888
`
`Continuity Type
`non provisional of
`PCT/EP2004/000888
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`Foreign Priority Information:
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`Prior Application Number
`60/444351
`
`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 1.5_5(d). When priority is claimed to a foreign application
`that is eligible for retrieval under the priority document exchange program (PDX)1 the information will be used by the Office to
`automatically attempt retrieval pursuant to 37 CFR 1.55(h)(1) and (2). Under the POX 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
`
`Countryi
`
`Filing Date (YYYY-MM-DD)
`
`J--~~eJri~!f:Jj
`Access Codei (if applicable)
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
`
`Statement under 37 CFR 1.55 or 1.78 for AlA (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
`JX] contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March
`16,2013.
`
`EFS Web 2.2.6
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`
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`
`PTO/AIA/14 (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 contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1. 76
`Title of Invention I LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`Attorney Docket Number
`
`23278.2.US.8
`
`Application Number
`
`Authorization to Permit Access:
`D Authorization to Permit Access to the Instant Application by the Participating Offices
`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 (WI PO),
`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, WI PO, 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.
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`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.
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`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 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.
`
`lo Legal Representative under 35 U.S.C. 117
`® Assignee
`lo
`0 Person to whom the inventor is obligated to assign.
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`Person who shows sufficient proprietary interest
`
`I Cl~ar · I
`lo Joint Inventor
`
`Name of the Deceased or Legally Incapacitated Inventor :I
`[g]
`
`If the Applicant is an Organization check here.
`I Helsinn Healthcare S.A.
`
`Organization Name
`
`I
`
`EFS Web 2.2.6
`
`Exh. 1015, Page 6 of 10
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`
`PTO/AIA/14 (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 contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1. 76
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`Application Number
`Title of Invention I LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`Attorney Docket Number
`
`23278.2.US.8
`
`Mailing Address Information For Applicant:
`Address 1
`P.O. Box 357, Pambio-Noranco
`Address 2
`City
`Count,.Y ) CH
`Phone Number
`
`+41 (0) 91 985.21.21
`
`Lugano
`
`State/Province
`Postal Code
`
`TC
`
`6915
`
`Fax Number
`
`+41 (0) 91993.21.22
`
`Email Address
`
`info-HHC@helsinn.com
`
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`Applicant 2
`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.
`ki~Di't:+?;l
`
`lo Legal Representative under 35 U.S.C. 117
`® Assignee
`lo
`0 Person to whom the inventor is obligated to assign.
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`lo Joint Inventor
`
`Person who shows sufficient proprietary interest
`
`Name of the Deceased or Legally Incapacitated Inventor:)
`[S]
`
`If the Applicant is an Organization check here.
`I Roche Palo Alto LLC
`Organization Name
`Mailing Address Information For Applicant:
`Address 1
`3431 Hillview Avenue
`Address 2
`City
`Country' / US
`Phone Number
`
`Palo Alto
`
`(650) 225-1000
`
`I
`
`I
`
`State/Province
`Postal Code
`
`CA
`
`94304
`
`Fax Number
`
`(650) 225-6000
`
`Email Address
`
`info@roche.com
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
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`
`PTO/AIA/14 (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 contains a valid OMB control number.
`Attorney Docket Number
`23278.2.US.8
`
`Application Data Sheet 37 CFR 1. 76
`Title of Invention I LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`
`Application Number
`
`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 1
`Complete this section only if non-applicant assignee information is desired to be included on the patent application publication in
`accordance with 37 CFR 1.215(b). Do not include in this section an applicant under 37 CFR 1.46 (assignee, person to whom the
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`
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`
`Prefix
`
`Given Name
`
`D
`Middle Name
`
`Family Name
`
`Suffix
`
`Mailing Address Information For Non-Applicant Assignee:
`
`Address 1
`Address 2
`City
`Countryi
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`I
`Phone Number
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`Email Address
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`I
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`Fax Number
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`Signature:
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4 for signature requirements and
`certifications.
`
`~~ .A .A
`I Last Name I Sullivan
`Additional Signature may be generated within this form by selecting the Add button.
`
`,.....
`
`Date (YYYY-MM-DD) 2013-05-23
`
`Registration Number
`
`36942
`
`Signature
`
`First Name
`
`Clark G.
`
`.~
`
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`
`PTO/AIA/14 (03-13)
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`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.
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
`
`23278.2.US.8
`
`Application Number
`
`Title of Invention
`
`LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
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`
`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 197 4, 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 Co o p eration 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 pursuan
`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 2.2.6
`
`Exh. 1015, Page 10 of 10